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Outstanding Issues 

  • The standard SDTM uses the term study treatment for several variables ( AEREL, AEACN. Should this be changes to study product (or another term).  
  • Needs correct reference   More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables. 

AEs were coded using MedDRA, and the sponsor’s procedures include the possibility of modifying the reported term to aid in coding. The CRF was structured so that seriousness category variables (e.g., AESDTH, AESHOSP) were checked only when AESER is answered “Y.” In this study, the study reference period started at the start of product exposure. Three AEs were reported for this subject. This SDTM dataset used AEENRF to represent Ongoing events. More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables. The expected variables (e,g,, AELLT, AELLTCD, AEPT, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLCTCD, AEBDSYCD, AESOC, AESOCCD) were not included to save space.  

The sponsor also collected information about whether the event was associated with a Device. These  subject's did not have any device related issues. See Tobacco Product Issues and Events for an example of device related events.  

Rows 1-2:

Show examples of modifying the reported term for coding purposes, with the modified term in AEMODIFY. These adverse events were not serious, so the seriousness criteria variables are null. Note that for the event in row 2, AESTDY = "1". Day 1 was the day treatment started; the AE start and end times, as well as dates, were collected to allow comparison of the AE timing to the start of treatment.


Row 3:Shows an example of the overall seriousness question AESER answered with "Y" and the relevant corresponding seriousness category variables (AESHOSP and AESLIFE) answered "Y". The other seriousness category variables are left blank. This row also shows AEENRF being populated because the AE was marked as “Continuing” as of the end of the study reference period for the subject (see Section 4.4.7, Relative Timing Variables).

ae.xpt

xx.xpt

RowSTUDYIDDOMAINSPDEVIDUSUBJIDAESEQAETERMAEMODIFYAEDECODAEBODSYSAESEVAESERAEACNAEACNDEVAERELAERLDEVAEOUTAESCONGAESDISABAESDTHAESHOSPAESLIFEAESMIEAECONTRTEPOCHAESTDTCAEENDTCAESTDYAEENDYAEENRF
1ABC123AE
ABC123-00011POUNDING HEADACHEHEADACHEHeadacheNervous system disordersSEVERENNOT APPLICABLE
DEFINITELY NOT RELATED
RECOVERED/RESOLVED





YPRODUCT EXPOSURE2006-10-142006-10-18xxxx
2ABC123AE
ABC123-00012BACK PAIN FOR 6 HOURSBACK PAINBack painMusculoskeletal and connective tissue disordersMODERATENDOSE REDUCED
PROBABLY RELATED
RECOVERED/RESOLVED






PRODUCT EXPOSURE2006-10-13T13:052006-10-13T19:00xxx
3ABC123AE
ABC123-00021INFLUENZA InfluenzaInfluenzaInfections and
infestations		SEVEREYDRUG WITHDRAWN
PROBABLY NOT RELATED
RECOVERING/RESOLVING


YY
YPRODUCT EXPOSURE2006-02-26
xx
AFTER

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