Date/Time of Define-XML document generation: 2025-12-10T23:42:36

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard
SDTM-IG 3.2
Study Name
XYZ123
Study Description
A PHASE IIB, DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED, PARALLEL GROUP TRIAL OF ANALGEZIA HCL FOR THE TREATMENT OF CHRONIC PAIN
Protocol Name
XYZ123
Metadata Name
XYZ123, SDTM Data Definitions
Metadata Description
XYZ123, SDTM Data Definitions

Datasets

Datasets
Dataset Description Class Structure Purpose Keys Documentation Location
AE Adverse Events Events Events - One record per event per subject Tabulation STUDYID, USUBJID, AEDECOD, AESTDTC ae.xpt
DM Demographics Special Purpose Special Purpose - One record per event per subject Tabulation STUDYID, USUBJID dm.xpt
EX Exposure Interventions One record per constant dosing interval per subject Tabulation STUDYID, USUBJID, EXTRT, EXENDTC ex.xpt
LB Laboratory Test Results Findings Findings - One record per lab test per subject Tabulation STUDYID, USUBJID, LBCAT, LBTESTCD, VISITNUM lb.xpt
XP Pain Scores Findings One record per subject per visit Tabulation STUDYID, USUBJID, XPTESTCD, VISITNUM xp.xpt
TA Trial Arms Trial Design One record per planned Element per Arm Tabulation STUDYID, ARMCD, TAETORD ta.xpt
TD Trial Disease Assessments Trial Design One record per planned schedule of assessments Tabulation STUDYID, TDORDER td.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 ti.xpt
TS Trial Summary Trial Design One record per trial summary parameter value Tabulation STUDYID, TSSEQ ts.xpt
TV Trial Visits Trial Design One record per planned Visit per Arm Tabulation STUDYID, VISITNUM, ARMCD tv.xpt
SUPPDM DM - Supplemental Qualifiers Relationship Supplemental Qualifier - One record per qualifier Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppdm.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
STUDYID Study Identifier text Identifier 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
USUBJID Unique Subject Identifier text Identifier 25
Assigned
AESEQ Sequence Number integer Identifier 8
Derived
Unique sequence based on sort order of studyid usubjid aedecod aestdtc aeendtc
AETERM Reported Term for the Adverse Event text Topic 200
CRF

Annotated Case Report Form [6 ]
AELLT Lowest Level Term text SynonymQualifier 200
Assigned
AELLTCD Lowest Level Term Code integer SynonymQualifier 8
Assigned
AEDECOD Dictionary-Derived Term text SynonymQualifier 200 AEDECOD

MedDRA 18.0
Assigned
AEPTCD Preferred Term Code integer VariableQualifier 8
Assigned
AEHLT High Level Term text VariableQualifier 200
Assigned
AEHLTCD High Level Term Code integer VariableQualifier 8
Assigned
AEHLGT High Level Group Term text VariableQualifier 200
Assigned
AEHLGTCD High Level Group Term Code integer VariableQualifier 8
Assigned
AEBODSYS Body System or Organ Class text RecordQualifier 200 AEBODSYS

MedDRA 18.0
Assigned
AEBDSYCD Body System or Organ Class Code integer RecordQualifier 8
Assigned
AESOC Primary System Organ Class text RecordQualifier 200
Assigned
AESOCCD Primary System Organ Class Code integer RecordQualifier 8
Assigned
AESEV Severity text RecordQualifier 20 AESEV
  • • "MILD" = "Grade 1; 1"
  • • "MODERATE" = "Grade 2; 2"
  • • "SEVERE" = "Grade 3; 3"
CRF

Annotated Case Report Form [6 ]
AESER Serious Event text RecordQualifier 2 NY
  • • "N" = "No"
  • • "NA" = "NA; Not Applicable"
  • • "U" = "U; UNK; Unknown"
  • • "Y" = "Yes"
CRF

Annotated Case Report Form [6 ]
AEACN Action Taken with Study Treatment text RecordQualifier 40 ACN

[7 Terms]

CRF

Annotated Case Report Form [6 ]
AEREL Causality text RecordQualifier 40 AEREL
  • • "NOT RELATED" = "NOT RELATED"
  • • "POSSIBLY RELATED" = "POSSIBLY RELATED"
  • • "PROBABLY RELATED" = "PROBABLY RELATED"
CRF

Annotated Case Report Form [6 ]
AESLIFE Is Life Threatening text RecordQualifier 2 NY
  • • "N" = "No"
  • • "NA" = "NA; Not Applicable"
  • • "U" = "U; UNK; Unknown"
  • • "Y" = "Yes"
CRF

Annotated Case Report Form [6 ]
EPOCH Epoch text Timing 40 EPOCH
  • • "SCREENING" = "SCREENING"
  • • "TREATMENT" = "TREATMENT"
Derived
Hardcoded to TREATMENT
AESTDTC Start Date/Time of Adverse Event date Timing 16 ISO 8601
CRF

Annotated Case Report Form [6 ]
AEENDTC End Date/Time of Adverse Event date Timing 16 ISO 8601
CRF

Annotated Case Report Form [6 ]
AESTDY Study Day of Start of Adverse Event integer Timing 8
Derived
If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.
AEENDY Study Day of End of Adverse Event integer Timing 8
Derived
If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.

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Demographics (DM)

DM (Demographics) - Special Purpose Location: dm.xpt
Related Supplemental Qualifiers Dataset: SUPPDM (DM - Supplemental Qualifiers)
Variable Label / Description Type Role Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text Identifier 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
USUBJID Unique Subject Identifier text Identifier 25
Assigned
SUBJID Subject Identifier for the Study text Identifier 7
Assigned
RFSTDTC Subject Reference Start Date/Time date RecordQualifier 16 ISO 8601
CRF

Annotated Case Report Form [1 ]
RFENDTC Subject Reference End Date/Time date RecordQualifier 16 ISO 8601
Derived
RFENDTC is the last date of dosing from the source dosing dataset
RFXSTDTC Date/Time of First Study Treatment date RecordQualifier 16 ISO 8601
CRF

Annotated Case Report Form [4 ]
RFXENDTC Date/Time of Last Study Treatment date RecordQualifier 16 ISO 8601
CRF

Annotated Case Report Form [4 ]
RFICDTC Date/Time of Informed Consent date RecordQualifier 16 ISO 8601
CRF

Annotated Case Report Form [1 ]
RFPENDTC Date/Time of End of Participation date RecordQualifier 16 ISO 8601
CRF

Annotated Case Report Form [30 ]
DTHDTC Date/Time of Death date RecordQualifier 16 ISO 8601
Derived
DTHDTC is set to null as no subjects died
DTHFL Subject Death Flag text RecordQualifier 2
Derived
DTHFL='N' since no subjects died
SITEID Study Site Identifier text RecordQualifier 7
Assigned
BRTHDTC Date/Time of Birth date RecordQualifier 16 ISO 8601
CRF

Annotated Case Report Form [1 ]
AGE Age integer RecordQualifier 3.0
Derived
integer value of (BRTHDTC - RFSTDTC)/365.25
AGEU Age Units text VariableQualifier 10 AGEU
  • • "YEARS" = "YEARS"
Derived
Hardcoded to YEARS
SEX Sex text RecordQualifier 2 SEX
  • • "F" = "Female"
  • • "M" = "Male"
  • • "U" = "U; UNK; Unknown"
CRF

Annotated Case Report Form [1 ]
RACE Race text RecordQualifier 80 RACE
  • • "BLACK OR AFRICAN AMERICAN" = "BLACK OR AFRICAN AMERICAN"
  • • "ASIAN" = "ASIAN"
  • • "WHITE" = "WHITE"
CRF

Annotated Case Report Form [1 ]
ARMCD Planned Arm Code text RecordQualifier 8 ARMCD
  • • "ALG123" = "Analgezia HCL 30 mg"
  • • "PLACEBO" = "Placebo"
eDT

Assigned based on Randomization Number.
ARM Description of Planned Arm text SynonymQualifier 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
eDT
ACTARMCD Actual Arm Code text RecordQualifier 8 ARMCD
  • • "ALG123" = "Analgezia HCL 30 mg"
  • • "PLACEBO" = "Placebo"
eDT
ACTARM Description of Actual Arm text SynonymQualifier 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
eDT
COUNTRY Country text RecordQualifier 3 COUNTRY
  • • "USA" = "UNITED STATES"
Derived
Hardcoded to USA

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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 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
USUBJID Unique Subject Identifier text Identifier 25
Assigned
EXSEQ Sequence Number integer Identifier 8
Derived
Unique sequence based on sort order of studyid usubjid extrt exstdtc
EXTRT Name of Actual Treatment text Topic 200
Derived
All subjects were dosed with what they were randomized to, so EXTRT=DM.ARM
EXDOSE Dose integer RecordQualifier 8
CRF

Annotated Case Report Form [4 ]
EXDOSU Dose Units text VariableQualifier 40 UNIT
  • • "%" = "Percentage"
  • • "g/dL" = "Gram per Deciliter"
  • • "IU/L" = "International Unit per Liter"
  • • "mg/dL" = "Milligram per Deciliter"
  • • "mg" = "Milligram"
Derived
Hardcoded to mg
EXDOSFRM Dose Form text RecordQualifier 80 FRM
  • • "TABLET, COATED" = "TABLET, COATED"
Derived
Hardcoded to TABLET, COATED
EPOCH Epoch text Timing 40 EPOCH
  • • "SCREENING" = "SCREENING"
  • • "TREATMENT" = "TREATMENT"
Derived
Hardcoded to TREATMENT
EXSTDTC Start Date/Time of Treatment date Timing 16 ISO 8601
CRF

Annotated Case Report Form [4 ]
EXENDTC End Date/Time of Treatment date Timing 16 ISO 8601
CRF

Annotated Case Report Form [4 ]
EXSTDY Study Day of Start of Treatment integer Timing 8
Derived
If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.
EXENDY Study Day of End of Treatment integer Timing 8
Derived
If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.

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Laboratory Test Results (LB)

LB (Laboratory Test Results) - 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 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
USUBJID Unique Subject Identifier text Identifier 25
Assigned
LBSEQ Sequence Number integer Identifier 8
Derived
Unique sequence based on sort order of studyid usubjid lbcat lbtestcd visitnum
LBTESTCD Lab Test or Examination Short Name text Topic 8 LBTESTCD

[11 Terms]

Derived
Source labs.labtest variable mapped to LBTESTCD controlled terminology
LBTEST Lab Test or Examination Name text SynonymQualifier 40 LBTEST

[11 Terms]

Derived
Source labs.labtest variable mapped to LBTEST controlled terminology
LBCAT Category for Lab Test text GroupingQualifier 40 LBCAT
  • • "CHEMISTRY" = "CHEMISTRY"
  • • "HEMATOLOGY" = "HEMATOLOGY"
  • • "URINALYSIS" = "URINALYSIS"
Derived
Source labs.labcat variable mapped to LBCAT controlled terminology
LBORRESVLM Result or Finding in Original Units text ResultQualifier 200
eDT
LBTESTCD = "ALB" (Albumin; Microalbumin) Albumin; Microalbumin float 4.2
eDT
LBTESTCD = "ALP" (Alkaline Phosphatase) Alkaline Phosphatase float 3.
eDT
LBTESTCD = "ALT" (Alanine Aminotransferase; SGPT) Alanine Aminotransferase; SGPT float 3.
eDT
LBTESTCD = "AST" (Aspartate Aminotransferase; SGOT) Aspartate Aminotransferase; SGOT float 3.
eDT
LBTESTCD = "BILDIR" (Direct Bilirubin) Direct Bilirubin float 4.2
eDT
LBTESTCD = "BILI" (Bilirubin; Total Bilirubin) Bilirubin; Total Bilirubin float 4.2
eDT
LBTESTCD = "GGT" (Gamma Glutamyl Transferase) Gamma Glutamyl Transferase float 3.
eDT
LBTESTCD = "HCT" (EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume) Hematocrit float 3.
eDT
LBTESTCD = "HGB" (FHGB; Free Hemoglobin; Hemoglobin) Hemoglobin float 5.2
eDT
LBTESTCD = "PROT" (Protein) Protein float 4.2
eDT
LBCAT = "CHEMISTRY" (CHEMISTRY) and
LBTESTCD = "GLUC" (Glucose)		 Glucose float 4.2
eDT
LBCAT = "URINALYSIS" (URINALYSIS) and
LBTESTCD = "GLUC" (Glucose)		 Glucose text 8 URINGLUC
  • • "NEGATIVE" = "Negative"
  • • "POSITIVE" = "Positive"
eDT
LBORRESU Original Units text VariableQualifier 40 UNIT
  • • "%" = "Percentage"
  • • "g/dL" = "Gram per Deciliter"
  • • "IU/L" = "International Unit per Liter"
  • • "mg/dL" = "Milligram per Deciliter"
  • • "mg" = "Milligram"
eDT
LBORNRLO Reference Range Lower Limit in Orig Unit text VariableQualifier 40
eDT
LBORNRHI Reference Range Upper Limit in Orig Unit text VariableQualifier 40
eDT
LBSTRESC Character Result/Finding in Std Format text ResultQualifier 200
Derived
Copied directly (and unrealistically) from LBORRES
LBSTRESN Numeric Result/Finding in Standard Units float ResultQualifier 8
Derived
Copied directly (and unrealistically) from LBORRES
LBSTRESU Standard Units text VariableQualifier 40 UNIT
  • • "%" = "Percentage"
  • • "g/dL" = "Gram per Deciliter"
  • • "IU/L" = "International Unit per Liter"
  • • "mg/dL" = "Milligram per Deciliter"
  • • "mg" = "Milligram"
Derived
Copied directly (and unrealistically) from LBORRESU
LBSTNRLO Reference Range Lower Limit-Std Units float VariableQualifier 8
Derived
Set equal to (and unrealistically) from the soucre labs.lownorm
LBSTNRHI Reference Range Upper Limit-Std Units float VariableQualifier 8
Derived
Set equal to (and unrealistically) from the soucre labs.highnorm
LBNRIND Reference Range Indicator text VariableQualifier 20 LBNRIND
  • • "HIGH" = "HIGH"
  • • "LOW" = "LOW"
  • • "NORMAL" = "NORMAL"
Derived
if lbtestcd = 'GLUC' and lbcat = 'URINALYSIS' and lborres = 'POSITIVE' then lbnrind = 'HIGH'; else if lbtestcd = 'GLUC' and lbcat = 'URINALYSIS' and lborres = 'NEGATIVE' then lbnrind = 'NORMAL'; else if lbstnrlo ne . and lbstresn ne . and round(lbstresn,.0000001) < round(lbstnrlo,.0000001) then lbnrind = 'LOW'; else if lbstnrhi ne . and lbstresn ne . and round(lbstresn,.0000001) > round(lbstnrhi,.0000001) then lbnrind = 'HIGH'; else if lbstnrhi ne . and lbstresn ne . then lbnrind = 'NORMAL';
LBBLFL Baseline Flag text RecordQualifier 2 NY
  • • "N" = "No"
  • • "NA" = "NA; Not Applicable"
  • • "U" = "U; UNK; Unknown"
  • • "Y" = "Yes"
Derived
If visit=Baseline then Y, else blank
VISITNUM Visit Number integer Timing 8
eDT
VISIT Visit Name text Timing 40 VISIT
  • • "Baseline" = "Baseline"
  • • "Month 3" = "Month 3"
  • • "Month 6" = "Month 6"
eDT
EPOCH Epoch text Timing 40 EPOCH
  • • "SCREENING" = "SCREENING"
  • • "TREATMENT" = "TREATMENT"
Derived
If VISITNUM < 0 then SCREENING and otherwise TREATMENT
LBDTC Date/Time of Specimen Collection date Timing 16 ISO 8601
eDT
LBDY Study Day of Specimen Collection integer Timing 8
Derived
If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.

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Pain Scores (XP)

XP (Pain Scores) - Findings Location: xp.xpt
Variable Label / Description Type Role Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text Identifier 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
USUBJID Unique Subject Identifier text Identifier 25
Assigned
XPSEQ Sequence Number integer Identifier 8
Derived
Unique sequence based on sort order of studyid usubjid xptestcd visitnum
XPTESTCD Pain Test Short Name text Topic 8 XPTESTCD
  • • "XPPAIN" = "XPPAIN"
Derived
Set to XPAIN
XPTEST Pain Test Name text SynonymQualifier 40 XPTEST
  • • "Pain Score" = "Pain Score"
Derived
Set to Pain Score
XPORRES Result or Finding in Original Units text ResultQualifier 200
CRF

Annotated Case Report Form [5 ]
XPSTRESC Character Result/Finding in Std Format text ResultQualifier 200
CRF

Annotated Case Report Form [5 ]
XPSTRESN Numeric Result/Finding in Std Format integer ResultQualifier 8
CRF

Annotated Case Report Form [5 ]
EPOCH Epoch text Timing 40 EPOCH
  • • "SCREENING" = "SCREENING"
  • • "TREATMENT" = "TREATMENT"
Derived
Hardcoded to TREATMENT
VISITNUM Visit Number integer Timing 8
Assigned
VISIT Visit Name text Timing 40 VISIT
  • • "Baseline" = "Baseline"
  • • "Month 3" = "Month 3"
  • • "Month 6" = "Month 6"
CRF

Annotated Case Report Form [5 ]


CRF

Annotated Case Report Form [6 ]


CRF

Annotated Case Report Form [7 ]
XPBLFL Baseline Flag text RecordQualifier 2 NY
  • • "N" = "No"
  • • "NA" = "NA; Not Applicable"
  • • "U" = "U; UNK; Unknown"
  • • "Y" = "Yes"
Derived
If visit=Baseline then Y, else blank
XPDTC Date/Time of Collection date Timing 16 ISO 8601
CRF

Annotated Case Report Form [5 ]
XPDY Study Day of Collection integer Timing 8
Derived
If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.

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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 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
ARMCD Planned Arm Code text Topic 8 ARMCD
  • • "ALG123" = "Analgezia HCL 30 mg"
  • • "PLACEBO" = "Placebo"
Derived
This variable consists of study level metadata that was manually entered
ARM Description of Planned Arm text SynonymQualifier 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
Derived
This variable consists of study level metadata that was manually entered
TAETORD Planned Order of Element within Arm integer Identifier 8
Derived
This variable consists of study level metadata that was manually entered
ETCD Element Code text RecordQualifier 8
Derived
This variable consists of study level metadata that was manually entered
ELEMENT Description of Element text SynonymQualifier 40
Derived
This variable consists of study level metadata that was manually entered
TABRANCH Branch text Rule 200
Derived
This variable consists of study level metadata that was manually entered
TATRANS Transition Rule text Rule 200
Derived
This variable consists of study level metadata that was manually entered
EPOCH Epoch text Timing 40 EPOCH
  • • "SCREENING" = "SCREENING"
  • • "TREATMENT" = "TREATMENT"
Derived
This variable consists of study level metadata that was manually entered

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Trial Disease Assessments (TD)

TD (Trial Disease Assessments) - Trial Design Location: td.xpt
Variable Label / Description Type Role Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text Identifier 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
TDORDER Sequence of Planned Assessment Schedule integer Timing 8
Derived
This variable consists of study level metadata that was manually entered
TDANCVAR Anchor Variable Name text Timing 8
Derived
This variable consists of study level metadata that was manually entered
TDSTOFF Offset from the Anchor date Timing 16 ISO 8601
Derived
This variable consists of study level metadata that was manually entered
TDTGTPAI Planned Assessment Interval date Timing 16 ISO 8601
Derived
This variable consists of study level metadata that was manually entered
TDMINPAI Planned Assessment Interval Minimum date Timing 16 ISO 8601
Derived
This variable consists of study level metadata that was manually entered
TDMAXPAI Planned Assessment Interval Maximum date Timing 16 ISO 8601
Derived
This variable consists of study level metadata that was manually entered
TDNUMRPT Maximum Number of Actual Assessments integer RecordQualifier 8
Derived
This variable consists of study level metadata that was manually entered

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Trial Elements (TE)

TE (Trial Elements) - Trial Design Location: te.xpt
Variable Label / Description Type Role Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text Identifier 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
ETCD Element Code text Topic 8
Derived
This variable consists of study level metadata that was manually entered
ELEMENT Description of Element text SynonymQualifier 40
Derived
This variable consists of study level metadata that was manually entered
TESTRL Rule for Start of Element text Rule 200
Derived
This variable consists of study level metadata that was manually entered
TEENRL Rule for End of Element text Rule 200
Derived
This variable consists of study level metadata that was manually entered
TEDUR Planned Duration of Element text Timing 64
Derived
This variable consists of study level metadata that was manually entered

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Trial Inclusion/Exclusion Criteria (TI)

TI (Trial Inclusion/Exclusion Criteria) - Trial Design Location: ti.xpt
Variable Label / Description Type Role Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text Identifier 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
IETESTCD Inclusion/Exclusion Criterion Short Name text Topic 8
Derived
This variable consists of study level metadata that was manually entered
IETEST Inclusion/Exclusion Criterion text SynonymQualifier 200
Derived
This variable consists of study level metadata that was manually entered
IECAT Inclusion/Exclusion Category text GroupingQualifier 40 IECAT
  • • "INCLUSION" = "INCLUSION"
  • • "EXCLUSION" = "EXCLUSION"
Derived
This variable consists of study level metadata that was manually entered

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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 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
TSSEQ Sequence Number integer Identifier 8
Derived
This variable consists of study level metadata that was manually entered
TSPARMCD Trial Summary Parameter Short Name text Topic 8 TSPARMCD

[41 Terms]

Derived
This variable consists of study level metadata that was manually entered
TSPARM Trial Summary Parameter text SynonymQualifier 40 TSPARM

[41 Terms]

Derived
This variable consists of study level metadata that was manually entered
TSVAL Parameter Value text ResultQualifier 200
Derived
This variable consists of study level metadata that was manually entered
TSVALCD Parameter Value Code text ResultQualifier 40
Derived
This variable consists of study level metadata that was manually entered
TSVCDREF Name of the Reference Terminology text ResultQualifier 40
Derived
This variable consists of study level metadata that was manually entered
TSVCDVER Version of the Reference Terminology text ResultQualifier 40
Derived
This variable consists of study level metadata that was manually entered

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Trial Visits (TV)

TV (Trial Visits) - Trial Design Location: tv.xpt
Variable Label / Description Type Role Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text Identifier 15
Assigned
DOMAIN Domain Abbreviation text Identifier 2
Derived
Hardcode to the name of the SDTM domain
VISITNUM Visit Number integer Topic 8
Derived
This variable consists of study level metadata that was manually entered
VISIT Visit Name text SynonymQualifier 40
Derived
This variable consists of study level metadata that was manually entered
ARMCD Planned Arm Code text RecordQualifier 8 ARMCD
  • • "ALG123" = "Analgezia HCL 30 mg"
  • • "PLACEBO" = "Placebo"
Derived
This variable consists of study level metadata that was manually entered
ARM Description of Planned Arm text SynonymQualifier 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
Derived
This variable consists of study level metadata that was manually entered
TVSTRL Visit Start Rule text Rule 200
Derived
This variable consists of study level metadata that was manually entered
TVENRL Visit End Rule text Rule 200
Derived
This variable consists of study level metadata that was manually entered

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DM - Supplemental Qualifiers (SUPPDM)

SUPPDM (DM - Supplemental Qualifiers) - Relationship Location: suppdm.xpt
Related Parent Dataset: DM (Demographics)
Variable Label / Description Type Role Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text NA 15
Assigned
RDOMAIN Related Domain Abbreviation text NA 2
Derived
Hardcode to the name of the SDTM domain
USUBJID Unique Subject Identifier text NA 25
Assigned
IDVAR Identifying Variable text NA 8
Assigned
IDVARVAL Identifying Variable Value text NA 200
Assigned
QNAM Qualifier Variable Name text NA 8
Assigned
QLABEL Qualifier Variable Label text NA 40
Assigned
QVALVLM Data Value text NA 200
➤ QNAM = "RACEOTH"
 Race, Other text 20
Derived
Set to other race from source demographics file
➤ QNAM = "RANDDTC"
 Randomization Date text 10
Derived
Set equal to the randomization date from the source demographics file
QORIG Origin text NA 20
Derived
Set to null
QEVAL Evaluator text NA 8
Derived
Set to null

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CodeLists

ACN
Permitted Value (Code) Display Value (Decode) Rank
DOSE INCREASED DOSE INCREASED 1
DOSE NOT CHANGED DOSE NOT CHANGED 2
DOSE REDUCED DOSE REDUCED 3
DRUG INTERRUPTED DRUG INTERRUPTED 4
DRUG WITHDRAWN DRUG WITHDRAWN 5
NOT APPLICABLE NA 6
UNKNOWN U; Unknown 7
AEREL
Permitted Value (Code) Display Value (Decode) Rank
NOT RELATED NOT RELATED 1
POSSIBLY RELATED POSSIBLY RELATED 2
PROBABLY RELATED PROBABLY RELATED 3
AESEV
Permitted Value (Code) Display Value (Decode) Rank
MILD Grade 1; 1 1
MODERATE Grade 2; 2 2
SEVERE Grade 3; 3 3
AGEU
Permitted Value (Code) Display Value (Decode) Rank
YEARS YEARS 1
ARM
Permitted Value (Code) Display Value (Decode) Rank
Analgezia HCL 30 mg Analgezia HCL 30 mg 1
Placebo Placebo 2
ARMCD
Permitted Value (Code) Display Value (Decode) Rank
ALG123 Analgezia HCL 30 mg 1
PLACEBO Placebo 2
COUNTRY
Permitted Value (Code) Display Value (Decode) Rank
USA UNITED STATES 1
EPOCH
Permitted Value (Code) Display Value (Decode) Rank
SCREENING SCREENING 1
TREATMENT TREATMENT 2
FRM
Permitted Value (Code) Display Value (Decode) Rank
TABLET, COATED TABLET, COATED 1
IECAT
Permitted Value (Code) Display Value (Decode) Rank
INCLUSION INCLUSION 1
EXCLUSION EXCLUSION 2
LBCAT
Permitted Value (Code) Display Value (Decode) Rank
CHEMISTRY CHEMISTRY 1
HEMATOLOGY HEMATOLOGY 2
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
NY
Permitted Value (Code) Display Value (Decode) Rank
N No 1
NA NA; Not Applicable 2
U U; UNK; Unknown 3
Y Yes 4
RACE
Permitted Value (Code) Display Value (Decode) Rank
BLACK OR AFRICAN AMERICAN BLACK OR AFRICAN AMERICAN 1
ASIAN ASIAN 2
WHITE WHITE 3
SEX
Permitted Value (Code) Display Value (Decode) Rank
F Female 1
M Male 2
U U; UNK; Unknown 3
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
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

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External Dictionaries

External Dictionaries
Reference Name External Dictionary Dictionary Version
AEBODSYS MedDRA 18.0
AEDECOD MedDRA 18.0

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Methods

Methods
Method Type Description
Hardcode to assign domain Computation
Hardcode to the name of the SDTM domain
--DY derivation Computation
If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.
Null Value Computation
Set to null
AESEQ derivation Computation
Unique sequence based on sort order of studyid usubjid aedecod aestdtc aeendtc
EPOCH hardcode Computation
Hardcoded to TREATMENT
RFENDTC derivation Computation
RFENDTC is the last date of dosing from the source dosing dataset
DTHDTC derivation Computation
DTHDTC is set to null as no subjects died
DTHFL derivation Computation
DTHFL='N' since no subjects died
Algorithm to compute age Computation
integer value of (BRTHDTC - RFSTDTC)/365.25
Age units hardcode Computation
Hardcoded to YEARS
Country hardcode Computation
Hardcoded to USA
EXSEQ derivation Computation
Unique sequence based on sort order of studyid usubjid extrt exstdtc
EXTRT derivation Computation
All subjects were dosed with what they were randomized to, so EXTRT=DM.ARM
EXDOSU hardcode Computation
Hardcoded to mg
EXDOSFRM hardcode Computation
Hardcoded to TABLET, COATED
EPOCH hardcode Computation
Hardcoded to TREATMENT
LBSEQ derivation Computation
Unique sequence based on sort order of studyid usubjid lbcat lbtestcd visitnum
LBTESTCD derivation Computation
Source labs.labtest variable mapped to LBTESTCD controlled terminology
LBTEST derivation Computation
Source labs.labtest variable mapped to LBTEST controlled terminology
LBCAT derivation Computation
Source labs.labcat variable mapped to LBCAT controlled terminology
LBSTRESC derivation Computation
Copied directly (and unrealistically) from LBORRES
LBSTRESN derivation Computation
Copied directly (and unrealistically) from LBORRES
LBSTRESN derivation Computation
Copied directly (and unrealistically) from LBORRESU
LBSTNRLO derivation Computation
Set equal to (and unrealistically) from the soucre labs.lownorm
LBSTNRHI derivation Computation
Set equal to (and unrealistically) from the soucre labs.highnorm
LBNRIND derivation Computation
if lbtestcd = 'GLUC' and lbcat = 'URINALYSIS' and lborres = 'POSITIVE' then lbnrind = 'HIGH'; else if lbtestcd = 'GLUC' and lbcat = 'URINALYSIS' and lborres = 'NEGATIVE' then lbnrind = 'NORMAL'; else if lbstnrlo ne . and lbstresn ne . and round(lbstresn,.0000001) < round(lbstnrlo,.0000001) then lbnrind = 'LOW'; else if lbstnrhi ne . and lbstresn ne . and round(lbstresn,.0000001) > round(lbstnrhi,.0000001) then lbnrind = 'HIGH'; else if lbstnrhi ne . and lbstresn ne . then lbnrind = 'NORMAL';
LBBLFL derivation Computation
If visit=Baseline then Y, else blank
EPOCH derivation Computation
If VISITNUM < 0 then SCREENING and otherwise TREATMENT
Manual entry Computation
This variable consists of study level metadata that was manually entered
XPSEQ derivation Computation
Unique sequence based on sort order of studyid usubjid xptestcd visitnum
XPTESTCD hardcode Computation
Set to XPAIN
XPTEST hardcode Computation
Set to Pain Score
EPOCH hardcode Computation
Hardcoded to TREATMENT
XPBLFL derivation Computation
If visit=Baseline then Y, else blank
RACEOTH derivation Computation
Set to other race from source demographics file
RANDDT derivation Computation
Set equal to the randomization date from the source demographics file

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