A nalysis Da ta M odel (ADaM)

Copyright © 2012 Quintiles

Analysis Data Model (ADaM)Case Studies

Wouter van Wyk, 27 Sep 2012

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Case Studies

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

Specific to Basic Data Structure (BDS)

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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

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Mapping multiple SDTM Variables to the same ADaM variable

DOMAIN VSSEQ VISIT VSTEST VSORRES VSORRESU VSSTRESN VSSTRESU

VS 1 SCR WEIGHT 158.7 LB 72 kg

VS 2 V1 WEIGHT 162 LB 73.5 kg

VS 3 V2 WEIGHT 161.8 LB 73.4 kg



VS 6 V5 WEIGHT 163 LB 74 kg

SDTM VS Dataset

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Mapping multiple SDTM Variables to the same ADaM variable

SRCDOM SRCSEQ SRCVAR VISIT PARAM AVAL

VS 1 VSORRES SCR WEIGHT (LB) 158.7

VS 1 VSSTRESN SCR WEIGHT (kg) 72

VS 2 VSORRES V1 WEIGHT (LB) 162

VS 2 VSSTRESN V1 WEIGHT (kg) 73.5

VS 3 VSORRES V2 WEIGHT (LB) 161.8






VS 6 VSORRES V5 WEIGHT (LB) 163

VS 6 VSSTRESN V5 WEIGHT (kg) 74

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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

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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

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Row USUBJID VISIT AVISIT ADY PARAM AVAL

1 1001 BASELINE BASELINE -4 SUPINE SYSBP (mm Hg) 145

2 1001 WEEK 1 WEEK 1 3 SUPINE SYSBP (mm Hg) 130






8 1003 BASELINE BASELINE 1 SUPINE SYSBP (mm Hg) 150


• DTYPE• LOCF

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Creating derived recordsRow USUBJID VISIT AVISIT ADY PARAM AVAL DTYPE







7 1002 WEEK 1 WEEK 2 7 SUPINE SYSBP (mm Hg) 130 LOCF


9 1003 BASELINE BASELINE 1 SUPINE SYSBP (mm Hg) 150




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• 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

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Row PARAM PARAMCD AVISIT AVISITN AVAL PARAMTYP

1 Weight (kg) WEIGHT SCR -4 99

2 Weight (kg) WEIGHT RUN-IN -2 101

3 Weight (kg) WEIGHT BASELINE 0 100

4 Weight (kg) WEIGHT WEEK 24 24 94



7 Log10(Weight (kg)) L10WT SCR -4 1.9956 DERIVED

8 Log10(Weight (kg)) L10WT RUN-IN -2 2.0043 DERIVED

9 Log10(Weight (kg)) L10WT BASELINE 0 2 DERIVED

10 Log10(Weight (kg)) L10WT WEEK 24 24 1.9731 DERIVED



• PARAMTYP

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• 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

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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

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Multiple baseline definitions in the same ADaM domain

Row BASETYPE EPOCH AVISIT AVAL ABLFL BASE CHG

1 RUN-IN RUN-IN BASELINE 34.5 Y 34.5 0

2 RUN-IN RUN-IN DAY 10 11.6 34.5 -22.9

4 RUN-IN STABILIZATION DAY 15 13.1 34.5 -21.4

6 RUN-IN DOUBLE BLIND DAY 20 13.7 34.5 -20.8



10 RUN-IN OPEN LABEL DAY 35 28.4 34.5 -6.1

11 RUN-IN OPEN LABEL DAY 40 30.5 34.5 -4

CDISC ADaM IG v1.0 Table 4.2.1.11

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Multiple baseline definitions in the same ADaM domain

Row BASETYPE EPOCH AVISIT AVAL ABLFL BASE CHG

1 RUN-IN RUN-IN BASELINE 34.5 Y 34.5 0

2 RUN-IN RUN-IN DAY 10 11.6 34.5 -22.9

4 RUN-IN STABILIZATION DAY 15 13.1 34.5 -21.4




10 RUN-IN OPEN LABEL DAY 35 28.4 34.5 -6.1

11 RUN-IN OPEN LABEL DAY 40 30.5 34.5 -4

12 DOUBLE BLIND DOUBLE BLIND DAY 20 13.7 Y 13.7 0

13 DOUBLE BLIND DOUBLE BLIND DAY 25 19.7 13.7 6

14 DOUBLE BLIND DOUBLE BLIND DAY 30 28.1 13.7 14.4

15 DOUBLE BLIND OPEN LABEL DAY 35 28.4 13.7 14.7

16 DOUBLE BLIND OPEN LABEL DAY 40 30.5 13.7 16.8

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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

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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

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Questions?

A nalysis Da ta M odel (ADaM)

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