CDISC-Sample CDISC-Sample Data Definition CDISC-Sample ACITM01 ACITM02 ACITM03 ACITM04 ACITM05 ACITM06 ACITM07 ACITM08 ACITM09 ACITM10 ACITM11 ACITM12 ACITM13 ACITM14 ACTOT ACTOT ACTOT ACTOT ACTOT Subject-Level Analysis adsl.xpt ADAS-Cog Analysis adqsadas.xpt Study Identifier ADSL.STUDYID Study Site Identifier ADSL.SITEID Pooled Site Group 1 ADSL.SITEGR1 Unique Subject Identifier ADSL.USUBJID Date of First Exposure to Treatment ADSL.TRTSDT Date of Last Exposure to Treatment ADSL.TRTEDT Planned Treatment ADSL.TRT01P Planned Treatment (N) ADSL.TRT01PN Age ADSL.AGE Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Race ADSL.RACE Race (N) ADSL.RACEN Sex ADSL.SEX Intent-to-Treat Population Flag ADSL.ITTFL Efficacy Population Flag ADSL.FASFL Completers of Week 24 Population Flag ADSL.COMP24FL Analysis Visit Analysis Visit (N) Visit Name QS.VISIT Visit Number QS.VISITNUM Analysis Relative Day Analysis Date Parameter Parameter Code Parameter (N) Analysis Value Baseline Value Change from Baseline Percent Change from Baseline ABLFL QS.QSBLFL Analysis Record Flag 01 Derivation Type Analysis Window Valid Relative Range Analysis Window Target Analysis Window Diff from Target Analysis Window Beginning Timepoint Analysis Window Ending Timepoint Analysis Window Unit Sequence Number Study Identifier DM.STUDYID Unique Subject Identifier DM.USUBJID Subject Identifier for the Study DM.SUBJID Study Site Identifier DM.SITEID Pooled Site Group 1 Description of Planned Arm DM.ARM Planned Treatment for Period 01 DM.ARM Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Date of First Exposure to Treatment Date of Last Exposure to Treatment Duration of Treatment (days) Avg Daily Dose (as planned) Cumulative Dose (as planned) Age DM.AGE Pooled Age Group 1 Pooled Age Group 1 (N) Age Units DM.AGEU Race DM.RACE Race (N) Sex DM.SEX Ethnicity DM.ETHNIC Safety Population Flag Intent-To-Treat Population Flag Efficacy Population Flag Completers of Week 8 Population Flag Completers of Week 16 Population Flag Completers of Week 24 Population Flag Did the Subject Discontinue the Study? Discontinued due to AE? Subject Died? DM.DTHFL Baseline BMI (kg/m^2) Pooled Baseline BMI Group 1 Baseline Height (cm) Baseline Weight (kg) Years of Education Date of Onset of Disease Duration of Disease (Months) Pooled Disease Duration Group 1 Date of Visit 1 Subject Reference Start Date/Time DM.RFSTDTC Subject Reference End Date/Time DM.RFENDTC End of Trt Visit (Vis 12 or Early Term.) Date of Discontinuation/Completion Standardized Disposition Term Reason for Discontinuation MMSE Total Analysis Value Analysis Value Derivation Type Derivation Type Sequence Number QS.QSSEQ Sequence Number <65 65-80 >80 Placebo Xanomeline Low Dose Xanomeline High Dose Baseline Week 8 Week 16 Week 24 Normal Overweight Obese Last Observation Carried Forward 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 Speech Recall Of Test Instructions Adas-Cog(11) Subscore 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 WHITE BLACK OR AFRICAN AMERICAN AMERICAN INDIAN OR ALASKA NATIVE ASIAN Female Male Unknown 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 No Yes Yes Derived based on windowing algorithm described in SAP, Section 8.2 ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT. SAS date from QS.QSDTC Derivations are described per parameter in the parameter value level metadata QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3) AVAL - BASE 100* (CHG/BASE) If multiple visits fall into the same visit window, then the one closest to the target date is chosen for analysis. These are flagged with ANL01FL="Y". Absolute difference between AWTARGET and ADY refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900 SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date 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. TRTEDT-TRTSDT+1 CUMDOSE/TRTDUR For ARMN=0 or 1: CUMDOSE=TRT01PN*TRTDUR. --- For ARMN=2: CUMDOSE will be based on 54mg per day for the # of days subj was in 1st dosing interval (i.e., visit4date-TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subj discontinued <=visit 4 and > visit 3), 81mg per day for the # of days subj was in 2nd dosing interval (i.e., visit12date-visit4date if 2nd interval completed, TRTEDT-visit4date if subj discontinued <= visit 12 and > visit 4), and 54mg per day for the # of days subj was in 3rd dosing interval (i.e., TRTEDT - visit12date if subj continued after visit 12). Character variable derived from ADSL.AGEGR1N Y if ITTFL='Y' and TRTSDT ne missing. N otherwise Y if ARMCD ne ' '. N otherwise 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 Y if subject has a SV.VISITNUM=8 and ENDDT >= date of visit 8, N otherwise Y if subject has a SV.VISITNUM=10 and ENDDT>=date of visit 10, N otherwise Y if subject has a SV.VISITNUM=12 and ENDDT>= date of visit 12 , N otherwise Y if DCREASCD ^= 'Completed'. Null otherwise Y if DCREASCD='Adverse Event'. Null otherwise WEIGHTBL / ((HEIGHTBL*100)**2) BMIBLGR1=Normal if . < BMIBL <25. BMIBLGR1=Overweight if 25 <=BMIBL <30. BMIBLGR1=Obese if BMIBL >=30 VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1 VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3 SC.SCSTRESN where SC.SCTESTCD=YEARSEDU MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date number of months between VISIT1DT and DISONSET grouping DURDIS values as <12 and >=12 SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED' RFENDTC converted to SAS date DS.DSDECOD where DSCAT='DISPOSITION EVENT' Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation sum of QS.QSORRES values for the subject QS.QSSTRESN where QSTESTCD=PARAMCD 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. Screen Failures are excluded since they are not needed for this study analysis See referenced dataset creation program and Analysis Data Reviewer's Guide, Section 2.1 Numeric code for AVISIT Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADQSADAS) Window range, specified in the SAP. Target day within the window, specified in the SAP. Start day of the window, specified in the SAP. End day of the window, specified in the SAP. Assigned as "DAYS". Numeric code for TRT01P which corresponds to the randomized dose TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study. Numeric code for TRT01A which corresponds to the randomized dose AGEGR1 = 1 if AGE <65. AGEGR1 = 2 if AGE 65-80. AGEGR1 = 3 if AGE >80. Numeric code for RACE Value: null Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit. Set QSSEQ to missing for post baseline records. Set to QS.QSSEQ where QS.VISIT=BASELINE and QS.QSTESTCD=ACTOT. Analysis Data Reviewer's Guide adqsadas.sas