Versions Compared

Old Version 18

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 19

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
AE.AEENRF
Example

This is an example of the input SDTM AE datasets used to create the ADAE.  

Include Page
SDTM Example ADaM AE
SDTM Example ADaM AE
 

Below is the example ADAE dataset and associated metadata. This is just an example and does not mean to indicate that ADAE must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study. 

Dataset wrap
NameADAE
Dataset2

STUDYID

USUBJIDASTDTASTDTMAENDTAENDTMASTDYAENDYPREFLTRTEMFLFUPFLAETRTEMAOCCFLAOCCPFLAOCCSFLAESERAERELRELGR1AESEVAEACNTRTASAFFLTRTSDT
ABC12312310112OCT200512OCT2005-1-1YNDEFINITELY NOT RELATEDNOT RELATEDSEVERENOT APPLICABLEProduct AY13OCT2005ABC12312310113OCT200513OCT2005:13:0513OCT200513OCT2005:19:0011YYYYYNProduct ARELATEDMODERATEDOSE REDUCEDProduct AY13OCT2005ABC12312310121OCT20059YYYYYYPROBABLY NOT RELATEDNOT RELATEDMODERATEDOSE REDUCEDProduct AY13OCT2005
Definexmltable
DatasetADAE
LevelVariable
PurposeAnalysis
Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study IdentifiertextReqAE.STUDYIDUSUBJIDUnique Subject IdentifiertextReqAE.USUBJIDASTDTAnalysis Start DateintegerCond

Created from converting AE.AESTDTC from character ISO8601 format to numeric date format

ASTDTMAnalysis Start Date/TimeintegerCondCreated from converting AE.AESTDTC from character ISO8601 format to numeric datetime formatAENDTAnalysis End DateintegerCond

Created from converting AE.AEENDTC from character ISO8601 format to numeric date format

AENDTMAnalysis End Date/TimeintegerCondCreated from converting AE.AEENDTC from character ISO8601 format to numeric datetime formatASTDYAnalysis Start Relative DayintegerCondASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDTAENDYAnalysis End Relative DayintegerCondAENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT
PREFLPre-treatment FlagtextYCondIf ASTDT < ADSL.TRTSDT then PREFL=’Y’
TRTEMFLTreatment Emergent Analysis FlagtextYCondIf ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’
FUPFLFollow-up FlagtextYCond
AETRTEMTreatment Emergent Flagtext(NY)PermSUPPAE.QVAL where QNAM=’AETRTEM’.
AOCCFL1st Occurrence within Subject FlagtextYPermSort the data in the required order and flag the first treatment emergent record for each subject.
AOCCPFL1st Occurrence of Preferred Term FlagtextYPermSort the data in the required order and flag the first treatment emergent record for each AEDECOD for each subject.
AOCCSFL1st Occurrence of SOC FlagtextYPerm Sort the data in the required order and flag the first treatment emergent record for each body system for each subject.
AESERSerious Eventtext(NY)ReqAE.AESER
AERELCausalitytextPermAE.AERELRELGR1Pooled Causality Group ytextPermset to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT)
AEACNAction Taken with Study Treatmenttext(ACN)PermAE.AEACN
TRTPPlanned TreatmenttextCondADSL.TRT01PTRTAActual TreatmenttextCondADSL.TRT01ASAFFLSafety Population FlagtextCondADSL.SAFFLTRTSDTDate of First Exposure to TreatmentintegerPermADSL.TRTSDTTRTEDTDate of Last Exposure to TreatmentintegerPermADSL.TRTEDTAETERMReported Term for the Adverse EventtextReqAE.AETERMAEBODSYSBody System or Organ ClasstextReqAE.AEBODSYSAEDECODDictionary-Derived TermtextReqAE.AEDECODAEOUTOutcome of Adverse EventtextPermAE.AEOUTAESEQSequence NumberintegerPermAE.AESEQAESTDTCStart Date/Time of
Adverse Event

text

PermAE.AESTDTCAEENDTCEnd Date/Time of
Adverse Event		textPermAE.AEENDTCAESTDYStudy Day of Start of
Adverse Event		textPermAE.AESTDYAEENDYStudy Day of End of
Adverse Event		textPermAE.AEENDYAEENRFEnd Relative to
Reference Period		textPerm

Include Page
ADaM Example.ADAE Adverse Events
ADaM Example.ADAE Adverse Events

Pagenav