Analysis Data Model (ADaM) To change this title, go to Notes Master 7/29/2019 Analysis Data Model (ADaM) Case Studies Wouter van Wyk, 27 Sep 2012

Case Studies Specific to Basic Data Structure (BDS) With the increased adoption of the Analysis Data Model (ADaM) we are facing a shift in our approach to creating Analysis datasets, as we are encouraged to create records rather than adding additional variables as we might have in the past.  With these Case Studies I hope to address some of the questions around: Mapping multiple SDTM Variables to the same ADaM variable Creating derived records Multiple baseline definitions in the same ADaM domain

Mapping multiple SDTM Variables to the same ADaM variable Finding domains Eg. LB, VS, EG **ORRES, **STRESN Map to BDS AVAL, AVALC Multiple variables mapping to a single ADaM BDS Result variable Traceability SRCDOM, SRCSEQ, SRCVAR

Mapping multiple SDTM Variables to the same ADaM variable SDTM VS Dataset DOMAIN VSSEQ VISIT VSTEST VSORRES VSORRESU VSSTRESN VSSTRESU VS 1 SCR WEIGHT 158.7 LB 72 kg 2 V1 162 73.5 3 V2 161.8 73.4 4 V3 161.6 73.3 5 V4 162.3 73.6 6 V5 163 74

Mapping multiple SDTM Variables to the same ADaM variable SRCDOM SRCSEQ SRCVAR VISIT PARAM AVAL VS 1 VSORRES SCR WEIGHT (LB) 158.7 VSSTRESN WEIGHT (kg) 72 2 V1 162 73.5 3 V2 161.8 73.4 4 V3 161.6 73.3 5 V4 162.3 73.6 6 V5 163 74

Mapping multiple SDTM Variables to the same ADaM variable Traceability The property that enables the understanding of the data’s lineage and/or the relationship between an element and its predecessor(s). Where did the data come from? SRCDOM: Identifies the SDTM domain SRCSEQ: Identifies the record in the SDTM domain SCRVAR: Identifies the SDTM variable used to create AVAL/AVALC

Creating derived records Derived Parameters Test is not present in SDTM BMI, BSA, Calculated Creatinine Clearance QTcF, QTcB Derived Value Test is in SDTM, but the record is not Baseline, Endpoint Last Observation Carried Forward Traceability PARAMTYP vs. DTYPE

Creating derived records DTYPE LOCF Row USUBJID VISIT AVISIT ADY PARAM AVAL 1 1001 BASELINE -4 SUPINE SYSBP (mm Hg) 145 2 WEEK 1 3 130 WEEK 2 9 133 4 WEEK 3 20 125 5 1002 -1 6 7 22 135 8 1003 150 140

Creating derived records Row USUBJID VISIT AVISIT ADY PARAM AVAL DTYPE 1 1001 BASELINE -4 SUPINE SYSBP (mm Hg) 145 2 WEEK 1 3 130 WEEK 2 9 133 4 WEEK 3 20 125 5 1002 -1 6 7 LOCF 8 22 135 1003 150 10 140 11 12

Creating derived records Duplicate the needed record Populate DTYPE to indicate new record Use something descriptive like, LOCF, BASELINE, ENDPOINT, WCCF SCRDOM, SRCVAR, SRCSEQ populated as with original record Do not modify SDTM variables

Creating derived records PARAMTYP Row PARAM PARAMCD AVISIT AVISITN AVAL PARAMTYP 1 Weight (kg) WEIGHT SCR -4 99 2 RUN-IN -2 101 3 BASELINE 100 4 WEEK 24 24 94 5 WEEK 48 48 92 6 WEEK 52 52 95 7 Log10(Weight (kg)) L10WT 1.9956 DERIVED 8 2.0043 9 10 1.9731 11 1.9638 12 1.9777

Creating derived records Add records needed New value for PARAM and AVAL SRCSEQ, SRCDOM, SRCVAR will be NULL AVAL did not have SDTM as source SDTM variables can be populated as appropriate Do not modify SDTM variables

Multiple baseline definitions in the same ADaM domain Multiple definitions of Baseline Last value prior to very first dose of active Last value prior to Run-in Last value prior to Double-Blind Last value prior to Open Label In case there is more than one definition of baseline, new rows must be created for each additional alternative definition of baseline Some data redundancy is expected BASETYPE

Multiple baseline definitions in the same ADaM domain CDISC ADaM IG v1.0 Table 4.2.1.11 Row BASETYPE EPOCH AVISIT AVAL ABLFL BASE CHG 1 RUN-IN BASELINE 34.5 Y 2 DAY 10 11.6 -22.9 4 STABILIZATION DAY 15 13.1 -21.4 6 DOUBLE BLIND DAY 20 13.7 -20.8 7 DAY 25 19.7 -14.8 8 DAY 30 28.1 -6.4 10 OPEN LABEL DAY 35 28.4 -6.1 11 DAY 40 30.5 -4

Multiple baseline definitions in the same ADaM domain Row BASETYPE EPOCH AVISIT AVAL ABLFL BASE CHG 1 RUN-IN BASELINE 34.5 Y 2 DAY 10 11.6 -22.9 4 STABILIZATION DAY 15 13.1 -21.4 6 DOUBLE BLIND DAY 20 13.7 -20.8 7 DAY 25 19.7 -14.8 8 DAY 30 28.1 -6.4 10 OPEN LABEL DAY 35 28.4 -6.1 11 DAY 40 30.5 -4 12 13 14 14.4 15 14.7 16 16.8

Multiple baseline definitions in the same ADaM domain Duplicate all records affected Populate BASETYPE with something descriptive SRCVAR, SRCDOM, SRCSEQ will be populated as records can be traced back to SDTM Some data redundancy is expected

Summary SRCVAR, SRCDOM, SRCSEQ used when multiple SDTM variables map to AVAL E.g. **ORRES and **STRESN DTYPE used when new record is created but AVAL is not modified. E.g. LOCF PARAMTYP used when new parameter is created and value of AVAL can not be traced back to SDTM BASETYPE used when there are multiple baseline definitions that require additional records to be added

Questions?