Date/Time of Define-XML document generation: 2022-09-25T09:41:40

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard: SDTM-IG 3.4
Study Name: oGvHD-2-SC
Study Description: A PHASE II/III TRIAL OF SAFETY AND EFFICACY OF PRO-OCULAR™ 1% IN DAILY SCLERAL LENS WEARING PATIENTS WITH OCULAR GRAFT-VERSUS-HOST DISEASE
Protocol Name: oGvHD-2-SC
Metadata Name: oGvHD-2-SC, SDTM Data Definitions
Metadata Description: oGvHD-2-SC, SDTM Data Definitions

Datasets

Datasets
Dataset	Description	Class	Structure	Purpose	Keys	Location
AE	Adverse Events	Events	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, AEDECOD, AESTDTC	ae.xpt
CM	Concomitant Medications	Interventions	One record per recorded intervention occurrence or constant- dosing interval per subject	Tabulation	STUDYID, USUBJID, CMTRT, CMSTDTC	cm.xpt
DA	Product Acountability	Findings	One record per product accountability finding per subject	Tabulation	STUDYID, USUBJID, DADTC	da.xpt
DM	Demographics	Special Purpose	One record per subject	Tabulation	STUDYID, USUBJID	dm.xpt
DS	Disposition	Events	One record per disposition status or protocol milestone per subject	Tabulation	STUDYID, USUBJID, DSDECOD, DSSTDTC	ds.xpt
DV	Protocol Deviations	Events	One record per protocol deviation per subject	Tabulation	STUDYID, USUBJID, DVSTDTC	dv.xpt
EX	Exposure	Interventions	One record per protocol-specified study treatment, constant-dosing interval, per subject	Tabulation	STUDYID, USUBJID, EXTRT, EXSTDTC	ex.xpt
IE	Inclusion/Exclusion Exceptions	Findings	One record per inclusion/exclusion criterion not met per subject	Tabulation	STUDYID, USUBJID, IETESTCD	ie.xpt
LB	Laboratory Tests	Findings	One record per lab test per time point per visit per subject	Tabulation	STUDYID, USUBJID, LBTESTCD, LBSPEC, VISITNUM, LBTPTREF, LBTPTNUM	lb.xpt
MH	Medical History	Events	One record per medical history event per subject	Tabulation	STUDYID, USUBJID, MHDECOD	mh.xpt
OE	Opthalmic Examinations	Findings	One record per ophthalmic finding per method per location, per time point per visit per subject	Tabulation	STUDYID, USUBJID, OETESTCD, OELOC, OELAT, VISITNUM, OEDTC	oe.xpt
QS	Questionnaires	Findings	One record per questionnaire per question per time point per visit per subject	Tabulation	STUDYID, USUBJID, QSCAT, QSSCAT, VISITNUM, QSTESTCD	qs.xpt
SC	Subject Characteristics	Findings	One record per characteristic per visit per subject	Tabulation	STUDYID, USUBJID, SCTESTCD	sc.xpt
SE	Subject Elements	Special Purpose	One record per actual Element per subject	Tabulation	STUDYID, USUBJID, ETCD, SESTDTC	se.xpt
SUPPAE	Supplemental Qualifiers for Adverse Events	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppae.xpt
SUPPCM	Supplemental Qualifiers for Concomitant Medications	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppcm.xpt
SUPPDM	Supplemental Qualifiers for Demographics	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppdm.xpt
SUPPIE	Supplemental Qualifiers for Inclusion/Exclusion Exceptions	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppie.xpt
SUPPMH	Supplemental Qualifiers for Medical History	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppmh.xpt
SUPPOE	Supplemental Qualifiers for Opthalmic Examinations	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppmh.xpt
SUPPQS	Supplemental Qualifiers for Questionnaires	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppmh.xpt
SUPPSV	Supplemental Qualifiers for Subject Visits	Relationship	One record per supplemental qualifier per related parent domain record(s)	Tabulation	STUDYID, USUBJID, IDVAR	suppsv.xpt
SV	Subject Visits	Special Purpose	One record per actual or planned visit per subject	Tabulation	STUDYID, USUBJID, VISITNUM	sv.xpt
TA	Trial Arms	Trial Design	One record per planned Element per Arm	Tabulation	STUDYID, ARMCD, TAETORD	ta.xpt
TE	Trial Elements	Trial Design	One record per planned Element	Tabulation	STUDYID, ETCD	te.xpt
TI	Trial Inclusion/ Exclusion Criteria	Trial Design	One record per I/E criterion	Tabulation	STUDYID, IETESTCD	tt.xpt
TS	Trial Summary	Trial Design	One record per trial summary parameter value	Tabulation	STUDYID, TSPARMCD, TSSEQ	ts.xpt
TV	Trial Visits	Trial Design	One record per planned Visit per Arm	Tabulation	STUDYID, ARM, VISIT	tv.xpt

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Adverse Events (AE)

AE (Adverse Events) - Events Location: ae.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPAE (Supplemental Qualifiers for Adverse Events)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
AESEQ	Sequence Number	integer	Identifier	$1.		Derived Unique sequence based on sort order of STUDYID USUBJID AEDECOD AESTDTC AEENDTC: ae <-ae %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., STUDYID, USUBJID, AESTDTC) %>% ## COMPUTATION - DERIVATION: AESEQ dplyr::mutate(.,AESEQ = 1:length(USUBJID))
AETERM	Reported Term for the Adverse Event	text	Topic	$72.		CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [137 ] CRF Annotated Case Report Form [157 ]
AELLT	Lowest Level Term	text	VariableQualifier	$32.	[unresolved: CL.AELLT]	Assigned
AELLTCD	Lowest Level Term Code	text	VariableQualifier	$8.	[unresolved: CL.AELLTCD]	Assigned
AEDECOD	Dictionary-Derived Term	text	SynonymQualifier	$8.	AEDECOD MedDRA 18.0	Assigned
AEPTCD	Preferred Term Code	text	VariableQualifier	$8.	[unresolved: CL.AEPTCD]	Assigned
AEHLT	High Level Term	text	VariableQualifier	$64.	[unresolved: CL.AEHLT]	Assigned
AEHLTCD	High Level Term Code	text	VariableQualifier	$8.	[unresolved: CL.AEHLTCD]	Assigned
AEHLGT	High Level Group Term	text	VariableQualifier	$55.	[unresolved: CL.AEHLGT]	Assigned
AEHLGTCD	High Level Group Term Code	text	VariableQualifier	$8.	[unresolved: CL.AEHLGTCD]	Assigned
AEBODSYS	Body System or Organ Class	text	RecordQualifier	$8.	AEBODSYS MedDRA 18.0	Assigned
AEBDSYCD	Body System or Organ Class Code	text	VariableQualifier	$8.	[unresolved: CL.AEBDSYCD]	Assigned
AESOC	Primary System Organ Class	text	VariableQualifier	$67.	[unresolved: CL.AESOC]	Assigned
AESOCCD	Primary System Organ Class Code	text	VariableQualifier	$8.	[unresolved: CL.AESOCCD]	Assigned
AESEV	Severity/Intensity	text	RecordQualifier	$8.	AESEV SDTM Terminology NA	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
AESER	Serious Event	text	RecordQualifier	$38.	YN • "No" = "No" • "Yes" = "Yes"	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
AEACN	Action Taken with Study Treatment	text	RecordQualifier	$24.	AEACN SDTM Terminology NA	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
AEACNOTH	Other Action Taken	text	RecordQualifier	$8.		CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
AEEXP	Expected/Unexpected	text	RecordQualifier	$10.	[unresolved: CL.AEEXP]	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
AEREL	Causality	text	RecordQualifier	$16.	AEREL • "Not Related" = "Not Related" • "Unlikely Related" = "Unlikely Related" • "Likely Related" = "Likely Related" • "Definitely Related" = "Definitely Related"	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
AEOUT	Outcome of Adverse Event	text	RecordQualifier	$28.	AEOUT [6 Terms]	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
EPOCH	Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived ## COMPUTATION - DERIVATION: AE.EPOCH epoch <- c() for (i in 1:length(ae$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = ae$USUBJID[i], dtc = ae$AESTDTC[i]) print(i) }
AEDTC	Date/Time of Collection	date	Timing	YYMMDD10.	ISO 8601	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ] Notes: The function di_map_options() maps variables to their options. This results in the mapping of month, day, and timing entries per the logical statments below: IF AEDTC_DD == 'UN' THEN AEDTC_DD == "01" IF AEDTC_MM == 'UNK' THEN AEDTC_MM == "01" ## Derive DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD variables ## The unite function is used to combine YEAR-MM-DD to derive --DTC variables ## The function lubridate:ymd(x) ensures the format is ISO8601 ## COMPUTATION - DERIVATION: AEDTC tidyr::unite(., col = 'AEDTC', 'AEDTC_YY', 'AEDTC_MM', 'AEDTC_DD', sep = '-', remove = TRUE) %>% dplyr::mutate(., AEDTC = lubridate::ymd(AEDTC)) %>%
AESTDTC	Start Date/Time of Adverse Event	date	Timing	YYMMDD10.	ISO 8601	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [137 ] CRF Annotated Case Report Form [157 ] Notes: The function di_map_options() maps variables to their options. This results in the mapping of month, day, and timing entries per the logical statments below: IF AESTDTC_DD == 'UN' THEN AESTDTC_DD == "01" IF AESTDTC_MM == 'UNK' THEN AESTDTC_MM == "01" CODE: ae <- ae %<% di_map_options(ae) ae %<% ##maps options tidyr::unite(., col = 'AESTDCT', 'AESTDCT_YY', 'AESTDCT_MM', 'AESTDCT_DD', sep = '-', remove = TRUE) %>% ##derives DTC variable lubridate::ymd(AESTDTC) ##ensures format of DTC variable is ISO8601
AEENDTC	End Date/Time of Adverse Event	date	Timing	YYMMDD10.	ISO 8601	CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ] Notes: The function di_map_options() maps variables to their options. This results in the mapping of month, day, and timing entries per the logical statments below: IF AEENDTC_DD == 'UN' THEN AEENDTC_DD == "01" IF AEENDTC_MM == 'UNK' THEN AEENDTC_MM == "01" CODE: ae <- ae %<% di_map_options(ae) ae %<% ##maps options tidyr::unite(., col = 'AEENDCT', 'AEDCT_YY', 'AEENDCT_MM', 'AEENDCT_DD', sep = '-', remove = TRUE) %>% ##derives DTC variable lubridate::ymd(AEENDTC) ##ensures format of DTC variable is ISO8601
AESTDY	Study Day of Start of Adverse Event	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
AEENDY	Study Day of End of Adverse Event	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
AEDUR	Duration of Adverse Event	integer	Timing	$2.		Derived All duration calculations are calculated as: duration = ymd(enddate) - ymd(startdate)

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Concomitant Medications (CM)

CM (Concomitant Medications) - Interventions Location: cm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPCM (Supplemental Qualifiers for Concomitant Medications)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
CMSEQ	Sequence Number	integer	Identifier	$2.		Derived ## COMPUTATION - DERIVATION: CMSEQ dplyr::mutate(.,CMSEQ = 1:length(USUBJID))
CMGRPID	Group ID	text	Identifier	$29.		Derived ## COMPUTATION - DERIVATION: CMGRPID epoch <- c() for (i in 1:length(cm$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = cm$USUBJID[i], dtc = cm$CMSTDTC[i]) print(i) } cm$EPOCH <- epoch
CMTRT	Reported Name of Drug, Med, or Therapy	text	Topic	$29.		CRF Annotated Case Report Form [4 ] CRF Annotated Case Report Form [10 ] CRF Annotated Case Report Form [11 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [140 ]
CMMODIFY	Modified Reported Name	text	SynonymQualifier	$8.		Assigned TBD
CMDECOD	Standardized Medication Name	text	SynonymQualifier	$8.		Assigned TBD
CMCAT	Category for Medication	text	GroupingQualifier	$36.		Assigned Each CM dataset is assigned a CAT (Ocular, Non-Ocular, Treatment Device, as example): logr::put("## READ TREATMENT DEVICES AND MAP TO VARIABLE COLNAMES AND OPTIONS") dbt_tdcm <- read_excel(paste0(.sys, .proj, .dmp, .db), sheet = "Concomitant_O...t_Device_(TD)") %>% dplyr::mutate(., CMCAT = "Occular Concomitant Treatment Device") %>% logr::put()
CMSCAT	Subcategory for Medication	text	GroupingQualifier	$17.		Assigned TBD
CMINDC	Indication	text	RecordQualifier	$28.	[unresolved: CL.CMCLASS]	Assigned
CMCLAS	Medication Class	text	VariableQualifier	$8.	[unresolved: CL.CMCLASCD]	Assigned
CMCLASCD	Medication Class Code	text	VariableQualifier	$8.		Assigned
CMDOSE	Dose per Administration	float	RecordQualifier	$28.	[unresolved: CL.CMDOSE]	eDT
CMDOSU	Dose Units	text	VariableQualifier	$23.	CMUNIT [8 Terms]	eDT
CMDOSFRM	Dose Form	text	VariableQualifier	$8.		eDT
CMDOSFRQ	Dosing Frequency per Interval	text	RecordQualifier	$23.	CMFREQ [17 Terms]	eDT
CMROUTE	Route of Administration	text	VariableQualifier	$13.	CMROUTE [14 Terms]	eDT
EPOCH	Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived ## COMPUTATION - DERIVATION: EPOCH epoch <- c() for (i in 1:length(cm$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = cm$USUBJID[i], dtc = cm$CMSTDTC[i]) print(i) } cm$EPOCH <- epoch
CMSTDTC	Start Date/Time of Medication	date	Timing	YYMMDD10.	ISO 8601	CRF Annotated Case Report Form [4 ] CRF Annotated Case Report Form [10 ] CRF Annotated Case Report Form [11 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [140 ] [unresolved: MT.CM.CMSTDTC]
CMENDTC	End Date/Time of Medication	date	Timing	YYMMDD10.	ISO 8601	CRF Annotated Case Report Form [4 ] CRF Annotated Case Report Form [10 ] CRF Annotated Case Report Form [11 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [140 ] [unresolved: MT.CM.CMENDTC]
CMSTDY	Study Day of Start of Medication	integer	Timing	$5.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
CMENDY	Study Day of End of Medication	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
CMDUR	Duration	integer	Timing	$2.		Derived All duration calculations are calculated as: duration = ymd(enddate) - ymd(startdate)

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Product Acountability (DA)

DA (Product Acountability) - Findings Location: da.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		eDT Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
DASEQ	Sequence Number	integer	Identifier	$1.		Derived ## COMPUTATION - DERIVATION: DASEQ dplyr::mutate(., DASEQ = 1:length(USUBJID)) %>%
DASPID	Sponsor-Defined Identifier	text	Identifier	$15.		CRF Annotated Case Report Form [32 ] CRF Annotated Case Report Form [68 ] CRF Annotated Case Report Form [103 ] CRF Annotated Case Report Form [131 ] CRF Annotated Case Report Form [158 ]
DAORRES	Result or Finding in Original Units	float	ResultQualifier	$2.		CRF Annotated Case Report Form [32 ] CRF Annotated Case Report Form [68 ] CRF Annotated Case Report Form [103 ] CRF Annotated Case Report Form [131 ] CRF Annotated Case Report Form [158 ]
DAORRESU	Original Units	text	VariableQualifier	$9.	UNIT • "%" = "Percentage" • "g/dL" = "Gram per Deciliter" • "IU/L" = "International Unit per Liter" • "mg/dL" = "Milligram per Deciliter" • "mg" = "Milligram"	CRF Annotated Case Report Form [32 ] CRF Annotated Case Report Form [68 ] CRF Annotated Case Report Form [103 ] CRF Annotated Case Report Form [131 ] CRF Annotated Case Report Form [158 ]
DASTRESC	Result or Finding in Standard Format	text	ResultQualifier	$9.		CRF Annotated Case Report Form [32 ] CRF Annotated Case Report Form [68 ] CRF Annotated Case Report Form [103 ] CRF Annotated Case Report Form [131 ] CRF Annotated Case Report Form [158 ]
DAREASND	Reason Not Done	text	RecordQualifier	$131.		CRF Annotated Case Report Form [32 ] CRF Annotated Case Report Form [68 ] CRF Annotated Case Report Form [103 ] CRF Annotated Case Report Form [131 ] CRF Annotated Case Report Form [158 ]
VISITNUM	Visit Number	integer	Timing	$1.		Derived ## COMPUTATION - DERIVATION: VISITNUM VISITNUM = str_extract(`Report Parent`, "[0-9]"))
VISIT	Visit Name	text	Timing	$37.		Derived ## COMPUTATION - HARDCODE: VISITNUM VISIT = `Report Parent`
VISITDY	Planned Study Day of Visit	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
TAETORD	Planned Order of Element within Arm	integer	Timing	$1.		Derived taeord = ifelse(is.na(dbt_da$VISITNUM) \| is.na(dbt_da$DASTRESC), NA, ifelse(dbt_da$VISITNUM == "1" & dbt_da$DASTRESC == "Dispensed", 1, ifelse(dbt_da$VISITNUM == "3" & dbt_da$DASTRESC == "Returned", 2, ifelse(dbt_da$VISITNUM == "3" & dbt_da$DASTRESC == "Dispensed", 3, ifelse(dbt_da$VISITNUM == "5" & dbt_da$DASTRESC == "Returned", 4, ifelse(dbt_da$VISITNUM == "5" & dbt_da$DASTRESC == "Dispensed", 5, ifelse(dbt_da$VISITNUM == "6" & dbt_da$DASTRESC == "Returned", 6, ifelse(dbt_da$VISITNUM == "6" & dbt_da$DASTRESC == "Dispensed", 7, ifelse(dbt_da$VISITNUM == "7" & dbt_da$DASTRESC == "Returned", 8, ""))))))))) ## COMPUTATION - HARDCODE: TAETORD TAETORD = taeord)
EPOCH	Epoch	text	Timing	$26.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived ## COMPUTATION - HARDCODE: EPOCH epoch = ifelse(is.na(dbt_da$VISITNUM), NA, ifelse(dbt_da$VISITNUM == "1", "Screening & Baseline", ifelse(dbt_da$VISITNUM == "3", "Masked Phase", ifelse(dbt_da$VISITNUM == "5", "Open-label Phase", ifelse(dbt_da$VISITNUM == "6", "Open-label Phase", ifelse(dbt_da$VISITNUM == "7", "Open-label Extension Phase", "")))))) ## COMPUTATION - HARDCODE: EPOCH EPOCH = epoch
DADTC	Date/Time of Collection	date	Timing	YYMMDD10.	ISO 8601	Derived ## COMPUTATION - DERIVATION: DADTC dbt_da <- dbt_da %>% tidyr::unite(., col = 'DADTC', 'DADTC_YY', 'DADTC_MM', 'DADTC_DD', sep = '-', remove = TRUE)
DADY	Study Day of Visit/Collection/Exam	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Demographics (DM)

DM (Demographics) - Special Purpose Location: dm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDM (Supplemental Qualifiers for Demographics)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
SUBJID	Subject Identifier for the Study	text	Topic	$6.		CRF Annotated Case Report Form [3 ]
RFSTDTC	Subject Reference Start Date/Time	text	RecordQualifier	YYMMDD10.		Derived Since subjects are consented and start study on the same visit, RFSTDTC is derived from RFICDTC: ## COMPUTATION - DERIVATION: RFSTDTC dplyr::mutate(RFSTDTC = lubridate::dmy(ICFDTC))
RFENDTC	Subject Reference End Date/Time	text	RecordQualifier	$10.		Derived logr::put("## CALCULATE ENDTC DATES") ## COMPUTATION - DERIVATION: RFENDTC rfendtc <- c() for (i in 1:length(dm$USUBJID)) { rfendtc[i] <- di_endtc_trial(usubjid = dm$USUBJID[i]) print(i) } dm$RFENDTC <- rfendtc
RFXSTDTC	Date/Time of First Study Treatment	date	Timing	YYMMDD10.	ISO 8601	Derived Since subjects are consented and start study on the same visit, RFXSTDTC is derived from RFICDTC + 1: ## COMPUTATION - DERIVATION: RFXSTDTC rfxstdtc <- as.Date(dm$RFSTDTC) + 1 dm$RFXSTDTC <- rfxstdtc
RFXENDTC	Date/Time of Last Study Treatment	date	Timing	YYMMDD10.	ISO 8601	Derived ## COMPUTATION - DERIVATION: RFENDTC rfxendtc <- as.Date(rfendtc) - 1 dm$RFXENDTC <- rfxendtc
RFICDTC	Date/Time of Informed Consent	date	Timing	YYMMDD10.	ISO 8601	CRF Annotated Case Report Form [2 ] ## COMPUTATION - DERIVATION: RFUCDTC dplyr::mutate(RFICDTC = lubridate::dmy(ICFDTC))
RFPENDTC	Date/Time of End of Participation	date	Timing	YYMMDD10.	ISO 8601	Derived RFPENDTC is the end of particpation dat from derived DSDTC variable
DTHDTC	Date/Time of Death	date	Timing	YYMMDD10.	ISO 8601	Derived logr::put("## DETERMINE DEATH DATES AND DEATH FLAGS") dthdtc <- c() for (i in 1:length(dm$USUBJID)) { dthdtc[i] <- di_dthdtc_trial(usubjid = dm$USUBJID[i]) print(i) } dm$DTHDTC <- dthdtc
DTHFL	Subject Death Flag	text	RecordQualifier	$1.	YN • "No" = "No" • "Yes" = "Yes"	Derived ## COMPUTATION - DERIVATION: DTHFL dthfl <- sapply(dthdtc, function(x) unlist(ifelse(str_detect( x,"[0-9]{4}-[0-9]{2}-[0-9]{2}"), "Y", "N"))) dm$DTHFL <- dthfl
SITEID	Study Site Identifier	text	RecordQualifier	$2.		Assigned
INVID	Investigator Identifier	text	RecordQualifier	$3.		Derived ## COMPUTATION - HARDCODE: INVID dplyr::mutate(INVID = "DCB")
INVNAM	Investigator Name	text	SynonymQualifier	$20.		CRF Annotated Case Report Form [3 ]
BRTHDTC	Date/Time of Birth	date	Timing	YYMMDD10.	ISO 8601	CRF Annotated Case Report Form [3 ] ## COMPUTATION - DERIVATION: BRTHDTC dplyr::mutate(BRTHDTC = lubridate::dmy(BRTHDT))
AGE	Age	integer	RecordQualifier	$2.		CRF Annotated Case Report Form [3 ]
AGEU	Age Units	text	VariableQualifier	$4.	AGEU • "YEARS" = "YEARS"	CRF Annotated Case Report Form [3 ] ## COMPUTATION - HARDCODE: AGEU dplyr::mutate(AGEU = "YEAR")
SEX	Sex	text	RecordQualifier	$6.	SEX • "Male" = "Male" • "Female" = "Female"	CRF Annotated Case Report Form [3 ]
RACE	Race	text	RecordQualifier	$5.	[unresolved: CL.RACE]	CRF Annotated Case Report Form [3 ] dm$RACE.American_Indian_or_Alaska_Native <- ifelse(dm$RACE.American_Indian_or_Alaska_Native == "1", "American Indian or Alaska Native", "") dm$DM.RACE.Asian <- ifelse(dm$RACE.Asian == "1", "Asian", "") dm$RACE.Black_or_African_American <- ifelse(dm$RACE.Black_or_African_American == "1", "Black or African American", "") dm$RACE.Native_Hawaiian_or_Other_Pacific_Islander <- ifelse(dm$DM.RACE.Native_Hawaiian_or_Other_Pacific_Islander == "1", "Native Hawaiian or Other Pacific Islander", "") dm$RACE.White <- ifelse(db$DM.RACE.White == "1", "White", "") dm <- dm %>% tidyr::unite(., col = 'RACE', 'RACE.American_Indian_or_Alaska_Native', 'RACE.Asian', 'RACE.Black_or_African_American', 'RACE.Native_Hawaiian_or_Other_Pacific_Islander', 'RACE.White', sep = ' ', remove = TRUE) dm$RACE <- str_trim(dm$RACE, "both") dm$RACE <- ifelse(dm$RACE.Other == 1, dm$RACEOTH, dm$RACE)
ETHNIC	Ethnicity	text	RecordQualifier	$22.	[unresolved: CL.ETHNIC]	CRF Annotated Case Report Form [3 ]
ARMCD	Planned Arm Code	text	RecordQualifier	$2.	ARMCD • "ACTIVE" = "Pro-ocular" • "PLACEBO" = "Placebo" • "AA" = "Active" • "BA" = "Placebo"	Assigned ## COMPUTATION - DERIVATION: AARMCD dplyr::mutate(ARMCD = ifelse(ARM == "Active", "AA", "BA"))
ARM	Description of Planned Arm	text	SynonymQualifier	$7.	ARM • "Active" = "Active" • "Placebo" = "Placebo"	Derived ## COMPUTATION - DERIVATION: ARM dplyr::mutate(ARM = randomization_scheme$Treatment.Arm[1:length(USUBJID)])
ACTARMCD	Actual Arm Code	text	RecordQualifier	$7.	[unresolved: CL.ACTARMCD]	Assigned
ACTARM	Description of Actual Arm	text	SynonymQualifier	$2.		Assigned Set to ARM == ACTARM because no unplanned arm occurred: ## COMPUTATION - HARDCODE: ACTARM dplyr::mutate(ACTARM = ARMCD)
ARMNRS	Reason Arm and/or Actual Arm is Null	text	RecordQualifier	$8.	[unresolved: CL.ARMNULRS]	Assigned Set to null because no subject was randomized to an unplanned arm and no reason needed
ACTARMUD	Description of Unplanned Actual Arm	text	RecordQualifier	$8.		Assigned Set is.null(ACTARMUD) because no unplanned arm occurred
COUNTRY	Country	text	RecordQualifier	$3.		Assigned ## COMPUTATION - HARDCODE: COUNTRY dplyr::mutate(COUNTRY = "USA")
DMDTC	Date/Time of Collection	date	Timing	YYMMDD10.	ISO 8601	Derived Since subjects are consented and start study on the same visit, DMDTC is derived from RFICDTC: ## COMPUTATION - DERIVATION: DMDTC dplyr::mutate(DMDTC = RFSTDTC)
DMDY	Study Day of Collection	integer	Timing	$1.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Disposition (DS)

DS (Disposition) - Events Location: ds.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
DSSEQ	Sequence Number	integer	Identifier	$2.		Derived logr::put("## ADD DSSEQ TO DS DATASET") ds <- ds %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., USUBJID, match(DSTERM, dsord)) %>% ## COMPUTATION - DERIVATION: DSSEQ dplyr::mutate(.,DSSEQ = 1:length(USUBJID))
DSTERM	Reported Term for the Disposition Event	text	Topic	$41.	DSTERM [15 Terms]	CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ] End of Particpation is from DSTERM in codelist; all others are hardcode to terms (for example): ds_v3mc <- ds %>% dplyr::select_at(., .vars = ds_cols_v3mc) %>% tidyr::pivot_longer(cols = "V3INVDTC", values_to = "DSSTDTC", names_to = "DSTERM") %>% dplyr::mutate(., DSTERM = ifelse(is.na(V3INV), "Double-masked Phase Not Completed", "Double-masked Phase Completed"))
DSDECOD	Standardized Disposition Term	text	SynonymQualifier	$7.		Derived All hardcode (for example): dplyr::mutate(., DSDECOD = "ENDMASKED")
DSCAT	Category for Disposition Event	text	GroupingQualifier	$20.	DSCAT • "Protocol Milestone" = "Protocol Milestone" • "Safety Event" = "Safety Event" • "Compliance Event" = "Compliance Event" • "Other Event" = "Other Event"	Derived All hardcode (for example): dplyr::mutate(., DSCAT = "Protocol Milestone")
EPOCH	Epoch	text	Timing	$26.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived All hardcode (for example): dplyr::mutate(., EPOCH = "Masked Phase") Alternatively, EOP is coded the following: logr::put("## SEARCH FOR EPOCH BASED ON DATES WITH di_epoch_trial FUNCTION") ## COMPUTATION - DERIVATION: EPOCH epoch <- c() for (i in 1:length(ds_eos$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = ds_eos$USUBJID[i], dtc = ds_eos$DSSTDTC[i]) print(i) } ds_eos$EPOCH <- epoch
DSSTDTC	Start Date/Time of Disposition Event	date	Timing	YYMMDDHHMM16.	ISO 8601	Derived logr::put("ADD ASSIGNED/HARDCODED VARIABLES AS REQUIRED") ds <- data.frame(ds) %>% dplyr::mutate_all(., as.character) %>% ## Derive DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD variables ## The unite function is used to combine YEAR-MM-DD to derive --DTC variables ## The function lubridate:ymd(x) ensures the format is ISO8601 ## COMPUTATION - DERIVATION: DSSTDTC dplyr::mutate(., ICFDTC = dmy(ICFDTC)) %>% # Disposition Event Date tidyr::unite(., col = 'DSDTC', 'DS_YY', 'DS_MM', 'DS_DD', sep = '-', remove = TRUE) %>% # Notification of Oncologist tidyr::unite(., col = 'ONNOTDTC', 'ONNOT_YY', 'ONNOT_MM', 'ONNOT_DD', sep = '-', remove = TRUE) %>% # Notification of Ophthalmologist tidyr::unite(., col = 'OPNOTDTC', 'OPNOT_YY', 'OPNOT_MM', 'OPNOT_DD', sep = '-', remove = TRUE) %>% # Visit 1 Completed tidyr::unite(., col = 'V1DTC', 'V1_YY', 'V1_MM', 'V1_DD', sep = '-', remove = TRUE) %>% # Visit 2 Completed tidyr::unite(., col = 'V2DTC', 'V2_YY', 'V2_MM', 'V2_DD', sep = '-', remove = FALSE) %>% # Visit 3 Scleral Lens Removed tidyr::unite(., col = 'OPNOTSCDTC', 'OPNOTDTC', 'V3SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 3 Assessments Begin tidyr::unite(., col = 'OPNOTASDTC', 'OPNOTDTC', 'V3SCRTM2', sep = ' ', remove = FALSE) %>% # Visit 3 Completed tidyr::unite(., col = 'V3DTC', 'V3_YY', 'V3_MM', 'V3_DD', sep = '-', remove = FALSE) %>% # End of Double-masked Phase tidyr::unite(., col = 'V3INVDTC', 'V3INV_Y', 'V3INV_M', 'V3INV_D', sep = '-', remove = TRUE) %>% # Informed of Open-Label dplyr::mutate(., V3INV2DTC = V3INVDTC) %>% # Visit 3 Scleral Lens Removed tidyr::unite(., col = 'V3INVSCDTC', 'V3INVDTC', 'V3SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 3 Assessments Begin tidyr::unite(., col = 'V3INVASDTC', 'V3INVDTC', 'V3SCRTM2', sep = ' ', remove = FALSE) %>% # Visit 4 Completed tidyr::unite(., col = 'V4DTC', 'V4_YY', 'V4_MM', 'V4_DD', sep = '-', remove = TRUE) %>% # Opt-in to Long Term Open Label Phase tidyr::unite(., col = 'V5OL3DTC', 'V5OL_Y', 'V5OL_M', 'V5OL_D', sep = '-', remove = TRUE) %>% # Visit 5 Completed dplyr::mutate(., 'V5DTC' = V5OL3DTC) %>% # Visit 5 Scleral Lens Removed tidyr::unite(., col = 'V5INVSCDTC', 'V5OL3DTC', 'V5SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 5 Assessments Begin tidyr::unite(., col = 'V5INVASDTC', 'V5OL3DTC', 'V5SCRTM2', sep = ' ', remove = FALSE) %>% # Opt-in to Long Term Open Label Phase Continuation tidyr::unite(., col = 'V6OL3DTC', 'V6OL_Y', 'V6OL_M', 'V6OL_D', sep = '-', remove = TRUE) %>% # Visit 6 Completed dplyr::mutate(., 'V6DTC' = V6OL3DTC) %>% # Visit 6 Scleral Lens Removed tidyr::unite(., col = 'V6INVSCDTC', 'V6OL3DTC', 'V6SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 6 Assessments Begin tidyr::unite(., col = 'V6INVASDTC', 'V6OL3DTC', 'V6SCRTM2', sep = ' ', remove = FALSE) %>% # Opt-in to Long Term Open Label Phase Continuation tidyr::unite(., col = 'V7OL3DTC', 'V7_YY', 'V7_MM', 'V7_DD', sep = '-', remove = TRUE) %>% # Visit 7 Completed dplyr::mutate(., 'V7DTC' = V7OL3DTC) %>% # Visit 7 Scleral Lens Removed tidyr::unite(., col = 'V7INVSCDTC', 'V7OL3DTC', 'V7SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 7 Assessments Begin tidyr::unite(., col = 'V7INVASDTC', 'V7OL3DTC', 'V7SCRTM2', sep = ' ', remove = FALSE) ds[apply(ds, 2, str_detect, "9999")] <- NA
DSSTDY	Study Day of Start of Disposition Event	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Protocol Deviations (DV)

DV (Protocol Deviations) - Events Location: dv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
DVSEQ	Sequence Number	integer	Identifier	$1.		Derived logr::put("DERIVE --SEQ WITH DEFINED SDTM_METADATA$TOC_METADATA$DOMAINKEYS") dv <-dv %>% dplyr::group_by(., STUDYID, USUBJID, DVTERM, DVSTDTC) %>% ## COMPUTATION - DERIVATION: DVSEQ dplyr::mutate(.,DVSEQ = 1:length(USUBJID))
DVTERM	Protocol Deviation Term	text	Topic	$87.		eDT
DVCAT	Category for Protocol Deviation	text	GroupingQualifier	$46.	DVCAT [8 Terms]	eDT
DVIMPACT	Impact of Protocol Deviation on Study	text	RecordQualifier	$46.	DVIMPACT • "No impact on data quality or subject safety" = "No impact on data quality or subject safety" • "Minor impact on data quality" = "Minor impact on data quality" • "Minor impact on subject safety" = "Minor impact on subject safety" • "Major impact on data quality or subject safety" = "Major impact on data quality or subject safety" • "Leading to subject(s) death" = "Leading to subject(s) death"	eDT
DVACN	Action Taken with Protocol Deviation	text	RecordQualifier	$27.	DVACN [7 Terms]	eDT
EPOCH	Epoch	text	Timing	$26.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived dv <- dv %>% # EPOCH is derived using the EPOCH function: di_epoch_trial() dplyr::mutate(EPOCH = unlist(sapply(1:length(USUBJID), function(x) di_epoch_trial(usubjid = USUBJID[x], dtc = DVENDTC[x]))))
DVSTDTC	Start Date/Time of Deviation	date	Timing	YYMMDD10.	ISO 8601	Derived logr::put("ADD ASSIGNED/HARDCODED VARIABLES AS REQUIRED") dv <- data.frame(dv) %>% tidyr::unite(., col = 'DVSTDTC', 'DVST_YY', 'DVST_MM', 'DVST_DD', sep = '-', remove = TRUE) %>% dplyr::mutate(., DVSTDTC = lubridate::ymd(DVSTDTC))
DVENDTC	End Date/Time of Deviation	date	Timing	YYMMDD10.	ISO 8601	Derived logr::put(""ADD ASSIGNED/HARDCODED VARIABLES AS REQUIRED"") ## COMPUTATION - DERIVATION: DVSTDTC dv <- data.frame(dv) %>% tidyr::unite(., col = 'DVENDTC', 'DVEN_YY', 'DVEN_MM', 'DVEN_DD', sep = '-', remove = TRUE) %>% dplyr::mutate(., DVENDTC = lubridate::ymd(DVENDTC))
DVSTDY	Study Day of Start of Deviation Event	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
DVENDY	Study Day of End of Deviation Event	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Exposure (EX)

EX (Exposure) - Interventions Location: ex.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
EXSEQ	Sequence Number	integer	Identifier	$3.		Derived Unique sequence based on sort order of studyid usubjid extrt exstdtc
EXGRPID	Group ID	text	Identifier	$8.		Assigned TBD
EXTRT	Name of Treatment	text	Topic	$7.		Assigned All subjects were dosed with what they were randomized to, so EXTRT=DM.ARM
EXCAT	Category of Treatment	text	GroupingQualifier	$5.		Assigned Hardcoded to IF ARM == 'Active' THEN EXCAT = 'Pro-ocular' ELSE 'Placebo'
EXSCAT	Subcategory of Treatment	text	GroupingQualifier	$8.		Assigned Hardcoded to IF ARM == 'Active' THEN EXTRT = 'Pro-ocular' ELSE 'Placebo'
EXDOSE	Dose	float	RecordQualifier	$3.		Derived Hardcoded to IF ARM == 'Active' THEN EXTRT = 'Pro-ocular' ELSE 'Placebo'
EXDOSTXT	Dose Description	text	RecordQualifier	$32.		Assigned Hardcoded to 'Topical cream applied to forhead'
EXDOSU	Dose Units	text	VariableQualifier	$2.		Assigned Hardcoded to mg
EXDOSFRM	Dose Form	text	VariableQualifier	$7.		Assigned Hardcoded to 'Topical'
EXDOSFRQ	Dosing Frequency per Interval	text	RecordQualifier	$3.		Assigned Hardcoded to 'BID'
EXDOSTOT	Total Daily Dose using EXDOSU	text	NA	$3.		Derived Hardcoded to IF ARM == 'Active' THEN EXTRT = 'Pro-ocular' ELSE 'Placebo'
EXDOSRGM	Intended Dose Regimen	text	RecordQualifier	$9.		Assigned Hardcoded to 'BID daily'
EXROUTE	Route of Administration	text	VariableQualifier	$6.	[unresolved: CL.ROUTE]	Assigned Hardcoded to "Dermal"
EXLOT	Lot Number	text	RecordQualifier	$6.		CRF Annotated Case Report Form [34 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [104 ] CRF Annotated Case Report Form [132 ] CRF Annotated Case Report Form [159 ] Hardcoded to Participant.Id
EXTRTV	Treatment Vehicle	text	NA	$8.		Assigned Hardcoded to 'Topical cream'
EXLOC	Location of Dose Administration	text	RecordQualifier	$13.	[unresolved: CL.LOC]	eDT Hardcoded to 'Forehead'
EXADJ	Reason for Dose Adjustment	text	NA	$76.		Assigned Hardcoded to EXCOM
TAETORD	Planned Order of Element within Arm	integer	Timing	$3.		Assigned
EPOCH	Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived Hardcoded to TREATMENT
EXSTDTC	Start Date/Time of Treatment	date	Timing	YYMMDD10.	ISO 8601	Derived Hardcoded to EXDTC dplyr::mutate(., EXSTDTC = EXDTC) %>%
EXENDTC	End Date/Time of Treatment	date	Timing	YYMMDD10.	ISO 8601	Derived # "End Date/Time of Medication" dplyr::mutate(EXENDTC = EXSTDTC + 1)
EXSTDY	Study Day of Start of Treatment	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
EXENDY	Study Day of End of Treatment	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Inclusion/Exclusion Exceptions (IE)

IE (Inclusion/Exclusion Exceptions) - Findings Location: ie.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPIE (Supplemental Qualifiers for Inclusion/Exclusion Exceptions)
STUDYID		Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN		Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID		Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IESEQ		Sequence Number	integer	Identifier	$2.		Derived logr::put("## GROUP VARIABLES BY IE KEYS AND SELECT VARIABLE IN ORDER") ie <- ie %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(.,STUDYID, USUBJID, IETESTCD) %>% ## COMPUTATION - DERIVATION: IESEQ dplyr::mutate(.,IESEQ = 1:length(USUBJID))
IETESTCD		Inclusion/Exclusion Criterion Short Name	text	Topic	$8.		CRF Annotated Case Report Form [5 ] CRF Annotated Case Report Form [6 ] CRF Annotated Case Report Form [7 ] Database variables are transposed to the IETESTCD variable: logr::put("## CREATE IE DATASET") ## COMPUTATION - HARDCODE: IETESTCD ie_ie <- ie %>% dplyr::select_at(., .vars = ie_cols_ie) %>% dplyr::mutate(., IEDTC = as.character(IEDTC)) %>% tidyr::pivot_longer(cols = all_of(ie_cols_ie[-c(1:10)]), values_to = "IESTRESC", names_to = "IETESTCD")
IETEST		Inclusion/Exclusion Criterion	text	SynonymQualifier	$348.		CRF Annotated Case Report Form [5 ] CRF Annotated Case Report Form [6 ] CRF Annotated Case Report Form [7 ] logr::put("## ADD TEST NAME FROM SDTM DICTIONARY") ## COMPUTATION - HARDCODE: IETEST ie$IETEST <- unlist(sapply(1:length(ie$IETESTCD), function(x) di_map_test(ie$IETESTCD[x])))
IECAT		Inclusion/Exclusion Category	text	GroupingQualifier	$11.	IECAT • "INCLUSION" = "Inclusion Criteria" • "EXCLUSION" = "Exclusion Criteria"	CRF Annotated Case Report Form [5 ] CRF Annotated Case Report Form [6 ] CRF Annotated Case Report Form [7 ] logr::put("## ADD CATEGORY FROM DATASET TI") ## COMPUTATION - HARDCODE: IECAT ie$IECAT <- sapply(1:length(ie$IETESTCD), function(x) di_map_tiiecat(ie$IETESTCD[x]))
IESCAT		Inclusion/Exclusion Subcategory	text	GroupingQualifier	$29.	IESCAT • "Major" = "Major" • "Minor" = "Minor" • "Pregnancy" = "Pregnancy"	Assigned logr::put("## ADD SUBCATEGORY FROM DATASET TI") ie$IESCAT <- sapply(1:length(ie$IETESTCD), function(x) di_map_tiiescat(ie$IETESTCD[x]))
IEORRESVLM		I/E Criterion Original Result	text	ResultQualifier	$1.		CRF Annotated Case Report Form [5 ] CRF Annotated Case Report Form [6 ] CRF Annotated Case Report Form [7 ]
	IETESTCD = "IC01"	1. Is subject a male or female of any race, at least 18 years of age at Visit 1	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC02"	2. Does subject have a diagnosis of ocular GvHD for at least 3 months prior to Visit 1	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC03"	3. Has subject used scleral lenses daily in both eyes for at least two months prior to Visit 1 for treatment of oGvHD and planning to continue using the same scleral lenses daily in both eyes throughout this study	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC04"	4. Excluding final scleral lens removal of the day, after successful daily insertion, does subject feel the need to remove or does subject remove one or both scleral lenses at least once per day due to physical discomfort or visual acuity issues (lenses have debris or deposit build up, or vision is foggy, cloudy, blurry)	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC05"	5. Does subject have staining score in central corneal region of 2 out of 10 in either eye at Visit 1	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC06"	6. Does subject have mean between OD and OS cores of 35 out of 100 in Frequency Score of Modified SANDE nighttime questionnaire without scleral lenses	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC07"	7. Has the subject provided verbal and written informed consent	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC08"	8. Is the subject (or subjects parent or legal guardian) able and willing to follow oral and written instructions provided in English, with or without assistance, and participate in all study assessments and visits	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC09"	9. Does subject have a telephone necessary for evaluations	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "IC10"	10. Has subject had an ophthalmological exam within the past year prior to Visit 1	text		1		CRF Annotated Case Report Form [5 ]
	IETESTCD = "EX01"	1. Has subject tested positive for COVID-19 within twenty-eight days prior to Visit 1	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX02"	2. Does subject have active trigeminal neuritis, trigeminal neuralgia, ocular herpes zoster (ophthalmic shingles), facial herpes zoster (facial shingles), ocular herpes simplex or neurotrophic keratitis at Visit 1	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX03"	3. Does subject have a history of ocular herpes zoster (ophthalmic shingles), facial herpes zoster (facial shingles), ocular herpes simplex or neurotrophic keratitis within the last 5 years that is not being medically managed including oral antivirals (patients with history of herpes simplex virus must be receiving appropriate antiviral therapy)	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX04"	4. Females with history of breast cancer in patient or immediate biological family (parents, siblings and children)	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX05"	5. Has subject had eyelid surgery or ocular surgery within the last 12 weeks prior to Visit 1 that in the judgment of the clinical investigator will interfere with study assessments	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX06"	6. Does subject have comorbidity with other severe, acute or chronic systemic or ocular conditions that in the judgment of the clinical investigator will interfere with study assessments or study participant safety	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX07"	7. Has the subject made a significant change (e.g. discontinuation) to the drug regimen of his or her oral corticosteroids, corticosteroid-containing eye drops or gels, cyclosporine ophthalmic emulsion (RESTASIS or CEQUA) or lifitegrast solution (XIIDRA) within seven days prior to Visit 1	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX08"	8. Does subject wear any type of lenses overnight (scleral lens(es), bandage contact lens(es))	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX09"	9. Is the subject a woman of childbearing potential who is pregnant, nursing an infant, planning a pregnancy, not receiving an adequate method of birth control or have a positive urine pregnancy test at Visit 1 or Is female subject of childbearing potential not willing to use contraception throughout this study	text		1		CRF Annotated Case Report Form [6 ]
	IETESTCD = "EX10"	10. Does subject have known adverse reaction and/or sensitivity to study drug (Progesterone USP) or its components (see informed consent)	text		1		CRF Annotated Case Report Form [7 ]
	IETESTCD = "EX11"	11. Is subject currently using or has subject ever used Pro-ocular	text		1		CRF Annotated Case Report Form [7 ]
	IETESTCD = "EX12"	12. Is subject unwilling to cease the use of sunscreen on the forehead or eye area	text		1		CRF Annotated Case Report Form [7 ]
	IETESTCD = "EX13"	13. Is subject currently on more than one preserved topical medication for glaucoma (combination drug products count as one medication)	text		1		CRF Annotated Case Report Form [7 ]
	IETESTCD = "EX14"	14. Is subject currently enrolled in any investigational drug or device clinical studies exclusively for Ocular GvHD	text		1		CRF Annotated Case Report Form [7 ]
	IETESTCD = "IEDIA"	DATE OF GRAFT-VERSUS-HOST DISEASE DIAGNOSIS	text		0		CRF Annotated Case Report Form [7 ]
	IETESTCD = "IEOC"	REVIEWED ONCOLOGIC MEDICAL RECORDS IF AVAILABLE	text		0		CRF Annotated Case Report Form [7 ]
	IETESTCD = "IEOC1"	TYPE OF STEM CELL TRANSPLANT (1)	text		0		CRF Annotated Case Report Form [7 ]
	IETESTCD = "IEOC2"	TYPE OF STEM CELL TRANSPLANT (2)	text		0		CRF Annotated Case Report Form [7 ]
	IETESTCD = "IEOP"	REVIEWED MOST RECENT OPHTHALMOLIGIC EXAM RECORDS	text		0		CRF Annotated Case Report Form [7 ]
	IETESTCD = "ELIGIBLE"	Did the subject qualify to continue the study	text		0		CRF Annotated Case Report Form [7 ]
IESTRESC		I/E Criterion Result in Std Format	text	ResultQualifier	$10.	YN • "No" = "No" • "Yes" = "Yes"	Derived Hardcoded to original results (IEORRES): ie_ieoc <- ie %>% dplyr::select_at(., .vars = ie_cols_ieoc) %>% tidyr::pivot_longer(cols = all_of(ie_cols_ieoc[-c(1:10)]), values_to = "IEORRES", names_to = "IETESTCD") %>% dplyr::mutate(., IESTRESC = ifelse(IEORRES == "1" , "Yes", ifelse(IEORRES == "0" , "No", NA)))
VISITNUM		Visit Number	integer	Timing	$1.		Assigned ## COMPUTATION - HARDCODE: VISITNNUM dplyr::mutate(., VISITNUM = "1")
VISIT		Visit Name	text	Timing	$28.		Assigned ## COMPUTATION - HARDCODE: VISIT dplyr::mutate(., VISIT = "Visit 1 Screening & Baseline")
VISITDY		Planned Study Day of Visit	integer	Timing	$1.		Assigned ## COMPUTATION - HARDCODE: VISITDY dplyr::mutate(., VISITDY = "0")
TAETORD		Planned Order of Element within Arm	integer	Timing	$1.		Assigned ## COMPUTATION - HARDCODE: TAETORD dplyr::mutate(., TAETORD = VISITNUM)
EPOCH		Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived ## COMPUTATION - HARDCODE: EPOCH dplyr::mutate(., EPOCH = "Screening & Baseline")
IEDTC		Date/Time of Collection	date	Timing	YYMMDD10.	ISO 8601	Derived ### COMPUTATION - HARDCODE: IEDTC dplyr::mutate(., IEDTC = dmy(ICFDTC))
IEDY		Study Day of Collection	integer	Timing	$5.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Laboratory Tests (LB)

LB (Laboratory Tests) - Findings Location: lb.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN		Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID		Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
LBSEQ		Sequence Number	integer	Identifier	$2.		Derived TBD
LBGRPID		Group ID	text	Identifier	$8.		Assigned TBD
LBREFID		Specimen ID	text	Identifier	$8.		Assigned TBD
LBSPID		Sponsor-Defined Identifier	text	Identifier	$13.		Assigned TBD
LBTESTCD		Lab Test or Examination Short Name	text	Topic	$8.	LBTESTCD [11 Terms]	Assigned TBD
LBTEST		Lab Test or Examination Name	text	SynonymQualifier	$27.	LBTEST [11 Terms]	Assigned TBD
LBCAT		Category for Lab Test	text	GroupingQualifier	$22.		Assigned TBD
LBSCAT		Subcategory for Lab Test	text	GroupingQualifier	$12.		Assigned TBD
LBORRESVLM		Result or Finding in Original Units	float	ResultQualifier	$9.		Assigned TBD
	LBTESTCD = "HCG"	Urine Pregnancy test	text		ND	[unresolved: CL.C64851]	CRF Annotated Case Report Form [4 ]
	LBTESTCD = "PROGEST"	Progesterone	float		4.2	[unresolved: CL.C74791]	CRF Annotated Case Report Form [30 ] CRF Annotated Case Report Form [48 ] CRF Annotated Case Report Form [66 ] CRF Annotated Case Report Form [83 ] CRF Annotated Case Report Form [101 ] CRF Annotated Case Report Form [111 ] CRF Annotated Case Report Form [129 ] CRF Annotated Case Report Form [139 ] CRF Annotated Case Report Form [156 ]
	LBTESTCD = "TESTOS"	Total Testosterone	float		3.	[unresolved: CL.C74793]	CRF Annotated Case Report Form [30 ] CRF Annotated Case Report Form [48 ] CRF Annotated Case Report Form [66 ] CRF Annotated Case Report Form [83 ] CRF Annotated Case Report Form [101 ] CRF Annotated Case Report Form [111 ] CRF Annotated Case Report Form [129 ] CRF Annotated Case Report Form [139 ] CRF Annotated Case Report Form [156 ]
	LBTESTCD = "ESTRDIOL"	Estradiol	float		3.	[unresolved: CL.C74782]	CRF Annotated Case Report Form [30 ] CRF Annotated Case Report Form [48 ] CRF Annotated Case Report Form [66 ] CRF Annotated Case Report Form [83 ] CRF Annotated Case Report Form [101 ] CRF Annotated Case Report Form [111 ] CRF Annotated Case Report Form [129 ] CRF Annotated Case Report Form [139 ] CRF Annotated Case Report Form [156 ]
	LBTESTCD = "DHT"	Dihydrotestosterone	float		3.	[unresolved: CL.C74853]	CRF Annotated Case Report Form [30 ] CRF Annotated Case Report Form [48 ] CRF Annotated Case Report Form [66 ] CRF Annotated Case Report Form [83 ] CRF Annotated Case Report Form [101 ] CRF Annotated Case Report Form [111 ] CRF Annotated Case Report Form [129 ] CRF Annotated Case Report Form [139 ] CRF Annotated Case Report Form [156 ]
	LBTESTCD = "LH"	Luteinizing Hormone	float		4.2	[unresolved: CL.C74790]	CRF Annotated Case Report Form [30 ] CRF Annotated Case Report Form [48 ] CRF Annotated Case Report Form [66 ] CRF Annotated Case Report Form [83 ] CRF Annotated Case Report Form [101 ] CRF Annotated Case Report Form [111 ] CRF Annotated Case Report Form [129 ] CRF Annotated Case Report Form [139 ] CRF Annotated Case Report Form [156 ]
	LBTESTCD = "FSH"	Follicle Stimulating Hormone	float		4.2	[unresolved: CL.C74783]	CRF Annotated Case Report Form [30 ] CRF Annotated Case Report Form [48 ] CRF Annotated Case Report Form [66 ] CRF Annotated Case Report Form [83 ] CRF Annotated Case Report Form [101 ] CRF Annotated Case Report Form [111 ] CRF Annotated Case Report Form [129 ] CRF Annotated Case Report Form [139 ] CRF Annotated Case Report Form [156 ]
LBORRESU		Original Units	text	VariableQualifier	$9.	UNIT • "%" = "Percentage" • "g/dL" = "Gram per Deciliter" • "IU/L" = "International Unit per Liter" • "mg/dL" = "Milligram per Deciliter" • "mg" = "Milligram"	Assigned TBD
LBORNRLO		Reference Range Lower Limit in Orig Unit	float	VariableQualifier	$8.		Assigned TBD
LBORNRHI		Reference Range Upper Limit in Orig Unit	float	VariableQualifier	$8.		Assigned TBD
LBSTRESC		Character Result/Finding in Std Format	text	ResultQualifier	$8.		Assigned TBD
LBSTRESN		Numeric Result/Finding in Standard Units	float	ResultQualifier	$8.		Assigned TBD
LBSTRESU		Standard Units	text	VariableQualifier	$8.	UNIT • "%" = "Percentage" • "g/dL" = "Gram per Deciliter" • "IU/L" = "International Unit per Liter" • "mg/dL" = "Milligram per Deciliter" • "mg" = "Milligram"	Assigned TBD
LBSTNRLO		Reference Range Lower Limit-Std Units	text	VariableQualifier	$8.		Assigned TBD
LBSTNRHI		Reference Range Upper Limit-Std Units	text	VariableQualifier	$8.		Assigned TBD
LBSTNRC		Reference Range for Char Rslt-Std Units	text	VariableQualifier	$8.		Assigned TBD
LBNRIND		Reference Range Indicator	text	VariableQualifier	$8.	[unresolved: CL.NRIND]	Assigned TBD
LBSTAT		Completion Status	text	RecordQualifier	$8.	[unresolved: CL.ND]	Assigned TBD
LBREASND		Reason Test Not Done	text	RecordQualifier	$8.		Assigned TBD
LBNAM		Vendor Name	text	RecordQualifier	$8.		Assigned TBD
LBLOINC		LOINC Code	text	SynonymQualifier	$8.	[unresolved: CL.LOINC]	Assigned TBD
LBSPEC		Specimen Type	text	RecordQualifier	$8.	[unresolved: CL.SPECTYPE]	Assigned TBD
LBSPCCND		Specimen Condition	text	RecordQualifier	$8.	[unresolved: CL.SPECCOND]	Assigned TBD
LBMETHOD		Method of Test or Examination	text	RecordQualifier	$8.	[unresolved: CL.METHOD]	Assigned TBD
LBBLFL		Baseline Flag	text	RecordQualifier	$8.	YN • "No" = "No" • "Yes" = "Yes"	Derived TBD
LBFAST		Fasting Status	text	RecordQualifier	$8.	YN • "No" = "No" • "Yes" = "Yes"	Assigned TBD
LBDRVFL		Derived Flag	text	RecordQualifier	$8.	[unresolved: CL.NY]	Derived TBD
LBTOX		Toxicity	text	VariableQualifier	$8.		Assigned TBD
LBTOXGR		Standard Toxicity Grade	text	RecordQualifier	$8.		Assigned TBD
VISITNUM		Visit Number	integer	Timing	$1.		Assigned TBD
VISIT		Visit Name	text	Timing	$28.		Assigned TBD
VISITDY		Planned Study Day of Visit	integer	Timing	$3.		Assigned TBD
LBDTC		Date/Time of Specimen Collection	date	Timing	YYMMDD10.	ISO 8601	Derived TBD
LBENDTC		End Date/Time of Specimen Collection	date	Timing	YYMMDD10.	ISO 8601	Derived TBD
LBDY		Study Day of Specimen Collection	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
LBTPT		Planned Time Point Name	text	Timing	$8.		Assigned TBD
LBTPTNUM		Planned Time Point Number	integer	Timing	$8.		Assigned TBD
LBELTM		Planned Elapsed Time from Time Point Ref	text	Timing	$8.		Assigned TBD
LBTPTREF		Time Point Reference	text	Timing	$8.		Assigned TBD
LBRFTDTC		Date/Time of Reference Time Point	date	Timing	YYMMDD10.	ISO 8601	Derived TBD

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Medical History (MH)

MH (Medical History) - Events Location: mh.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPMH (Supplemental Qualifiers for Medical History)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
MHSEQ	Sequence Number	integer	Identifier	$2.		Derived ## COMPUTATION - DERIVATION: MHSEQ dplyr::mutate(.,MHSEQ = 1:length(USUBJID))
MHTERM	Reported Term for the Medical History	text	Topic	$38.		CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [8 ] CRF Annotated Case Report Form [9 ]
MHMODIFY	Modified Reported Term	text	SynonymQualifier	$8.		Assigned TBD
MHDECOD	Dictionary-Derived Term	text	SynonymQualifier	$8.	[unresolved: CL.MHDECOD]	Assigned TBD
MHCAT	Category for Medical History	text	GroupingQualifier	$26.		Assigned MHCAT is hardcoded for each dataset in MH (for example): ## COMPUTATION - HARDCODE: MHCAT dplyr::mutate(., MHCAT = "Surgical History")
MHSCAT	Subcategory for Medical History	text	GroupingQualifier	$8.		Assigned TBD
MHPRESP	Medical History Event Pre-Specified	text	GroupingQualifier	$3.	YN • "No" = "No" • "Yes" = "Yes"	Assigned All terms related to GVHD are considered prespecified: ## COMPUTATION - DERIVATION: MHPRESP dplyr::mutate(., MHPRESP = ifelse( MHTERM %in% c("oGVHD", "stem cell transplant", "GVHD", "Graft versus host disease", "allogeneic Stem cell transplant", "graft versus host disease", "Allogeneic Stem Cell Transplant", "Ocular Graft versus host disease", "Allogeneic stem cell transplant", "Allogeneic Stem cell transplant", "allogenic Stem cell transplant", "Graft vs host disease", "o GVHD", "Allogeneic stem cell transplant", "Allogeneic stem call transplant", "Stem cell transplant", "Allogeneic Bone Marrow Transplant", "Autologous Bone marrow transplant" ), "Yes", "No"))
MHOCCUR	Medical History Occurrence	text	RecordQualifier	$3.	YN • "No" = "No" • "Yes" = "Yes"	CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [8 ] CRF Annotated Case Report Form [9 ]
MHREASND	Reason Medical History Not Collected	text	RecordQualifier	$8.		CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [8 ] CRF Annotated Case Report Form [9 ] TBD
MHBODSYS	Body System or Organ Class	text	RecordQualifier	$8.	[unresolved: CL.MHBODSYS]	Assigned TBD
MHDTC	Date/Time of History Collection	date	Timing	YYMMDDHHMMSSTZ19.	ISO 8601	Derived MHDTC is derived from each MH dataset (for example): ## COMPUTATION - DERIVATION: MHDTC dplyr::mutate(., MHDTC = dmy_hms(MHDTC))
MHSTDTC	Start Date/Time of Medical History Event	date	Timing	YYMMDD10.	ISO 8601	Derived MHSTDTC is derived from each MH dataset (for example): ## COMPUTATION - DERIVATION: MHSTDTC tidyr::unite(., col = 'MHSTDTC', 'OHDY', 'OHDM', 'OHDD', sep = '-', remove = TRUE)
MHENDTC	End Date/Time of Medical History Event	date	Timing	YYMMDD10.	ISO 8601	Derived MHENDTC is derived from each MH dataset (for example): ## COMPUTATION - DERIVATION: MHSTDTC tidyr::unite(., col = 'MHENDTC', 'OHSY', 'OHSM', 'OHSD', sep = '-', remove = TRUE)
MHDY	Study Day of History Collection	integer	Timing	$5.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Opthalmic Examinations (OE)

OE (Opthalmic Examinations) - Findings Location: oe.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPOE (Supplemental Qualifiers for Opthalmic Examinations)
STUDYID		Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN		Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID		Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
OESEQ		Sequence Number	integer	Identifier	$4.		Derived oe <- data.frame(oe) %>% dplyr::mutate(., DOMAIN = "OE") %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., USUBJID, VISITNUM, TAETORD) %>% ## COMPUTATION - DERIVATION: SEQ dplyr::mutate(.,OESEQ = 1:length(USUBJID))
OEGRPID		Group ID	text	Identifier	$8.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OETESTCD		Short Name of Ophthalmic Test or Exam	text	Topic	$8.	[unresolved: CL.OETESTCD]	Assigned
OETEST		Name of Ophthalmic Test or Exam	text	SynonymQualifier	$41.	[unresolved: CL.OETEST]	CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OECAT		Category for Ophthalmic Test or Exam	text	GroupingQualifier	$51.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OESCAT		Subcategory for Ophthalmic Test or Exam	text	GroupingQualifier	$50.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OEORRESVLM		Result or Finding in Original Units	float	ResultQualifier	$7.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
	OETESTCD = "VACA1NOD"	Visual Acuity (OD) - Numerator	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1NOS"	Visual Acuity (OS) - Numerator	float		2		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1NOU"	Visual Acuity (OU) - Numerator	float		4		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1DOD"	Visual Acuity (OD) - Denominator	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1DOS"	Visual Acuity (OS) - Denominator	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1DOU"	Visual Acuity (OU) - Denominator	float		4		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1MOD"	Visual Acuity (OS) - Missed or Additional Letters	float		2		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1MOS"	Visual Acuity (OS) - Missed or Additional Letters	float		2		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	OETESTCD = "VACA1MOU"	Visual Acuity (OS) - Missed or Additional Letters	float		4		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSBRTOD.OEGRPID.KRSWSL]	Bulbar Redness Temporal (OD)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSBRTOS.OEGRPID.KRSWSL]	Bulbar Redness Temporal (OS)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSBRTOU.OEGRPID.KRSWSL]	Bulbar Redness Temporal (OU)	float		6		Derived
	[unresolved: WC.WC.OE.OETESTCD.KRSBRNOD.OEGRPID.KRSWSL]	Bulbar Redness Nasal (OD)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSBRNOS.OEGRPID.KRSWSL]	Bulbar Redness Nasal (OS)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSBRNOU.OEGRPID.KRSWSL]	Bulbar Redness Nasal (OU)	float		6		Derived
	[unresolved: WC.WC.OE.OETESTCD.KRSLRTOD.OEGRPID.KRSWSL]	Limbal Redness - Temporal (OD)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSLRTOS.OEGRPID.KRSWSL]	Limbal Redness - Temporal (OS)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSLRTOU.OEGRPID.KRSWSL]	Limbal Redness - Temporal (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.KRSLRNOD.OEGRPID.KRSWSL]	Limbal Redness - Nasal (OD)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSLRNOS.OEGRPID.KRSWSL]	Limbal Redness - Nasal (OS)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSLRNOU.OEGRPID.KRSWSL]	Limbal Redness - Nasal (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.KRSABROD.OEGRPID.KRSWSL]	Average Bulbar Redness (OD)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSABROS.OEGRPID.KRSWSL]	Average Bulbar Redness (OS)	float		3		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSABROU.OEGRPID.KRSWSL]	Average Bulbar Redness (OU)	float		6		Derived
	[unresolved: WC.WC.OE.OETESTCD.KRSAASOD.OEGRPID.KRSWSL]	Analyzed Area (Size) (OD)	float		4		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSAASOS.OEGRPID.KRSWSL]	Analyzed Area (Size) (OS)	float		4		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [148 ]
	[unresolved: WC.WC.OE.OETESTCD.KRSAASOU.OEGRPID.KRSWSL]	Analyzed Area (Size) (OU)	float		5		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSBLEOD.OEGRPID.EGSWSL]	Blephritis (OD)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSBLEOS.OEGRPID.EGSWSL]	Blephritis (OS)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSBLEOU.OEGRPID.EGSWSL]	Blephritis (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSCRNOD.OEGRPID.EGSWSL]	Conjuntival Redness - Nasal (OD)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRNOS.OEGRPID.EGSWSL]	Conjuntival Redness - Nasal (OS)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRNOU.OEGRPID.EGSWSL]	Conjuntival Redness - Nasal (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSCRUOD.OEGRPID.EGSWSL]	Conjuntival Redness - Under Lens (OD)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRUOS.OEGRPID.EGSWSL]	Conjuntival Redness - Under Lens (OS)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRUOU.OEGRPID.EGSWSL]	Conjuntival Redness - Under Lens (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSCRTOD.OEGRPID.EGSWSL]	Conjuntival Redness - Temporal (OD)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRTOS.OEGRPID.EGSWSL]	Conjuntival Redness - Temporal (OS)	float		3		CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [149 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRTOU.OEGRPID.EGSWSL]	Conjuntival Redness - Temporal (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.KSOBRTOD.OEGRPID.KRSWOSL]	Bulbar Redness Temporal (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOBRTOS.OEGRPID.KRSWOSL]	Bulbar Redness Temporal (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOBRTOU.OEGRPID.KRSWOSL]	Bulbar Redness Temporal (OU)	float		6		Derived
	[unresolved: WC.WC.OE.OETESTCD.KSOBRNOD.OEGRPID.KRSWOSL]	Bulbar Redness Nasal (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOBRNOS.OEGRPID.KRSWOSL]	Bulbar Redness Nasal (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOBRNOU.OEGRPID.KRSWOSL]	Bulbar Redness Nasal (OU)	float		6		Derived
	[unresolved: WC.WC.OE.OETESTCD.KSOLRTOD.OEGRPID.KRSWOSL]	Limbal Redness - Temporal (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOLRTOS.OEGRPID.KRSWOSL]	Limbal Redness - Temporal (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOLRTOU.OEGRPID.KRSWOSL]	Limbal Redness - Temporal (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.KSOLRNOD.OEGRPID.KRSWOSL]	Limbal Redness - Nasal (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOLRNOS.OEGRPID.KRSWOSL]	Limbal Redness - Nasal (OS)	float		4		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOLRNOU.OEGRPID.KRSWOSL]	Limbal Redness - Nasal (OU)	float		6		Derived
	[unresolved: WC.WC.OE.OETESTCD.KSOABROD.OEGRPID.KRSWOSL]	Average Bulbar Redness (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOABROS.OEGRPID.KRSWOSL]	Average Bulbar Redness (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOABROU.OEGRPID.KRSWOSL]	Average Bulbar Redness (OU)	float		5		Derived
	[unresolved: WC.WC.OE.OETESTCD.KSOAASOD.OEGRPID.KRSWOSL]	Analyzed Area (Size) (OD)	float		4		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOAASOS.OEGRPID.KRSWOSL]	Analyzed Area (Size) (OS)	float		4		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.KSOAASOU.OEGRPID.KRSWOSL]	Analyzed Area (Size) (OU)	float		6		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSBLEOD.OEGRPID.EGSWOSL]	Blephritis (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSBLEOS.OEGRPID.EGSWOSL]	Blephritis (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSBLEOU.OEGRPID.EGSWOSL]	Blephritis (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSCRNOD.OEGRPID.EGSWOSL]	Conjuntival Redness - Nasal (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRNOS.OEGRPID.EGSWOSL]	Conjuntival Redness - Nasal (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRNOU.OEGRPID.EGSWOSL]	Conjuntival Redness - Nasal (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSCRUOD.OEGRPID.EGSWOSL]	Conjuntival Redness - Under Lens (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRUOS.OEGRPID.EGSWOSL]	Conjuntival Redness - Under Lens (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRUOU.OEGRPID.EGSWOSL]	Conjuntival Redness - Under Lens (OU)	float		4		Derived
	[unresolved: WC.WC.OE.OETESTCD.EGSCRTOD.OEGRPID.EGSWOSL]	Conjuntival Redness - Temporal (OD)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRTOS.OEGRPID.EGSWOSL]	Conjuntival Redness - Temporal (OS)	float		3		CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [69 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [150 ]
	[unresolved: WC.WC.OE.OETESTCD.EGSCRTOU.OEGRPID.EGSWOSL]	Conjuntival Redness - Temporal (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.SLBLBLOD.OEGRPID.SLBRES]	Blepharitis (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLBLOS.OEGRPID.SLBRES]	Blepharitis (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLBLOD.OEGRPID.SLBCS]	Blepharitis (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLBLOS.OEGRPID.SLBCS]	Blepharitis (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLBLOU.OEGRPID.SLBRES]	Blepharitis (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.SLBLMEOD.OEGRPID.SLBRES]	Lid Margin Erythema (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLMEOS.OEGRPID.SLBRES]	Lid Margin Erythema (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLMEOD.OEGRPID.SLBCS]	Lid Margin Erythema (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLMEOS.OEGRPID.SLBCS]	Lid Margin Erythema (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLMEOU.OEGRPID.SLBRES]	Lid Margin Erythema (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.SLBLLUOD.OEGRPID.SLBRES]	Lid Margin Ulceration (OD)	float		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLLUOS.OEGRPID.SLBRES]	Lid Margin Ulceration (OS)	float		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLLUOD.OEGRPID.SLBCS]	Lid Margin Ulceration (OD)	text		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLLUOS.OEGRPID.SLBCS]	Lid Margin Ulceration (OS)	text		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLLUOU.OEGRPID.SLBRES]	Lid Margin Ulceration (OU)	float		ND		Derived
	[unresolved: WC.WC.OETESTCD.SLBLOPOD.OEGRPID.SLBOP]	Lid - Other Pathology (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLOPOS.OEGRPID.SLBOP]	Lid - Other Pathology (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLOPOD.OEGRPID.SLBCS]	Lid - Other Pathology (OD)	text		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBLOPOS.OEGRPID.SLBCS]	Lid - Other Pathology (OS)	text		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSLOD.OEGRPID.SLBRES]	Superior Limbic Keratoconjunctivitis (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSLOS.OEGRPID.SLBRES]	Superior Limbic Keratoconjunctivitis (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSLOD.OEGRPID.SLBCS]	Superior Limbic Keratoconjunctivitis (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSLOS.OEGRPID.SLBCS]	Superior Limbic Keratoconjunctivitis (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSLOU.OEGRPID.SLBRES]	Superior Limbic Keratoconjunctivitis (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.SLBJPCOD.OEGRPID.SLBRES]	Papillary Conjunctivitis (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJPCOS.OEGRPID.SLBRES]	Papillary Conjunctivitis (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJPCOD.OEGRPID.SLBCS]	Papillary Conjunctivitis (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJPCOS.OEGRPID.SLBCS]	Papillary Conjunctivitis (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJPCOU.OEGRPID.SLBRES]	Papillary Conjunctivitis (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.SLBJCSOD.OEGRPID.SLBRES]	Conjunctival Scarring (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJCSOS.OEGRPID.SLBRES]	Conjunctival Scarring (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJCSOD.OEGRPID.SLBCS]	Conjunctival Scarring (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJCSOS.OEGRPID.SLBCS]	Conjunctival Scarring (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJCSOU.OEGRPID.SLBRES]	Conjunctival Scarring (OU)	float		6		Derived
	[unresolved: WC.WC.OETESTCD.SLBJFSOD.OEGRPID.SLBRES]	Fornix Shortening (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJFSOS.OEGRPID.SLBRES]	Fornix Shortening (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJFSOD.OEGRPID.SLBCS]	Fornix Shortening (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJFSOS.OEGRPID.SLBCS]	Fornix Shortening (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJFSOU.OEGRPID.SLBRES]	Fornix Shortening (OU)	float		6		Derived
	[unresolved: WC.WC.OETESTCD.SLBJSYOD.OEGRPID.SLBRES]	Symblepharon (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSYOS.OEGRPID.SLBRES]	Symblepharon (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSYOD.OEGRPID.SLBCS]	Symblepharon (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSYOS.OEGRPID.SLBCS]	Symblepharon (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJSYOU.OEGRPID.SLBRES]	Symblepharon (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.SLBJKEOD.OEGRPID.SLBRES]	Keratinization (OD)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJKEOS.OEGRPID.SLBRES]	Keratinization (OS)	float		3		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJKEOD.OEGRPID.SLBCS]	Keratinization (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJKEOS.OEGRPID.SLBCS]	Keratinization (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJKEOU.OEGRPID.SLBRES]	Keratinization (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.SLBJOPOD.OEGRPID.SLBOP]	Conjunctival - Other Pathology (OD)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJOPOS.OEGRPID.SLBOP]	Conjunctival - Other Pathology (OS)	text		0		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJOPOD.OEGRPID.SLBCS]	Conjunctival - Other Pathology (OD)	text		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBJOPOS.OEGRPID.SLBCS]	Conjunctival - Other Pathology (OS)	text		ND		CRF Annotated Case Report Form [23 ] CRF Annotated Case Report Form [60 ] CRF Annotated Case Report Form [95 ] CRF Annotated Case Report Form [123 ] CRF Annotated Case Report Form [151 ]
	[unresolved: WC.WC.OETESTCD.SLBCCROD.OEGRPID.SLBRES]	Corneal Infiltrates (OD)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCROS.OEGRPID.SLBRES]	Corneal Infiltrates (OS)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCROD.OEGRPID.SLBCS]	Corneal Infiltrates (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCROS.OEGRPID.SLBCS]	Corneal Infiltrates (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCROU.OEGRPID.SLBRES]	Corneal Infiltrates (OU)	float		1		Derived
	[unresolved: WC.WC.OETESTCD.SLBCAUOD.OEGRPID.SLBRES]	Active Corneal Ulceration (OD)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCAUOS.OEGRPID.SLBRES]	Active Corneal Ulceration (OS)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCAUOD.OEGRPID.SLBCS]	Active Corneal Ulceration (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCAUOS.OEGRPID.SLBCS]	Active Corneal Ulceration (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCAUOU.OEGRPID.SLBRES]	Active Corneal Ulceration (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.SLBCCNOD.OEGRPID.SLBRES]	Corneal Neovascularization (OD)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCNOS.OEGRPID.SLBRES]	Corneal Neovascularization (OS)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCNOD.OEGRPID.SLBCS]	Corneal Neovascularization (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCNOS.OEGRPID.SLBCS]	Corneal Neovascularization (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCNOU.OEGRPID.SLBRES]	Corneal Neovascularization (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.SLBCFKOD.OEGRPID.SLBRES]	Filamentary Keratitis (OD)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCFKOS.OEGRPID.SLBRES]	Filamentary Keratitis (OS)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCFKOD.OEGRPID.SLBCS]	Filamentary Keratitis (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCFKOS.OEGRPID.SLBCS]	Filamentary Keratitis (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCFKOU.OEGRPID.SLBRES]	Filamentary Keratitis (OU)	float		3		Derived
	[unresolved: WC.WC.OETESTCD.SLBCCTOD.OEGRPID.SLBRES]	Chronic Corneal Thinning (OD)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCTOS.OEGRPID.SLBRES]	Chronic Corneal Thinning (OS)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCTOD.OEGRPID.SLBCS]	Chronic Corneal Thinning (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCTOS.OEGRPID.SLBCS]	Chronic Corneal Thinning (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCTOU.OEGRPID.SLBRES]	Chronic Corneal Thinning (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.SLBCSCOD.OEGRPID.SLBRES]	Corneal Scars (OD)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCSCOS.OEGRPID.SLBRES]	Corneal Scars (OS)	float		3		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCSCOD.OEGRPID.SLBCS]	Corneal Scars (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCSCOS.OEGRPID.SLBCS]	Corneal Scars (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCSCOU.OEGRPID.SLBRES]	Corneal Scars (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.SLBCMEOD.OEGRPID.SLBRES]	Microcystic Edema (OD)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCMEOS.OEGRPID.SLBRES]	Microcystic Edema (OS)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCMEOD.OEGRPID.SLBCS]	Microcystic Edema (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCMEOS.OEGRPID.SLBCS]	Microcystic Edema (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCMEOU.OEGRPID.SLBRES]	Microcystic Edema (OU)	float		1		Derived
	[unresolved: WC.WC.OETESTCD.SLBCCEOD.OEGRPID.SLBRES]	Corneal Edema (OD)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCEOS.OEGRPID.SLBRES]	Corneal Edema (OS)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCEOD.OEGRPID.SLBCS]	Corneal Edema (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCEOS.OEGRPID.SLBCS]	Corneal Edema (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCCEOU.OEGRPID.SLBRES]	Corneal Edema (OU)	float		1		Derived
	[unresolved: WC.WC.OETESTCD.SLBCOPOD.OEGRPID.SLBOP]	Cornea - Other Pathology (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCOPOS.OEGRPID.SLBOP]	Cornea - Other Pathology (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCOPOD.OEGRPID.SLBCS]	Cornea - Other Pathology (OD)	text		ND		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBCOPOS.OEGRPID.SLBCS]	Cornea - Other Pathology (OS)	text		ND		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACCOD.OEGRPID.SLBRES]	Anterior Chamber Cells (OD)	text		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACCOS.OEGRPID.SLBRES]	Anterior Chamber Cells (OS)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACCOD.OEGRPID.SLBCS]	Anterior Chamber Cells (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACCOS.OEGRPID.SLBCS]	Anterior Chamber Cells (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACCOU.OEGRPID.SLBRES]	Anterior Chamber Cells (OU)	float		1		Derived
	[unresolved: WC.WC.OETESTCD.SLBACFOD.OEGRPID.SLBRES]	Anterior Chamber Flare (OD)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACFOS.OEGRPID.SLBRES]	Anterior Chamber Flare (OS)	float		1		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACFOD.OEGRPID.SLBCS]	Anterior Chamber Flare (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACFOS.OEGRPID.SLBCS]	Anterior Chamber Flare (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBACFOU.OEGRPID.SLBRES]	Anterior Chamber Flare (OU)	float		1		Derived
	[unresolved: WC.WC.OETESTCD.SLBAOPOD.OEGRPID.SLBOP]	Anterior Chamber - Other Pathology (OD)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBAOPOS.OEGRPID.SLBOP]	Anterior Chamber - Other Pathology (OS)	text		0		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBAOPOD.OEGRPID.SLBCS]	Anterior Chamber - Other Pathology (OD)	text		ND		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBAOPOS.OEGRPID.SLBCS]	Anterior Chamber - Other Pathology (OS)	text		ND		CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [152 ]
	[unresolved: WC.WC.OETESTCD.SLBALSOD.OEGRPID.SLBRES]	Lens Status (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.SLBALSOS.OEGRPID.SLBRES]	Lens Status (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.SLBALSOU.OEGRPID.SLBRES]	Lens Status (OU)	text		ND		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.SLBALOOD.OEGRPID.SLBRES]	Lens Opacity (Phakic Eye ONLY) (OD)	text		1		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.SLBALOOS.OEGRPID.SLBRES]	Lens Opacity (Phakic Eye ONLY) (OS)	text		1		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.SLBALOOU.OEGRPID.SLBRES]	Lens Opacity (Phakic Eye ONLY) (OU)	text		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.SLBLSCOM.OEGRPID.SLBRES]	Comments	text		ND		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ2IOD.OEGRPID.CLSRES]	Conjunctival Staining - Zone 2 (OD)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ2IOS.OEGRPID.CLSRES]	Conjunctival Staining - Zone 2 (OS)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ2IOD.OEGRPID.CLSCS]	Conjunctival Staining - Zone 2 (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ2IOS.OEGRPID.CLSCS]	Conjunctival Staining - Zone 2 (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ2IOU.OEGRPID.CLSRES]	Conjunctival Staining - Zone 2 (OU)	float		6		Derived
	[unresolved: WC.WC.OETESTCD.CLSZ3IOD.OEGRPID.CLSRES]	Conjunctival Staining - Zone 3 (OD)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ3IOS.OEGRPID.CLSRES]	Conjunctival Staining - Zone 3 (OS)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ3IOD.OEGRPID.CLSCS]	Conjunctival Staining - Zone 3 (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ3IOS.OEGRPID.CLSCS]	Conjunctival Staining - Zone 3 (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ3IOU.OEGRPID.CLSRES]	Conjunctival Staining - Zone 3 (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.CLSZ4IOD.OEGRPID.CLSRES]	Conjunctival Staining - Zone 4 (OD)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ4IOS.OEGRPID.CLSRES]	Conjunctival Staining - Zone 4 (OS)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ4IOD.OEGRPID.CLSCS]	Conjunctival Staining - Zone 4 (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ4IOS.OEGRPID.CLSCS]	Conjunctival Staining - Zone 4 (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ4IOU.OEGRPID.CLSRES]	Conjunctival Staining - Zone 4 (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.CLSZ5IOD.OEGRPID.CLSRES]	Conjunctival Staining - Zone 5 (OD)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ5IOS.OEGRPID.CLSRES]	Conjunctival Staining - Zone 5 (OS)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ5IOD.OEGRPID.CLSCS]	Conjunctival Staining - Zone 5 (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ5IOS.OEGRPID.CLSCS]	Conjunctival Staining - Zone 5 (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ5IOU.OEGRPID.CLSRES]	Conjunctival Staining - Zone 5 (OU)	float		6		Derived
	[unresolved: WC.WC.OETESTCD.CLSOTIOD.OEGRPID.CLSOP]	Conjunctival Staining - Inside Scleral Lens Parimeter, Other Pathology (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSOTIOS.OEGRPID.CLSOP]	Conjunctival Staining - Inside Scleral Lens Parimeter, Other Pathology (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSOTIOD.OEGRPID.CLSCS]	Conjunctival Staining - Inside Scleral Lens Parimeter, Other Pathology (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSOTIOS.OEGRPID.CLSCS]	Conjunctival Staining - Inside Scleral Lens Parimeter, Other Pathology (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ1OOD.OEGRPID.CLSRES]	Conjunctival Staining - Zone 1 (OD)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ1OOS.OEGRPID.CLSRES]	Conjunctival Staining - Zone 1 (OS)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ1OOD.OEGRPID.CLSCS]	Conjunctival Staining - Zone 1 (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ1OOS.OEGRPID.CLSCS]	Conjunctival Staining - Zone 1 (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ1OOU.OEGRPID.CLSRES]	Conjunctival Staining - Zone 1 (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.CLSZ6OOD.OEGRPID.CLSRES]	Conjunctival Staining - Zone 6 (OD)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ6OOS.OEGRPID.CLSRES]	Conjunctival Staining - Zone 6 (OS)	float		3		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ6OOD.OEGRPID.CLSCS]	Conjunctival Staining - Zone 6 (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ6OOS.OEGRPID.CLSCS]	Conjunctival Staining - Zone 6 (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSZ6OOU.OEGRPID.CLSRES]	Conjunctival Staining - Zone 6 (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.CLSOTOOD.OEGRPID.CLSOP]	Conjunctival Staining - Outside Scleral Lens Parimeter, Other Pathology (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSOTOOS.OEGRPID.CLSOP]	Conjunctival Staining - Outside Scleral Lens Parimeter, Other Pathology (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSOTOOD.OEGRPID.CLSCS]	Conjunctival Staining - Outside Scleral Lens Parimeter, Other Pathology (OD)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CLSOTOOS.OEGRPID.CLSCS]	Conjunctival Staining - Outside Scleral Lens Parimeter, Other Pathology (OS)	text		0		CRF Annotated Case Report Form [25 ] CRF Annotated Case Report Form [62 ] CRF Annotated Case Report Form [97 ] CRF Annotated Case Report Form [125 ] CRF Annotated Case Report Form [153 ]
	[unresolved: WC.WC.OETESTCD.CFSSUPOD.OEGRPID.CFSRES]	Corneal Staining - Superior (OD)	float		3		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSSUPOS.OEGRPID.CFSRES]	Corneal Staining - Superior (OS)	float		3		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSSUPOD.OEGRPID.CFSCS]	Corneal Staining - Superior (OD)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSSUPOS.OEGRPID.CFSCS]	Corneal Staining - Superior (OS)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSSUPOU.OEGRPID.CFSRES]	Corneal Staining - Superior (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.CFSCTLOD.OEGRPID.CFSRES]	Corneal Staining - Central (OD)	float		3		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSCTLOS.OEGRPID.CFSRES]	Corneal Staining - Central (OS)	float		3		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSCTLOD.OEGRPID.CFSCS]	Corneal Staining - Central (OD)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSCTLOS.OEGRPID.CFSCS]	Corneal Staining - Central (OS)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSCTLOU.OEGRPID.CFSRES]	Corneal Staining - Central (OU)	float		4		Derived
	[unresolved: WC.WC.OETESTCD.CFSINFOD.OEGRPID.CFSRES]	Corneal Staining - Inferior (OD)	float		3		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSINFOS.OEGRPID.CFSRES]	Corneal Staining - Inferior (OS)	float		4		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSINFOD.OEGRPID.CFSCS]	Corneal Staining - Inferior (OD)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSINFOS.OEGRPID.CFSCS]	Corneal Staining - Inferior (OS)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSINFOU.OEGRPID.CFSRES]	Corneal Staining - Inferior (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.CFSOTHOD.OEGRPID.CFSOP]	Corneal Staining - Other Pathology (OD)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSOTHOS.OEGRPID.CFSOP]	Corneal Staining - Other Pathology (OS)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSOTHOD.OEGRPID.CFSCS]	Corneal Staining - Other Pathology (OD)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSOTHOS.OEGRPID.CFSCS]	Corneal Staining - Other Pathology (OS)	text		0		CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [154 ]
	[unresolved: WC.WC.OETESTCD.CFSTOTOD.OEGRPID.CFSRES]	Corneal Staining - Total Score (OD)	float		ND		Derived
	[unresolved: WC.WC.OETESTCD.CFSTOTOS.OEGRPID.CFSRES]	Corneal Staining - Total Score (OS)	float		ND		Derived
	[unresolved: WC.WC.OETESTCD.CFSTOTOU.OEGRPID.CFSRES]	Corneal Staining - Total Score (OU)	float		ND		Derived
	[unresolved: WC.WC.OETESTCD.TBUTWOOD.OEGRPID.TBUT]	Tear Break-Up Time (OD)	float		4		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OETESTCD.TBUTWOOS.OEGRPID.TBUT]	Tear Break-Up Time (OS)	float		4		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OETESTCD.TBUTWOOU.OEGRPID.TBUT]	Tear Break-Up Time (OU)	float		5		Derived
	[unresolved: WC.WC.OETESTCD.IOPOD.OEGRPID.IOP]	Intraocular Pressure (OD)	float		2		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OETESTCD.IOPOS.OEGRPID.IOP]	Intraocular Pressure (OS)	float		2		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OETESTCD.IOPOU.OEGRPID.IOP]	Intraocular Pressure (OU	float		4		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	OETESTCD = "VACA2NOD"	Visual Acuity (OD) - Numerator	float		3		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2NOS"	Visual Acuity (OS) - Numerator	float		2		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2NOU"	Visual Acuity (OU) - Numerator	float		4		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2DOD"	Visual Acuity (OD) - Denominator	float		3		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2DOS"	Visual Acuity (OS) - Denominator	float		3		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2DOU"	Visual Acuity (OU) - Denominator	float		4		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2MOD"	Visual Acuity (OS) - Missed or Additional Letters	float		2		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2MOS"	Visual Acuity (OS) - Missed or Additional Letters	float		2		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	OETESTCD = "VACA2MOU"	Visual Acuity (OS) - Missed or Additional Letters	float		4		CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [156 ]
	[unresolved: WC.WC.OE.OETESTCD.UFVHOD.OEGRPID.UNDFUND]	Undilated Fundoscopy - Vitreous Humour (OD)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFVHOS.OEGRPID.UNDFUND]	Undilated Fundoscopy - Vitreous Humour (OS)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFVHOU.OEGRPID.UNDFUND]	Undilated Fundoscopy - Vitreous Humour (OU)	float		ND		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFVHODA.OEGRPID.UNDFUNDA]	Undilated Fundoscopy - Vitreous Humour (OD)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFVHOSA.OEGRPID.UNDFUNDA]	Undilated Fundoscopy - Vitreous Humour (OU)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFONOD.OEGRPID.UNDFUND]	Undilated Fundoscopy - Optic Nerve (OD)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFONOS.OEGRPID.UNDFUND]	Undilated Fundoscopy - Optic Nerve (OS)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFONOU.OEGRPID.UNDFUND]	Undilated Fundoscopy - Optic Nerve (OU)	float		ND		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFONODA.OEGRPID.UNDFUNDA]	Undilated Fundoscopy - Optic Nerve (OD)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFONOSA.OEGRPID.UNDFUNDA]	Undilated Fundoscopy - Optic Nerve (OS)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFCDOD.OEGRPID.UNDFUND]	Undilated Fundoscopy - Cup to Disc Ratio (Vertical) (OD)	float		4		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFCDOS.OEGRPID.UNDFUND]	Undilated Fundoscopy - Cup to Disc Ratio (Vertical) (OS)	float		4		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFCDOU.OEGRPID.UNDFUND]	Undilated Fundoscopy - Cup to Disc Ratio (Vertical) (OU)	float		7		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFMAOD.OEGRPID.UNDFUND]	Undilated Fundoscopy - Macula (OD)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFMAOS.OEGRPID.UNDFUND]	Undilated Fundoscopy - Macula (OS)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFMAOU.OEGRPID.UNDFUND]	Undilated Fundoscopy - Macula (OU)	float		ND		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFMAODA.OEGRPID.UNDFUNDA]	Undilated Fundoscopy - Macula (OD)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
	[unresolved: WC.WC.OE.OETESTCD.UFMAOSA.OEGRPID.UNDFUNDA]	Undilated Fundoscopy - Macula (OS)	float		0		CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [155 ]
OEORRESU		Original Units	text	VariableQualifier	$7.	UNIT • "%" = "Percentage" • "g/dL" = "Gram per Deciliter" • "IU/L" = "International Unit per Liter" • "mg/dL" = "Milligram per Deciliter" • "mg" = "Milligram"	CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OESTRESC		Character Result/Finding in Std Format	text	ResultQualifier	$81.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OESTRESU		Standard Units	text	VariableQualifier	$8.	UNIT • "%" = "Percentage" • "g/dL" = "Gram per Deciliter" • "IU/L" = "International Unit per Liter" • "mg/dL" = "Milligram per Deciliter" • "mg" = "Milligram"	CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OELOC		Location Used for the Measurement	text	RecordQualifier	$16.	[unresolved: CL.LOC]	CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OELAT		Laterality	text	VariableQualifier	$2.	LAT • "Both Eyes" = "Both Eyes" • "Left Eye" = "Left Eye" • "Right Eye" = "Right Eye"	CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ]
OELOBXFL		Last Observation Before Exposure Flag	text	RecordQualifier	$8.	YN • "No" = "No" • "Yes" = "Yes"	Derived Set to null
OEBLFL		Baseline Flag	text	RecordQualifier	$1.	YN • "No" = "No" • "Yes" = "Yes"	Derived ## COMPUTATION - DERIVATION: OEBLFL logr::put("## ADD BASELINE FLAG FROM SDTM DICTIONARY") oe_od$OEBLFL <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_blfl(oe_od$OETESTCD[x])))
OEDRVFL		Derived Flag	text	RecordQualifier	$1.	[unresolved: CL.NY]	Derived ## COMPUTATION - HARDCODE: DRVFL oe$OEDRVFL[str_detect(oe$OETESTCD, "OU$")] <- "Y" oe$OEDRVFL[!str_detect(oe$OETESTCD, "OU$")] <- "N"
OEREPNUM		Repetition Number	integer	RecordQualifier	$8.		Assigned
VISITNUM		Visit Number	integer	Timing	$1.		Derived ## COMPUTATION - DERIVATION: VISITNUM logr::put("## ADD PLANNED VISITNUM FROM SDTM DICTIONARY") oe_od$VISITNUM <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_visitnum(oe_od$OETESTCD[x])))
VISIT		Visit Name	text	Timing	$28.		Derived ## COMPUTATION - DERIVATION: VISIT logr::put("## ADD PLANNED VISIT FROM SDTM DICTIONARY") oe_od$VISIT <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_visit(oe_od$OETESTCD[x])))
VISITDY		Planned Study Day of Visit	integer	Timing	$3.		Assigned ## COMPUTATION - DERIVATION: STUDYDAYS logr::put("## ADD PLANNED VISITDY FROM SDTM DICTIONARY") oe_od$VISITDY <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_visitdy(oe_od$OETESTCD[x])))
TAETORD		Planned Order of Element within Arm	integer	Timing	$3.		Assigned [unresolved: MT.OE.TAETORD]
EPOCH		Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived sv_oe <- sv %>% dplyr::select(USUBJID, VISITNUM, SVSTDTC, SVSTDY) %>% ## COMPUTATION - DERIVATION: EPOCH dplyr::mutate(EPOCH = unlist(sapply(1:length(USUBJID), function(x) di_epoch_trial( usubjid = USUBJID[x], dtc = SVSTDTC[x])))) ## join datasets oe <- join(oe, sv_oe, type = "left", match = "all")
OEDTC		Date/Time of Collection	date	Timing	YYMMDDHHMM16.	ISO 8601	Derived oe <- oe %>% ## COMPUTATION - DERIVATION: DTC dplyr::mutate(OEDTC = SVSTDTC) %>% dplyr::mutate(OEDY = SVSTDY)
OEDY		Study Day of Visit/Collection/Exam	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Questionnaires (QS)

QS (Questionnaires) - Findings Location: qs.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPQS (Supplemental Qualifiers for Questionnaires)
STUDYID		Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN		Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID		Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
QSSEQ		Sequence Number	integer	Identifier	$3.		Derived qs <- data.frame(qs) %>% dplyr::mutate(., DOMAIN = "QS") %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., USUBJID, VISITNUM, TAETORD) %>% ## COMPUTATION - DERIVATION: SEQ dplyr::mutate(.,QSSEQ = 1:length(USUBJID))
QSGRPID		Group ID	text	Identifier	$6.		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
QSTESTCD		Question Short Name	text	Topic	$8.		Assigned
QSTEST		Question Name	text	SynonymQualifier	$65.		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
QSCAT		Category of Question	text	GroupingQualifier	$72.		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
QSSCAT		Subcategory for Question	text	GroupingQualifier	$59.		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
QSORRESVLM		Finding in Original Units	float	ResultQualifier	$6.		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDFDOS"	SANDE Daytime Frequency (OS)	float		NA		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDFDOD"	SANDE Daytime Frequency (OD)	float		NA		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDFDOU"	SANDE Daytime Frequency (OU)	float		NA		Derived
	QSTESTCD = "SANDSDOS"	SANDE Daytime Severity (OS)	float		NA		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDSDOD"	SANDE Daytime Severity (OD)	float		NA		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDSDOU"	SANDE Daytime Severity (OU)	float		NA		Derived
	QSTESTCD = "SANDFNOS"	SANDE Nighttime Frequency (OS)	float		NA		CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDFNOD"	SANDE Nighttime Frequency (OD)	float		NA		CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDFNOU"	SANDE Nighttime Frequency (OU)	float		NA		Derived
	QSTESTCD = "SANDSNOS"	SANDE Nighttime Severity (OS)	float		NA		CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDSNOD"	SANDE Nighttime Severity (OD)	float		NA		CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDSNOU"	SANDE Nighttime Severity (OU)	float		NA		Derived
	QSTESTCD = "GOSDODOS"	GOSDSQ - Ocular Discomfort (OS)	float		NA		CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDODOD"	GOSDSQ - Ocular Discomfort (OD)	float		NA		CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDODOU"	GOSDSQ - Ocular Discomfort (OU)	float		NA		Derived
	QSTESTCD = "GOSDDROS"	GOSDSQ - Dryness (OS)	float		NA		CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDDROD"	GOSDSQ - Dryness (OD)	float		NA		CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDDROU"	GOSDSQ - Dryness (OU)	float		NA		Derived
	QSTESTCD = "GOSDEROS"	GOSDSQ - Eye Redness (OS)	float		NA		CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDEROD"	GOSDSQ - Eye Redness (OD)	float		NA		CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDEROU"	GOSDSQ - Eye Redness (OU)	float		NA		Derived
	QSTESTCD = "GOSDSLOS"	GOSDSQ - Light Sensitivity (OS)	float		NA		CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDSLOD"	GOSDSQ - Light Sensitivity (OD)	float		NA		CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDSLOU"	GOSDSQ - Light Sensitivity (OU)	float		NA		Derived
	QSTESTCD = "GOSDBCOS"	GOSDSQ - Blurred or Cloudy Vision (OS)	float		NA		CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDBCOD"	GOSDSQ - Blurred or Cloudy Vision (OD)	float		NA		CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDBCOU"	GOSDSQ - Blurred or Cloudy Vision (OU)	float		NA		Derived
	QSTESTCD = "GOSDBDOS"	GOSDSQ - Blinking Discomfort (OS)	float		NA		CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDBDOD"	GOSDSQ - Blinking Discomfort (OD)	float		NA		CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "GOSDBDOU"	GOSDSQ - Blinking Discomfort (OU)	float		NA		Derived
	QSTESTCD = "GOSDSDIS"	GOSDSQ - Sleep Disturbance (OU)	float		ND		CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SLWG01OD"	SLWGQ - Hours Lens in Eye (OD)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG01OS"	SLWGQ - Hours Lens in Eye (OS)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG01OU"	SLWGQ - Hours Lens in Eye (OU)	float		NA		Derived
	QSTESTCD = "SLWG02OD"	SLWGQ - Fewest Hours Due to Physical Discomfort (OD)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG02OS"	SLWGQ - Fewest Hours Due to Physical Discomfort (OS)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG02OU"	SLWGQ - Fewest Hours Due to Physical Discomfort (OU)	float		NA		Derived
	QSTESTCD = "SLWG03OD"	SLWGQ - Fewest Hours Due to Lens Dirtiness or Blurred Vision (OD)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG03OS"	SLWGQ - Fewest Hours Due to Lens Dirtiness or Blurred Vision (OS)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG03OU"	SLWGQ - Fewest Hours Due to Lens Dirtiness or Blurred Vision (OU)	float		NA		Derived
	QSTESTCD = "SLWG04OD"	SLWGQ - Number of Times Removed, Cleaned and Reinserted Lens (OD)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG04OS"	SLWGQ - Number of Times Removed, Cleaned and Reinserted Lens (OS)	float		NA		CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [147 ]
	QSTESTCD = "SLWG04OU"	SLWGQ - Number of Times Removed, Cleaned and Reinserted Lens (OU)	float		NA		Derived
	QSTESTCD = "SANDGDOS"	SANDE Daytime Global Score (OS)	float		NA		CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDGDOD"	SANDE Daytime Global Score (OD)	float		NA		CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDGDOU"	SANDE Daytime Global Score (OU)	float		NA		Derived
	QSTESTCD = "SANDGNOS"	SANDE Nightime Global Score (OS)	float		NA		CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDGNOD"	SANDE Nighttime Global Score (OD)	float		NA		CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [161 ]
	QSTESTCD = "SANDGNOU"	SANDE Nighttime Global Score (OU)	float		NA		Derived
QSORRESU		Original Units	text	VariableQualifier	$5.	UNIT • "%" = "Percentage" • "g/dL" = "Gram per Deciliter" • "IU/L" = "International Unit per Liter" • "mg/dL" = "Milligram per Deciliter" • "mg" = "Milligram"	CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
QSSTRESC		Character Result/Finding in Std Format	text	ResultQualifier	$2.		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
QSSTRESN		Numeric Finding in Standard Units	float	ResultQualifier	$2.		CRF Annotated Case Report Form [13 ] CRF Annotated Case Report Form [14 ] CRF Annotated Case Report Form [15 ] CRF Annotated Case Report Form [16 ] CRF Annotated Case Report Form [17 ] CRF Annotated Case Report Form [18 ] CRF Annotated Case Report Form [19 ] CRF Annotated Case Report Form [36 ] CRF Annotated Case Report Form [42 ] CRF Annotated Case Report Form [45 ] CRF Annotated Case Report Form [50 ] CRF Annotated Case Report Form [51 ] CRF Annotated Case Report Form [52 ] CRF Annotated Case Report Form [53 ] CRF Annotated Case Report Form [54 ] CRF Annotated Case Report Form [55 ] CRF Annotated Case Report Form [56 ] CRF Annotated Case Report Form [71 ] CRF Annotated Case Report Form [77 ] CRF Annotated Case Report Form [80 ] CRF Annotated Case Report Form [85 ] CRF Annotated Case Report Form [86 ] CRF Annotated Case Report Form [87 ] CRF Annotated Case Report Form [88 ] CRF Annotated Case Report Form [89 ] CRF Annotated Case Report Form [90 ] CRF Annotated Case Report Form [91 ] CRF Annotated Case Report Form [106 ] CRF Annotated Case Report Form [113 ] CRF Annotated Case Report Form [114 ] CRF Annotated Case Report Form [115 ] CRF Annotated Case Report Form [116 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [118 ] CRF Annotated Case Report Form [119 ] CRF Annotated Case Report Form [134 ] CRF Annotated Case Report Form [141 ] CRF Annotated Case Report Form [142 ] CRF Annotated Case Report Form [143 ] CRF Annotated Case Report Form [144 ] CRF Annotated Case Report Form [145 ] CRF Annotated Case Report Form [146 ] CRF Annotated Case Report Form [147 ] CRF Annotated Case Report Form [161 ]
QSBLFL		Baseline Flag	text	RecordQualifier	$1.	YN • "No" = "No" • "Yes" = "Yes"	Derived ## COMPUTATION - DERIVATION: BLFL logr::put("## ADD BASELINE FLAG FROM SDTM DICTIONARY") qs_od$QSBLFL <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_blfl(qs_od$QSTESTCD[x])))
QSDRVFL		Derived Flag	text	RecordQualifier	$1.	[unresolved: CL.NY]	Derived ## COMPUTATION - HARDCODE: DRVFL qs$QSDRVFL[str_detect(qs$QSTESTCD, "OU$")] <- "Y" qs$QSDRVFL[!str_detect(qs$QSTESTCD, "OU$")] <- "N"
VISITNUM		Visit Number	integer	Timing	$1.		Derived ## COMPUTATION - DERIVATION: VISITNUM logr::put("## ADD PLANNED VISITNUM FROM SDTM DICTIONARY") qs_od$VISITNUM <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_visitnum(qs_od$QSTESTCD[x])))
VISIT		Visit Name	text	Timing	$28.		Derived ## COMPUTATION - DERIVATION: VISIT logr::put("## ADD PLANNED VISIT FROM SDTM DICTIONARY") qs_od$VISIT <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_visit(qs_od$QSTESTCD[x])))
VISITDY		Planned Study Day of Visit	integer	Timing	$3.		Assigned ## COMPUTATION - DERIVATION: VISITDY logr::put("## ADD PLANNED VISITDY FROM SDTM DICTIONARY") qs_od$VISITDY <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_visitdy(qs_od$QSTESTCD[x])))
TAETORD		Planned Order of Element within Arm	integer	Timing	$2.		Assigned parmcd_dt <- sdtm_value[sdtm_value$DOMAIN %in% "QS",] ## COMPUTATION - DERIVATION: TAETORD qs$TAETORD <- NA for(i in 1:length(parmcd_dt$VALUENAME)) { qs$TAETORD[str_detect(qs$QSTESTCD, parmcd_dt$VALUENAME[i])] <- parmcd_dt$VARNUM[i] print(i) }
EPOCH		Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived sv_qs <- sv %>% dplyr::select(USUBJID, VISITNUM, SVSTDTC, SVSTDY) %>% ## COMPUTATION - DERIVATION: EPOCH dplyr::mutate(EPOCH = unlist(sapply(1:length(USUBJID), function(x) di_epoch_trial( usubjid = USUBJID[x], dtc = SVSTDTC[x])))) ## join datasets qs <- join(qs, sv_qs, type = "left", match = "all")
QSDTC		Date/Time of Finding	date	Timing	YYMMDD10.	ISO 8601	Derived qs <- qs %>% ## COMPUTATION - DERIVATION: DTC dplyr::mutate(QSDTC = SVSTDTC) %>% dplyr::mutate(QSDY = SVSTDY)
QSDY		Study Day of Finding	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Subject Characteristics (SC)

SC (Subject Characteristics) - Findings Location: sc.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
SCSEQ	Sequence Number	integer	Identifier	$1.		Derived ## COMPUTATION - DERIVATION: SCSEQ dplyr::mutate(.,SCSEQ = 1:length(USUBJID))
SCTESTCD	Subject Characteristic Short Name	text	Topic	$4.	[unresolved: CL.SCTESTCD]	CRF Annotated Case Report Form [3 ] SCTESTCD are hardcoded depending on the Eye (for example): ## COMPUTATION - HARDCODE: DOMAIN, SCTEST, SCTESTCD dplyr::mutate(., ICOD = ifelse(is.na(ICOS_Spe), ICOS, ICOS_Spec)) %>% dplyr::mutate(., DOMAIN = "SC") %>% dplyr::mutate(., SCTEST = "Iris Color, OS") %>% dplyr::mutate(., SCTESTCD = "ICOS")
SCTEST	Subject Characteristic	text	SynonymQualifier	$14.	[unresolved: CL.SCTEST]	CRF Annotated Case Report Form [3 ] SCTEST are hardcoded depending on the Eye (for example): ## COMPUTATION - HARDCODE: DOMAIN, SCTEST, SCTESTCD dplyr::mutate(., ICOD = ifelse(is.na(ICOS_Spe), ICOS, ICOS_Spec)) %>% dplyr::mutate(., DOMAIN = "SC") %>% dplyr::mutate(., SCTEST = "Iris Color, OS") %>% dplyr::mutate(., SCTESTCD = "ICOS")
VISITNUM	Visit Number	integer	Timing	$1.		Derived ## COMPUTATION - HARDCODE: VISITNUM dplyr::mutate(VISITNUM = "1")
SCORRES	Result or Finding in Original Units	float	ResultQualifier	$5.		CRF Annotated Case Report Form [3 ]
SCSTRESC	Character Result/Finding in Std Format	text	ResultQualifier	$5.		CRF Annotated Case Report Form [3 ] ## COMPUTATION - DERIVATION: SCSTRESC dplyr::mutate(SCSTRESC = str_to_title(SCORRES))
SCDTC	Date/Time of Collection	date	Timing	YYMMDD10.	ISO 8601	Derived ## COMPUTATION - DERIVATION: SCDTC dplyr::mutate(., SCDTC = dmy(ICFDTC))
SCDY	Study Day of Examination	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Subject Elements (SE)

SE (Subject Elements) - Special Purpose Location: se.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
SESEQ	Sequence Number	integer	Identifier	$1.		Derived ## COMPUTATION - HARDCODE: SESEQ se$SESEQ <- se$VISITNUM
ETCD	Element Code	text	Topic	$7.		Derived ## COMPUTATION - DERIVATION: ETCD se$ETCD <- ifelse(se$VISITNUM %in% c(1), "SCREEN", ifelse(se$VISITNUM %in% c(2,3), "MASKED", ifelse(se$VISITNUM %in% c(4,5), "OPEN", ifelse(se$VISITNUM %in% c(6,7), "OPENEXT", NA))))
ELEMENT	Description of Element	text	SynonymQualifier	$26.		Derived ## COMPUTATION - DERIVATION: VISITNUM se$ELEMENT <- ifelse(se$VISITNUM %in% c(1), "Screening & Baseline", ifelse(se$VISITNUM %in% c(2,3), "Masked Phase", ifelse(se$VISITNUM %in% c(4,5), "Open-label Phase", ifelse(se$VISITNUM %in% c(6,7), "Open-label Extension Phase", NA))))
TAETORD	Planned Order of Element within Arm	integer	Timing	$1.		Derived ### COMPUTATION - HARDCODE: VISITNUM dplyr::mutate(., TAETORD = VISITNUM)
EPOCH	Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived ## COMPUTATION - DERIVATION: EPOCH se$EPOCH <- ifelse(se$VISITNUM %in% c(1), "Screening & Baseline", ifelse(se$VISITNUM %in% c(2,3), "Masked Phase", ifelse(se$VISITNUM %in% c(4,5), "Open-label Phase", ifelse(se$VISITNUM %in% c(6,7), "Open-label Extension Phase", NA))))
SESTDTC	Start Date/Time of Element	date	Timing	YYMMDD10.	ISO 8601	Derived Assigned based on VISITNUM & SVSTDTC
SEENDTC	End Date/Time of Element	date	Timing	YYMMDD10.	ISO 8601	Derived Assigned based on VISITNUM & SVENDTC & EOP: logr::put("## MAPS SEENDTC TO THE NEXT VISIT -1 DAY OR END OF PARTICIPATION") di_seendtc <- function(x) { ## Capture end of participation date if available xx <- db %>% tidyr::unite(., col = 'SE.SEENDTC', "DS_YY", "DS_MM", "DS_DD", sep = '-', remove = FALSE) %>% dplyr::select(., USUBJID, SE.SEENDTC) ## Replace missing dates with NA xx$SE.SEENDTC[xx$SE.SEENDTC == "NA-NA-NA"] <- NA ## Replace missing dates with NA x$SESTDTC[x$SESTDTC == "NA-NA-NA"] <- NA ## Define the end of participation date eop <- xx$SE.SEENDTC[xx$USUBJID %in% x$USUBJID[1]] ## Assign an index for the first missing date (NA) in SESTDTC indx <- which(is.na(x$SESTDTC))[1] ## Apply an end of participation date if applicable to the last SESTDTC x$SESTDTC[indx] <- eop ## Define the end of the SESTDTC period by the next SESTDTC - 1 day x$SEENDTC <- dplyr::lead(ymd(x$SESTDTC), n = 1, default = NA) -1 ## If subject has no EOP date, end the function if (is.na(eop)) { xxx <- x %>% dplyr::select(STUDYID, DOMAIN, USUBJID, SESEQ, ETCD, ELEMENT, TAETORD, EPOCH, SESTDTC, SEENDTC, SESTDY,SEENDY) xxx } else ## Define the EOP as the last element and return the dates x$SEENDTC[indx] <- eop # x$SEENDTC[length(x$SESTDTC)] <- x$SESTDTC[length(x$SESTDTC)] xxx <- x %>% dplyr::select(STUDYID, DOMAIN, USUBJID, SESEQ, ETCD, ELEMENT, TAETORD, EPOCH, SESTDTC, SEENDTC, SESTDY,SEENDY) xxx } logr::put("## CALCULATE START STUDY DAYS FOR DATASET") sestdy <- c() for (i in 1:length(se$USUBJID)) { sestdy[i] <- di_dy_trial(usubjid = se$USUBJID[i], dtc = se$SESTDTC[i]) print(i) } se$SESTDY[] <- unlist(as.character(sestdy))
SESTDY	Study Day of Start of Element	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
SEENDY	Study Day of End of Element	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Supplemental Qualifiers for Adverse Events (SUPPAE)

SUPPAE (Supplemental Qualifiers for Adverse Events) - Relationship Location: suppae.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: AE (Adverse Events)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.SV]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$13.		Assigned IDVAR = "USUBJID.AESEQ"
IDVARVAL	Identifying Variable Value	text	Identifier	$13.		Assigned IDVARVAL is the unique concatenation of USUBJID and AESEQ: dplyr::mutate(., IDVARVAL = paste0(USUBJID, ".", AESEQ))
QNAM	Qualifier Variable Name	text	Topic	$20.		CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ] logr::put("## RESHAPE V4EVA FROM WIDE TO LONG AND MAP TO VISITS IN SUPPSV") suppae <- ae %>% ## DERIVATION - COMPUTATION: SUPPAE.QNAM dplyr::select_at(., suppae_cols) %>% tidyr::pivot_longer(cols = suppae_cols[-c(5:7)], values_to = "QVAL", names_to = "QNAM")
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$20.		CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ] ## DERIVATION - COMPUTATION: SUPPAE.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QVALVLM	Data Value	text	RecordQualifier	$72.		CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ] Values from variable (QNAM) are assigned to QVAL: dplyr::select_at(., suppae_cols) %>% tidyr::pivot_longer(cols = suppae_cols[-c(5:7)], values_to = "QVAL", names_to = "QNAM")
➤ QNAM = "AECOM"	Comments	text		4		CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ]
QORIG	Origin	text	RecordQualifier	$39.		CRF Annotated Case Report Form [31 ] CRF Annotated Case Report Form [44 ] CRF Annotated Case Report Form [67 ] CRF Annotated Case Report Form [79 ] CRF Annotated Case Report Form [102 ] CRF Annotated Case Report Form [130 ] CRF Annotated Case Report Form [157 ] ## DERIVATION - HARDCODE: SUPPAE.QORIG dplyr::mutate(., QORIG = "CRF Pages 31, 44, 67, 79, 102, 130, 157")
QEVAL	Evaluator	text	RecordQualifier	$8.		Assigned

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Supplemental Qualifiers for Concomitant Medications (SUPPCM)

SUPPCM (Supplemental Qualifiers for Concomitant Medications) - Relationship Location: suppcm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: CM (Concomitant Medications)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.DM]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$7.		Assigned ## COMPUTATION - HARDCODE: CM.IDVAR dplyr::mutate(., IDVAR = "USUBJID")
IDVARVAL	Identifying Variable Value	text	Identifier	$11.		Assigned ## COMPUTATION - DERIVATION: CM.IDVARVAL dplyr::mutate(., IDVARVAL = paste0(USUBJID))
QNAM	Qualifier Variable Name	text	Topic	$72.		CRF Annotated Case Report Form [4 ] CRF Annotated Case Report Form [10 ] CRF Annotated Case Report Form [11 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [140 ] logr::put("## RESHAPE V4EVA FROM WIDE TO LONG AND MAP TO VISITS IN SUPPSV") suppcm <- db %>% dplyr::select_at(., .vars = suppcm_cols) %>% ## COMPUTATION - DERIVATION: QNAM tidyr::pivot_longer(cols = suppcm_cols[-c(16:17)], values_to = "QVAL", names_to = "QNAM")
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$57.		CRF Annotated Case Report Form [4 ] CRF Annotated Case Report Form [10 ] CRF Annotated Case Report Form [11 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [140 ] ## COMPUTATION - DERIVATION: CM.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QVALVLM	Data Value	text	RecordQualifier	$28.		CRF Annotated Case Report Form [4 ] CRF Annotated Case Report Form [10 ] CRF Annotated Case Report Form [11 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [140 ] ## COMPUTATION - DERIVATION: QNAM tidyr::pivot_longer(cols = suppcm_cols[-c(16:17)], values_to = "QVAL", names_to = "QNAM")
➤ QNAM = "V1CPYCON_Oth"	Other, specify	text		0		CRF Annotated Case Report Form [4 ]
➤ QNAM = "V1CPYCONYN_Oth"	Does subject agree to use one of the acceptable methods of birth control if she becomes sexually active	text		ND		CRF Annotated Case Report Form [4 ]
➤ QNAM = "V1NOMH60YN"	Is there any Non-Ocular Medication history for the past sixty days	text		ND		CRF Annotated Case Report Form [10 ]
➤ QNAM = "V1NOMHBLYN"	Hormone Replacement Therapy Blockers	text		ND		CRF Annotated Case Report Form [10 ]
➤ QNAM = "V1TDYN"	Is subject using any Concomitant Ocular Treatment Device	text		1		CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDPPYN"	Is subject using any Punctal Plugs	text		ND		CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDPPDTC"	Date First in Use (od upper)	date		ND	ISO 8601	CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDPP1DTC"	Date First in Use (od lower)	date		ND	ISO 8601	CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDPP2DTC"	Date First in Use (OS upper)	date		ND	ISO 8601	CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDPP3DTC"	Date First in Use (OS lower)	date		ND	ISO 8601	CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDGYM"	Does subject wear goggles or eyewear at night	text		ND		CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDGOD"	Type of Scleral Lens OD	text		28		CRF Annotated Case Report Form [11 ]
➤ QNAM = "V1TDGOS"	Type of Scleral Lens OS	text		28		CRF Annotated Case Report Form [11 ]
QORIG	Origin	text	RecordQualifier	$11.		CRF Annotated Case Report Form [4 ] CRF Annotated Case Report Form [10 ] CRF Annotated Case Report Form [11 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [117 ] CRF Annotated Case Report Form [140 ] logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: CM.QORIG suppcm$QORIG <- unlist(sapply(1:length(suppcm$QNAM), function(x) di_map_qorig(suppcm$QNAM[x])))
QEVAL	Evaluator	text	RecordQualifier	$8.		Assigned

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Supplemental Qualifiers for Demographics (SUPPDM)

SUPPDM (Supplemental Qualifiers for Demographics) - Relationship Location: suppdm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: DM (Demographics)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.DM]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$7.		Assigned ## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
IDVARVAL	Identifying Variable Value	text	Identifier	$11.		Assigned ## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QNAM	Qualifier Variable Name	text	Topic	$7.		CRF Annotated Case Report Form [2 ] CRF Annotated Case Report Form [3 ] ## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$31.		CRF Annotated Case Report Form [2 ] CRF Annotated Case Report Form [3 ] ## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QVALVLM	Data Value	text	RecordQualifier	$36.		CRF Annotated Case Report Form [2 ] CRF Annotated Case Report Form [3 ] ## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
➤ QNAM = "SCREENO"	Screenning Number	text		1		CRF Annotated Case Report Form [2 ] [unresolved: MT.SUPPDM.SCREENO]
➤ QNAM = "RANDNO"	Randomization Number	text		1		Derived [unresolved: MT.SUPPDM.RANDNO]
➤ QNAM = "RACEOTH"	Race, Other	text		ND		CRF Annotated Case Report Form [3 ] [unresolved: MT.SUPPDM.RACEOTH]
➤ QNAM = "ONNOT"	Does subject agree to have Principal Investigator notify subjects oncologist of subjects participation in this study	text		ND		CRF Annotated Case Report Form [12 ]
➤ QNAM = "ONNOTDTC"	Notification Date	text		ND		CRF Annotated Case Report Form [12 ]
➤ QNAM = "OPNOT"	Does subject agree to have Principal Investigator notify subjects ophthalmologist of subjects participation in this study	text		ND		CRF Annotated Case Report Form [12 ]
➤ QNAM = "OPNOTDTC"	Notification Date	text		ND		CRF Annotated Case Report Form [12 ]
QORIG	Origin	text	RecordQualifier	$2.		CRF Annotated Case Report Form [2 ] CRF Annotated Case Report Form [3 ] ## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QEVAL	Evaluator	text	RecordQualifier	$36.		Assigned ## Evaluators -- "Wei-wei Chang, Jonathan D. Stallings"

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Supplemental Qualifiers for Inclusion/Exclusion Exceptions (SUPPIE)

SUPPIE (Supplemental Qualifiers for Inclusion/Exclusion Exceptions) - Relationship Location: suppie.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: IE (Inclusion/Exclusion Exceptions)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.SI]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$5.		Assigned ## COMPUTATION - HARDCODE: SUPPIE.IDVAR dplyr::mutate(., IDVAR = "IESEQ")
IDVARVAL	Identifying Variable Value	text	Identifier	$2.		Assigned logr::put("## HARDCODE IDVARVAL BASED ON IESEQ") ## COMPUTATION - DERIVATION: SUPPIE.IDVARVAL suppie$IDVARVAL <- ifelse(suppie$QNAM %in% c("IEOC1_chk", "IEOC1_imp"), "28", ifelse(suppie$QNAM %in% c("IEOC2_chk", "IEOC2_imp"), "29", ifelse(suppie$QNAM == "REASON", "1", NA)))
QNAM	Qualifier Variable Name	text	Topic	$9.		CRF Annotated Case Report Form [7 ] logr::put("## CREATE SUPPIE (SUPPLEMENTAL) DATASET") suppie <- suppie %>% ## COMPUTATION - DERIVATION: SUPPIE.QNAM tidyr::pivot_longer(cols = suppie_cols[!(suppie_cols %in% c(keep_cols))], values_to = "QVAL", names_to = "QNAM")
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$35.		CRF Annotated Case Report Form [7 ] di_map_test function is used to map the db dictionary labels to QLABEL: ## COMPUTATION - DERIVATION: SUPPIE.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QVALVLM	Data Value	text	RecordQualifier	$96.		CRF Annotated Case Report Form [7 ] Values from variable (QNAM) are assigned to QVAL: tidyr::pivot_longer(cols = suppie_cols[!(suppie_cols %in% c(keep_cols))], values_to = "QVAL", names_to = "QNAM")
➤ QNAM = "REASON"	reason for screen failure	text		96		CRF Annotated Case Report Form [28 ]
➤ QNAM = "IEOC1_chk"	SYSTEM CALCULATION Date check	text		23		CRF Annotated Case Report Form [7 ]
➤ QNAM = "IEOC1_imp"	SYSTEM CALCULATION Imputed date	text		10		CRF Annotated Case Report Form [7 ]
➤ QNAM = "IEOC2_chk"	SYSTEM CALCULATION Date check	text		23		CRF Annotated Case Report Form [7 ]
➤ QNAM = "IEOC2_imp"	SYSTEM CALCULATION Imputed date	text		10		CRF Annotated Case Report Form [7 ]
QORIG	Origin	text	RecordQualifier	$10.		CRF Annotated Case Report Form [7 ] logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: SUPPIE.QORIG suppie$QORIG <- unlist(sapply(1:length(suppie$QNAM), function(x) di_map_qorig(suppie$QNAM[x])))
QEVAL	Evaluator	text	RecordQualifier	$8.		Assigned

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Supplemental Qualifiers for Medical History (SUPPMH)

SUPPMH (Supplemental Qualifiers for Medical History) - Relationship Location: suppmh.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: MH (Medical History)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.SV]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$6.		Assigned ## COMPUTATION - HARDCODE: SUPPMH.IDVAR dplyr::mutate(., IDVAR = "MHTERM")
IDVARVAL	Identifying Variable Value	text	Identifier	$2.		Assigned ## COMPUTATION - DERIVATION: SUPPMH.IDVARVAL dplyr::mutate(., IDVARVAL = MHSEQ)
QNAM	Qualifier Variable Name	text	Topic	$5.		CRF Annotated Case Report Form [8 ] ## COMPUTATION - DERIVATION: SUPPMH.QNAM dplyr::mutate(., QNAM = ifelse(MHCAT %in% "Ocular Medical History", "OHCOM", ifelse(MHCAT %in% "Non-Ocular Medical History", "MHCOM", NA)))
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$7.		CRF Annotated Case Report Form [8 ] ## COMPUTATION - HARDCODE: SUPPMH.QLABEL dplyr::mutate(., QLABEL = "Comment")
QVALVLM	Data Value	text	RecordQualifier	$9.		CRF Annotated Case Report Form [8 ] Values for QVAL are assigned from the MHCOM from each MH Dataset: ## COMPUTATION - HARDCODE: SUPPMH.QVAL dplyr::mutate(., QVAL = MHCOM)
➤ QNAM = "V1CVCON"	Have subject been in contact with anyone confirmed or suspected to have COVID-19 in the past 28 days	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVSUS"	Has subject been diagnosed with or suspected to have COVID-19	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVLOC"	Location	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVRES"	Residence	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVFEV"	Fever or chills	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVCOU"	Cough	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVBRE"	Shortness of Breath	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVCHP"	Chest pain	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVSTH"	Sore throat	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVNVG"	Nausea, vomiting, GI distress	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVTST"	Have you experienced loss of taste or smell	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVMAC"	New onset muscles aches	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVFAT"	Generally feeling unwell, fatigue	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVANY"	Any other concerning symptoms	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "V1CVANY_Oth"	Any other concerning symptoms	text		ND		CRF Annotated Case Report Form [1 ] [unresolved: COM.SettoNULLbecausenosubjectsreportedCOVID19]
➤ QNAM = "OHCOM"	Comment	text		4		CRF Annotated Case Report Form [8 ]
➤ QNAM = "OPCOM"	Comment	text		ND		CRF Annotated Case Report Form [8 ]
➤ QNAM = "MHCOM"	Comment	text		9		CRF Annotated Case Report Form [9 ]
➤ QNAM = "PRYN"	Is there any Surgical History	text		ND		CRF Annotated Case Report Form [9 ]
➤ QNAM = "PRCOM"	Comment	text		ND		CRF Annotated Case Report Form [9 ]
➤ QNAM = "V1CPHY"	Has subject had hysterectomy	text		ND		CRF Annotated Case Report Form [9 ]
➤ QNAM = "V1CPOO"	Oophorectomy	text		ND		CRF Annotated Case Report Form [9 ]
QORIG	Origin	text	RecordQualifier	$10.		CRF Annotated Case Report Form [8 ] ## COMPUTATION - HARDCODE: SUPPMH.QORIG dplyr::mutate(., QORIG = "CRF Page 8")
QEVAL	Evaluator	text	RecordQualifier	$8.		Assigned

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Supplemental Qualifiers for Opthalmic Examinations (SUPPOE)

SUPPOE (Supplemental Qualifiers for Opthalmic Examinations) - Relationship Location: suppmh.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: OE (Opthalmic Examinations)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.SV]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$8.		Assigned ## COMPUTATION - HARDCODE: SUPPOE.IDVAR dplyr::mutate(., IDVAR = "VISITNUM")
IDVARVAL	Identifying Variable Value	text	Identifier	$1.		Assigned logr::put("## ADD VISITNUM FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: SUPPOE.IDVARVAL suppoe$IDVARVAL <- unlist(sapply(1:length(suppoe$QNAM), function(x) di_map_visitnum(suppoe$QNAM[x])))
QNAM	Qualifier Variable Name	text	Topic	$14.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ] suppoe <- oe %>% dplyr::select_at(., .vars = suppoe_cols) %>% ## COMPUTATION - DERIVATION: SUPPOE.QNAM tidyr::pivot_longer(cols = suppoe_cols[-c(1)], values_to = "QVAL", names_to = "QNAM")
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$89.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ] ## COMPUTATION - DERIVATION: SUPPOE.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QVALVLM	Data Value	text	RecordQualifier	$77.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ] Values from variable (QNAM) are assigned to QVAL: tidyr::pivot_longer(cols = suppoe_cols[-c(1)], values_to = "QVAL", names_to = "QNAM")
➤ QNAM = "V1A1YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1A1N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1W_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1W_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1W_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1WKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1WKN"	If No, then please provide reason	text		47		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1WK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1WK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [20 ]
➤ QNAM = "V1WEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [21 ]
➤ QNAM = "V1WEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [21 ]
➤ QNAM = "V1WO_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [21 ]
➤ QNAM = "V1WO_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [21 ]
➤ QNAM = "V1WO_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [21 ]
➤ QNAM = "V1WOKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [22 ]
➤ QNAM = "V1WOKN"	If No, then please provide reason	text		75		CRF Annotated Case Report Form [22 ]
➤ QNAM = "V1WOK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [22 ]
➤ QNAM = "V1WOK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [22 ]
➤ QNAM = "V1WOEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [22 ]
➤ QNAM = "V1WOEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [22 ]
➤ QNAM = "V1IPWO_YN"	Was Intraocular Pressure measured	text		3		CRF Annotated Case Report Form [27 ]
➤ QNAM = "V1IPWO_N"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [27 ]
➤ QNAM = "V1UFWO_YN"	Undilated Fundoscopy	text		0		CRF Annotated Case Report Form [27 ]
➤ QNAM = "V1UFWO_N"	If No, then please provide reason	text		33		CRF Annotated Case Report Form [27 ]
➤ QNAM = "V1A2YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [28 ]
➤ QNAM = "V1A2N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [28 ]
➤ QNAM = "V3A1YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3A1N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3W_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3W_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3W_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3WKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3WKN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3WK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3WK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [57 ]
➤ QNAM = "V3WEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [58 ]
➤ QNAM = "V3WEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [58 ]
➤ QNAM = "V3WO_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [58 ]
➤ QNAM = "V3WO_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [58 ]
➤ QNAM = "V3WO_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [58 ]
➤ QNAM = "V3WOKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [58 ]
➤ QNAM = "V3WOKN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [59 ]
➤ QNAM = "V3WOK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [59 ]
➤ QNAM = "V3WOK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [59 ]
➤ QNAM = "V3WOEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [59 ]
➤ QNAM = "V3WOEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [59 ]
➤ QNAM = "V3IPWO_YN"	Was Intraocular Pressure measured	text		3		CRF Annotated Case Report Form [64 ]
➤ QNAM = "V3IPWO_N"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [64 ]
➤ QNAM = "V3UFWO_YN"	Undilated Fundoscopy	text		0		CRF Annotated Case Report Form [64 ]
➤ QNAM = "V3UFWO_N"	If No, then please provide reason	text		42		CRF Annotated Case Report Form [64 ]
➤ QNAM = "V3A2YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [65 ]
➤ QNAM = "V3A2N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [65 ]
➤ QNAM = "V5A1YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5A1N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5W_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5W_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5W_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5WKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5WKN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5WK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5WK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [92 ]
➤ QNAM = "V5WEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [93 ]
➤ QNAM = "V5WEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [93 ]
➤ QNAM = "V5WO_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [93 ]
➤ QNAM = "V5WO_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [93 ]
➤ QNAM = "V5WO_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [93 ]
➤ QNAM = "V5WOKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [94 ]
➤ QNAM = "V5WOKN"	If No, then please provide reason	text		23		CRF Annotated Case Report Form [94 ]
➤ QNAM = "V5WOK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [94 ]
➤ QNAM = "V5WOK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [94 ]
➤ QNAM = "V5WOEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [94 ]
➤ QNAM = "V5WOEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [94 ]
➤ QNAM = "V5IPWO_YN"	Was Intraocular Pressure measured	text		3		CRF Annotated Case Report Form [99 ]
➤ QNAM = "V5IPWO_N"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [99 ]
➤ QNAM = "V5UFWO_YN"	Undilated Fundoscopy	text		0		CRF Annotated Case Report Form [99 ]
➤ QNAM = "V5UFWO_N"	If No, then please provide reason	text		32		CRF Annotated Case Report Form [99 ]
➤ QNAM = "V5A2YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [100 ]
➤ QNAM = "V5A2N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [100 ]
➤ QNAM = "V6A1YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6A1N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6W_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6W_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6W_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6WKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6WKN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6WK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6WK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [120 ]
➤ QNAM = "V6WEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [121 ]
➤ QNAM = "V6WEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [121 ]
➤ QNAM = "V6WO_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [121 ]
➤ QNAM = "V6WO_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [121 ]
➤ QNAM = "V6WO_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [121 ]
➤ QNAM = "V6WOKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [122 ]
➤ QNAM = "V6WOKN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [122 ]
➤ QNAM = "V6WOK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [122 ]
➤ QNAM = "V6WOK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [122 ]
➤ QNAM = "V6WOEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [122 ]
➤ QNAM = "V6WOEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [122 ]
➤ QNAM = "V6IPWO_YN"	Was Intraocular Pressure measured	text		3		CRF Annotated Case Report Form [127 ]
➤ QNAM = "V6IPWO_N"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [127 ]
➤ QNAM = "V6UFWO_YN"	Undilated Fundoscopy	text		0		CRF Annotated Case Report Form [127 ]
➤ QNAM = "V6UFWO_N"	If No, then please provide reason	text		32		CRF Annotated Case Report Form [127 ]
➤ QNAM = "V6A2YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [128 ]
➤ QNAM = "V6A2N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [128 ]
➤ QNAM = "V7A1YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7A1N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7W_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7W_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7W_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7WKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7WKN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7WK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7WK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [148 ]
➤ QNAM = "V7WEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [149 ]
➤ QNAM = "V7WEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [149 ]
➤ QNAM = "V7WO_FPYN"	Was facial photo of subject taken	text		3		CRF Annotated Case Report Form [149 ]
➤ QNAM = "V7WO_TSYNOD"	Was TearScan image taken and saved (od right eye)	text		3		CRF Annotated Case Report Form [149 ]
➤ QNAM = "V7WO_TSYNOS"	Was TearScan image taken and saved (OS LEFT EYE)	text		3		CRF Annotated Case Report Form [149 ]
➤ QNAM = "V7WOKYN"	Was Keratograph Redness Scan performed	text		3		CRF Annotated Case Report Form [150 ]
➤ QNAM = "V7WOKN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [150 ]
➤ QNAM = "V7WOK_OD"	Could od (right eye) image be obtained	text		ND		CRF Annotated Case Report Form [150 ]
➤ QNAM = "V7WOK_OS"	Could OS (LEFT EYE) image be obtained	text		ND		CRF Annotated Case Report Form [150 ]
➤ QNAM = "V7WOEGSYN"	Was Efron Grading Scale performed	text		3		CRF Annotated Case Report Form [150 ]
➤ QNAM = "V7WOEGSN"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [150 ]
➤ QNAM = "V7IPWO_YN"	Was Intraocular Pressure measured	text		3		CRF Annotated Case Report Form [155 ]
➤ QNAM = "V7IPWO_N"	If No, then please provide reason	text		0		CRF Annotated Case Report Form [155 ]
➤ QNAM = "V7UFWO_YN"	Undilated Fundoscopy	text		0		CRF Annotated Case Report Form [155 ]
➤ QNAM = "V7UFWO_N"	If No, then please provide reason	text		32		CRF Annotated Case Report Form [155 ]
➤ QNAM = "V7A2YN"	Was visual acuity performed	text		ND		CRF Annotated Case Report Form [156 ]
➤ QNAM = "V7A2N"	If No, then please provide reason	text		ND		CRF Annotated Case Report Form [156 ]
QORIG	Origin	text	RecordQualifier	$18.		CRF Annotated Case Report Form [20 ] CRF Annotated Case Report Form [21 ] CRF Annotated Case Report Form [22 ] CRF Annotated Case Report Form [24 ] CRF Annotated Case Report Form [26 ] CRF Annotated Case Report Form [27 ] CRF Annotated Case Report Form [28 ] CRF Annotated Case Report Form [38 ] CRF Annotated Case Report Form [41 ] CRF Annotated Case Report Form [49 ] CRF Annotated Case Report Form [57 ] CRF Annotated Case Report Form [58 ] CRF Annotated Case Report Form [59 ] CRF Annotated Case Report Form [61 ] CRF Annotated Case Report Form [63 ] CRF Annotated Case Report Form [64 ] CRF Annotated Case Report Form [65 ] CRF Annotated Case Report Form [73 ] CRF Annotated Case Report Form [76 ] CRF Annotated Case Report Form [84 ] CRF Annotated Case Report Form [92 ] CRF Annotated Case Report Form [93 ] CRF Annotated Case Report Form [94 ] CRF Annotated Case Report Form [96 ] CRF Annotated Case Report Form [98 ] CRF Annotated Case Report Form [99 ] CRF Annotated Case Report Form [100 ] CRF Annotated Case Report Form [108 ] CRF Annotated Case Report Form [112 ] CRF Annotated Case Report Form [120 ] CRF Annotated Case Report Form [121 ] CRF Annotated Case Report Form [122 ] CRF Annotated Case Report Form [124 ] CRF Annotated Case Report Form [126 ] CRF Annotated Case Report Form [127 ] CRF Annotated Case Report Form [128 ] CRF Annotated Case Report Form [136 ] CRF Annotated Case Report Form [140 ] CRF Annotated Case Report Form [148 ] CRF Annotated Case Report Form [149 ] CRF Annotated Case Report Form [150 ] CRF Annotated Case Report Form [152 ] CRF Annotated Case Report Form [154 ] CRF Annotated Case Report Form [155 ] CRF Annotated Case Report Form [156 ] CRF Annotated Case Report Form [163 ] logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: SUPPOE.QORIG suppoe$QORIG <- unlist(sapply(1:length(suppoe$QNAM), function(x) di_map_qorig(suppoe$QNAM[x])))
QEVAL	Evaluator	text	RecordQualifier	$8.		Assigned

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Supplemental Qualifiers for Questionnaires (SUPPQS)

SUPPQS (Supplemental Qualifiers for Questionnaires) - Relationship Location: suppmh.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: QS (Questionnaires)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.SV]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$8.		Assigned ## COMPUTATION - HARDCODE: IDVAR dplyr::mutate(., IDVAR = "VISITNUM")
IDVARVAL	Identifying Variable Value	text	Identifier	$2.		Assigned ## COMPUTATION - DERIVATION: IDVARVAL dplyr::mutate(., IDVARVAL = ifelse(QNAM == "V2EVA", "2", ifelse(QNAM == "V4EVA", "4", NA)))
QNAM	Qualifier Variable Name	text	Topic	$9.		CRF Annotated Case Report Form [42 ] ## COMPUTATION - HARDCODE: SUPPQS.QNAM dplyr::mutate(., QNAM = QSTESTCD)
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$78.		CRF Annotated Case Report Form [42 ] ## COMPUTATION - DERIVATION: SUPPQS.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QVALVLM	Data Value	text	RecordQualifier	$1.		CRF Annotated Case Report Form [42 ] ## COMPUTATION - HARDCODE: SUPPQS.QVAL dplyr::mutate(., QVAL = QSORRES)
➤ QNAM = "V2D_MSEVA"	Did evaluator complete SANDE daytime (without lenses) with patient by phone	text		1		CRF Annotated Case Report Form [42 ]
➤ QNAM = "V2N_MSEVA"	Did evaluator complete SANDE nighttime (without lenses) with patient by phone	text		1		CRF Annotated Case Report Form [42 ]
➤ QNAM = "V2_GOSDS"	Did evaluator complete GOSDS with patient by phone	text		1		CRF Annotated Case Report Form [42 ]
➤ QNAM = "V4D_MSEVA"	Did evaluator complete SANDE daytime (without lenses) with patient by phone	text		1		CRF Annotated Case Report Form [77 ]
➤ QNAM = "V4N_MSEVA"	Did evaluator complete SANDE nighttime (without lenses) with patient by phone	text		1		CRF Annotated Case Report Form [77 ]
➤ QNAM = "V4_GOSDS"	Did evaluator complete GOSDS with patient by phone	text		1		CRF Annotated Case Report Form [77 ]
QORIG	Origin	text	RecordQualifier	$11.		CRF Annotated Case Report Form [42 ] ## COMPUTATION - DERIVATION: SUPPQS.QORIG dplyr::mutate(., QORIG = ifelse(QNAM %in% c("V2D_MSEVA", "V2N_MSEVA", "V2_GOSDS"), "CRF Page 42", ifelse(QNAM %in% c("V2D_MSEVA", "V2N_MSEVA", "V2_GOSDS"), "CRF Page 77", NA)))
QEVAL	Evaluator	text	RecordQualifier	$8.		Assigned

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Supplemental Qualifiers for Subject Visits (SUPPSV)

SUPPSV (Supplemental Qualifiers for Subject Visits) - Relationship Location: suppsv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: SV (Subject Visits)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
RDOMAIN	Related Domain Abbreviation	text	Identifier	$2.	[unresolved: CL.SV]	Assigned All hardcode (for example): CDISC domain for demographics is "DM"
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
IDVAR	Identifying Variable	text	Identifier	$8.		Assigned ## COMPUTATION - HARDCODE: IDVAR dplyr::mutate(., IDVAR = "VISITNUM")
IDVARVAL	Identifying Variable Value	text	Identifier	$8.		Assigned logr::put("## ADD VISITNUM FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: IDVARVAL suppsv$IDVARVAL <- unlist(sapply(1:length(suppsv$QNAM), function(x) di_map_visitnum(suppsv$QNAM[x])))
QNAM	Qualifier Variable Name	text	Topic	$9.		CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [74 ] logr::put("## RESHAPE COLNAMES FOR SUPPSV FROM FROM WIDE TO LONG AND MAP TO VISITS IN SUPPSV") suppsv_cols <- sv_cols[str_detect(sv_cols, "EVA")] suppsv_cols <- c(suppsv_cols, "STUDYID", "USUBJID") suppsv <- sv %>% dplyr::select_at(., suppsv_cols) %>% tidyr::pivot_longer(cols = suppsv_cols[-c(3:4)], values_to = "QVAL", names_to = "QNAM")
QLABEL	Qualifier Variable Label	text	SynonymQualifier	$78.		CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [74 ] di_map_test function is used to map the db dictionary labels to QLABEL: dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QVAL	Data Value	text	RecordQualifier	$1.		CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [74 ] Values from variable (QNAM) are assigned to QVAL: ## COMPUTATION - DERIVATION: QNAM tidyr::pivot_longer(cols = suppsv_cols[-c(3:4)], values_to = ""QVAL"", names_to = ""QNAM"")
QORIG	Origin	text	RecordQualifier	$11.		CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [74 ] logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: QORIG suppsv$QORIG <- unlist(sapply(1:length(suppsv$QNAM), function(x) di_map_qorig(suppsv$QNAM[x])))
QEVAL	Evaluator	text	RecordQualifier	$8.		Assigned

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Subject Visits (SV)

SV (Subject Visits) - Special Purpose Location: sv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPSV (Supplemental Qualifiers for Subject Visits)
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Assigned Hardcode to the name of the SDTM domain
USUBJID	Unique Subject Identifier	text	Identifier	$11.		Assigned USUBJID = paste0("GL2SC", SUBJID)
VISITNUM	Visit Number	integer	Timing	$1.		CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [137 ] Based in numeric value in visit STDTC inputs. I.e., V1_DD: dplyr::mutate(., VISITNUM = gsub("[^0-9.-]", "", VISITNUM))
VISIT	Visit Name	text	SynonymQualifier	$28.		CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [137 ] Asssigned based on VISITNUM: ## COMPUTATION - DERIVATION: VISIT dplyr::mutate(., VISIT = paste0("Visit ", VISITNUM)) logr::put("## Recode Visit 1 Screening & Baseline from Visit 1") sv_visit$VISIT[sv_visit$VISITNUM == 1] <- "Visit 1 Screening & Baseline"
SVPRESP	Pre-specified	text	VariableQualifier	$1.		CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [137 ] # Hardcode Prespecified visits ## COMPUTATION - HARDCODE: SV.SVPRESP dplyr::mutate(., SVPRESP = "Y")
SVOCCUR	Occurrence	text	RecordQualifier	$3.	YN • "No" = "No" • "Yes" = "Yes"	CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [137 ] All occurance is determined by VXYN variables for each visit (i.e., V1YN): logr::put("## RESHAPE SVOCCUR FROM WIDE TO LONG AND MAP TO VISITS") ## COMPUTATION - DERIVATION: SVOCCUR sv_cols_occur <- sv_cols[str_detect(sv_cols, "YN")] sv_cols_occur <- c(sv_cols_occur, "USUBJID") sv_occur <- sv %>% dplyr::select_at(., sv_cols_occur) %>% tidyr::pivot_longer(cols = sv_cols_occur[-c(8)], values_to = "SVOCCUR") sv_visit$SVOCCUR <- sv_occur$SVOCCUR
SVREASOC	Reason for Occur Value	text	RecordQualifier	$2.		CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [137 ] All reason is determined by VXRSN variables for each visit (i.e., V1RSN): logr::put("## RESHAPE SVREASOC FROM WIDE TO LONG AND MAP TO VISITS") ## COMPUTATION - DERIVATION: SVREASON sv_cols_reason <- sv_cols[str_detect(sv_cols, "RSN")] sv_cols_reason <- c(sv_cols_reason, "USUBJID") sv_reason <- sv %>% dplyr::select_at(., sv_cols_reason) %>% tidyr::pivot_longer(cols = sv_cols_reason[-c(8)], values_to = "SVREASOC") sv_visit$SVREASOC <- sv_reason$SVREASOC
SVCNTMOD	Contact Mode	text	RecordQualifier	$15.	CNTMODE • "Clinic Visit" = "Clinic Visit" • "Telephone Visit" = "Telephone Visit"	CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [137 ] ## COMPUTATION - HARDCODE: SVCNTMOD sv_visit$SVCNTMOD <- ifelse(!sv_visit$VISITNUM %in% c("2","4"), "CLINIC VISIT", "TELEPHONE VISIT")
VISITDY	Planned Study Day of Visit	integer	Timing	$3.		CRF Annotated Case Report Form [1 ] CRF Annotated Case Report Form [39 ] CRF Annotated Case Report Form [46 ] CRF Annotated Case Report Form [74 ] CRF Annotated Case Report Form [81 ] CRF Annotated Case Report Form [109 ] CRF Annotated Case Report Form [137 ] Hardcode to the planned study day: logr::put("## HARDCODE/DERIVE PLANNED VISITDY AND CONTACT METHOD FROM PROTOCOL") ## COMPUTATION - HARDCODE: VISITDY sv_visit$VISITDY <- ifelse( sv_visit$VISITNUM == 1, 1, ifelse(sv_visit$VISITNUM == 2, 42, ifelse(sv_visit$VISITNUM == 3, 84, ifelse(sv_visit$VISITNUM == 4, 126, ifelse(sv_visit$VISITNUM == 5, 168, ifelse(sv_visit$VISITNUM == 6, 252, 364))))))
SVSTDTC	Start Date/Time of Observation	date	Timing	YYMMDD10.	ISO 8601	Derived logr::put("## DERIVE DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD") ## COMPUTATION - DERIVATION: SV.STDTC sv <- sv %>% ## Derive DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD variables ## The unite function is used to combine YEAR-MM-DD to derive --DTC variables ## The function lubridate:ymd(x) ensures the format is ISO8601 # Site visit 1 tidyr::unite(., col = 'SVSTDTC1', 'V1_YY', 'V1_MM', 'V1_DD', sep = '-', remove = TRUE) %>% # Site visit 2 tidyr::unite(., col = 'SVSTDTC2', 'V2_YY', 'V2_MM', 'V2_DD', sep = '-', remove = TRUE) %>% # Site visit 3 tidyr::unite(., col = 'SVSTDTC3', 'V3_YY', 'V3_MM', 'V3_DD', sep = '-', remove = TRUE) %>% # Site visit 4 tidyr::unite(., col = 'SVSTDTC4', 'V4_YY', 'V4_MM', 'V4_DD', sep = '-', remove = TRUE) %>% # Site visit 5 tidyr::unite(., col = 'SVSTDTC5', 'V5_YY', 'V5_MM', 'V5_DD', sep = '-', remove = TRUE) %>% # Site visit 6 tidyr::unite(., col = 'SVSTDTC6', 'V6_YY', 'V6_MM', 'V6_DD', sep = '-', remove = TRUE) %>% # Site visit 7 tidyr::unite(., col = 'SVSTDTC7', 'V7_YY', 'V7_MM', 'V7_DD', sep = '-', remove = TRUE)
SVENDTC	End Date/Time of Observation	date	Timing	YYMMDD10.	ISO 8601	Derived ## COMPUTATION - DERIVATION: SVSTDC ## All visits occur on a single day, start == end dplyr::mutate(., SVENDTC = SVSTDTC)
SVSTDY	Study Day of Start of Observation	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
SVENDY	Study Day of End of Observation	integer	Timing	$3.		Derived If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)

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Trial Arms (TA)

TA (Trial Arms) - Trial Design Location: ta.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Derived Hardcode to the name of the SDTM domain
ARMCD	Planned Arm Code	text	Topic	$2.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
ARM	Description of Planned Arm	text	SynonymQualifier	$7.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TAETORD	Planned Order of Element within Arm	integer	Timing	$1.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
ETCD	Element Code	text	RecordQualifier	$7.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
ELEMENT	Description of Element	text	SynonymQualifier	$26.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TABRANCH	Branch	text	Rule	$20.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TATRANS	Transition Rule	text	Rule	$62.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
EPOCH	Epoch	text	Timing	$20.	EPOCH • "Screening & Baseline" = "Screening & Baseline" • "Masked Phase" = "Masked Phase" • "Open-label Phase" = "Open-label Phase" • "Open-label Extension Phase" = "Open-label Extension Phase"	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx

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Trial Elements (TE)

TE (Trial Elements) - Trial Design Location: te.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.	Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.	Derived Hardcode to the name of the SDTM domain
ETCD	Element Code	text	Topic	$7.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
ELEMENT	Description of Element	text	SynonymQualifier	$26.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TESTRL	Rule for Start of Element	text	Rule	$68.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TEENRL	Rule for End of Element	text	Rule	$51.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TEDUR	Planned Duration of Element	text	Timing	$3.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx

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Trial Inclusion/ Exclusion Criteria (TI)

TI (Trial Inclusion/ Exclusion Criteria) - Trial Design Location: tt.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	StudyÂ Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	DomainÂ Abbreviation	text	Identifier	$2.		Derived Hardcode to the name of the SDTM domain
IETESTCD	Incl/ExclÂ CriterionÂ ShortÂ Name	text	Topic	$4.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
IETEST	Inclusion/ExclusionÂ Criterion	text	SynonymQualifier	$345.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
IECAT	Inclusion/ExclusionÂ Category	text	GroupingQualifier	$9.	IECAT • "INCLUSION" = "Inclusion Criteria" • "EXCLUSION" = "Exclusion Criteria"	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
IESCAT	Inclusion/ExclusionÂ Subcategory	text	GroupingQualifier	$9.	IESCAT • "Major" = "Major" • "Minor" = "Minor" • "Pregnancy" = "Pregnancy"	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TIRL	Inclusion/ExclusionÂ CriterionÂ Rule	text	Rule	$62.	[unresolved: CL.TIRL]	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TIVERS	ProtocolÂ CriteriaÂ Versions	text	RecordQualifier	$4.	[unresolved: CL.TIVERS]	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx

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Trial Summary (TS)

TS (Trial Summary) - Trial Design Location: ts.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.		Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.		Derived Hardcode to the name of the SDTM domain
TSSEQ	Sequence Number	integer	Identifier	$1.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSGRPID	Group ID	text	Identifier	$9.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSPARMCD	Trial Summary Parameter Short Name	text	Topic	$8.	TSPARMCD [41 Terms]	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSPARM	Trial Summary Parameter	text	SynonymQualifier	$40.	TSPARM [41 Terms]	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSVAL	Parameter Value	text	ResultQualifier	$26.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSVALNF	Parameter Value Null Flavor	text	ResultQualifier	$4.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSVALCD	Parameter Value Code	text	ResultQualifier	$11.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSVCDREF	Name of the Reference Terminology	text	ResultQualifier	$9.	[unresolved: CL.DICTNAM]	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TSVCDVER	Version of the Reference Terminology	text	ResultQualifier	$2.		Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx

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Trial Visits (TV)

TV (Trial Visits) - Trial Design Location: tv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	$10.	Assigned Hardcode STUDYID = "oGvHD-2-SC"
DOMAIN	Domain Abbreviation	text	Identifier	$2.	Derived Hardcode to the name of the SDTM domain
VISITNUM	Visit Number	integer	Timing	$1.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
VISIT	Visit Name	text	SynonymQualifier	$28.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
VISITDY	Planned Study Day of Visit	integer	Timing	$3.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
ARMCD	Planned Arm Code	text	RecordQualifier	$2.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
ARM	Description of Planned Arm	text	SynonymQualifier	$7.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TVSTRL	Visit Start Rule	text	Rule	$40.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
TVENRL	Visit End Rule	text	Rule	$29.	Derived This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx

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ABLENABLE

Permitted Value (Code)	Display Value (Decode)	Rank
Able to Assess	Able to Assess	1
Unable to Assess	Unable to Assess	2

ACTION

Permitted Value (Code)	Display Value (Decode)	Rank
		NA

ACTION2

Permitted Value (Code)	Display Value (Decode)	Rank
		NA

AEOUT

Permitted Value (Code)	Display Value (Decode)	Rank
Recovered / Resolved	Recovered / Resolved	1
Recovering / Resolving	Recovering / Resolving	2
Not Recovered / Not Resolved	Not Recovered / Not Resolved	3
Recovered / Resolved with sequelae	Recovered / Resolved with sequelae	4
Fatal	Fatal	5
Unknown	Unknown	6

AEREL

Permitted Value (Code)	Display Value (Decode)	Rank
Not Related	Not Related	1
Unlikely Related	Unlikely Related	2
Likely Related	Likely Related	3
Definitely Related	Definitely Related	4

AESER

Permitted Value (Code)	Display Value (Decode)	Rank
Death	Death	1
Life threatening	Life threatening	2
Hospitalization (initial or prolonged)	Hospitalization (initial or prolonged)	3
Disability or permanent damage	Disability or permanent damage	4
Congenital anomaly or birth defect	Congenital anomaly or birth defect	5
Other	Other	6

AESERYN

Permitted Value (Code)	Display Value (Decode)	Rank
Yes	Yes	1
No	No	2

AGEU

Permitted Value (Code)	Display Value (Decode)	Rank
YEARS	YEARS	1

ARM

Permitted Value (Code)	Display Value (Decode)	Rank
Active	Active	1
Placebo	Placebo	2

ARMCD

Permitted Value (Code)	Display Value (Decode)	Rank
ACTIVE	Pro-ocular	1
AA	Active	1
PLACEBO	Placebo	2
BA	Placebo	2

BIRTH

Permitted Value (Code)	Display Value (Decode)	Rank
Diaphragm / Spermicide	Diaphragm / Spermicide	1
Norplant	Norplant	2
Condom / Spermicide	Condom / Spermicide	3
IUCD (Intrauterine Contraceptive Device with a failure rate of <1%)	IUCD (Intrauterine Contraceptive Device with a failure rate of <1%)	4
Oral contraceptives	Oral contraceptives	5
Vasectomized partner	Vasectomized partner	6
Depo provera	Depo provera	7
Other	Other	8

CHILD

Permitted Value (Code)	Display Value (Decode)	Rank
Post-menopausal	Post-menopausal	1
Surgically sterile	Surgically sterile	2

CMFORM

Permitted Value (Code)	Display Value (Decode)	Rank
Tablet	Tablet	1
Capsule	Capsule	2
Ointment	Ointment	3
Suppository	Suppository	4
Aerosol	Aerosol	5
Spray	Spray	6
Suspension	Suspension	7
Patch	Patch	8
Gas	Gas	9
Gel	Gel	10
Cream	Cream	11
Powder	Powder	12
Implant	Implant	13
Chewable	Chewable	14
Liquid	Liquid	15
Other	Other	16

CMFREQ

Permitted Value (Code)	Display Value (Decode)	Rank
QD (once a day)	QD (once a day)	1
BID (twice a day)	BID (twice a day)	2
TID (three times a day)	TID (three times a day)	3
QID (four times a day)	QID (four times a day)	4
QOD (every other day)	QOD (every other day)	5
QM (every month)	QM (every month)	6
QOM (every other mo)	QOM (every other mo)	7
QH (every hour)	QH (every hour)	8
AC (before meals)	AC (before meals)	9
PC (after meals)	PC (after meals)	10
PRN (as needed)	PRN (as needed)	11
Other	Other	12
3 times per year	3 times per year	13
5 times per day	5 times per day	14
6 times a day	6 times a day	15
8 times per day	8 times per day	16
Every evening	Every evening	17

CMLOC

Permitted Value (Code)	Display Value (Decode)	Rank
OD	Right Eye	1
OS	Left Eye	2
OU	Both Eyes	3

CMROUTE

Permitted Value (Code)	Display Value (Decode)	Rank
Oral	Oral	1
Topical	Topical	2
Subcutaneous	Subcutaneous	3
Intradermal	Intradermal	4
Transdermal	Transdermal	5
Intraocular	Intraocular	6
Intramuscular	Intramuscular	7
Inhalation	Inhalation	8
Intravenous	Intravenous	9
Intraperitoneal	Intraperitoneal	10
Nasal	Nasal	11
Vaginal	Vaginal	12
Rectal	Rectal	13
Other	Other	14

CMUNIT

Permitted Value (Code)	Display Value (Decode)	Rank
g (gram)	g (gram)	1
mg (milligram)	mg (milligram)	2
Âµg (microgram)	Âµg (microgram)	3
L (liter)	L (liter)	4
mL (milliliter)	mL (milliliter)	5
IU (International Unit)	IU (International Unit)	6
Other	Other	7
Drops	Drops	8

CNTMODE

Permitted Value (Code)	Display Value (Decode)	Rank
Clinic Visit	Clinic Visit	1
Telephone Visit	Telephone Visit	2

COHORT

Permitted Value (Code)	Display Value (Decode)	Rank
Group 1	Group 1	1
Group 2	Group 2	2

COUNTRY

Permitted Value (Code)	Display Value (Decode)	Rank
USA	UNITED STATES	1

CSNCS

Permitted Value (Code)	Display Value (Decode)	Rank
Clinically Significant	Clinically Significant	1
Not Clinically Significant	Not Clinically Significant	2

Permitted Value (Code)	Display Value (Decode)	Rank
Dispensed	Dispensed	1
Returned	Returned	2

DAY

Permitted Value (Code)	Display Value (Decode)	Rank
01	01	1
02	02	2
03	03	3
04	04	4
05	05	5
06	06	6
07	07	7
08	08	8
09	09	9
10	10	10
11	11	11
12	12	12
13	13	13
14	14	14
15	15	15
16	16	16
17	17	17
18	18	18
19	19	19
20	20	20
21	21	21
22	22	22
23	23	23
24	24	24
25	25	25
26	26	26
27	27	27
28	28	28
29	29	29
30	30	30
31	31	31
01	01	32

DSCAT

Permitted Value (Code)	Display Value (Decode)	Rank
Protocol Milestone	Protocol Milestone	1
Safety Event	Safety Event	2
Compliance Event	Compliance Event	3
Other Event	Other Event	4

DSDECOD

Permitted Value (Code)	Display Value (Decode)	Rank
ASSESS	ASSESS	1
CONSENT	CONSENT	2
EOS	EOS	3
MASKED	MASKED	4
OPEN	OPEN	5
OPENEXT	OPENEXT	6
SCLERAL	SCLERAL	7
SCREEN	SCREEN	8

DSTERM

DVACN

Permitted Value (Code)	Display Value (Decode)	Rank
Notified sponsor	Notified sponsor	1
Notified IRB	Notified IRB	2
Re-trained staff	Re-trained staff	3
Re-educated subject	Re-educated subject	4
Implemented written instructions / procedures	Implemented written instructions / procedures	5
Implemented CAPA	Implemented CAPA	6
Other	Other	7

DVCAT

Permitted Value (Code)	Display Value (Decode)	Rank
Informed Consent	Informed Consent	1
Safety reporting	Safety reporting	2
Inclusion / Exclusion	Inclusion / Exclusion	3
Study medication	Study medication	4
Prohibited concomitant medication	Prohibited concomitant medication	5
Study procedures	Study procedures	6
Study participation discontinuation	Study participation discontinuation	7
Other	Other	8

DVIMPACT

Permitted Value (Code)	Display Value (Decode)	Rank
No impact on data quality or subject safety	No impact on data quality or subject safety	1
Minor impact on data quality	Minor impact on data quality	2
Minor impact on subject safety	Minor impact on subject safety	3
Major impact on data quality or subject safety	Major impact on data quality or subject safety	4
Leading to subject(s) death	Leading to subject(s) death	5

EFRON

Permitted Value (Code)	Display Value (Decode)	Rank
0	0	1
0.5	0.5	2
1	1	3
1.5	1.5	4
2	2	5
2.5	2.5	6
3	3	7
3.5	3.5	8
4	4	9

EOS

Permitted Value (Code)	Display Value (Decode)	Rank
Completed	Completed	1
Screen Failure	Screen Failure	2
Adverse Event	Adverse Event	3
Death	Death	4
Disease Relapse	Disease Relapse	5
Failure to Meet Randomization Criteria	Failure to Meet Randomization Criteria	6
Lack of Efficacy	Lack of Efficacy	7
Lost to Follow-Up	Lost to Follow-Up	8
Non-compliance with Study Drug	Non-compliance with Study Drug	9
Physician Decision	Physician Decision	10
Pregnancy	Pregnancy	11
Progressive Disease	Progressive Disease	12
Protocol Deviation	Protocol Deviation	13
Recovery	Recovery	14
Site Terminated by Sponsor	Site Terminated by Sponsor	15
Study Terminated by Sponsor	Study Terminated by Sponsor	16
Technical Problems	Technical Problems	17
Withdrawal by Parent / Guardian	Withdrawal by Parent / Guardian	18
Withdrawal by Subject	Withdrawal by Subject	19
Other	Other	20

EPOCH

Permitted Value (Code)	Display Value (Decode)	Rank
Screening & Baseline	Screening & Baseline	1
Masked Phase	Masked Phase	2
Open-label Phase	Open-label Phase	3
Open-label Extension Phase	Open-label Extension Phase	4

ETCD

Permitted Value (Code)	Display Value (Decode)	Rank
SCREEN	Screening & Baseline	1
MASKED	Masked Phase	2
OPEN	Open-label Phase	3
OPENEXT	Open-label Extension Phase	4

ETHNICITY

Permitted Value (Code)	Display Value (Decode)	Rank
Hispanic or Latino	Hispanic or Latino	1
Not Hispanic or Latino	Not Hispanic or Latino	2
Unknown	Unknown	3

EXUNE

Permitted Value (Code)	Display Value (Decode)	Rank
Expected	Expected	1
Unexpected	Unexpected	2

FILM

Permitted Value (Code)	Display Value (Decode)	Rank
No tear film	No tear film	1
Tear film visible	Tear film visible	2
Reliable tear film	Reliable tear film	3
Copious tear film	Copious tear film	4

Permitted Value (Code)	Display Value (Decode)	Rank
High	High	1
Low	Low	2

IECAT

Permitted Value (Code)	Display Value (Decode)	Rank
INCLUSION	Inclusion Criteria	1
EXCLUSION	Exclusion Criteria	2

IESCAT

Permitted Value (Code)	Display Value (Decode)	Rank
Major	Major	1
Minor	Minor	2
Pregnancy	Pregnancy	3

IMPACT

Permitted Value (Code)	Display Value (Decode)	Rank
MINOR	Minor	1
MAJOR	Major	2

IRIS

Permitted Value (Code)	Display Value (Decode)	Rank
BROWN	BROWN	1
HAZEL	HAZEL	2
BLUE	BLUE	3
GRAY	GRAY	4
GREEN	GREEN	5
BLACK	BLACK	6
OTHER	OTHER	7

LAT

Permitted Value (Code)	Display Value (Decode)	Rank
Both Eyes	Both Eyes	1
Left Eye	Left Eye	2
Right Eye	Right Eye	3

LBCAT

Permitted Value (Code)	Display Value (Decode)	Rank
CHEMISTRY	Chemistry	1
URINALYSIS	Urinalysis	3

LBNRIND

Permitted Value (Code)	Display Value (Decode)	Rank
HIGH	HIGH	1
LOW	LOW	2
NORMAL	NORMAL	3

LBTEST

Permitted Value (Code)	Display Value (Decode)	Rank
Albumin; Microalbumin	Albumin; Microalbumin	1
Alkaline Phosphatase	Alkaline Phosphatase	2
Alanine Aminotransferase; SGPT	Alanine Aminotransferase; SGPT	3
Aspartate Aminotransferase; SGOT	Aspartate Aminotransferase; SGOT	4
Direct Bilirubin	Direct Bilirubin	5
Bilirubin; Total Bilirubin	Bilirubin; Total Bilirubin	6
Gamma Glutamyl Transferase	Gamma Glutamyl Transferase	7
EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume	EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume	8
FHGB; Free Hemoglobin; Hemoglobin	FHGB; Free Hemoglobin; Hemoglobin	9
Protein	Protein	10
Glucose	Glucose	11

LBTESTCD

Permitted Value (Code)	Display Value (Decode)	Rank
ALB	Albumin; Microalbumin	1
ALP	Alkaline Phosphatase	2
ALT	Alanine Aminotransferase; SGPT	3
AST	Aspartate Aminotransferase; SGOT	4
BILDIR	Direct Bilirubin	5
BILI	Bilirubin; Total Bilirubin	6
GGT	Gamma Glutamyl Transferase	7
HCT	EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume	8
HGB	FHGB; Free Hemoglobin; Hemoglobin	9
PROT	Protein	10
GLUC	Glucose	11

LENS

Permitted Value (Code)	Display Value (Decode)	Rank
Phakic	Phakic	1
Pseudophakic	Pseudophakic	2
Aphakic	Aphakic	3

MONTH

Permitted Value (Code)	Display Value (Decode)	Rank
01	JAN	1
02	FEB	2
03	MAR	3
04	APR	4
05	MAY	5
06	JUN	6
07	JUL	7
08	AUG	8
09	SEP	9
10	OCT	10
11	NOV	11
12	DEC	12
01	UNK	13

NABN

Permitted Value (Code)	Display Value (Decode)	Rank
Normal	Normal	1
Abnormal - Clinically Significant	Abnormal - Clinically Significant	2
Abnormal - Not Clinically Significant	Abnormal - Not Clinically Significant	3

NYND

Permitted Value (Code)	Display Value (Decode)	Rank
Not done	Not done	3

NYOYB

Permitted Value (Code)	Display Value (Decode)	Rank
No	No	1
Yes (One)	Yes (One)	2
yes (Both)	yes (Both)	3

Permitted Value (Code)	Display Value (Decode)	Rank
One	One	1
Both	Both	2

ODOSOU

Permitted Value (Code)	Display Value (Decode)	Rank
OD (oculus dextrus)	OD (oculus dextrus)	1
OS (oculus sinister)	OS (oculus sinister)	2
OU	OU	3

OPAC

Permitted Value (Code)	Display Value (Decode)	Rank
0	0	1
+ 1	+ 1	2
+ 2	+ 2	3
+ 3	+ 3	4

PHY

Permitted Value (Code)	Display Value (Decode)	Rank
Complete	Complete	1
Abbreviated	Abbreviated	2

PHYDISC

Permitted Value (Code)	Display Value (Decode)	Rank
Adverse event	Adverse event	1
Rejection	Rejection	2
Graft loss	Graft loss	3
Death	Death	4
Pregnancy	Pregnancy	5
Other	Other	6

PLUGS

Permitted Value (Code)	Display Value (Decode)	Rank
OD upper	OD upper	1
OD lower	OD lower	2
OS upper	OS upper	3
OS lower	OS lower	4

Permitted Value (Code)	Display Value (Decode)	Rank
Negative	Negative	1
Positive	Positive	2

PREG

Permitted Value (Code)	Display Value (Decode)	Rank
Serum pregnancy test	Serum pregnancy test	1
Urine pregnancy test	Urine pregnancy test	2

SEX

Permitted Value (Code)	Display Value (Decode)	Rank
Male	Male	1
Female	Female	2

STATE

Permitted Value (Code)	Display Value (Decode)	Rank
Lower Risk State	Lower Risk State	1
Higher Risk State (not deemed lower risk state)	Higher Risk State (not deemed lower risk state)	2

STATUS

Permitted Value (Code)	Display Value (Decode)	Rank
0 = eyes closed	0 = eyes closed	1
1 = eyes partially open	1 = eyes partially open	2
2 = eyes open	2 = eyes open	3

TOX

Permitted Value (Code)	Display Value (Decode)	Rank
Absent	Absent	1
Mild	Mild	2
Moderate	Moderate	3
Severe	Severe	4
Life Threatening	Life Threatening	5
Fatal	Fatal	6

TSPARM

Permitted Value (Code)	Display Value (Decode)	Rank
Added on to Existing Treatments	Added on to Existing Treatments	1
Planned Maximum Age of Subjects	Planned Maximum Age of Subjects	2
Planned Minimum Age of Subjects	Planned Minimum Age of Subjects	3
Planned Trial Length	Planned Trial Length	4
Planned Number of Subjects	Planned Number of Subjects	5
Trial is Randomized	Trial is Randomized	6
Sex of Participants	Sex of Participants	7
Study Stop Rules	Study Stop Rules	8
Trial Blinding Schema	Trial Blinding Schema	9
Control Type	Control Type	10
Diagnosis Group	Diagnosis Group	11
Trial Indication Type	Trial Indication Type	12
Trial Title	Trial Title	13
Trial Phase Classification	Trial Phase Classification	14
Trial Type	Trial Type	15
Current Therapy or Treatment	Current Therapy or Treatment	16
Trial Primary Objective	Trial Primary Objective	17
Trial Secondary Objective	Trial Secondary Objective	18
Clinical Study Sponsor	Clinical Study Sponsor	19
Trial Indication	Trial Indication	20
Investigational Therapy or Treatment	Investigational Therapy or Treatment	21
Randomization Quotient	Randomization Quotient	22
Registry Identifier	Registry Identifier	23
Primary Outcome Measure	Primary Outcome Measure	24
Secondary Outcome Measure	Secondary Outcome Measure	25
Exploratory Outcome Measure	Exploratory Outcome Measure	26
Pharmacological Class of Investigational Therapy	Pharmacological Class of Investigational Therapy	27
Planned Country of Investigational Site(s)	Planned Country of Investigational Site(s)	28
Adaptive Design	Adaptive Design	29
Data Cutoff Date	Data Cutoff Date	30
Data Cutoff Description	Data Cutoff Description	31
Intervention Model	Intervention Model	32
Planned Number of Arms	Planned Number of Arms	33
Study Type	Study Type	34
Intervention Type	Intervention Type	35
Study Start Date	Study Start Date	36
Study End Date	Study End Date	37
Actual Number of Subjects	Actual Number of Subjects	38
Healthy Subject	Healthy Subject	39
Stable Disease Minimum Duration	Stable Disease Minimum Duration	40
Confirmed Response Minimum Duration	Confirmed Response Minimum Duration	41

TSPARMCD

Permitted Value (Code)	Display Value (Decode)	Rank
ADDON	Added on to Existing Treatments	1
AGEMAX	Planned Maximum Age of Subjects	2
AGEMIN	Planned Minimum Age of Subjects	3
LENGTH	Planned Trial Length	4
PLANSUB	Planned Number of Subjects	5
RANDOM	Trial is Randomized	6
SEXPOP	Sex of Participants	7
STOPRULE	Study Stop Rules	8
TBLIND	Trial Blinding Schema	9
TCNTRL	Control Type	10
TDIGRP	Diagnosis Group	11
TINDTP	Trial Indication Type	12
TITLE	Trial Title	13
TPHASE	Trial Phase Classification	14
TTYPE	Trial Type	15
CURTRT	Current Therapy or Treatment	16
OBJPRIM	Trial Primary Objective	17
OBJSEC	Trial Secondary Objective	18
SPONSOR	Clinical Study Sponsor	19
INDIC	Trial Indication	20
TRT	Investigational Therapy or Treatment	21
RANDQT	Randomization Quotient	22
REGID	Registry Identifier	23
OUTMSPRI	Primary Outcome Measure	24
OUTMSSEC	Secondary Outcome Measure	25
OUTMSEXP	Exploratory Outcome Measure	26
PCLAS	Pharmacological Class of Investigational Therapy	27
FCNTRY	Planned Country of Investigational Site(s)	28
ADAPT	Adaptive Design	29
DCUTDTC	Data Cutoff Date	30
DCUTDESC	Data Cutoff Description	31
INTMODEL	Intervention Model	32
NARMS	Planned Number of Arms	33
STYPE	Study Type	34
INTTYPE	Intervention Type	35
SSTDTC	Study Start Date	36
SENDTC	Study End Date	37
ACTSUB	Actual Number of Subjects	38
HLTSUBJI	Healthy Subject	39
SDMDUR	Stable Disease Minimum Duration	40
CRMDUR	Confirmed Response Minimum Duration	41

UNIT

Permitted Value (Code)	Display Value (Decode)	Rank
%	Percentage	1
g/dL	Gram per Deciliter	2
IU/L	International Unit per Liter	3
mg/dL	Milligram per Deciliter	4
mg	Milligram	5

URINGLUC

Permitted Value (Code)	Display Value (Decode)	Rank
NEGATIVE	Negative	1
POSITIVE	Positive	2

Permitted Value (Code)	Display Value (Decode)	Rank
-1	-1	1
-2	-2	2
-3	-3	3
NA	NA	4
+1	+1	5
+2	+2	6
+3	+3	7

VISIT

Permitted Value (Code)	Display Value (Decode)	Rank
Baseline	Baseline	1
Month 3	Month 3	2
Month 6	Month 6	3

XPTEST

Permitted Value (Code)	Display Value (Decode)	Rank
Pain Score	Pain Score	1

XPTESTCD

Permitted Value (Code)	Display Value (Decode)	Rank
XPPAIN	XPPAIN	1

Permitted Value (Code)	Display Value (Decode)	Rank
No	No	1
Yes	Yes	2

YNA

Permitted Value (Code)	Display Value (Decode)	Rank
Yes	Yes	1
Not applicable	Not applicable	2

YNNA

Permitted Value (Code)	Display Value (Decode)	Rank
No	No	1
Yes	Yes	2
Not applicable	Not applicable	3

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External Dictionaries

External Dictionaries
Reference Name	External Dictionary	Dictionary Version
AEACN	SDTM Terminology	NA
AEACN	SDTM Terminology	NA
AEACN	SDTM Terminology	NA
AEACN	SDTM Terminology	NA
AEBODSYS	MedDRA	18.0
AEDECOD	MedDRA	18.0
AESEV	SDTM Terminology	NA
AESEV	SDTM Terminology	NA
AESEV	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA
DOMAINS	SDTM Terminology	NA

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Methods

Methods
Method	Type	Description
AEDTC derivation	Computation	Notes: The function di_map_options() maps variables to their options. This results in the mapping of month, day, and timing entries per the logical statments below: IF AEDTC_DD == 'UN' THEN AEDTC_DD == "01" IF AEDTC_MM == 'UNK' THEN AEDTC_MM == "01" ## Derive DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD variables ## The unite function is used to combine YEAR-MM-DD to derive --DTC variables ## The function lubridate:ymd(x) ensures the format is ISO8601 ## COMPUTATION - DERIVATION: AEDTC tidyr::unite(., col = 'AEDTC', 'AEDTC_YY', 'AEDTC_MM', 'AEDTC_DD', sep = '-', remove = TRUE) %>% dplyr::mutate(., AEDTC = lubridate::ymd(AEDTC)) %>%
AESEQ derivation	Computation	Unique sequence based on sort order of STUDYID USUBJID AEDECOD AESTDTC AEENDTC: ae <-ae %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., STUDYID, USUBJID, AESTDTC) %>% ## COMPUTATION - DERIVATION: AESEQ dplyr::mutate(.,AESEQ = 1:length(USUBJID))
AEENDTC derivation	Computation	Notes: The function di_map_options() maps variables to their options. This results in the mapping of month, day, and timing entries per the logical statments below: IF AEENDTC_DD == 'UN' THEN AEENDTC_DD == "01" IF AEENDTC_MM == 'UNK' THEN AEENDTC_MM == "01" CODE: ae <- ae %<% di_map_options(ae) ae %<% ##maps options tidyr::unite(., col = 'AEENDCT', 'AEDCT_YY', 'AEENDCT_MM', 'AEENDCT_DD', sep = '-', remove = TRUE) %>% ##derives DTC variable lubridate::ymd(AEENDTC) ##ensures format of DTC variable is ISO8601
EPOCH hardcode	Computation	## COMPUTATION - DERIVATION: AE.EPOCH epoch <- c() for (i in 1:length(ae$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = ae$USUBJID[i], dtc = ae$AESTDTC[i]) print(i) }
AESTDTC derivation	Computation	Notes: The function di_map_options() maps variables to their options. This results in the mapping of month, day, and timing entries per the logical statments below: IF AESTDTC_DD == 'UN' THEN AESTDTC_DD == "01" IF AESTDTC_MM == 'UNK' THEN AESTDTC_MM == "01" CODE: ae <- ae %<% di_map_options(ae) ae %<% ##maps options tidyr::unite(., col = 'AESTDCT', 'AESTDCT_YY', 'AESTDCT_MM', 'AESTDCT_DD', sep = '-', remove = TRUE) %>% ##derives DTC variable lubridate::ymd(AESTDTC) ##ensures format of DTC variable is ISO8601
CM.CMCAT	Other	Each CM dataset is assigned a CAT (Ocular, Non-Ocular, Treatment Device, as example): logr::put("## READ TREATMENT DEVICES AND MAP TO VARIABLE COLNAMES AND OPTIONS") dbt_tdcm <- read_excel(paste0(.sys, .proj, .dmp, .db), sheet = "Concomitant_O...t_Device_(TD)") %>% dplyr::mutate(., CMCAT = "Occular Concomitant Treatment Device") %>% logr::put()
CMDECOD derivation	Computation	TBD
CMMODIFY derivation	Computation	TBD
CMSCAT derivation	Computation	TBD
ENDTC derivation	Computation	Dates are compiled from multiple CM tables, and unknown values replaced with 01: ## COMPUTATION - DERIVATION: CMSTDTC cm$CMEND <- sapply(cm$CMEND, function(x) gsub(""UN"", ""01"", x)) ## COMPUTATION - DERIVATION: CMENDTC tidyr::unite(., col = 'CMENDTC', 'CMENY', 'CMENM', 'CMEND', sep = '-', remove = TRUE) %>% dplyr::mutate(., CMSTDTC = lubridate::ymd(CMSTDTC))
EPOCH derivation	Computation	## COMPUTATION - DERIVATION: EPOCH epoch <- c() for (i in 1:length(cm$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = cm$USUBJID[i], dtc = cm$CMSTDTC[i]) print(i) } cm$EPOCH <- epoch
CMGRPID derivation	Computation	## COMPUTATION - DERIVATION: CMGRPID epoch <- c() for (i in 1:length(cm$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = cm$USUBJID[i], dtc = cm$CMSTDTC[i]) print(i) } cm$EPOCH <- epoch
CMSEQ derivation	Computation	## COMPUTATION - DERIVATION: CMSEQ dplyr::mutate(.,CMSEQ = 1:length(USUBJID))
STDTC derivation	Computation	Dates are compiled from multiple CM tables, and unknown values replaced with 01: ## COMPUTATION - DERIVATION: CMSTDTC cm$CMSTD <- sapply(cm$CMSTD, function(x) gsub("UN", "01", x)) cm <- cm %>% ## COMPUTATION - DERIVATION: CMSTDTC tidyr::unite(., col = 'CMSTDTC', 'CMSTY', 'CMSTM', 'CMSTD', sep = '-', remove = TRUE) %>% dplyr::mutate(., CMSTDTC = lubridate::ymd(CMSTDTC))
DADTC derivation	Computation	## COMPUTATION - DERIVATION: DADTC dbt_da <- dbt_da %>% tidyr::unite(., col = 'DADTC', 'DADTC_YY', 'DADTC_MM', 'DADTC_DD', sep = '-', remove = TRUE)
DASEQ derivation	Computation	## COMPUTATION - DERIVATION: DASEQ dplyr::mutate(., DASEQ = 1:length(USUBJID)) %>%
EPOCH derivation	Computation	## COMPUTATION - HARDCODE: EPOCH epoch = ifelse(is.na(dbt_da$VISITNUM), NA, ifelse(dbt_da$VISITNUM == "1", "Screening & Baseline", ifelse(dbt_da$VISITNUM == "3", "Masked Phase", ifelse(dbt_da$VISITNUM == "5", "Open-label Phase", ifelse(dbt_da$VISITNUM == "6", "Open-label Phase", ifelse(dbt_da$VISITNUM == "7", "Open-label Extension Phase", "")))))) ## COMPUTATION - HARDCODE: EPOCH EPOCH = epoch
TAETORD derivation	Computation	taeord = ifelse(is.na(dbt_da$VISITNUM) \| is.na(dbt_da$DASTRESC), NA, ifelse(dbt_da$VISITNUM == "1" & dbt_da$DASTRESC == "Dispensed", 1, ifelse(dbt_da$VISITNUM == "3" & dbt_da$DASTRESC == "Returned", 2, ifelse(dbt_da$VISITNUM == "3" & dbt_da$DASTRESC == "Dispensed", 3, ifelse(dbt_da$VISITNUM == "5" & dbt_da$DASTRESC == "Returned", 4, ifelse(dbt_da$VISITNUM == "5" & dbt_da$DASTRESC == "Dispensed", 5, ifelse(dbt_da$VISITNUM == "6" & dbt_da$DASTRESC == "Returned", 6, ifelse(dbt_da$VISITNUM == "6" & dbt_da$DASTRESC == "Dispensed", 7, ifelse(dbt_da$VISITNUM == "7" & dbt_da$DASTRESC == "Returned", 8, ""))))))))) ## COMPUTATION - HARDCODE: TAETORD TAETORD = taeord)
VISIT derivation	Computation	## COMPUTATION - HARDCODE: VISITNUM VISIT = `Report Parent`
VISITNUM derivation	Computation	## COMPUTATION - DERIVATION: VISITNUM VISITNUM = str_extract(`Report Parent`, "[0-9]"))
ACTARM	Computation	Set to ARM == ACTARM because no unplanned arm occurred: ## COMPUTATION - HARDCODE: ACTARM dplyr::mutate(ACTARM = ARMCD)
ACTARMUD hardcode	Other	Set is.null(ACTARMUD) because no unplanned arm occurred
AGEU hardcode	Computation	## COMPUTATION - HARDCODE: AGEU dplyr::mutate(AGEU = "YEAR")
DM.ARM	Other	## COMPUTATION - DERIVATION: ARM dplyr::mutate(ARM = randomization_scheme$Treatment.Arm[1:length(USUBJID)])
DM.ARMCD	Other	## COMPUTATION - DERIVATION: AARMCD dplyr::mutate(ARMCD = ifelse(ARM == "Active", "AA", "BA"))
ARMNULRS derivation	Computation	Set to null because no subject was randomized to an unplanned arm and no reason needed
DM.BRTHDTC	Other	## COMPUTATION - DERIVATION: BRTHDTC dplyr::mutate(BRTHDTC = lubridate::dmy(BRTHDT))
Country hardcode	Computation	## COMPUTATION - HARDCODE: COUNTRY dplyr::mutate(COUNTRY = "USA")
DMDTC derivation	Computation	Since subjects are consented and start study on the same visit, DMDTC is derived from RFICDTC: ## COMPUTATION - DERIVATION: DMDTC dplyr::mutate(DMDTC = RFSTDTC)
DTHDTC derivation	Computation	logr::put("## DETERMINE DEATH DATES AND DEATH FLAGS") dthdtc <- c() for (i in 1:length(dm$USUBJID)) { dthdtc[i] <- di_dthdtc_trial(usubjid = dm$USUBJID[i]) print(i) } dm$DTHDTC <- dthdtc
DTHFL derivation	Computation	## COMPUTATION - DERIVATION: DTHFL dthfl <- sapply(dthdtc, function(x) unlist(ifelse(str_detect( x,"[0-9]{4}-[0-9]{2}-[0-9]{2}"), "Y", "N"))) dm$DTHFL <- dthfl
DM.INVID	Other	## COMPUTATION - HARDCODE: INVID dplyr::mutate(INVID = "DCB")
RACE derivation	Computation	dm$RACE.American_Indian_or_Alaska_Native <- ifelse(dm$RACE.American_Indian_or_Alaska_Native == "1", "American Indian or Alaska Native", "") dm$DM.RACE.Asian <- ifelse(dm$RACE.Asian == "1", "Asian", "") dm$RACE.Black_or_African_American <- ifelse(dm$RACE.Black_or_African_American == "1", "Black or African American", "") dm$RACE.Native_Hawaiian_or_Other_Pacific_Islander <- ifelse(dm$DM.RACE.Native_Hawaiian_or_Other_Pacific_Islander == "1", "Native Hawaiian or Other Pacific Islander", "") dm$RACE.White <- ifelse(db$DM.RACE.White == "1", "White", "") dm <- dm %>% tidyr::unite(., col = 'RACE', 'RACE.American_Indian_or_Alaska_Native', 'RACE.Asian', 'RACE.Black_or_African_American', 'RACE.Native_Hawaiian_or_Other_Pacific_Islander', 'RACE.White', sep = ' ', remove = TRUE) dm$RACE <- str_trim(dm$RACE, "both") dm$RACE <- ifelse(dm$RACE.Other == 1, dm$RACEOTH, dm$RACE)
RFENDTC derivation	Computation	logr::put("## CALCULATE ENDTC DATES") ## COMPUTATION - DERIVATION: RFENDTC rfendtc <- c() for (i in 1:length(dm$USUBJID)) { rfendtc[i] <- di_endtc_trial(usubjid = dm$USUBJID[i]) print(i) } dm$RFENDTC <- rfendtc
DM.RFICDTC	Other	## COMPUTATION - DERIVATION: RFUCDTC dplyr::mutate(RFICDTC = lubridate::dmy(ICFDTC))
RFPENDTC derivation	Computation	RFPENDTC is the end of particpation dat from derived DSDTC variable
RFSTDTC derivation	Computation	Since subjects are consented and start study on the same visit, RFSTDTC is derived from RFICDTC: ## COMPUTATION - DERIVATION: RFSTDTC dplyr::mutate(RFSTDTC = lubridate::dmy(ICFDTC))
DM.RFXENDTC	Other	## COMPUTATION - DERIVATION: RFENDTC rfxendtc <- as.Date(rfendtc) - 1 dm$RFXENDTC <- rfxendtc
RFXSTDTC derivation	Computation	Since subjects are consented and start study on the same visit, RFXSTDTC is derived from RFICDTC + 1: ## COMPUTATION - DERIVATION: RFXSTDTC rfxstdtc <- as.Date(dm$RFSTDTC) + 1 dm$RFXSTDTC <- rfxstdtc
DOMAINS	Other	All hardcode (for example): CDISC domain for demographics is "DM"
DSCAT derivation	Computation	All hardcode (for example): dplyr::mutate(., DSCAT = "Protocol Milestone")
DSDECOD derivation	Computation	All hardcode (for example): dplyr::mutate(., DSDECOD = "ENDMASKED")
DSSEQ derivation	Computation	logr::put("## ADD DSSEQ TO DS DATASET") ds <- ds %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., USUBJID, match(DSTERM, dsord)) %>% ## COMPUTATION - DERIVATION: DSSEQ dplyr::mutate(.,DSSEQ = 1:length(USUBJID))
DSSTDTC derivation	Computation	logr::put("ADD ASSIGNED/HARDCODED VARIABLES AS REQUIRED") ds <- data.frame(ds) %>% dplyr::mutate_all(., as.character) %>% ## Derive DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD variables ## The unite function is used to combine YEAR-MM-DD to derive --DTC variables ## The function lubridate:ymd(x) ensures the format is ISO8601 ## COMPUTATION - DERIVATION: DSSTDTC dplyr::mutate(., ICFDTC = dmy(ICFDTC)) %>% # Disposition Event Date tidyr::unite(., col = 'DSDTC', 'DS_YY', 'DS_MM', 'DS_DD', sep = '-', remove = TRUE) %>% # Notification of Oncologist tidyr::unite(., col = 'ONNOTDTC', 'ONNOT_YY', 'ONNOT_MM', 'ONNOT_DD', sep = '-', remove = TRUE) %>% # Notification of Ophthalmologist tidyr::unite(., col = 'OPNOTDTC', 'OPNOT_YY', 'OPNOT_MM', 'OPNOT_DD', sep = '-', remove = TRUE) %>% # Visit 1 Completed tidyr::unite(., col = 'V1DTC', 'V1_YY', 'V1_MM', 'V1_DD', sep = '-', remove = TRUE) %>% # Visit 2 Completed tidyr::unite(., col = 'V2DTC', 'V2_YY', 'V2_MM', 'V2_DD', sep = '-', remove = FALSE) %>% # Visit 3 Scleral Lens Removed tidyr::unite(., col = 'OPNOTSCDTC', 'OPNOTDTC', 'V3SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 3 Assessments Begin tidyr::unite(., col = 'OPNOTASDTC', 'OPNOTDTC', 'V3SCRTM2', sep = ' ', remove = FALSE) %>% # Visit 3 Completed tidyr::unite(., col = 'V3DTC', 'V3_YY', 'V3_MM', 'V3_DD', sep = '-', remove = FALSE) %>% # End of Double-masked Phase tidyr::unite(., col = 'V3INVDTC', 'V3INV_Y', 'V3INV_M', 'V3INV_D', sep = '-', remove = TRUE) %>% # Informed of Open-Label dplyr::mutate(., V3INV2DTC = V3INVDTC) %>% # Visit 3 Scleral Lens Removed tidyr::unite(., col = 'V3INVSCDTC', 'V3INVDTC', 'V3SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 3 Assessments Begin tidyr::unite(., col = 'V3INVASDTC', 'V3INVDTC', 'V3SCRTM2', sep = ' ', remove = FALSE) %>% # Visit 4 Completed tidyr::unite(., col = 'V4DTC', 'V4_YY', 'V4_MM', 'V4_DD', sep = '-', remove = TRUE) %>% # Opt-in to Long Term Open Label Phase tidyr::unite(., col = 'V5OL3DTC', 'V5OL_Y', 'V5OL_M', 'V5OL_D', sep = '-', remove = TRUE) %>% # Visit 5 Completed dplyr::mutate(., 'V5DTC' = V5OL3DTC) %>% # Visit 5 Scleral Lens Removed tidyr::unite(., col = 'V5INVSCDTC', 'V5OL3DTC', 'V5SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 5 Assessments Begin tidyr::unite(., col = 'V5INVASDTC', 'V5OL3DTC', 'V5SCRTM2', sep = ' ', remove = FALSE) %>% # Opt-in to Long Term Open Label Phase Continuation tidyr::unite(., col = 'V6OL3DTC', 'V6OL_Y', 'V6OL_M', 'V6OL_D', sep = '-', remove = TRUE) %>% # Visit 6 Completed dplyr::mutate(., 'V6DTC' = V6OL3DTC) %>% # Visit 6 Scleral Lens Removed tidyr::unite(., col = 'V6INVSCDTC', 'V6OL3DTC', 'V6SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 6 Assessments Begin tidyr::unite(., col = 'V6INVASDTC', 'V6OL3DTC', 'V6SCRTM2', sep = ' ', remove = FALSE) %>% # Opt-in to Long Term Open Label Phase Continuation tidyr::unite(., col = 'V7OL3DTC', 'V7_YY', 'V7_MM', 'V7_DD', sep = '-', remove = TRUE) %>% # Visit 7 Completed dplyr::mutate(., 'V7DTC' = V7OL3DTC) %>% # Visit 7 Scleral Lens Removed tidyr::unite(., col = 'V7INVSCDTC', 'V7OL3DTC', 'V7SCRTM1', sep = ' ', remove = FALSE) %>% # Visit 7 Assessments Begin tidyr::unite(., col = 'V7INVASDTC', 'V7OL3DTC', 'V7SCRTM2', sep = ' ', remove = FALSE) ds[apply(ds, 2, str_detect, "9999")] <- NA
DSTERM derivation	Computation	End of Particpation is from DSTERM in codelist; all others are hardcode to terms (for example): ds_v3mc <- ds %>% dplyr::select_at(., .vars = ds_cols_v3mc) %>% tidyr::pivot_longer(cols = "V3INVDTC", values_to = "DSSTDTC", names_to = "DSTERM") %>% dplyr::mutate(., DSTERM = ifelse(is.na(V3INV), "Double-masked Phase Not Completed", "Double-masked Phase Completed"))
EPOCH derivation	Computation	All hardcode (for example): dplyr::mutate(., EPOCH = "Masked Phase") Alternatively, EOP is coded the following: logr::put("## SEARCH FOR EPOCH BASED ON DATES WITH di_epoch_trial FUNCTION") ## COMPUTATION - DERIVATION: EPOCH epoch <- c() for (i in 1:length(ds_eos$USUBJID)) { epoch[i] <- di_epoch_trial(usubjid = ds_eos$USUBJID[i], dtc = ds_eos$DSSTDTC[i]) print(i) } ds_eos$EPOCH <- epoch
DURATION derivation	Computation	All duration calculations are calculated as: duration = ymd(enddate) - ymd(startdate)
DVENDTC derivation	Computation	logr::put(""ADD ASSIGNED/HARDCODED VARIABLES AS REQUIRED"") ## COMPUTATION - DERIVATION: DVSTDTC dv <- data.frame(dv) %>% tidyr::unite(., col = 'DVENDTC', 'DVEN_YY', 'DVEN_MM', 'DVEN_DD', sep = '-', remove = TRUE) %>% dplyr::mutate(., DVENDTC = lubridate::ymd(DVENDTC))
DVSEQ derivation	Computation	logr::put("DERIVE --SEQ WITH DEFINED SDTM_METADATA$TOC_METADATA$DOMAINKEYS") dv <-dv %>% dplyr::group_by(., STUDYID, USUBJID, DVTERM, DVSTDTC) %>% ## COMPUTATION - DERIVATION: DVSEQ dplyr::mutate(.,DVSEQ = 1:length(USUBJID))
DVSTDTC derivation	Computation	logr::put("ADD ASSIGNED/HARDCODED VARIABLES AS REQUIRED") dv <- data.frame(dv) %>% tidyr::unite(., col = 'DVSTDTC', 'DVST_YY', 'DVST_MM', 'DVST_DD', sep = '-', remove = TRUE) %>% dplyr::mutate(., DVSTDTC = lubridate::ymd(DVSTDTC))
EPOCH derivation	Computation	dv <- dv %>% # EPOCH is derived using the EPOCH function: di_epoch_trial() dplyr::mutate(EPOCH = unlist(sapply(1:length(USUBJID), function(x) di_epoch_trial(usubjid = USUBJID[x], dtc = DVENDTC[x]))))
EPOCH hardcode	Computation	Hardcoded to TREATMENT
EXADJ hardcode	Computation	Hardcoded to EXCOM
EXCAT hardcode	Computation	Hardcoded to IF ARM == 'Active' THEN EXCAT = 'Pro-ocular' ELSE 'Placebo'
EXDOSE hardcode	Computation	Hardcoded to IF ARM == 'Active' THEN EXTRT = 'Pro-ocular' ELSE 'Placebo'
EXDOSETOT hardcode	Computation	Hardcoded to IF ARM == 'Active' THEN EXTRT = 'Pro-ocular' ELSE 'Placebo'
EXDOSFRM hardcode	Computation	Hardcoded to 'Topical'
EXDOSEFRQ hardcode	Computation	Hardcoded to 'BID'
EXDISRGM hardcode	Computation	Hardcoded to 'BID daily'
EXDOSTXT hardcode	Computation	Hardcoded to 'Topical cream applied to forhead'
EXDOSU hardcode	Computation	Hardcoded to mg
EXENDTC derivation	Computation	# "End Date/Time of Medication" dplyr::mutate(EXENDTC = EXSTDTC + 1)
EXGRPID derivation	Computation	TBD
EXLOC hardcode	Computation	Hardcoded to 'Forehead'
EXLOT hardcode	Computation	Hardcoded to Participant.Id
EXROUTE hardcode	Computation	Hardcoded to "Dermal"
EXSCAT derivation	Computation	Hardcoded to IF ARM == 'Active' THEN EXTRT = 'Pro-ocular' ELSE 'Placebo'
EXSEQ derivation	Computation	Unique sequence based on sort order of studyid usubjid extrt exstdtc
EXSTDTC hardcoded	Computation	Hardcoded to EXDTC dplyr::mutate(., EXSTDTC = EXDTC) %>%
EXTRT hardcode	Computation	All subjects were dosed with what they were randomized to, so EXTRT=DM.ARM
EXTRTTV hardcoded	Computation	Hardcoded to 'Topical cream'
EPOCH derivation	Computation	## COMPUTATION - HARDCODE: EPOCH dplyr::mutate(., EPOCH = "Screening & Baseline")
IECAT derivation	Computation	logr::put("## ADD CATEGORY FROM DATASET TI") ## COMPUTATION - HARDCODE: IECAT ie$IECAT <- sapply(1:length(ie$IETESTCD), function(x) di_map_tiiecat(ie$IETESTCD[x]))
IEDTC derivation	Computation	### COMPUTATION - HARDCODE: IEDTC dplyr::mutate(., IEDTC = dmy(ICFDTC))
IESCAT derivation	Computation	logr::put("## ADD SUBCATEGORY FROM DATASET TI") ie$IESCAT <- sapply(1:length(ie$IETESTCD), function(x) di_map_tiiescat(ie$IETESTCD[x]))
IESEQ derivation	Computation	logr::put("## GROUP VARIABLES BY IE KEYS AND SELECT VARIABLE IN ORDER") ie <- ie %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(.,STUDYID, USUBJID, IETESTCD) %>% ## COMPUTATION - DERIVATION: IESEQ dplyr::mutate(.,IESEQ = 1:length(USUBJID))
IESTRESC derivation	Computation	Hardcoded to original results (IEORRES): ie_ieoc <- ie %>% dplyr::select_at(., .vars = ie_cols_ieoc) %>% tidyr::pivot_longer(cols = all_of(ie_cols_ieoc[-c(1:10)]), values_to = "IEORRES", names_to = "IETESTCD") %>% dplyr::mutate(., IESTRESC = ifelse(IEORRES == "1" , "Yes", ifelse(IEORRES == "0" , "No", NA)))
IETEST derivation	Computation	logr::put("## ADD TEST NAME FROM SDTM DICTIONARY") ## COMPUTATION - HARDCODE: IETEST ie$IETEST <- unlist(sapply(1:length(ie$IETESTCD), function(x) di_map_test(ie$IETESTCD[x])))
IETESTCD derivation	Computation	Database variables are transposed to the IETESTCD variable: logr::put("## CREATE IE DATASET") ## COMPUTATION - HARDCODE: IETESTCD ie_ie <- ie %>% dplyr::select_at(., .vars = ie_cols_ie) %>% dplyr::mutate(., IEDTC = as.character(IEDTC)) %>% tidyr::pivot_longer(cols = all_of(ie_cols_ie[-c(1:10)]), values_to = "IESTRESC", names_to = "IETESTCD")
TAETORD derivation	Computation	## COMPUTATION - HARDCODE: TAETORD dplyr::mutate(., TAETORD = VISITNUM)
VISIT derivation	Computation	## COMPUTATION - HARDCODE: VISIT dplyr::mutate(., VISIT = "Visit 1 Screening & Baseline")
VISITDY derivation	Computation	## COMPUTATION - HARDCODE: VISITDY dplyr::mutate(., VISITDY = "0")
VISITNUM derivation	Computation	## COMPUTATION - HARDCODE: VISITNNUM dplyr::mutate(., VISITNUM = "1")
LBBLFL derivation	Computation	TBD
LBCAT derivation	Computation	TBD
LBDRVFLderivation	Computation	TBD
LBDTC derivation	Computation	TBD
LBEMTM derivation	Computation	TBD
LBENDTC derivation	Computation	TBD
LBFAST derivation	Computation	TBD
LBGRPID derivation	Computation	TBD
LBLOIN derivation	Computation	TBD
LBMETHOD derivation	Computation	TBD
LBNAM derivation	Computation	TBD
LBNRIND derivation	Computation	TBD
LBORNRHI derivation	Computation	TBD
LBORNRLO derivation	Computation	TBD
LBORRES derivation	Computation	TBD
LBORRESU derivation	Computation	TBD
LBREASND derivation	Computation	TBD
LBREFID derivation	Computation	TBD
LBRFTDTC derivation	Computation	TBD
LBSCAT derivation	Computation	TBD
LBSEQ derivation	Computation	TBD
LBSPCCND derivation	Computation	TBD
LBSPEC derivation	Computation	TBD
LBSPID derivation	Computation	TBD
LBSTAT derivation	Computation	TBD
LBSTNRC derivation	Computation	TBD
LBSTNRHI derivation	Computation	TBD
LBSTNRLO derivation	Computation	TBD
LBSTRESC derivation	Computation	TBD
LBSTRESN derivation	Computation	TBD
LBSTRESN derivation	Computation	TBD
LBTEST derivation	Computation	TBD
LBTESTCD derivation	Computation	TBD
LBTOX derivation	Computation	TBD
LBTOXGR derivation	Computation	TBD
LBTPT derivation	Computation	TBD
LBTPTNUM derivation	Computation	TBD
LBTPTREF derivation	Computation	TBD
VISIT derivation	Computation	TBD
VISITDY derivation	Computation	TBD
VISITNUM derivation	Computation	TBD
MAPOPTIONS derivation	Computation	logr::put("## MAPS VARIABLE OPTIONS BASED ON SDTM_METADATA CODELISTS") di_map_options <- function(x) { # Collect variable names from the dataset cols <- base::colnames(x) # Collect date variable names from the dataset cols_dtc <- cols[stringr::str_detect(base::colnames(x), "DTC_\|OCMST(M\|D\|Y)\|_(DD\|MM\|YY)")] # Collect non-date variable names from the dataset cols_var <- cols[-which(cols %in% cols_dtc)] # For loop to map nonb-date variable options from source variables for (i in base::which(cols %in% cols_var)) { # Determine unique CODELISTNAME (grouping name) indx <- which(sdtm_dictionary$`Variable name` %in% cols[i]) gname = base::unique(sdtm_dictionary$`Optiongroup name`[indx]) # If the variable does not exist in sdtm_dictionary$`Variable name` # and returns character(0) sets conditions for next if(length(indx) < 1) { gname = 1 } # If the variable is in sdtm_dictionary$`Variable name` but # no sdtm_dictionary$`Optiongroup name` sets conditions for next if(is.na(gname)) { gname = 1 } # If variable does not exist in sdtm_code$sourcevariable move to next variable if(gname == 1) { next } else { # Filter the sdtm_code based on unique CODELISTNAME lookup <- base::data.frame(sdtm_code) %>% dplyr::filter(., CODELISTNAME %in% gname) %>% dplyr::select(., sourcevalue, CODEDVALUE) # Map map variable options from sourcevalue to CODEVALUE via lookup x[,i] <- sapply(x[,i], function(y) lookup$CODEDVALUE[match(y, lookup$sourcevalue)]) } } if(length(cols_dtc) < 1) { return(x) } else { # For loop to map variable date (DAY. MONTH) options from source variables for (ii in base::which(cols %in% cols_dtc)) { # Maps MONTH variables, DERIVES "01" if MONTH == UNK if(stringr::str_detect(cols[ii], "DTC_MM\|DTC_M\|OCMSTM\|_MM")) { # Filter the sdtm_code based on unique CODELISTNAME lookup <- base::data.frame(sdtm_code) %>% dplyr::filter(., CODELISTNAME %in% "MONTH") %>% dplyr::select(., sourcevalue, CODEDVALUE) # Map map variable options from sourcevalue to CODEVALUE via lookup x[,ii] <- sapply(x[,ii], function(y) lookup$CODEDVALUE[match(y, lookup$sourcevalue)]) } # Maps DAY variables, DERIVES "01" if DAY == UN if(stringr::str_detect(cols[ii], "DTC_DD\|DTC_D\|OCMSTD\|_DD")) { # Filter the sdtm_code based on unique CODELISTNAME lookup <- base::data.frame(sdtm_code) %>% dplyr::filter(., CODELISTNAME %in% "DAY") %>% dplyr::select(., sourcevalue, CODEDVALUE) # Map map variable options from sourcevalue to CODEVALUE via lookup x[,ii] <- sapply(x[,ii], function(y) lookup$CODEDVALUE[match(y, lookup$sourcevalue)]) } # Ignores any mapping of YEAR variables if(stringr::str_detect(cols[ii], "DTC_YY\|DTC_Y\|OCMSTY\|_YY")){ # x[,ii] <- base::sapply(x[,ii], # function(y) base::ifelse(base::is.na(x[,ii]), "9999", # base::unlist(x[,ii]))) } # Collect time variable names from the dataset cols_tm <- cols[stringr::str_detect(base::colnames(x), "TM\|TIM\|FSWO")] } } x }
Manual entry	Computation	This variable consists of study level metadata that was manually entered into SDTM_METADATA.xlsx
MHBODSYS derivation	Computation	TBD
MHCAT hardcode	Computation	MHCAT is hardcoded for each dataset in MH (for example): ## COMPUTATION - HARDCODE: MHCAT dplyr::mutate(., MHCAT = "Surgical History")
MHDECOD derivation	Computation	TBD
MHDTC derivation	Computation	MHDTC is derived from each MH dataset (for example): ## COMPUTATION - DERIVATION: MHDTC dplyr::mutate(., MHDTC = dmy_hms(MHDTC))
MHENDTC derivation	Computation	MHENDTC is derived from each MH dataset (for example): ## COMPUTATION - DERIVATION: MHSTDTC tidyr::unite(., col = 'MHENDTC', 'OHSY', 'OHSM', 'OHSD', sep = '-', remove = TRUE)
MHMODIFY derivation	Computation	TBD
MHPRESP derivation	Computation	All terms related to GVHD are considered prespecified: ## COMPUTATION - DERIVATION: MHPRESP dplyr::mutate(., MHPRESP = ifelse( MHTERM %in% c("oGVHD", "stem cell transplant", "GVHD", "Graft versus host disease", "allogeneic Stem cell transplant", "graft versus host disease", "Allogeneic Stem Cell Transplant", "Ocular Graft versus host disease", "Allogeneic stem cell transplant", "Allogeneic Stem cell transplant", "allogenic Stem cell transplant", "Graft vs host disease", "o GVHD", "Allogeneic stem cell transplant", "Allogeneic stem call transplant", "Stem cell transplant", "Allogeneic Bone Marrow Transplant", "Autologous Bone marrow transplant" ), "Yes", "No"))
MHREASND derivation	Computation	TBD
MHSCAT hardcode	Computation	TBD
MHSEQ derivation	Computation	## COMPUTATION - DERIVATION: MHSEQ dplyr::mutate(.,MHSEQ = 1:length(USUBJID))
MHSTDTC derivation	Computation	MHSTDTC is derived from each MH dataset (for example): ## COMPUTATION - DERIVATION: MHSTDTC tidyr::unite(., col = 'MHSTDTC', 'OHDY', 'OHDM', 'OHDD', sep = '-', remove = TRUE)
EPOCH derivation	Computation	sv_oe <- sv %>% dplyr::select(USUBJID, VISITNUM, SVSTDTC, SVSTDY) %>% ## COMPUTATION - DERIVATION: EPOCH dplyr::mutate(EPOCH = unlist(sapply(1:length(USUBJID), function(x) di_epoch_trial( usubjid = USUBJID[x], dtc = SVSTDTC[x])))) ## join datasets oe <- join(oe, sv_oe, type = "left", match = "all")
OEBLFL derivation	Computation	## COMPUTATION - DERIVATION: OEBLFL logr::put("## ADD BASELINE FLAG FROM SDTM DICTIONARY") oe_od$OEBLFL <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_blfl(oe_od$OETESTCD[x])))
OEDRVFL hardcode	Computation	## COMPUTATION - HARDCODE: DRVFL oe$OEDRVFL[str_detect(oe$OETESTCD, "OU$")] <- "Y" oe$OEDRVFL[!str_detect(oe$OETESTCD, "OU$")] <- "N"
OEDTC derivation	Computation	oe <- oe %>% ## COMPUTATION - DERIVATION: DTC dplyr::mutate(OEDTC = SVSTDTC) %>% dplyr::mutate(OEDY = SVSTDY)
OELOBXFL hardcode	Computation	Set to null
OESEQ derivation	Computation	oe <- data.frame(oe) %>% dplyr::mutate(., DOMAIN = "OE") %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., USUBJID, VISITNUM, TAETORD) %>% ## COMPUTATION - DERIVATION: SEQ dplyr::mutate(.,OESEQ = 1:length(USUBJID))
TAETORD derivation	Computation	parmcd_dt <- sdtm_value[sdtm_value$DOMAIN %in% "OE",] ## COMPUTATION - DERIVATION: TAEORD oe$TAETORD <- NA for(i in 1:length(parmcd_dt$VALUENAME)) { gripid <- str_extract(parmcd_dt$WHERECLAUSEOID[i], "(\\.)[0-9\|A-Z]+$") gripid <- sub(".", "", gripid ) oe$TAETORD[str_detect(oe$OETESTCD, parmcd_dt$VALUENAME[i]) & str_detect(oe$OEGRPID, gripid)] <- parmcd_dt$VARNUM[i] print(i) }
VISIT derivation	Computation	## COMPUTATION - DERIVATION: VISIT logr::put("## ADD PLANNED VISIT FROM SDTM DICTIONARY") oe_od$VISIT <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_visit(oe_od$OETESTCD[x])))
VISITDY derivation	Computation	## COMPUTATION - DERIVATION: STUDYDAYS logr::put("## ADD PLANNED VISITDY FROM SDTM DICTIONARY") oe_od$VISITDY <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_visitdy(oe_od$OETESTCD[x])))
VISITNUM derivation	Computation	## COMPUTATION - DERIVATION: VISITNUM logr::put("## ADD PLANNED VISITNUM FROM SDTM DICTIONARY") oe_od$VISITNUM <- unlist(sapply(1:length(oe_od$OETESTCD), function(x) di_map_visitnum(oe_od$OETESTCD[x])))
EPOCH derivation	Computation	sv_qs <- sv %>% dplyr::select(USUBJID, VISITNUM, SVSTDTC, SVSTDY) %>% ## COMPUTATION - DERIVATION: EPOCH dplyr::mutate(EPOCH = unlist(sapply(1:length(USUBJID), function(x) di_epoch_trial( usubjid = USUBJID[x], dtc = SVSTDTC[x])))) ## join datasets qs <- join(qs, sv_qs, type = "left", match = "all")
QSBLFL derivation	Computation	## COMPUTATION - DERIVATION: BLFL logr::put("## ADD BASELINE FLAG FROM SDTM DICTIONARY") qs_od$QSBLFL <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_blfl(qs_od$QSTESTCD[x])))
QSDRVFL derivation	Computation	## COMPUTATION - HARDCODE: DRVFL qs$QSDRVFL[str_detect(qs$QSTESTCD, "OU$")] <- "Y" qs$QSDRVFL[!str_detect(qs$QSTESTCD, "OU$")] <- "N"
QSDTC derivation	Computation	qs <- qs %>% ## COMPUTATION - DERIVATION: DTC dplyr::mutate(QSDTC = SVSTDTC) %>% dplyr::mutate(QSDY = SVSTDY)
QSSEQ derivation	Computation	qs <- data.frame(qs) %>% dplyr::mutate(., DOMAIN = "QS") %>% dplyr::group_by(., USUBJID) %>% dplyr::arrange(., USUBJID, VISITNUM, TAETORD) %>% ## COMPUTATION - DERIVATION: SEQ dplyr::mutate(.,QSSEQ = 1:length(USUBJID))
TAETORD derivation	Computation	parmcd_dt <- sdtm_value[sdtm_value$DOMAIN %in% "QS",] ## COMPUTATION - DERIVATION: TAETORD qs$TAETORD <- NA for(i in 1:length(parmcd_dt$VALUENAME)) { qs$TAETORD[str_detect(qs$QSTESTCD, parmcd_dt$VALUENAME[i])] <- parmcd_dt$VARNUM[i] print(i) }
VISIT derivation	Computation	## COMPUTATION - DERIVATION: VISIT logr::put("## ADD PLANNED VISIT FROM SDTM DICTIONARY") qs_od$VISIT <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_visit(qs_od$QSTESTCD[x])))
VISITDY derivation	Computation	## COMPUTATION - DERIVATION: VISITDY logr::put("## ADD PLANNED VISITDY FROM SDTM DICTIONARY") qs_od$VISITDY <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_visitdy(qs_od$QSTESTCD[x])))
VISITNUM derivation	Computation	## COMPUTATION - DERIVATION: VISITNUM logr::put("## ADD PLANNED VISITNUM FROM SDTM DICTIONARY") qs_od$VISITNUM <- unlist(sapply(1:length(qs_od$QSTESTCD), function(x) di_map_visitnum(qs_od$QSTESTCD[x])))
SCDTC derivation	Computation	## COMPUTATION - DERIVATION: SCDTC dplyr::mutate(., SCDTC = dmy(ICFDTC))
SCSEQ derivation	Computation	## COMPUTATION - DERIVATION: SCSEQ dplyr::mutate(.,SCSEQ = 1:length(USUBJID))
SCSTRESC derivation	Computation	## COMPUTATION - DERIVATION: SCSTRESC dplyr::mutate(SCSTRESC = str_to_title(SCORRES))
SCTEST hardcode	Computation	SCTEST are hardcoded depending on the Eye (for example): ## COMPUTATION - HARDCODE: DOMAIN, SCTEST, SCTESTCD dplyr::mutate(., ICOD = ifelse(is.na(ICOS_Spe), ICOS, ICOS_Spec)) %>% dplyr::mutate(., DOMAIN = "SC") %>% dplyr::mutate(., SCTEST = "Iris Color, OS") %>% dplyr::mutate(., SCTESTCD = "ICOS")
SCTESTCD hardcode	Computation	SCTESTCD are hardcoded depending on the Eye (for example): ## COMPUTATION - HARDCODE: DOMAIN, SCTEST, SCTESTCD dplyr::mutate(., ICOD = ifelse(is.na(ICOS_Spe), ICOS, ICOS_Spec)) %>% dplyr::mutate(., DOMAIN = "SC") %>% dplyr::mutate(., SCTEST = "Iris Color, OS") %>% dplyr::mutate(., SCTESTCD = "ICOS")
VISITNUM hardcode	Computation	## COMPUTATION - HARDCODE: VISITNUM dplyr::mutate(VISITNUM = "1")
ELEMENT derivation	Computation	## COMPUTATION - DERIVATION: VISITNUM se$ELEMENT <- ifelse(se$VISITNUM %in% c(1), "Screening & Baseline", ifelse(se$VISITNUM %in% c(2,3), "Masked Phase", ifelse(se$VISITNUM %in% c(4,5), "Open-label Phase", ifelse(se$VISITNUM %in% c(6,7), "Open-label Extension Phase", NA))))
EPOCH derivation	Computation	## COMPUTATION - DERIVATION: EPOCH se$EPOCH <- ifelse(se$VISITNUM %in% c(1), "Screening & Baseline", ifelse(se$VISITNUM %in% c(2,3), "Masked Phase", ifelse(se$VISITNUM %in% c(4,5), "Open-label Phase", ifelse(se$VISITNUM %in% c(6,7), "Open-label Extension Phase", NA))))
ECTD derivation	Computation	## COMPUTATION - DERIVATION: ETCD se$ETCD <- ifelse(se$VISITNUM %in% c(1), "SCREEN", ifelse(se$VISITNUM %in% c(2,3), "MASKED", ifelse(se$VISITNUM %in% c(4,5), "OPEN", ifelse(se$VISITNUM %in% c(6,7), "OPENEXT", NA))))
SEENDTC derivation	Computation	Assigned based on VISITNUM & SVENDTC & EOP: logr::put("## MAPS SEENDTC TO THE NEXT VISIT -1 DAY OR END OF PARTICIPATION") di_seendtc <- function(x) { ## Capture end of participation date if available xx <- db %>% tidyr::unite(., col = 'SE.SEENDTC', "DS_YY", "DS_MM", "DS_DD", sep = '-', remove = FALSE) %>% dplyr::select(., USUBJID, SE.SEENDTC) ## Replace missing dates with NA xx$SE.SEENDTC[xx$SE.SEENDTC == "NA-NA-NA"] <- NA ## Replace missing dates with NA x$SESTDTC[x$SESTDTC == "NA-NA-NA"] <- NA ## Define the end of participation date eop <- xx$SE.SEENDTC[xx$USUBJID %in% x$USUBJID[1]] ## Assign an index for the first missing date (NA) in SESTDTC indx <- which(is.na(x$SESTDTC))[1] ## Apply an end of participation date if applicable to the last SESTDTC x$SESTDTC[indx] <- eop ## Define the end of the SESTDTC period by the next SESTDTC - 1 day x$SEENDTC <- dplyr::lead(ymd(x$SESTDTC), n = 1, default = NA) -1 ## If subject has no EOP date, end the function if (is.na(eop)) { xxx <- x %>% dplyr::select(STUDYID, DOMAIN, USUBJID, SESEQ, ETCD, ELEMENT, TAETORD, EPOCH, SESTDTC, SEENDTC, SESTDY,SEENDY) xxx } else ## Define the EOP as the last element and return the dates x$SEENDTC[indx] <- eop # x$SEENDTC[length(x$SESTDTC)] <- x$SESTDTC[length(x$SESTDTC)] xxx <- x %>% dplyr::select(STUDYID, DOMAIN, USUBJID, SESEQ, ETCD, ELEMENT, TAETORD, EPOCH, SESTDTC, SEENDTC, SESTDY,SEENDY) xxx } logr::put("## CALCULATE START STUDY DAYS FOR DATASET") sestdy <- c() for (i in 1:length(se$USUBJID)) { sestdy[i] <- di_dy_trial(usubjid = se$USUBJID[i], dtc = se$SESTDTC[i]) print(i) } se$SESTDY[] <- unlist(as.character(sestdy))
SESEQ derivation	Computation	## COMPUTATION - HARDCODE: SESEQ se$SESEQ <- se$VISITNUM
SESTDTC derivation	Computation	Assigned based on VISITNUM & SVSTDTC
TAETORD derivation	Computation	### COMPUTATION - HARDCODE: VISITNUM dplyr::mutate(., TAETORD = VISITNUM)
Hardcode to assign domain	Computation	Hardcode to the name of the SDTM domain
Null Value	Computation	Set to null
--DY derivation	Computation	If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1. Uses the di_dy_trial function (see com.STUDYDAYS)
STUDYID hardcode	Computation	Hardcode STUDYID = "oGvHD-2-SC"
IDVAR hardcode	Computation	IDVAR = "USUBJID.AESEQ"
IDVARVAL derivation	Computation	IDVARVAL is the unique concatenation of USUBJID and AESEQ: dplyr::mutate(., IDVARVAL = paste0(USUBJID, ".", AESEQ))
QLABEL derivation	Computation	## DERIVATION - COMPUTATION: SUPPAE.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QNAM derivation	Computation	logr::put("## RESHAPE V4EVA FROM WIDE TO LONG AND MAP TO VISITS IN SUPPSV") suppae <- ae %>% ## DERIVATION - COMPUTATION: SUPPAE.QNAM dplyr::select_at(., suppae_cols) %>% tidyr::pivot_longer(cols = suppae_cols[-c(5:7)], values_to = "QVAL", names_to = "QNAM")
QORIG derivation	Computation	## DERIVATION - HARDCODE: SUPPAE.QORIG dplyr::mutate(., QORIG = "CRF Pages 31, 44, 67, 79, 102, 130, 157")
QVAL derivation	Computation	Values from variable (QNAM) are assigned to QVAL: dplyr::select_at(., suppae_cols) %>% tidyr::pivot_longer(cols = suppae_cols[-c(5:7)], values_to = "QVAL", names_to = "QNAM")
IDVAR	Computation	## COMPUTATION - HARDCODE: CM.IDVAR dplyr::mutate(., IDVAR = "USUBJID")
IDVARVAL	Computation	## COMPUTATION - DERIVATION: CM.IDVARVAL dplyr::mutate(., IDVARVAL = paste0(USUBJID))
QLABEL	Computation	## COMPUTATION - DERIVATION: CM.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QNAM	Computation	logr::put("## RESHAPE V4EVA FROM WIDE TO LONG AND MAP TO VISITS IN SUPPSV") suppcm <- db %>% dplyr::select_at(., .vars = suppcm_cols) %>% ## COMPUTATION - DERIVATION: QNAM tidyr::pivot_longer(cols = suppcm_cols[-c(16:17)], values_to = "QVAL", names_to = "QNAM")
QORIG	Computation	logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: CM.QORIG suppcm$QORIG <- unlist(sapply(1:length(suppcm$QNAM), function(x) di_map_qorig(suppcm$QNAM[x])))
QVAL	Computation	## COMPUTATION - DERIVATION: QNAM tidyr::pivot_longer(cols = suppcm_cols[-c(16:17)], values_to = "QVAL", names_to = "QNAM")
IDVAR	Computation	## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
IDVARVAL	Computation	## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QEVAL hardocde	Computation	## Evaluators -- "Wei-wei Chang, Jonathan D. Stallings"
QLABEL	Computation	## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QNAM	Computation	## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QORIG	Computation	## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
QVAL	Computation	## Manually derived/hardcoded by Sponsor / Biostatistician while in review of population flags
IDVAR derivation	Computation	## COMPUTATION - HARDCODE: SUPPIE.IDVAR dplyr::mutate(., IDVAR = "IESEQ")
IDVARVAL derivation	Computation	logr::put("## HARDCODE IDVARVAL BASED ON IESEQ") ## COMPUTATION - DERIVATION: SUPPIE.IDVARVAL suppie$IDVARVAL <- ifelse(suppie$QNAM %in% c("IEOC1_chk", "IEOC1_imp"), "28", ifelse(suppie$QNAM %in% c("IEOC2_chk", "IEOC2_imp"), "29", ifelse(suppie$QNAM == "REASON", "1", NA)))
QLABEL derivation	Computation	di_map_test function is used to map the db dictionary labels to QLABEL: ## COMPUTATION - DERIVATION: SUPPIE.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QNAM derivation	Computation	logr::put("## CREATE SUPPIE (SUPPLEMENTAL) DATASET") suppie <- suppie %>% ## COMPUTATION - DERIVATION: SUPPIE.QNAM tidyr::pivot_longer(cols = suppie_cols[!(suppie_cols %in% c(keep_cols))], values_to = "QVAL", names_to = "QNAM")
QORIG derivation	Computation	logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: SUPPIE.QORIG suppie$QORIG <- unlist(sapply(1:length(suppie$QNAM), function(x) di_map_qorig(suppie$QNAM[x])))
QVAL derivation	Computation	Values from variable (QNAM) are assigned to QVAL: tidyr::pivot_longer(cols = suppie_cols[!(suppie_cols %in% c(keep_cols))], values_to = "QVAL", names_to = "QNAM")
IDVAR hardcode	Computation	## COMPUTATION - HARDCODE: SUPPMH.IDVAR dplyr::mutate(., IDVAR = "MHTERM")
IDVARVAL derivation	Computation	## COMPUTATION - DERIVATION: SUPPMH.IDVARVAL dplyr::mutate(., IDVARVAL = MHSEQ)
QLABEL derivation	Computation	## COMPUTATION - HARDCODE: SUPPMH.QLABEL dplyr::mutate(., QLABEL = "Comment")
QNAM derivation	Computation	## COMPUTATION - DERIVATION: SUPPMH.QNAM dplyr::mutate(., QNAM = ifelse(MHCAT %in% "Ocular Medical History", "OHCOM", ifelse(MHCAT %in% "Non-Ocular Medical History", "MHCOM", NA)))
QORIG derivation	Computation	## COMPUTATION - HARDCODE: SUPPMH.QORIG dplyr::mutate(., QORIG = "CRF Page 8")
QVAL derivation	Computation	Values for QVAL are assigned from the MHCOM from each MH Dataset: ## COMPUTATION - HARDCODE: SUPPMH.QVAL dplyr::mutate(., QVAL = MHCOM)
IDVAR	Computation	## COMPUTATION - HARDCODE: SUPPOE.IDVAR dplyr::mutate(., IDVAR = "VISITNUM")
IDVARVAL	Computation	logr::put("## ADD VISITNUM FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: SUPPOE.IDVARVAL suppoe$IDVARVAL <- unlist(sapply(1:length(suppoe$QNAM), function(x) di_map_visitnum(suppoe$QNAM[x])))
QLABEL	Computation	## COMPUTATION - DERIVATION: SUPPOE.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QNAM	Computation	suppoe <- oe %>% dplyr::select_at(., .vars = suppoe_cols) %>% ## COMPUTATION - DERIVATION: SUPPOE.QNAM tidyr::pivot_longer(cols = suppoe_cols[-c(1)], values_to = "QVAL", names_to = "QNAM")
QORIG	Computation	logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: SUPPOE.QORIG suppoe$QORIG <- unlist(sapply(1:length(suppoe$QNAM), function(x) di_map_qorig(suppoe$QNAM[x])))
QVAL	Computation	Values from variable (QNAM) are assigned to QVAL: tidyr::pivot_longer(cols = suppoe_cols[-c(1)], values_to = "QVAL", names_to = "QNAM")
IDVAR	Computation	## COMPUTATION - HARDCODE: IDVAR dplyr::mutate(., IDVAR = "VISITNUM")
IDVARVAL	Computation	## COMPUTATION - DERIVATION: IDVARVAL dplyr::mutate(., IDVARVAL = ifelse(QNAM == "V2EVA", "2", ifelse(QNAM == "V4EVA", "4", NA)))
QLABEL	Computation	## COMPUTATION - DERIVATION: SUPPQS.QLABEL dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QNAM	Computation	## COMPUTATION - HARDCODE: SUPPQS.QNAM dplyr::mutate(., QNAM = QSTESTCD)
QORIG	Computation	## COMPUTATION - DERIVATION: SUPPQS.QORIG dplyr::mutate(., QORIG = ifelse(QNAM %in% c("V2D_MSEVA", "V2N_MSEVA", "V2_GOSDS"), "CRF Page 42", ifelse(QNAM %in% c("V2D_MSEVA", "V2N_MSEVA", "V2_GOSDS"), "CRF Page 77", NA)))
QVAL	Computation	## COMPUTATION - HARDCODE: SUPPQS.QVAL dplyr::mutate(., QVAL = QSORRES)
IDVAR hardcode	Computation	## COMPUTATION - HARDCODE: IDVAR dplyr::mutate(., IDVAR = "VISITNUM")
IDVARVAL derivation	Computation	logr::put("## ADD VISITNUM FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: IDVARVAL suppsv$IDVARVAL <- unlist(sapply(1:length(suppsv$QNAM), function(x) di_map_visitnum(suppsv$QNAM[x])))
QLABEL derivation	Computation	di_map_test function is used to map the db dictionary labels to QLABEL: dplyr::mutate(., QLABEL = unlist( sapply(1:length(QNAM), function(x) di_map_test(QNAM[x]))))
QNAM derivation	Computation	logr::put("## RESHAPE COLNAMES FOR SUPPSV FROM FROM WIDE TO LONG AND MAP TO VISITS IN SUPPSV") suppsv_cols <- sv_cols[str_detect(sv_cols, "EVA")] suppsv_cols <- c(suppsv_cols, "STUDYID", "USUBJID") suppsv <- sv %>% dplyr::select_at(., suppsv_cols) %>% tidyr::pivot_longer(cols = suppsv_cols[-c(3:4)], values_to = "QVAL", names_to = "QNAM")
QORIG derivation	Computation	logr::put("## ADD CRF PAGE FROM SDTM DICTIONARY") ## COMPUTATION - DERIVATION: QORIG suppsv$QORIG <- unlist(sapply(1:length(suppsv$QNAM), function(x) di_map_qorig(suppsv$QNAM[x])))
QVAL derivation	Computation	Values from variable (QNAM) are assigned to QVAL: ## COMPUTATION - DERIVATION: QNAM tidyr::pivot_longer(cols = suppsv_cols[-c(3:4)], values_to = ""QVAL"", names_to = ""QNAM"")
SVCNTMOD hardcode	Computation	## COMPUTATION - HARDCODE: SVCNTMOD sv_visit$SVCNTMOD <- ifelse(!sv_visit$VISITNUM %in% c("2","4"), "CLINIC VISIT", "TELEPHONE VISIT")
SVENDTC derivation	Computation	## COMPUTATION - DERIVATION: SVSTDC ## All visits occur on a single day, start == end dplyr::mutate(., SVENDTC = SVSTDTC)
SVOCCUR derivation	Computation	All occurance is determined by VXYN variables for each visit (i.e., V1YN): logr::put("## RESHAPE SVOCCUR FROM WIDE TO LONG AND MAP TO VISITS") ## COMPUTATION - DERIVATION: SVOCCUR sv_cols_occur <- sv_cols[str_detect(sv_cols, "YN")] sv_cols_occur <- c(sv_cols_occur, "USUBJID") sv_occur <- sv %>% dplyr::select_at(., sv_cols_occur) %>% tidyr::pivot_longer(cols = sv_cols_occur[-c(8)], values_to = "SVOCCUR") sv_visit$SVOCCUR <- sv_occur$SVOCCUR
SVPRESP hardcode	Computation	# Hardcode Prespecified visits ## COMPUTATION - HARDCODE: SV.SVPRESP dplyr::mutate(., SVPRESP = "Y")
SVREASOC derivation	Computation	All reason is determined by VXRSN variables for each visit (i.e., V1RSN): logr::put("## RESHAPE SVREASOC FROM WIDE TO LONG AND MAP TO VISITS") ## COMPUTATION - DERIVATION: SVREASON sv_cols_reason <- sv_cols[str_detect(sv_cols, "RSN")] sv_cols_reason <- c(sv_cols_reason, "USUBJID") sv_reason <- sv %>% dplyr::select_at(., sv_cols_reason) %>% tidyr::pivot_longer(cols = sv_cols_reason[-c(8)], values_to = "SVREASOC") sv_visit$SVREASOC <- sv_reason$SVREASOC
SVSTDTC derivation	Computation	logr::put("## DERIVE DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD") ## COMPUTATION - DERIVATION: SV.STDTC sv <- sv %>% ## Derive DTC, STDTC, and ENDTC from --DTC_YY, --DTC_MM, --DTC_DD variables ## The unite function is used to combine YEAR-MM-DD to derive --DTC variables ## The function lubridate:ymd(x) ensures the format is ISO8601 # Site visit 1 tidyr::unite(., col = 'SVSTDTC1', 'V1_YY', 'V1_MM', 'V1_DD', sep = '-', remove = TRUE) %>% # Site visit 2 tidyr::unite(., col = 'SVSTDTC2', 'V2_YY', 'V2_MM', 'V2_DD', sep = '-', remove = TRUE) %>% # Site visit 3 tidyr::unite(., col = 'SVSTDTC3', 'V3_YY', 'V3_MM', 'V3_DD', sep = '-', remove = TRUE) %>% # Site visit 4 tidyr::unite(., col = 'SVSTDTC4', 'V4_YY', 'V4_MM', 'V4_DD', sep = '-', remove = TRUE) %>% # Site visit 5 tidyr::unite(., col = 'SVSTDTC5', 'V5_YY', 'V5_MM', 'V5_DD', sep = '-', remove = TRUE) %>% # Site visit 6 tidyr::unite(., col = 'SVSTDTC6', 'V6_YY', 'V6_MM', 'V6_DD', sep = '-', remove = TRUE) %>% # Site visit 7 tidyr::unite(., col = 'SVSTDTC7', 'V7_YY', 'V7_MM', 'V7_DD', sep = '-', remove = TRUE)
VISIT derivation	Computation	Asssigned based on VISITNUM: ## COMPUTATION - DERIVATION: VISIT dplyr::mutate(., VISIT = paste0("Visit ", VISITNUM)) logr::put("## Recode Visit 1 Screening & Baseline from Visit 1") sv_visit$VISIT[sv_visit$VISITNUM == 1] <- "Visit 1 Screening & Baseline"
VISITDY derivation	Computation	Hardcode to the planned study day: logr::put("## HARDCODE/DERIVE PLANNED VISITDY AND CONTACT METHOD FROM PROTOCOL") ## COMPUTATION - HARDCODE: VISITDY sv_visit$VISITDY <- ifelse( sv_visit$VISITNUM == 1, 1, ifelse(sv_visit$VISITNUM == 2, 42, ifelse(sv_visit$VISITNUM == 3, 84, ifelse(sv_visit$VISITNUM == 4, 126, ifelse(sv_visit$VISITNUM == 5, 168, ifelse(sv_visit$VISITNUM == 6, 252, 364))))))
VISITNUM derivation	Computation	Based in numeric value in visit STDTC inputs. I.e., V1_DD: dplyr::mutate(., VISITNUM = gsub("[^0-9.-]", "", VISITNUM))
Unique Subject IDs	Computation	USUBJID = paste0("GL2SC", SUBJID)

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Permitted Value (Code)	Display Value (Decode)	Rank
01	01	1
02	02	2
03	03	3
04	04	4
05	05	5
06	06	6
07	07	7
08	08	8
09	09	9
10	10	10
11	11	11
12	12	12
13	13	13
14	14	14
15	15	15
16	16	16
17	17	17
18	18	18
19	19	19
20	20	20
21	21	21
22	22	22
23	23	23
24	24	24
25	25	25
26	26	26
27	27	27
28	28	28
29	29	29
30	30	30
31	31	31
01	01	32

Permitted Value (Code)	Display Value (Decode)	Rank
Completed	Completed	1
Early Termination Screen Failure	Early Termination Screen Failure	2
Early Termination Adverse Event	Early Termination Adverse Event	3
Early Termination Death	Early Termination Death	4
Early Termination Lost to Follow-up	Early Termination Lost to Follow-up	5
Early Termination Non-compliance with Study Drug	Early Termination Non-compliance with Study Drug	6
Early Termination Physician Decision	Early Termination Physician Decision	7
Early Termination Pregnancy	Early Termination Pregnancy	8
Early Termination Protocol Deviation	Early Termination Protocol Deviation	9
Early Termination Recovery	Early Termination Recovery	10
Early Termination Site Terminated by Sponsor	Early Termination Site Terminated by Sponsor	11
Early Termination Study Terminated by Sponsor	Early Termination Study Terminated by Sponsor	12
Early Termination Technical Problems	Early Termination Technical Problems	13
Early Termination Withdrawal by Subject	Early Termination Withdrawal by Subject	14
Early Termination Other	Early Termination Other	15

Permitted Value (Code)	Display Value (Decode)	Rank
01	JAN	1
02	FEB	2
03	MAR	3
04	APR	4
05	MAY	5
06	JUN	6
07	JUL	7
08	AUG	8
09	SEP	9
10	OCT	10
11	NOV	11
12	DEC	12
01	UNK	13

Permitted Value (Code)	Display Value (Decode)	Rank
01	01	1
02	02	2
03	03	3
04	04	4
05	05	5
06	06	6
07	07	7
08	08	8
09	09	9
10	10	10
11	11	11
12	12	12
13	13	13
14	14	14
15	15	15
16	16	16
17	17	17
18	18	18
19	19	19
20	20	20
21	21	21
22	22	22
23	23	23
24	24	24
25	25	25
26	26	26
27	27	27
28	28	28
29	29	29
30	30	30
31	31	31
01	01	32

Permitted Value (Code)	Display Value (Decode)	Rank
01	JAN	1
02	FEB	2
03	MAR	3
04	APR	4
05	MAY	5
06	JUN	6
07	JUL	7
08	AUG	8
09	SEP	9
10	OCT	10
11	NOV	11
12	DEC	12
01	UNK	13

Datasets

Adverse Events (AE)

Concomitant Medications (CM)

Product Acountability (DA)

Demographics (DM)

Disposition (DS)

Protocol Deviations (DV)

Exposure (EX)

Inclusion/Exclusion Exceptions (IE)

Laboratory Tests (LB)

Medical History (MH)

Opthalmic Examinations (OE)

Questionnaires (QS)

Subject Characteristics (SC)

Subject Elements (SE)

Supplemental Qualifiers for Adverse Events (SUPPAE)

Supplemental Qualifiers for Concomitant Medications (SUPPCM)

Supplemental Qualifiers for Demographics (SUPPDM)

Supplemental Qualifiers for Inclusion/Exclusion Exceptions (SUPPIE)

Supplemental Qualifiers for Medical History (SUPPMH)

Supplemental Qualifiers for Opthalmic Examinations (SUPPOE)

Supplemental Qualifiers for Questionnaires (SUPPQS)

Supplemental Qualifiers for Subject Visits (SUPPSV)

Subject Visits (SV)

Trial Arms (TA)

Trial Elements (TE)

Trial Inclusion/ Exclusion Criteria (TI)

Trial Summary (TS)

Trial Visits (TV)

CodeLists

External Dictionaries

Methods

Permitted Value (Code)	Display Value (Decode)	Rank
01	01	1
02	02	2
03	03	3
04	04	4
05	05	5
06	06	6
07	07	7
08	08	8
09	09	9
10	10	10
11	11	11
12	12	12
13	13	13
14	14	14
15	15	15
16	16	16
17	17	17
18	18	18
19	19	19
20	20	20
21	21	21
22	22	22
23	23	23
24	24	24
25	25	25
26	26	26
27	27	27
28	28	28
29	29	29
30	30	30
31	31	31
01	01	32

Permitted Value (Code)	Display Value (Decode)	Rank
01	JAN	1
02	FEB	2
03	MAR	3
04	APR	4
05	MAY	5
06	JUN	6
07	JUL	7
08	AUG	8
09	SEP	9
10	OCT	10
11	NOV	11
12	DEC	12
01	UNK	13