Date of Define-XML document generation: 2016-07-08T05:47:46-04:00
Define-XML version: 2.0.0
Stylesheet version: 2016-07-05
- Standard
- ADaM-IG 1.0
- Study Name
- CDISC-Sample
- Study Description
- CDISC-Sample Data Definition
- Protocol Name
- CDISC-Sample
- Metadata Name
- Data Definitions for CDISC-Sample, ADaM-IG 1.0
- Metadata Description
- Data Definitions for CDISC-Sample, ADaM-IG 1.0
Analysis Results Metadata - Summary
Dose response analysis for ADAS-Cog changes from baseline
Pairwise comparisons to placebo for ADAS-Cog changes from baseline
Incidence of Treatment Emergent Serious Adverse Events by Treatment Group
Analysis Results Metadata - Detail
Display | Table 14-3.01 [page=2] Primary Endpoint Analysis: ADAS-Cog - Summary at Week 24 - LOCF (Efficacy Population) |
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Analysis Result | Dose response analysis for ADAS-Cog changes from baseline |
Analysis Parameter(s) | PARAMCD = "ACTOT" (Adas-Cog(11) Subscore) |
Analysis Variable(s) | CHG (Change from Baseline) |
Analysis Reason | SPECIFIED IN SAP |
Analysis Purpose | PRIMARY OUTCOME MEASURE |
Data References (incl. Selection Criteria) | |
Documentation | Linear model analysis of CHG for dose response; using randomized dose (0 for placebo; 54 for low dose; 81 for high dose) and site group in model. Used PROC GLM in SAS to produce p-value (from Type III SS for treatment dose). See page 4 (section 10.1.1) in the Statistical Analysis Plan. |
Programming Statements | [SAS version 9.2]proc glm data = ADQSADAS; where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ACTOT"; class SITEGR1; model CHG = TRTPN SITEGR1; run; |
Analysis Result | Pairwise comparisons to placebo for ADAS-Cog changes from baseline |
Analysis Parameter(s) | PARAMCD = "ACTOT" (Adas-Cog(11) Subscore) |
Analysis Variable(s) | CHG (Change from Baseline) |
Analysis Reason | SPECIFIED IN SAP |
Analysis Purpose | PRIMARY OUTCOME MEASURE |
Data References (incl. Selection Criteria) | |
Documentation | ANCOVA analysis of CHG performed to provide pairwise comparisons among treatment groups and adjusted means; using randomized treatment as class variable and site group as class variable in model and the baseline value as a covariate. See page 4 (section 10.1.1) in the Statistical Analysis Plan. |
Programming Statements | [SAS version 9.2]proc glm data = ADQSADAS; where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ACTOT"; class TRTPN SITEGR1; model CHG = TRTPN SITEGR1 BASE; means TRTPN; lsmeans TRTPN / OM STDERR PDIFF CL; run; |
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Display | Table 14-5.02 [page=3] Incidence of Treatment Emergent Serious Adverse Events by Treatment Group |
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Analysis Result | Incidence of Treatment Emergent Serious Adverse Events by Treatment Group |
Analysis Parameter(s) | |
Analysis Variable(s) | AEBODSYS (Body System or Organ Class) AEDECOD (Dictionary-Derived Term) |
Analysis Reason | SPECIFIED IN SAP |
Analysis Purpose | PRIMARY OUTCOME MEASURE |
Data References (incl. Selection Criteria) | Get denominators for percentages from ADSL and counts and numerators from ADAE. Join ADAE with ADSL based on the unique subject identifier (USUBJID) keeping only records in ADAE for the numerator. |
Documentation | Unique count of subjects that experienced an Adverse Event by Preferred Term, System Organ Class, and Treatment Group and percentages based on the number of subjects in the safety population within each treatment group. The total number of times an event occurred was recorded by Preferred Term, System Organ Class, and Treatment Group. Fisher's exact test was used for treatment comparison of event rates. See page 5 (section 11.2) in the Statistical Analysis Plan. |
Programming Statements | [SAS version 9.2] |
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Analysis Datasets for Study CDISC-Sample (ADaM-IG 1.0)
Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
---|---|---|---|---|---|---|---|
ADSL | Subject Level Analysis | SUBJECT LEVEL ANALYSIS DATASET | one record per subject | Analysis | STUDYID, USUBJID | adsl.xpt | Screen Failures are excluded since they are not needed for this study analysis. See Analysis Data Reviewer's Guide, page 6. |
ADQSADAS | ADAS-Cog Analysis | BASIC DATA STRUCTURE | One record per subject per parameter per analysis visit per analysis date | Analysis | STUDYID, USUBJID, PARAMCD, AVISIT, ADT | adqsadas.xpt | See referenced dataset creation program and Analysis Data Reviewer's Guide, Section 2.1 |
ADAE | Adverse Events Analysis | OCCURRENCE DATA STRUCTURE | one record per subject per adverse event | Analysis | STUDYID, USUBJID, AETERM, ASTDT, AESEQ | adae.xpt | See SAS program |
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Subject Level Analysis (ADSL)
Variable | Label | Key | Type | Length or Display Format | Controlled Terms or Format | Source / Derivation / Comment |
---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 12 | Predecessor: DM.STUDYID | |
USUBJID | Unique Subject Identifier | 2 | text | 11 | Predecessor: DM.USUBJID | |
SUBJID | Subject Identifier for the Study | text | 4 | Predecessor: DM.SUBJID | ||
SITEID | Study Site Identifier | text | 3 | Predecessor: DM.SITEID | ||
SITEGR1 | Pooled Site Group 1 | text | 3 | Derived: refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900 | ||
ARM | Description of Planned Arm | text | 20 | Actual Treatment
| Predecessor: DM.ARM | |
TRT01P | Planned Treatment for Period 01 | text | 20 | Actual Treatment
| Predecessor: DM.ARM | |
TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Actual Treatment (N)
| Assigned: Numeric code for TRT01P which corresponds to the randomized dose | |
TRT01A | Actual Treatment for Period 01 | text | 20 | Actual Treatment
| Assigned: TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study. | |
TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Actual Treatment (N)
| Assigned: Numeric code for TRT01A which corresponds to the randomized dose | |
TRTSDT | Date of First Exposure to Treatment | integer | date9. | Derived: SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date | ||
TRTEDT | Date of Last Exposure to Treatment | integer | date9. | Derived: The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date. | ||
TRTDURD | Total Treatment Duration (Days) | integer | 8 | Derived: TRTEDT-TRTSDT+1 | ||
AVGDD | Avg Daily Dose (as planned) | float | 8 | Derived: CUMDOSE/TRTDURD | ||
CUMDOSE | Cumulative Dose (as planned) | float | 8 | Derived: For TRT01PN=0 or 54: CUMDOSE=TRT01PN*TRTDURD. For TRT01PN=81: CUMDOSE will be based on 54 mg per day for the # of days subject was in 1st dosing interval (i.e., VISIT4DATE-TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subject discontinued <= Visit 4 (Week 4) and > Visit 3 (Baseline)), 81 mg per day for the # of days subject was in 2nd dosing interval (i.e., VISIT12DATE-VISIT4DATE if 2nd interval completed, TRTEDT-VISIT4DATE if subject discontinued <= Visit 12 (Week 24) and > Visit 4), and 54 mg per day for the # of days subject was in 3rd dosing interval (i.e., TRTEDT - VISIT12DATE if subject continued after Visit 12). Note that VISIT4DATE=SV.SVSTDTC where VISITNUM=4 and VISIT12DATE=SV.SVSTDTC where VISITNUM=12. | ||
AGE | Age | integer | 8 | Predecessor: DM.AGE | ||
AGEGR1 | Pooled Age Group 1 | text | 5 | Age Group
| Derived: Character variable derived from ADSL.AGEGR1N | |
AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Age Group (N)
| Assigned: AGEGR1 = 1 if AGE <65. AGEGR1 = 2 if AGE 65-80. AGEGR1 = 3 if AGE >80. | |
AGEU | Age Units | text | 5 | Age Unit
| Predecessor: DM.AGEU | |
RACE | Race | text | 32 | Race
| Predecessor: DM.RACE | |
RACEN | Race (N) | integer | 8 | Race (N)
| Assigned: Numeric code for RACE | |
SEX | Sex | text | 1 | Sex
| Predecessor: DM.SEX | |
ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: DM.ETHNIC | |
SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Derived: Y if ITTFL='Y' and TRTSDT ne missing. N otherwise | |
ITTFL | Intent-To-Treat Population Flag | text | 1 | No Yes Response
| Derived: Y if ARMCD ne ' '. N otherwise | |
EFFFL | Efficacy Population Flag | text | 1 | No Yes Response
| Derived: Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM>3 AND at least one record in QS for CIBIC+ with VISITNUM>3, N otherwise | |
COMP8FL | Completers of Week 8 Population Flag | text | 1 | No Yes Response
| Derived: Y if subject has a SV.VISITNUM=8 and TRTEDT>= date of visit 8, N otherwise | |
COMP16FL | Completers of Week 16 Population Flag | text | 1 | No Yes Response
| Derived: Y if subject has a SV.VISITNUM=10 and TRTEDT>=date of visit 10, N otherwise | |
COMP24FL | Completers of Week 24 Population Flag | text | 1 | No Yes Response
| Derived: Y if subject has a SV.VISITNUM=12 and TRTEDT>= date of visit 12 , N otherwise | |
DISCONFL | Subject Discontinued Study Flag | text | 1 | No Yes Response - Y subset
| Derived: Y if DCSREAS ^= 'Completed'. Null otherwise | |
DSRAEFL | Subject Discontinued due to AE Flag | text | 1 | No Yes Response - Y subset
| Derived: Y if DCSREAS='Adverse Event'. Null otherwise | |
DTHFL | Subject Death Flag | text | 1 | No Yes Response - Y subset
| Predecessor: DM.DTHFL | |
BMIBL | Baseline BMI (kg/m^2) | float | 8 | Derived: WEIGHTBL / ((HEIGHTBL*100)**2) | ||
BMIBLGR1 | Pooled Baseline BMI Group 1 | text | 6 | Body Mass Index Category
| Derived: BMIBLGR1=Normal if . < BMIBL <25. BMIBLGR1=Overweight if 25 <=BMIBL <30. BMIBLGR1=Obese if BMIBL >=30 | |
HEIGHTBL | Baseline Height (cm) | float | 8 | Derived: VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1 | ||
WEIGHTBL | Baseline Weight (kg) | float | 8 | Derived: VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3 | ||
EDUCLVL | Years of Education | integer | 8 | Derived: SC.SCSTRESN where SC.SCTESTCD="EDLEVEL" | ||
DISONDT | Date of Onset of Disease | integer | date9. | Derived: MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date | ||
DURDIS | Duration of Disease (Months) | float | 8 | Derived: number of months between VISIT1DT and DISONDT | ||
DURDSGR1 | Pooled Disease Duration Group 1 | text | 4 | Disease Duration Group
| Derived: grouping DURDIS values as <12 and >=12 | |
VISIT1DT | Date of Visit 1 | integer | date9. | Derived: SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date | ||
RFSTDTC | Subject Reference Start Date/Time | date | ISO8601 | Predecessor: DM.RFSTDTC | ||
RFENDTC | Subject Reference End Date/Time | date | ISO8601 | Predecessor: DM.RFENDTC | ||
VISNUMEN | End of Trt Visit (Vis 12 or Early Term.) | integer | 8 | Derived: if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED' | ||
RFENDT | Date of Discontinuation/Completion | integer | 8 | Derived: RFENDTC converted to SAS date | ||
DCDECOD | Standardized Disposition Term | text | 27 | Completion/Reason for Non-Completion [9 Terms] | Derived: DS.DSDECOD where DSCAT='DISPOSITION EVENT' | |
DCSREAS | Reason for Discontinuation from Study | text | 18 | Reason for Discontinuation [10 Terms] | Derived: Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation | |
MMSETOT | MMSE Total | integer | 8 | Derived: Sum of QS.QSORRES values where QS.QSCAT="MINI-MENTAL STATE" for the subject |
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ADAS-Cog Analysis (ADQSADAS)
Variable | Label | Key | Type | Length or Display Format | Controlled Terms or Format | Source / Derivation / Comment |
---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 12 | Predecessor: ADSL.STUDYID | |
SITEID | Study Site Identifier | text | 3 | Predecessor: ADSL.SITEID | ||
SITEGR1 | Pooled Site Group 1 | text | 3 | Predecessor: ADSL.SITEGR1 | ||
USUBJID | Unique Subject Identifier | 2 | text | 11 | Predecessor: ADSL.USUBJID | |
TRTSDT | Date of First Exposure to Treatment | integer | date9. | Predecessor: ADSL.TRTSDT | ||
TRTEDT | Date of Last Exposure to Treatment | integer | date9. | Predecessor: ADSL.TRTEDT | ||
TRTP | Planned Treatment | text | 20 | Actual Treatment
| Predecessor: ADSL.TRT01P | |
TRTPN | Planned Treatment (N) | integer | 8 | Actual Treatment (N)
| Predecessor: ADSL.TRT01PN | |
AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
AGEGR1 | Pooled Age Group 1 | text | 5 | Age Group
| Predecessor: ADSL.AGEGR1 | |
AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Age Group (N)
| Predecessor: ADSL.AGEGR1N | |
RACE | Race | text | 32 | Race
| Predecessor: ADSL.RACE | |
RACEN | Race (N) | integer | 8 | Race (N)
| Predecessor: ADSL.RACEN | |
SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
ITTFL | Intent-To-Treat Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.ITTFL | |
EFFFL | Efficacy Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASFL | |
COMP24FL | Completers of Week 24 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COMP24FL | |
AVISIT | Analysis Visit | 4 | text | 16 | Analysis Visit
| Derived: Derived based on windowing algorithm described in SAP, Section 8.2 |
AVISITN | Analysis Visit (N) | integer | 8 | Analysis Visit (N)
| Assigned: Numeric code for AVISIT | |
VISIT | Visit Name | text | 19 | Visit [37 Terms] | Predecessor: QS.VISIT | |
VISITNUM | Visit Number | float | 8 | Visit Number [37 Terms] | Predecessor: QS.VISITNUM | |
ADY | Analysis Relative Day | integer | 8 | Derived: ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT. | ||
ADT | Analysis Date | 5 | integer | date9. | Derived: SAS date from QS.QSDTC | |
PARAM | Parameter | text | 100 | ADAS-Cog Parameter [15 Terms] | Assigned: | |
PARAMCD | Parameter Code | 3 | text | 8 | ADAS-Cog Parameter Code [15 Terms] | Assigned: |
PARAMN | Parameter (N) | integer | 8 | ADAS-Cog Parameter Code (N) [15 Terms] | Assigned: Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADQSADAS) | |
AVAL | Analysis Value | integer | 8 | Derivations are described per parameter in the parameter value level metadata | ||
BASE | Baseline Value | integer | 8 | Derived: QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3) | ||
CHG | Change from Baseline | integer | 8 | Derived: AVAL - BASE | ||
PCHG | Percent Change from Baseline | integer | 8 | Derived: 100* (CHG/BASE) | ||
ABLFL | Baseline Record Flag | text | 1 | No Yes Response - Y subset
| Predecessor: QS.QSBLFL | |
ANL01FL | Analysis Record Flag 01 | text | 1 | No Yes Response - Y subset
| Derived: If multiple visits fall into the same visit window, then the one closest to the target day is chosen for analysis. These are flagged with ANL01FL="Y". | |
DTYPE | Derivation Type | text | 7 | Derivation Type
| ||
AWRANGE | Analysis Window Valid Relative Range | text | 9 | Assigned: Window range, specified in the SAP. | ||
AWTARGET | Analysis Window Target | integer | 8 | Assigned: Target day within the window, specified in the SAP. | ||
AWTDIFF | Analysis Window Diff from Target | integer | 8 | Derived: Absolute difference between AWTARGET and ADY | ||
AWLO | Analysis Window Beginning Timepoint | integer | 8 | Assigned: Start day of the window, specified in the SAP. | ||
AWHI | Analysis Window Ending Timepoint | integer | 8 | Assigned: End day of the window, specified in the SAP. | ||
AWU | Analysis Window Unit | text | 4 | Unit - AWU
| Assigned: Assigned as "DAYS". | |
QSSEQ | Sequence Number | integer | 8 |
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Adverse Events Analysis (ADAE)
Variable | Label | Key | Type | Length or Display Format | Controlled Terms or Format | Source / Derivation / Comment |
---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 12 | Predecessor: ADSL.STUDYID | |
SITEID | Study Site Identifier | text | 3 | Predecessor: ADSL.SITEID | ||
USUBJID | Unique Subject Identifier | 2 | text | 11 | Predecessor: ADSL.USUBJID | |
TRTA | Actual Treatment | text | 20 | Actual Treatment
| Predecessor: ADSL.TRT01A | |
TRTAN | Actual Treatment (N) | integer | 8 | Actual Treatment (N)
| Predecessor: ADSL.TRT01AN | |
AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
AGEGR1 | Pooled Age Group 1 | text | 5 | Age Group
| Predecessor: ADSL.AGEGR1 | |
AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Age Group (N)
| Predecessor: ADSL.AGEGR1N | |
RACE | Race | text | 32 | Race
| Predecessor: ADSL.RACE | |
RACEN | Race (N) | integer | 8 | Race (N)
| Predecessor: ADSL.RACEN | |
SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
TRTSDT | Date of First Exposure to Treatment | integer | date9. | Predecessor: ADSL.TRTSDT | ||
TRTEDT | Date of Last Exposure to Treatment | integer | date9. | Predecessor: ADSL.TRTEDT | ||
ASTDT | Analysis Start Date | 4 | integer | date9. | Derived: AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates. | |
ASTDTF | Analysis Start Date Imputation Flag | text | 1 | Date Imputation Flag
| Derived: ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study | |
ASTDY | Analysis Start Relative Day | integer | 8 | Derived: IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT | ||
AENDT | Analysis End Date | integer | date9. | Derived: AE.AEENDTC, converted to a numeric SAS date | ||
AENDY | Analysis End Relative Day | integer | 8 | Derived: IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT | ||
ADURN | AE Duration (N) | integer | 8 | Derived: ADURN=AENDT-ASTDT+1 | ||
ADURU | AE Duration Units | text | 3 | Derived: If ADURN is not missing then ADURU='DAY' | ||
AETERM | Reported Term for the Adverse Event | 3 | text | 46 | Predecessor: AE.AETERM | |
AELLT | Lowest Level Term | text | 46 | Adverse Event Dictionary MedDRA 8.0 | Predecessor: AE.AELLT | |
AELLTCD | Lowest Level Term Code | integer | 8 | Predecessor: AE.AELLTCD | ||
AEDECOD | Dictionary-Derived Term | text | 46 | Adverse Event Dictionary MedDRA 8.0 | Predecessor: AE.AEDECOD | |
AEPTCD | Preferred Term Code | integer | 8 | Predecessor: AE.AEPTCD | ||
AEHLT | High Level Term | text | 8 | Adverse Event Dictionary MedDRA 8.0 | Predecessor: AE.AEHLT | |
AEHLTCD | High Level Term Code | integer | 8 | Predecessor: AE.AEHLTCD | ||
AEHLGT | High Level Group Term | text | 9 | Adverse Event Dictionary MedDRA 8.0 | Predecessor: AE.AEHLGT | |
AEHLGTCD | High Level Group Term Code | integer | 8 | Predecessor: AE.AEHLGTCD | ||
AEBODSYS | Body System or Organ Class | text | 67 | Adverse Event Dictionary MedDRA 8.0 | Predecessor: AE.AEBODSYS | |
AESOC | Primary System Organ Class | text | 67 | Adverse Event Dictionary MedDRA 8.0 | Predecessor: AE.AESOC | |
AESOCCD | Primary System Organ Class Code | integer | 8 | Predecessor: AE.AESOCCD | ||
AESEV | Severity/Intensity | text | 8 | Severity/Intensity Scale for Adverse Events
| Predecessor: AE.AESEV | |
AESER | Serious Event | text | 1 | No Yes Response
| Predecessor: AE.AESER | |
AESCAN | Involves Cancer | text | 1 | No Yes Response
| Predecessor: AE.AESCAN | |
AESCONG | Congenital Anomaly or Birth Defect | text | 1 | No Yes Response
| Predecessor: AE.AESCONG | |
AESDISAB | Persist or Signif Disability/Incapacity | text | 1 | No Yes Response
| Predecessor: AE.AESDISAB | |
AESDTH | Results in Death | text | 1 | No Yes Response
| Predecessor: AE.AESDTH | |
AESHOSP | Requires or Prolongs Hospitalization | text | 1 | No Yes Response
| Predecessor: AE.AESHOSP | |
AESLIFE | Is Life Threatening | text | 1 | No Yes Response
| Predecessor: AE.AESLIFE | |
AESOD | Occurred with Overdose | text | 1 | No Yes Response
| Predecessor: AE.AESOD | |
AEREL | Causality | text | 8 | Causality
| Predecessor: AE.AEREL | |
AEACN | Action Taken with Study Treatment | text | 1 | Predecessor: AE.AEACN | ||
AEOUT | Outcome of Adverse Event | text | 26 | Outcome of Adverse Event
| Predecessor: AE.AEOUT | |
AESEQ | Sequence Number | 5 | integer | 8 | Predecessor: AE.AESEQ | |
TRTEMFL | Treatment Emergent Analysis Flag | text | 1 | No Yes Response
| Derived: If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N' | |
AOCCFL | 1st Occurrence of Any AE Flag | text | 1 | No Yes Response - Y subset
| Derived: Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL='Y') within each Subject | |
AOCCSFL | 1st Occurrence of SOC Flag | text | 1 | No Yes Response - Y subset
| Derived: Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL='Y') within each Subject and SOC | |
AOCCPFL | 1st Occurrence of Preferred Term Flag | text | 1 | No Yes Response - Y subset
| Derived: Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL='Y') within each Subject, SOC, and PT | |
AOCC02FL | 1st Occurrence of Serious 02 Flag | text | 1 | No Yes Response - Y subset
| Derived: Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL='Y') within each Subject | |
AOCC03FL | 1st Occurrence of Serious SOC 03 Flag | text | 1 | No Yes Response - Y subset
| Derived: Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL='Y') within each Subject and SOC | |
AOCC04FL | 1st Occurrence of Serious PT 04 Flag | text | 1 | No Yes Response - Y subset
| Derived: Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL='Y') within each Subject, SOC, and PT | |
CQ01NAM | Customized Query 01 Name | text | 19 | Derived: If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL | ||
AOCC01FL | 1st Occurrence of CQ01 01 Flag | text | 1 | No Yes Response - Y subset
| Derived: Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL='Y') within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis) |
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Parameter Value Lists
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Source / Derivation / Comment |
---|---|---|---|---|---|
AVAL | PARAMCD IN ( "ACITM01" (Word Recall Task) , "ACITM02" (Naming Objects And Fingers (Refer To 5 C) , "ACITM03" (Delayed Word Recall) , "ACITM04" (Commands) , "ACITM05" (Constructional Praxis) , "ACITM06" (Ideational Praxis) , "ACITM07" (Orientation) , "ACITM08" (Word Recognition) , "ACITM09" (Attention/Visual Search Task) , "ACITM10" (Maze Solution) , "ACITM11" (Spoken Language Ability) , "ACITM12" (Comprehension Of Spoken Language) , "ACITM13" (Word Finding Difficulty In Spontaneous Speech) , "ACITM14" (Recall Of Test Instructions) ) | integer | 8 | Derived: QS.QSSTRESN where QSTESTCD=PARAMCD | |
AVAL | PARAMCD = "ACTOT" (Adas-Cog(11) Subscore) | integer | 8 | Derived: Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see Analysis Data Reviewers Guide (Page 3) for details on adjusting for missing values. |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Source / Derivation / Comment |
---|---|---|---|---|---|
DTYPE | PARAMCD ≠ "ACTOT" (Adas-Cog(11) Subscore) | text | 7 | Derivation Type
| Assigned: Value: null |
DTYPE | PARAMCD = "ACTOT" (Adas-Cog(11) Subscore) | text | 7 | Derivation Type
| Assigned: Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit. |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Source / Derivation / Comment |
---|---|---|---|---|---|
QSSEQ | PARAMCD ≠ "ACTOT" (Adas-Cog(11) Subscore) | integer | 8 | Predecessor: QS.QSSEQ | |
QSSEQ | PARAMCD = "ACTOT" (Adas-Cog(11) Subscore) | integer | 8 | Assigned: Set QSSEQ to missing for post baseline records. Set to QS.QSSEQ where QS.VISIT=BASELINE and QS.QSTESTCD=ACTOT. |
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Controlled Terms
Permitted Value (Code) |
---|
NONE |
POSSIBLE |
PROBABLE |
REMOTE |
Permitted Value (Code) | Display Value (Decode) |
---|---|
MILD [C41338] | Grade 1 |
MODERATE [C41339] | Grade 2 |
SEVERE [C41340] | Grade 3 |
Permitted Value (Code) |
---|
<65 |
65-80 |
>80 |
Permitted Value (Code) | Display Value (Decode) |
---|---|
1 | <65 |
2 | 65-80 |
3 | >80 |
Permitted Value (Code) |
---|
YEARS [C29848] |
Permitted Value (Code) |
---|
Placebo |
Xanomeline Low Dose |
Xanomeline High Dose |
Permitted Value (Code) | Display Value (Decode) |
---|---|
0 | Placebo |
54 | Xanomeline Low Dose |
81 | Xanomeline High Dose |
Permitted Value (Code) |
---|
Baseline |
Week 8 |
Week 16 |
Week 24 |
Permitted Value (Code) | Display Value (Decode) |
---|---|
0 | Baseline |
8 | Week 8 |
16 | Week 16 |
24 | Week 24 |
Permitted Value (Code) |
---|
DAYS [C25301] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
<25 | Normal |
25-<30 | Overweight |
>30 | Obese |
Permitted Value (Code) | Display Value (Decode) |
---|---|
D [C81212] | Day Imputed: Day is imputed |
M [C81211] | Month Imputed: Month and day are imputed |
Y [C81210] | Year Imputed: Entire date (year, month and day) is imputed |
Permitted Value (Code) |
---|
COMPLETED [C25250] |
ADVERSE EVENT [C41331] |
DEATH [C28554] |
LACK OF EFFICACY [C48226] |
LOST TO FOLLOW-UP [C48227] |
PHYSICIAN DECISION [C48250] |
PROTOCOL VIOLATION [C48251] |
STUDY TERMINATED BY SPONSOR [C49632] |
WITHDRAWAL BY SUBJECT [C49634] |
Permitted Value (Code) |
---|
Completed |
Adverse Event |
Death |
I/E Not Met |
Lack of Efficacy |
Lost to Follow-up |
Physician Decision |
Protocol Violation |
Sponsor Decision |
Withdrew Consent |
Permitted Value (Code) | Display Value (Decode) |
---|---|
LOCF [C81198] | Last Observation Carried Forward |
Permitted Value (Code) |
---|
<12 |
>=12 |
Permitted Value (Code) |
---|
HISPANIC OR LATINO [C17459] |
NOT HISPANIC OR LATINO [C41222] |
Permitted Value (Code) |
---|
RECOVERED/RESOLVED [C49498] |
NOT RECOVERED/NOT RESOLVED [C49494] |
FATAL [C48275] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
ACITM01 | Word Recall Task |
ACITM02 | Naming Objects And Fingers (Refer To 5 C |
ACITM03 | Delayed Word Recall |
ACITM04 | Commands |
ACITM05 | Constructional Praxis |
ACITM06 | Ideational Praxis |
ACITM07 | Orientation |
ACITM08 | Word Recognition |
ACITM09 | Attention/Visual Search Task |
ACITM10 | Maze Solution |
ACITM11 | Spoken Language Ability |
ACITM12 | Comprehension Of Spoken Language |
ACITM13 | Word Finding Difficulty In Spontaneous Speech |
ACITM14 | Recall Of Test Instructions |
ACTOT | Adas-Cog(11) Subscore |
Permitted Value (Code) | Display Value (Decode) |
---|---|
1 | Word Recall Task |
2 | Naming Objects And Fingers (Refer To 5 C |
3 | Delayed Word Recall |
4 | Commands |
5 | Constructional Praxis |
6 | Ideational Praxis |
7 | Orientation |
8 | Word Recognition |
9 | Attention/Visual Search Task |
10 | Maze Solution |
11 | Spoken Language Ability |
12 | Comprehension Of Spoken Language |
13 | Word Finding Difficulty In Spontaneous S |
14 | Recall Of Test Instructions |
15 | Adas-Cog(11) Subscore |
Permitted Value (Code) |
---|
Word Recall Task |
Naming Objects And Fingers (Refer To 5 C |
Delayed Word Recall |
Commands |
Constructional Praxis |
Ideational Praxis |
Orientation |
Word Recognition |
Attention/Visual Search Task |
Maze Solution |
Spoken Language Ability |
Comprehension Of Spoken Language |
Word Finding Difficulty In Spontaneous S |
Recall Of Test Instructions |
Adas-Cog(11) Subscore |
Permitted Value (Code) |
---|
WHITE [C41261] |
BLACK OR AFRICAN AMERICAN [C16352] |
ASIAN [C41260] |
AMERICAN INDIAN OR ALASKA NATIVE [C41259] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
1 | WHITE |
2 | BLACK OR AFRICAN AMERICAN |
6 | AMERICAN INDIAN OR ALASKA NATIVE |
7 | ASIAN |
Permitted Value (Code) | Display Value (Decode) |
---|---|
F [C16576] | Female |
M [C20197] | Male |
U [C17998] | Unknown |
Permitted Value (Code) |
---|
SCREENING 1 |
UNSCHEDULED 1.1 |
UNSCHEDULED 1.2 |
UNSCHEDULED 1.3 |
SCREENING 2 |
BASELINE |
UNSCHEDULED 3.1 |
AMBUL ECG PLACEMENT |
WEEK 2 |
UNSCHEDULED 4.1 |
UNSCHEDULED 4.2 |
WEEK 4 |
UNSCHEDULED 5.1 |
AMBUL ECG REMOVAL |
UNSCHEDULED 6.1 |
WEEK 6 |
UNSCHEDULED 7.1 |
WEEK 8 |
WEEK 10 (T) |
UNSCHEDULED 8.2 |
WEEK 12 |
WEEK 14 (T) |
UNSCHEDULED 9.2 |
UNSCHEDULED 9.3 |
WEEK 16 |
WEEK 18 (T) |
UNSCHEDULED 10.2 |
WEEK 20 |
WEEK 22 (T) |
UNSCHEDULED 11.2 |
WEEK 24 |
UNSCHEDULED 12.1 |
WEEK 26 |
UNSCHEDULED 13.1 |
AE FOLLOW-UP |
RETRIEVAL |
Rash followup |
Permitted Value (Code) | Display Value (Decode) |
---|---|
1 | SCREENING 1 |
1.1 | UNSCHEDULED 1.1 |
1.2 | UNSCHEDULED 1.2 |
1.3 | UNSCHEDULED 1.3 |
2 | SCREENING 2 |
3 | BASELINE |
3.1 | UNSCHEDULED 3.1 |
3.5 | AMBUL ECG PLACEMENT |
4 | WEEK 2 |
4.1 | UNSCHEDULED 4.1 |
4.2 | UNSCHEDULED 4.2 |
5 | WEEK 4 |
5.1 | UNSCHEDULED 5.1 |
6 | AMBUL ECG REMOVAL |
6.1 | UNSCHEDULED 6.1 |
7 | WEEK 6 |
7.1 | UNSCHEDULED 7.1 |
8 | WEEK 8 |
8.1 | WEEK 10 (T) |
8.2 | UNSCHEDULED 8.2 |
9 | WEEK 12 |
9.1 | WEEK 14 (T) |
9.2 | UNSCHEDULED 9.2 |
9.3 | UNSCHEDULED 9.3 |
10 | WEEK 16 |
10.1 | WEEK 18 (T) |
10.2 | UNSCHEDULED 10.2 |
11 | WEEK 20 |
11.1 | WEEK 22 (T) |
11.2 | UNSCHEDULED 11.2 |
12 | WEEK 24 |
12.1 | UNSCHEDULED 12.1 |
13 | WEEK 26 |
13.1 | UNSCHEDULED 13.1 |
101 | AE FOLLOW-UP |
201 | RETRIEVAL |
501 | Rash followup |
Permitted Value (Code) | Display Value (Decode) |
---|---|
N [C49487] | No |
Y [C49488] | Yes |
Permitted Value (Code) | Display Value (Decode) |
---|---|
Y [C49488] | Yes |
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External Dictionaries
Reference Name | External Dictionary | Dictionary Version |
---|---|---|
Adverse Event Dictionary (CL.AEDICT) | MedDRA | 8.0 |
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Analysis Derivations
Method | Type | Description |
---|---|---|
MT.ADAE.ADURN | Computation | ADURN=AENDT-ASTDT+1 |
MT.ADAE.ADURU | Computation | If ADURN is not missing then ADURU='DAY' |
MT.ADAE.AENDT | Computation | AE.AEENDTC, converted to a numeric SAS date |
MT.ADAE.AENDY | Computation | IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT |
MT.ADAE.AOCC01FL | Computation | Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL='Y') within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis) |
MT.ADAE.AOCC02FL | Computation | Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL='Y') within each Subject |
MT.ADAE.AOCC03FL | Computation | Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL='Y') within each Subject and SOC |
MT.ADAE.AOCC04FL | Computation | Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL='Y') within each Subject, SOC, and PT |
MT.ADAE.AOCCFL | Computation | Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL='Y') within each Subject |
MT.ADAE.AOCCPFL | Computation | Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL='Y') within each Subject, SOC, and PT |
MT.ADAE.AOCCSFL | Computation | Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL='Y') within each Subject and SOC |
MT.ADAE.ASTDT | Computation | AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates. |
MT.ADAE.ASTDTF | Computation | ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study |
MT.ADAE.ASTDY | Computation | IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT |
MT.ADAE.CQ01NAM | Computation | If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL |
MT.ADAE.TRTEMFL | Computation | If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N' |
MT.ADQSADAS.ADT | Computation | SAS date from QS.QSDTC |
MT.ADQSADAS.ADY | Computation | ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT. |
MT.ADQSADAS.ANL01FL | Computation | If multiple visits fall into the same visit window, then the one closest to the target day is chosen for analysis. These are flagged with ANL01FL="Y". |
MT.ADQSADAS.AVAL | Computation | Derivations are described per parameter in the parameter value level metadata |
MT.ADQSADAS.AVISIT | Computation | Derived based on windowing algorithm described in SAP, Section 8.2 |
MT.ADQSADAS.AWTDIFF | Computation | Absolute difference between AWTARGET and ADY |
MT.ADQSADAS.BASE | Computation | QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3) |
MT.ADQSADAS.CHG | Computation | AVAL - BASE |
MT.ADQSADAS.PCHG | Computation | 100* (CHG/BASE) |
MT.ADSL.AGEGR1 | Computation | Character variable derived from ADSL.AGEGR1N |
MT.ADSL.AVGDD | Computation | CUMDOSE/TRTDURD |
MT.ADSL.BMIBL | Computation | WEIGHTBL / ((HEIGHTBL*100)**2) |
MT.ADSL.BMIBLGR1 | Computation | BMIBLGR1=Normal if . < BMIBL <25. BMIBLGR1=Overweight if 25 <=BMIBL <30. BMIBLGR1=Obese if BMIBL >=30 |
MT.ADSL.COMP16FL | Computation | Y if subject has a SV.VISITNUM=10 and TRTEDT>=date of visit 10, N otherwise |
MT.ADSL.COMP24FL | Computation | Y if subject has a SV.VISITNUM=12 and TRTEDT>= date of visit 12 , N otherwise |
MT.ADSL.COMP8FL | Computation | Y if subject has a SV.VISITNUM=8 and TRTEDT>= date of visit 8, N otherwise |
MT.ADSL.CUMDOSE | Computation | For TRT01PN=0 or 54: CUMDOSE=TRT01PN*TRTDURD. For TRT01PN=81: CUMDOSE will be based on 54 mg per day for the # of days subject was in 1st dosing interval (i.e., VISIT4DATE-TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subject discontinued <= Visit 4 (Week 4) and > Visit 3 (Baseline)), 81 mg per day for the # of days subject was in 2nd dosing interval (i.e., VISIT12DATE-VISIT4DATE if 2nd interval completed, TRTEDT-VISIT4DATE if subject discontinued <= Visit 12 (Week 24) and > Visit 4), and 54 mg per day for the # of days subject was in 3rd dosing interval (i.e., TRTEDT - VISIT12DATE if subject continued after Visit 12). Note that VISIT4DATE=SV.SVSTDTC where VISITNUM=4 and VISIT12DATE=SV.SVSTDTC where VISITNUM=12. |
MT.ADSL.DCDECOD | Computation | DS.DSDECOD where DSCAT='DISPOSITION EVENT' |
MT.ADSL.DCSREAS | Computation | Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation |
MT.ADSL.DISCONFL | Computation | Y if DCSREAS ^= 'Completed'. Null otherwise |
MT.ADSL.DISONDT | Computation | MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date |
MT.ADSL.DSRAEFL | Computation | Y if DCSREAS='Adverse Event'. Null otherwise |
MT.ADSL.DURDIS | Computation | number of months between VISIT1DT and DISONDT |
MT.ADSL.DURDSGR1 | Computation | grouping DURDIS values as <12 and >=12 |
MT.ADSL.EDUCLVL | Computation | SC.SCSTRESN where SC.SCTESTCD="EDLEVEL" |
MT.ADSL.EFFFL | Computation | Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM>3 AND at least one record in QS for CIBIC+ with VISITNUM>3, N otherwise |
MT.ADSL.HEIGHTBL | Computation | VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1 |
MT.ADSL.ITTFL | Computation | Y if ARMCD ne ' '. N otherwise |
MT.ADSL.MMSETOT | Computation | Sum of QS.QSORRES values where QS.QSCAT="MINI-MENTAL STATE" for the subject |
MT.ADSL.RFENDT | Computation | RFENDTC converted to SAS date |
MT.ADSL.SAFFL | Computation | Y if ITTFL='Y' and TRTSDT ne missing. N otherwise |
MT.ADSL.SITEGR1 | Computation | refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900 |
MT.ADSL.TRTDURD | Computation | TRTEDT-TRTSDT+1 |
MT.ADSL.TRTEDT | Computation | The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date. |
MT.ADSL.TRTSDT | Computation | SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date |
MT.ADSL.VISIT1DT | Computation | SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date |
MT.ADSL.VISNUMEN | Computation | if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED' |
MT.ADSL.WEIGHTBL | Computation | VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3 |
MT.ADQSADAS.AVAL.WC.ADQSADAS.AVAL.00001 | Computation | Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see Analysis Data Reviewers Guide (Page 3) for details on adjusting for missing values. |
MT.ADQSADAS.AVAL.WC.ADQSADAS.AVAL.00002 | Computation | QS.QSSTRESN where QSTESTCD=PARAMCD |
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Comments
CommentOID | Description |
---|---|
COM.ADAE | See SAS program |
COM.ADQSADAS | See referenced dataset creation program and Analysis Data Reviewer's Guide, Section 2.1 |
COM.ADSL | Screen Failures are excluded since they are not needed for this study analysis. See Analysis Data Reviewer's Guide, page 6. |
COM.ADQSADAS.AVISITN | Numeric code for AVISIT |
COM.ADQSADAS.AWHI | End day of the window, specified in the SAP. |
COM.ADQSADAS.AWLO | Start day of the window, specified in the SAP. |
COM.ADQSADAS.AWRANGE | Window range, specified in the SAP. |
COM.ADQSADAS.AWTARGET | Target day within the window, specified in the SAP. |
COM.ADQSADAS.AWU | Assigned as "DAYS". |
COM.ADQSADAS.PARAMN | Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADQSADAS) |
COM.ADSL.AGEGR1N | AGEGR1 = 1 if AGE <65. AGEGR1 = 2 if AGE 65-80. AGEGR1 = 3 if AGE >80. |
COM.ADSL.RACEN | Numeric code for RACE |
COM.ADSL.TRT01A | TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study. |
COM.ADSL.TRT01AN | Numeric code for TRT01A which corresponds to the randomized dose |
COM.ADSL.TRT01PN | Numeric code for TRT01P which corresponds to the randomized dose |
COM.ADQSADAS.DTYPE.WC.ADQSADAS.DTYPE.00003 | Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit. |
COM.ADQSADAS.DTYPE.WC.ADQSADAS.DTYPE.00004 | Value: null |
COM.ADQSADAS.QSSEQ.WC.ADQSADAS.QSSEQ.00005 | Set QSSEQ to missing for post baseline records. Set to QS.QSSEQ where QS.VISIT=BASELINE and QS.QSTESTCD=ACTOT. |
COM.ARM.AR.Table_14-5.02.R.1 | Get denominators for percentages from ADSL and counts and numerators from ADAE. Join ADAE with ADSL based on the unique subject identifier (USUBJID) keeping only records in ADAE for the numerator. |
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