Date/Time of Define-XML document generation: 2022-12-06T14:51:17

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard
ADaM-IG 1.0
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, ADaM Data Definitions
Metadata Description
XYZ123, ADaM Data Definitions

Analysis Results Metadata - Summary

Table14.1.1Summary of Demographics (ITT Population)

Summary of Demographics

Table14.2.1Responder Analysis by Visit

Responder Analysis by Visit

Table14.2.2Mean Pain Assessments and Changes from Baseline

Summary of Pain Relief

Figure14.2.1Time to Pain Relief Analysis by Treatment Group

Time to Pain Relief Kaplan Meier Analysis

Time to Pain Relief Hazard Ratio Derivation

Table14.3.2.1Incidence Rates of TEAEs by System Organ Class and Preferred Term

Incidence Rates of TEAEs by System Organ Class and Preferred Term


Analysis Results Metadata - Detail

Table14.1.1
Display Table 14.1.1 [302 ] Summary of Demographics (ITT Population)
Analysis Result Summary of Demographics
Analysis Parameter(s)
Analysis Variable(s)

ADSL.AGE (Age)

ADSL.AGEGR1 (Pooled Age Group 1)

ADSL.SEX (Sex)

ADSL.RACE (Race)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Comparisons of baseline characteristics by treatment group
Data References (incl. Selection Criteria)
ADSL [ITTFL = "Y"]
Documentation Rates and chi-squared tests of categorical demographic variables

SAP Section 9.1.1

Programming Statements [SAS Version 9.4]
PROC FREQ DATA=ADSL; where ittfl='Y';  tables trt01pn * (agegr1 sex race) / cmh; run;

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Table14.2.1
Display Table 14.2.1 [352 ] Responder Analysis by Visit
Analysis Result Responder Analysis by Visit
Analysis Parameter(s) PARAMCD = "XPPAIN" (Pain Score)
Analysis Variable(s)

ADEF.CRIT1FL (Criterion 1 Evaluation Result Flag)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Primary efficacy endpoint
Data References (incl. Selection Criteria)
ADEF [ITTFL = "Y" and ABLFL ≠ "Y" and PARAMCD = "XPPAIN"]
Documentation Chi-squared test of responder rates by treatment group

SAP Section 9.2.1

Programming Statements [SAS Version 9.4]
proc freq data = adef; by crit1 avisitn; where ittfl='Y'; tables trtpn * crit1fl / chisq; run;

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Table14.2.2
Display Table 14.2.2 [353 ] Mean Pain Assessments and Changes from Baseline
Analysis Result Summary of Pain Relief
Analysis Parameter(s) PARAMCD = "XPPAIN" (Pain Score)
Analysis Variable(s)

ADEF.AVAL (Analysis Value)

ADEF.CHG (Change from Baseline)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Secondary efficacy endpoint
Data References (incl. Selection Criteria)
ADEF [ITTFL = "Y" and ABLFL ≠ "Y" and PARAMCD = "XPPAIN"]
Documentation ANCOVA analysis of the treatment group effect with a baseline covariate, by visit

SAP Section 9.2.1

Programming Statements [SAS Version 9.4]
proc glm data = adef; by avisitn avisit; class trtpn; model aval = trtpn base; run;

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Figure14.2.1
Display Figure 14.2.1 [354 ] Time to Pain Relief Analysis by Treatment Group
Analysis Result Time to Pain Relief Kaplan Meier Analysis
Analysis Parameter(s) PARAMCD = "TTPNRELF" (Time to first pain relief)
Analysis Variable(s)

ADTTE.AVAL (Analysis Value)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Secondary efficacy endpoint
Data References (incl. Selection Criteria)
ADTTE [ITTFL = "Y" and PARAMCD = "TTPNRELF"]
Documentation Kaplan-Meier estimates and log-rank test for the treatment effect

SAP Section 9.2.2

Programming Statements [SAS Version 9.4]
proc lifetest  data = adtte plots=s;  where ittfl = 'Y' and paramcd = 'TTPNRELF';  id usubjid;  strata trtpn;  time aval*cnsr (1 2 3);   test trtpn; run;
Analysis Result Time to Pain Relief Hazard Ratio Derivation
Analysis Parameter(s) PARAMCD = "TTPNRELF" (Time to first pain relief)
Analysis Variable(s)

ADTTE.AVAL (Analysis Value)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Secondary efficacy endpoint
Data References (incl. Selection Criteria)
ADTTE [ITTFL = "Y" and PARAMCD = "TTPNRELF"]
Documentation Cox proportional hazards model used to derive the hazard ratio for the treatment group effect

SAP Section 9.2.2

Programming Statements [SAS Version 9.4]
proc phreg data = adtte; model aval*cnsr(1, 2, 3) = trtpn; run;

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Table14.3.2.1
Display Incidence Rates of TEAEs by System Organ Class and Preferred Term
Analysis Result Incidence Rates of TEAEs by System Organ Class and Preferred Term
Analysis Parameter(s)
Analysis Variable(s)

ADAE.AEBODSYS (Body System or Organ Class)

ADAE.AEDECOD (Dictionary-Derived Term)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Secondary safety endpoint
Data References (incl. Selection Criteria)
ADAE [TRTEMFL = "Y"]
Documentation Incidence rates of TEAEs by System Organ Class and Preferred Term

SAP Section 9.3.1

Programming Statements [SAS Version 9.4]

AE Analysis Program

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Datasets

Datasets
Dataset Description Class Structure Purpose Keys Documentation Location
ADAE Adverse Events Analysis Datasets Occurrence data structure ADAE - One record per event per subject Analysis STUDYID, USUBJID, ASTDT, AEDECOD

Primarily derived from SDTM.AE

 ADAE.xpt
ADSL Subject Level Analysis Dataset Subject level analysis dataset ADSL - One record per subject Analysis STUDYID, USUBJID

Derived from multiple SDTM domains

 ADSL.xpt
ADEF Efficacy/Pain Scores Analysis Dataset Basic data structure One record per subject per visit Analysis STUDYID, USUBJID, PARAMCD, AVISITN, ADT

Primarily derived from SDTM.XP

 ADEF.xpt
ADTTE Time-to-Pain Relief Analysis Dataset Basic data structure One record per subject Analysis STUDYID, USUBJID, PARAMCD

Primarily derived from ADaM.ADAE

 ADTTE.xpt

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Adverse Events Analysis Datasets (ADAE)

ADAE (Adverse Events Analysis Datasets) - Occurrence data structure Location: ADAE.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 15
Predecessor: ADSL
USUBJID Unique Subject Identifier text 25
Predecessor: ADSL
SITEID Study Site Identifier text 7
Predecessor: ADSL
COUNTRY Country text 3 COUNTRY
  • • "USA" = "UNITED STATES"
Predecessor: ADSL
AESEQ Sequence Number integer 8
Predecessor: AE
AGE Unique Subject Identifier integer 8
Predecessor: ADSL
AGEGR1N Pooled Age Group 1 (N) integer 8
Predecessor: ADSL
See codelist
AGEGR1 Pooled Age Group 1 text 20 AGEGR1
  • • "<55 YEARS" = "<55 Years"
  • • ">=55 YEARS" = ">=55 Years"
Predecessor: ADSL
If age<55 then "<55 years"; else if age>=55 then ">=55 YEARS"
SEX Sex text 1
Predecessor: ADSL
TRTAN Actual Treatment (N) integer 8
Predecessor: ADSL.TRT01AN
TRTA Actual Treatment text 40
Predecessor: ADSL.TRT01A
AETERM Reported Term for the Adverse Event text 200
Predecessor: AE
AEDECOD Dictionary-Derived Term text 200 [unresolved: CL.MedDRA]
Predecessor: AE
AEBODSYS Body System or Organ Class text 200 [unresolved: CL.MedDRA]
Predecessor: AE
ASTDT Start Date/Time of Adverse Events integer 8
Derived
AESTDTC converted to a SAS date. See SAP for missing or partial value imputations
AENDT End Date/Time of Adverse Events integer 8
Derived
AEENDTC converted to a SAS date. See SAP for missing or partial value imputations
ASTDY Study Day of Start of Adverse Event integer 8
Derived
ASTDT - ADSL.TRTSDT + 1
AENDY Study Day of End of Adverse Event integer 8
Derived
AENDT - ADSL.TRTEDT + 1
AESEV Severity/Intensity text 40 AESEV
  • • "MILD" = "Grade 1; 1"
  • • "MODERATE" = "Grade 2; 2"
  • • "SEVERE" = "Grade 3; 3"
Predecessor: AE
AESEVN Severity/Intensity (N) integer 1 AESEVN
  • • 1 = "Mild"
  • • 2 = "Moderate"
  • • 3 = "Severe"
Derived
See codelist
AESER Serious Event text 40 YN
  • • "Y" = "YES"
  • • "N" = "NO"
Predecessor: AE
AEACN Action Taken with Study Treatment text 40 ACN

[7 Terms]

Predecessor: AE
AEREL Causality text 40 AEREL
  • • "NOT RELATED" = "NOT RELATED"
  • • "POSSIBLY RELATED" = "POSSIBLY RELATED"
  • • "PROBABLY RELATED" = "PROBABLY RELATED"
Predecessor: AE
AERELN Causality (N) integer 1 AERELN
  • • 0 = "NOT RELATED"
  • • 1 = "POSSIBLY RELATED"
  • • 2 = "PROBABLY RELATED"
Derived
See codelist
CQ01NAM CQ 01 Name text 200
Derived
[unresolved: MT.CQ01NAME]
RELGR1 Pooled Causality Group 1 text 15 RELGR1
  • • "Not related" = "Not related"
  • • "Related" = "Related"
Derived
If AEREL=NOT RELATED then NOT RELATED; Otherwise RELATED
RELGR1N Pooled Causality Group 1 (N) integer 8 RELGR1N
  • • 0 = "Not related"
  • • 1 = "Related"
Derived
See codelist
TRTEMFL Treatment Emergent Flag text 1 FLAGS
  • • "Y" = "Yes"
Derived
SAFFL Safety Population Flag text 1 FLAGS
  • • "Y" = "Yes"
Predecessor: ADSL

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Subject Level Analysis Dataset (ADSL)

ADSL (Subject Level Analysis Dataset) - Subject level analysis dataset Location: ADSL.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 15
Predecessor: DM
USUBJID Unique Subject Identifier text 25
Predecessor: DM
SUBJID Subject Identifier for the Study text 7
Predecessor: DM
SITEID Study Site Identifier text 7
Predecessor: DM
COUNTRY Country text 3 COUNTRY
  • • "USA" = "UNITED STATES"
Predecessor: DM
BRTHDT Date of Birth date 8 ISO 8601
Predecessor: DM.BIRTHDTC
AGE Age integer 3.0
Predecessor: DM
AGEU Age Units text 5 AGEU
  • • "YEARS" = "YEARS"
Predecessor: DM
AGEGR1 Pooled Age Group 1 text 40 AGEGR1
  • • "<55 YEARS" = "<55 Years"
  • • ">=55 YEARS" = ">=55 Years"
Derived
If age<55 then "<55 years"; else if age>=55 then ">=55 YEARS"
AGEGR1N Pooled Age Group 1 (N) integer 8 AGEGR1N
  • • 1 = "<55 Years"
  • • 2 = ">=55 Years"
Derived
See codelist
SEX Sex text 1 SEX
  • • "F" = "FEMALE"
  • • "M" = "MALE"
  • • "U" = "UNKNOWN"
Predecessor: DM
RACE Race text 40 RACE
  • • "BLACK OR AFRICAN AMERICAN" = "BLACK OR AFRICAN AMERICAN"
  • • "ASIAN" = "ASIAN"
  • • "WHITE" = "WHITE"
Predecessor: DM
RACEOTH Race, Other, Specify text 40
Predecessor: DM
RANDDT Date of Randomization integer 8
Derived
SUPPDM.QVAL where SUPPDM.QNAM=RANDDTC, converted to a SAS date
TRTSDT Date of First Exposure to Treatment integer 8
Derived
EX.EXSTDTC where EXSEQ=1, converted to a SAS date. See SAP for missing or partial value imputations.
TRTEDT Date of Last Exposure to Treatment integer 8
Derived
EX.EXENDTC converted to a SAS date for the last record in EX. See SAP for missing or partial value imputations.
ARM Description of Planned Arm text 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
Predecessor: DM
TRT01P Planned Treatment for Period 01 text 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
Predecessor: DM.ARM
TRT01A Actual Treatment for Period 01 text 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
Predecessor: DM.ARM
TRT01PN Planned Treatment for Period 01 (N) integer 8 ARMN
  • • 1 = "Analgezia HCL 30 mg"
  • • 0 = "Placebo"
Derived
See codelist
TRT01AN Actual Treatment for Period 01 (N) integer 8 ARMN
  • • 1 = "Analgezia HCL 30 mg"
  • • 0 = "Placebo"
Derived
See codelist
ITTFL Intent-To-Treat Population Flag text 1 FLAGS
  • • "Y" = "Yes"
Derived
If ADSL.RANDDT ^= missing then Y, else Null
SAFFL Safety Population Flag text 1 FLAGS
  • • "Y" = "Yes"
Derived
If ADSL.TRTSDT^=missing then Y, else Null
RESPFL Efficacy Responder Flag text 1 YN
  • • "Y" = "YES"
  • • "N" = "NO"
Derived
If XP.VISIT='Month 6' and XPSTRESN represents at least a two-point improvement from the baseline record then Y, else N

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Efficacy/Pain Scores Analysis Dataset (ADEF)

ADEF (Efficacy/Pain Scores Analysis Dataset) - Basic data structure Location: ADEF.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 15
Predecessor: ADSL
USUBJID Unique Subject Identifier text 25
Predecessor: ADSL
SITEID Study Site Identifier text 7
Predecessor: ADSL
COUNTRY Country text 3 COUNTRY
  • • "USA" = "UNITED STATES"
Predecessor: ADSL
RANDDT Date of Randomization integer date9.
Predecessor: ADSL
AGE Age integer 8
Predecessor: ADSL
AGEGR1N Pooled Age Group 1 (N) integer 8 AGEGR1N
  • • 1 = "<55 Years"
  • • 2 = ">=55 Years"
Predecessor: ADSL
See codelist
AGEGR1 Pooled Age Group 1 text 20 AGEGR1
  • • "<55 YEARS" = "<55 Years"
  • • ">=55 YEARS" = ">=55 Years"
Predecessor: ADSL
If age<55 then "<55 years"; else if age>=55 then ">=55 YEARS"
SEX Sex text 1 SEX
  • • "F" = "FEMALE"
  • • "M" = "MALE"
  • • "U" = "UNKNOWN"
Predecessor: ADSL
RACE Race text 40 RACE
  • • "BLACK OR AFRICAN AMERICAN" = "BLACK OR AFRICAN AMERICAN"
  • • "ASIAN" = "ASIAN"
  • • "WHITE" = "WHITE"
Predecessor: ADSL
TRTPN Planned Treatment (N) integer 8 ARMN
  • • 1 = "Analgezia HCL 30 mg"
  • • 0 = "Placebo"
Predecessor: ADSL.TRT01PN
TRTP Planned Treatment text 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
Predecessor: ADSL.TRT01P
[unresolved: MT.TRTP]
PARAMCD Parameter Code text 8 ADEF.PARAMCD
  • • "XPPAIN" = "Pain Score"
Assigned

See codelist
PARAM Parameter text 40 ADEF.PARAM
  • • "Pain Score" = "Pain Score"
Assigned

See codelist
AVISIT Analysis Visit text 16 VISIT
  • • "Baseline" = "Baseline"
  • • "Month 3" = "Month 3"
  • • "Month 6" = "Month 6"
Predecessor: XP.VISIT
AVISITN Analysis Visit (N) integer 8 AVISITN
  • • 0 = "Baseline"
  • • 3 = "Month 3"
  • • 6 = "Month 6"
Derived
See codelist
ABLFL Baseline Record Flag text 1 FLAGS
  • • "Y" = "Yes"
Derived
Last visit with a non-missing record prior to first dose
XPSEQ Sequence Number integer 8
Predecessor: XP
VISITNUM Visit Number integer 8 VISITNUM
  • • "0" = "Baseline"
  • • "1" = "Month 3"
  • • "2" = "Month 6"
Predecessor: XP
ADT Analysis Date integer date9.
Derived
XPDTC converted to a SAS date. See SAP for missing or partial value imputations
ADY Analysis Relative Day integer 8
Derived
ADT - ADSL.RANDDT + 1
AVAL Analysis Value integer 8
Derived
See parameter value-level metadata
AVALC Analysis Value (C) text 12
Derived
See parameter value-level metadata
BASE Baseline Value integer 8
Derived
Last non-missing value of AVAL prior to first dose
CHG Change from Baseline integer 8
Derived
AVAL-BASE
CRIT1FL Criterion 1 Evaluation Result Flag text 1 YN
  • • "Y" = "YES"
  • • "N" = "NO"
Derived
See parameter value-level metadata
CRIT1 Analysis Criterion 1 text 60
Derived
See parameter value-level metadata

Assignment per the codelist
ITTFL Intent-to-Treat Flag text 1 FLAGS
  • • "Y" = "Yes"
Predecessor: ADSL

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Time-to-Pain Relief Analysis Dataset (ADTTE)

ADTTE (Time-to-Pain Relief Analysis Dataset) - Basic data structure Location: ADTTE.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 15
Predecessor: ADSL
USUBJID Domain Abbreviation text 25
Predecessor: ADSL
SITEID Study Site Identifier text 7
Predecessor: ADSL
COUNTRY Country text 3 COUNTRY
  • • "USA" = "UNITED STATES"
Predecessor: ADSL
AGE Unique Subject Identifier integer 8
Predecessor: ADSL
AGEGR1N Pooled Age Group 1 (N) integer 8
Predecessor: ADSL
See codelist
AGEGR1 Pooled Age Group 1 text 20 AGEGR1
  • • "<55 YEARS" = "<55 Years"
  • • ">=55 YEARS" = ">=55 Years"
Predecessor: ADSL
If age<55 then "<55 years"; else if age>=55 then ">=55 YEARS"
SEX Sex text 1
Predecessor: ADSL
RACE Race text 40 RACE
  • • "BLACK OR AFRICAN AMERICAN" = "BLACK OR AFRICAN AMERICAN"
  • • "ASIAN" = "ASIAN"
  • • "WHITE" = "WHITE"
Predecessor: ADSL
TRTPN Planned Treatment (N) integer 8 ARMN
  • • 1 = "Analgezia HCL 30 mg"
  • • 0 = "Placebo"
Predecessor: ADSL.TRT01PN
TRTP Planned Treatment text 40 ARM
  • • "Analgezia HCL 30 mg" = "Analgezia HCL 30 mg"
  • • "Placebo" = "Placebo"
Predecessor: ADSL.TRT01P
PARAMCD Parameter Code text 8 ADTTE.PARAMCD
  • • "TTPNRELF" = "Time to first pain relief"
Assigned
PARAM Parameter text 40 ADTTE.PARAM
  • • "Time to first pain relief" = "Time to first pain relief"
Assigned
ADT Analysis Date integer 8
Derived
STARTDT Time to Event Origin Date for Subject integer 8
Predecessor: ADSL.RANDDT
AVAL Analysis Value integer 8
Derived
See parameter value-level metadata
CNSR Censor integer 8
Derived
See parameter value-level metadata
EVNTDESC Event description text 50
Derived
See parameter value-level metadata
SRCDOM Source Domain text 6
Derived
[unresolved: MT.ADTTE.SRCDOM]
SRCVAR Source Variable text 8
Derived
SRCVAR = ADEF if first event is a negative pain score or if worsening occurs before an improvement. SRCVAR = ADAE if ADAE.CQ01NAM is non-missing on a date prior to a pain improvement or worsening.
SRCSEQ Source Sequence Number integer 8
Derived
if SRCVAR=ADEF then SRCSEQ=ADEF.XPSEQ from the corresponding record; else if SRCVAR=ADAE then SRCSEQ=ADAE.AESEQ from the corresponding record.
ITTFL Intent-to-Treat Flag text 1 FLAGS
  • • "Y" = "Yes"
Predecessor: ADSL

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CodeLists

ACN
Permitted Value (Code) Display Value (Decode)
DOSE INCREASED DOSE INCREASED
DOSE NOT CHANGED DOSE NOT CHANGED
DOSE REDUCED DOSE REDUCED
DRUG INTERRUPTED DRUG INTERRUPTED
DRUG WITHDRAWN DRUG WITHDRAWN
NOT APPLICABLE NA
UNKNOWN U; Unknown
ADEF.CRIT1
Permitted Value (Code) Display Value (Decode)
Pain improvement from baseline of at least 2 points Pain improvement from baseline of at least 2 points
ADEF.PARAM
Permitted Value (Code) Display Value (Decode)
Pain Score Pain Score
ADEF.PARAMCD
Permitted Value (Code) Display Value (Decode)
XPPAIN Pain Score
ADTTE.PARAM
Permitted Value (Code) Display Value (Decode)
Time to first pain relief Time to first pain relief
ADTTE.PARAMCD
Permitted Value (Code) Display Value (Decode)
TTPNRELF Time to first pain relief
AEREL
Permitted Value (Code) Display Value (Decode)
NOT RELATED NOT RELATED
POSSIBLY RELATED POSSIBLY RELATED
PROBABLY RELATED PROBABLY RELATED
AERELN
Permitted Value (Code) Display Value (Decode)
0 NOT RELATED
1 POSSIBLY RELATED
2 PROBABLY RELATED
AESEV
Permitted Value (Code) Display Value (Decode)
MILD Grade 1; 1
MODERATE Grade 2; 2
SEVERE Grade 3; 3
AESEVN
Permitted Value (Code) Display Value (Decode)
1 Mild
2 Moderate
3 Severe
AGEGR1
Permitted Value (Code) Display Value (Decode)
<55 YEARS <55 Years
>=55 YEARS >=55 Years
AGEGR1N
Permitted Value (Code) Display Value (Decode)
1 <55 Years
2 >=55 Years
AGEU
Permitted Value (Code) Display Value (Decode)
YEARS YEARS
ARM
Permitted Value (Code) Display Value (Decode)
Analgezia HCL 30 mg Analgezia HCL 30 mg
Placebo Placebo
ARMCD
Permitted Value (Code) Display Value (Decode)
ALG123 Analgezia HCL 30 mg
PLACEBO Placebo
ARMN
Permitted Value (Code) Display Value (Decode)
1 Analgezia HCL 30 mg
0 Placebo
AVISITN
Permitted Value (Code) Display Value (Decode)
0 Baseline
3 Month 3
6 Month 6
CENSOR
Permitted Value (Code) Display Value (Decode)
0 Pain relief
1 Pain worsening prior to relief
2 Pain adverse event prior to relief
3 No relief and no worsening at last assessment
COUNTRY
Permitted Value (Code) Display Value (Decode)
USA UNITED STATES
CRIT1VALUES
Permitted Value (Code) Display Value (Decode)
Pain improvement from baseline of at least 2 points Pain improvement from baseline of at least 2 points
EVNTDESC
Permitted Value (Code) Display Value (Decode)
PAIN RELIEF Pain relief
PAIN WORSENING PRIOR TO RELIEF Pain worsening prior to relief
PAIN ADVERSE EVENT PRIOR TO RELIEF Pain adverse event prior to relief
NO RELIEF AND NO WORSENING AT LAST ASSESSMENT No relief and no worsening at last assessment
FLAGS
Permitted Value (Code) Display Value (Decode)
Y Yes
PAINSCORE
Permitted Value (Code) Display Value (Decode)
0 None
1 Mild
2 Moderate
3 Severe
RACE
Permitted Value (Code) Display Value (Decode)
BLACK OR AFRICAN AMERICAN BLACK OR AFRICAN AMERICAN
ASIAN ASIAN
WHITE WHITE
RELGR1
Permitted Value (Code) Display Value (Decode)
Not related Not related
Related Related
RELGR1N
Permitted Value (Code) Display Value (Decode)
0 Not related
1 Related
SEX
Permitted Value (Code) Display Value (Decode)
F FEMALE
M MALE
U UNKNOWN
TRT01PN
Permitted Value (Code) Display Value (Decode)
0 Placebo
1 Analgezia HCL 30 mg
VISIT
Permitted Value (Code) Display Value (Decode)
Baseline Baseline
Month 3 Month 3
Month 6 Month 6
VISITNUM
Permitted Value (Code) Display Value (Decode)
0 Baseline
1 Month 3
2 Month 6
YN
Permitted Value (Code) Display Value (Decode)
N NO
Y YES

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Methods

Methods
Method Type Description
Baseline value derivation Computation
Last non-missing value of AVAL prior to first dose
Change from baseline calculation Computation
AVAL-BASE
Responder derivation Computation
IF (.Z<CHG<=-2) THEN CRIT1FL='Y' ELSE CRIT1FL='N'
Time to first pain relief without worsening derivation Computation
Derived from ADEF.ADY (where PARAMCD=XPPAIN and ADY>1) or ADAE.ASDY where CQ01NAM=PAIN EVENT. Value is the earliest day when ADEF.CHG<0 (for an event) or (ADEF.CHG>0 or ADAE.ASDY>0) (for subjects censored due to pain worsening) or the last record where ADEF.CHG=0 (for subjects censored due to no improvement or worsening by the time of the last assessment)
Censoring algorithm for Time to First Pain Relief Computation
if pain relief occurs before worsening, then CNSR=0; else if worsening from pain data, then CNSR=1; else if worsening from AE data, then CNSR=3; else if no relief and no worsening at time of last observation, then CNSR=4
Event descriptions for Time to First Pain Relief Computation
if CNSR=0, then EVNTDESC=PAIN RELIEF; if CNSR=1, then EVNTDESC=PAIN WORSENING PRIOR TO RELIEF; if CNSR=2, then EVNTDESC=PAIN ADVERSE EVENT PRIOR TO RELIEF; if CNSR=3, then EVNTDESC=NO RELIEF AND NO WORSENING AT LAST ASSESSMENT
Date of first exposure to treatment derivation Computation
EX.EXSTDTC where EXSEQ=1, converted to a SAS date. See SAP for missing or partial value imputations.
Date of last exposure to treatment derivation Computation
EX.EXENDTC converted to a SAS date for the last record in EX. See SAP for missing or partial value imputations.
Intent-to-Treat flag derivation Computation
If ADSL.RANDDT ^= missing then Y, else Null
Safety population flag derivation Computation
If ADSL.TRTSDT^=missing then Y, else Null
Responder population flag derivation Computation
If XP.VISIT='Month 6' and XPSTRESN represents at least a two-point improvement from the baseline record then Y, else N
Randomization date derivation Computation
SUPPDM.QVAL where SUPPDM.QNAM=RANDDTC, converted to a SAS date
Analysis baseline record flag Computation
Last visit with a non-missing record prior to first dose
Analysis date calculation Computation
XPDTC converted to a SAS date. See SAP for missing or partial value imputations
Analysis day calculation Computation
ADT - ADSL.RANDDT + 1
Analysis start date calculation Computation
AESTDTC converted to a SAS date. See SAP for missing or partial value imputations
Analysis end date calculation Computation
AEENDTC converted to a SAS date. See SAP for missing or partial value imputations
Analysis start day calculation Computation
ASTDT - ADSL.TRTSDT + 1
Analysis end day calculation Computation
AENDT - ADSL.TRTEDT + 1
SRCVAR algorithm Computation
SRCVAR = ADEF if first event is a negative pain score or if worsening occurs before an improvement. SRCVAR = ADAE if ADAE.CQ01NAM is non-missing on a date prior to a pain improvement or worsening.
SRCSEQ algorithm Computation
if SRCVAR=ADEF then SRCSEQ=ADEF.XPSEQ from the corresponding record; else if SRCVAR=ADAE then SRCSEQ=ADAE.AESEQ from the corresponding record.
See codelist Computation
See codelist
See parameter value-level metadata Computation
See parameter value-level metadata
AE relatedness derivation Computation
If AEREL=NOT RELATED then NOT RELATED; Otherwise RELATED
Age group derivation Computation
If age<55 then "<55 years"; else if age>=55 then ">=55 YEARS"

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