Monika Kawohl

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Exposurein Draft SDTM IG 3.1.4

• Monika Kawohl
• Principal Statistical Programmer
• Accovion

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Current Issues with Exposure in SDTMIG 3.1.2

• Doses not taken may be of interest
• but only doses taken should be included
• There are no standard variables for commonly
  collected exposure information
• e.g. planned doses
• Dose collected in a different unit that specified
  in protocol and required for analysis
• How to populate EX when the study is still
  blinded

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Proposed Solution in Draft SDTM IG 3.1.4

• 2 Interventions Domains
• EX Exposure (dose in protocol-specified units)
• EC Exposure as Collected
• General Rules
• EX domain required for all studies that include
  protocol-specified study treatment
• EC should be used where collected exposure
  information cannot/ should not be directly
  represented in EX or DA
• If EC is an exact duplicate of EX, then EC is not
  necessary
• Exposure data either in EX only or EC EX or DA
  EX dose in alternative units (if needed) in
  FA
• RELREC for relationhips

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Example
EC Exposure as Collected
USUBJ-ID ECLNK-GRP ECTRT ECMOOD EC-OCCUR EC-REASND EC-DOSE EC-DOSEU EC-STDTC EC-PTTMFL
1 V1 SOLUTION A SCHEDULED 10 mg/kg 2012-09-25 Y
1 V1 SOLUTION A PERFORMED Y 95 mL 2012-09-25 T1400 Y
2 V1 SOLUTION A SCHEDULED 10 mg/kg 2012-09-25 Y
2 V1 SOLUTION A PERFORMED N PATIENT FORGOT
EX Exposure
USUBJ-ID EXLNK-GRP EXTRT EX-OCCUR EX-REASND EX-DOSE EX-DOSEU EX-STDTC EX-PTTMFL
1 V1 PLACEBO Y 0 mg 2012-09-25 T1400 Y
2 V1 DRUG X N PATIENT FORGOT
Many to One Link between ECLNKGRP EXLNKGRP in
RELREC
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Summary of New Variables for EX/EC
Variable Description
--LNKID Link ID (available as of SDTM 1.3)
--LNKGRP Link Group ID (available as of SDTM 1.3)
--MOOD Mood (valid values SCHEDULED, PERFORMED)
--OCCUR Occurence (valid values N, Y)
--REASND Reason Not Done or Not Occurred
--DOSTKN Number of Doses Taken
--LAT Laterality (further specification of --LOC, valid values LEFT,CENTRAL, RIGHT)
--DIR Directionality (further specification of --LOC, valid values DIR Codelist, e.g. OUTER)
--PORTOT Distribution (further specification of --LOC, valid values PORTOT (Portion/Totality) Codelist, e.g. PARTIAL)
--METHOD Method of Administration (e.g. INFUSION PUMP)
--FAST Fasting Status
--MTHOBS Method of Observation (e.g. OBSERVED, SUBJECT DIARY, SUBJECT RECALL)
--PTTMFL Point in Time Flag (valid values Y)
ECPSTRG Pharmaceutical Strength (e.g., amount of active ingredient per dose unit (mg/mL))
ECPSTRGU Pharmaceutical Strength Unit