cdiscpilotadam.adae

Adverse Events Analysis Dataset

cdiscpilotadam.adae: Final[DataFrame]

1191 rows x 55 columns. Structure: one record per subject per adverse event.

Variables:

  • STUDYID (String): Study Identifier
  • SITEID (String): Study Site Identifier
  • USUBJID (String): Unique Subject Identifier
  • TRTA (String): Actual Treatment
  • TRTAN (Float64): Actual Treatment (N)
  • AGE (Float64): Age
  • AGEGR1 (String): Pooled Age Group 1
  • AGEGR1N (Float64): Pooled Age Group 1 (N)
  • RACE (String): Race
  • RACEN (Float64): Race (N)
  • SEX (String): Sex
  • SAFFL (String): Safety Population Flag
  • TRTSDT (Date): Date of First Exposure to Treatment
  • TRTEDT (Date): Date of Last Exposure to Treatment
  • ASTDT (Date): Analysis Start Date
  • ASTDTF (String): Analysis Start Date Imputation Flag
  • ASTDY (Float64): Analysis Start Relative Day
  • AENDT (Date): Analysis End Date
  • AENDY (Float64): Analysis End Relative Day
  • ADURN (Float64): AE Duration (N)
  • ADURU (String): AE Duration Units
  • AETERM (String): Reported Term for the Adverse Event
  • AELLT (String): Lowest Level Term
  • AELLTCD (Float64): Lowest Level Term Code
  • AEDECOD (String): Dictionary-Derived Term
  • AEPTCD (Float64): Preferred Term Code
  • AEHLT (String): High Level Term
  • AEHLTCD (Float64): High Level Term Code
  • AEHLGT (String): High Level Group Term
  • AEHLGTCD (Float64): High Level Group Term Code
  • AEBODSYS (String): Body System or Organ Class
  • AESOC (String): Primary System Organ Class
  • AESOCCD (Float64): Primary System Organ Class Code
  • AESEV (String): Severity/Intensity
  • AESER (String): Serious Event
  • AESCAN (String): Involves Cancer
  • AESCONG (String): Congenital Anomaly or Birth Defect
  • AESDISAB (String): Persist or Signif Disability/Incapacity
  • AESDTH (String): Results in Death
  • AESHOSP (String): Requires or Prolongs Hospitalization
  • AESLIFE (String): Is Life Threatening
  • AESOD (String): Occurred with Overdose
  • AEREL (String): Causality
  • AEACN (String): Action Taken with Study Treatment
  • AEOUT (String): Outcome of Adverse Event
  • AESEQ (Float64): Sequence Number
  • TRTEMFL (String): Treatment Emergent Analysis Flag
  • AOCCFL (String): 1st Occurrence of Any AE Flag
  • AOCCSFL (String): 1st Occurrence of SOC Flag
  • AOCCPFL (String): 1st Occurrence of Preferred Term Flag
  • AOCC02FL (String): 1st Occurrence 02 Flag for Serious
  • AOCC03FL (String): 1st Occurrence 03 Flag for Serious SOC
  • AOCC04FL (String): 1st Occurrence 04 Flag for Serious PT
  • CQ01NAM (String): Customized Query 01 Name
  • AOCC01FL (String): 1st Occurrence 01 Flag for CQ01