Versions Compared

Key

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

...

Dataset wrap
Rowcaps
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).
Dataset2
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SEVEREYDRUG WITHDRAWN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