pharmaverseadam.adae

Adverse Events Analysis

pharmaverseadam.adae: Final[DataFrame]

1191 rows x 107 columns. Structure: One record per subject per adverse event.

Variables:

• STUDYID (String): Study Identifier
• USUBJID (String): Unique Subject Identifier
• SUBJID (String): Subject Identifier for the Study
• SITEID (String): Study Site Identifier
• COUNTRY (String): Country
• DOMAIN (String): Domain Abbreviation
• RFSTDTC (String): Subject Reference Start Date/Time
• RFENDTC (String): Subject Reference End Date/Time
• RFXSTDTC (String): Date/Time of First Study Treatment
• RFXENDTC (String): Date/Time of Last Study Treatment
• RFPENDTC (String): Date/Time of End of Participation
• SCRFDT (Date): Screen Failure Date
• FRVDT (Date): Final Retrieval Visit Date
• DTHDTC (String): Date/Time of Death
• DTHADY (Float64): Relative Day of Death
• DTHFL (String): Subject Death Flag
• LDDTHELD (Float64): Elapsed Days from Last Dose to Death
• LDDTHGR1 (String): Last Dose to Death - Days Elapsed Grp 1
• DTH30FL (String): Death Within 30 Days of Last Trt Flag
• DTHA30FL (String): Death After 30 Days from Last Trt Flag
• DTHDOM (String): Domain for Date of Death Collection
• DTHB30FL (String): Death Within 30 Days of First Trt Flag
• REGION1 (String): Geographic Region 1
• DMDTC (String): Date/Time of Collection
• DMDY (Float64): Study Day of Collection
• AGE (Float64): Age
• AGEU (String): Age Units
• AGEGR1 (String): Pooled Age Group 1
• SEX (String): Sex
• RACE (String): Race
• RACEGR1 (String): Pooled Race Group 1
• ETHNIC (String): Ethnicity
• SAFFL (String): Safety Population Flag
• ARM (String): Description of Planned Arm
• ARMCD (String): Planned Arm Code
• ACTARM (String): Description of Actual Arm
• ACTARMCD (String): Actual Arm Code
• TRT01P (String): Planned Treatment for Period 01
• TRT01A (String): Actual Treatment for Period 01
• TRTSDT (Date): Date of First Exposure to Treatment
• TRTSDTM (Datetime): Datetime of First Exposure to Treatment
• TRTSTMF (String): Time of First Exposure Imput. Flag
• TRTEDT (Date): Date of Last Exposure to Treatment
• TRTEDTM (Datetime): Datetime of Last Exposure to Treatment
• TRTETMF (String): Time of Last Exposure Imput. Flag
• EOSSTT (String): End of Study Status
• EOSDT (Date): End of Study Date
• RFICDTC (String): Date/Time of Informed Consent
• RANDDT (Date): Date of Randomization
• LSTALVDT (Date): Date Last Known Alive
• TRTDURD (Float64): Total Treatment Duration (Days)
• DTHDT (Date): Date of Death
• DTHDTF (String): Date of Death Imputation Flag
• DTHCAUS (String): Cause of Death
• DTHCGR1 (String): Cause of Death Reason 1
• AESEQ (Float64): Sequence Number
• AETERM (String): Reported Term for the Adverse Event
• AEDECOD (String): Dictionary-Derived Term
• AEBODSYS (String): Body System or Organ Class
• AEBDSYCD (Float64): Body System or Organ Class Code
• AELLT (String): Lowest Level Term
• AELLTCD (Float64): Lowest Level Term Code
• 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
• AESOC (String): Primary System Organ Class
• AESOCCD (Float64): Primary System Organ Class Code
• AESTDTC (String): Start Date/Time of Adverse Event
• ASTDT (Date): Analysis Start Date
• ASTDTM (Datetime): Analysis Start Date/Time
• ASTDTF (String): Analysis Start Date Imputation Flag
• ASTTMF (String): Analysis Start Time Imputation Flag
• AEENDTC (String): End Date/Time of Adverse Event
• AENDT (Date): Analysis End Date
• AENDTM (Datetime): Analysis End Date/Time
• AENDTF (String): Analysis End Date Imputation Flag
• AENTMF (String): Analysis End Time Imputation Flag
• ASTDY (Float64): Analysis Start Relative Day
• AESTDY (Float64): Study Day of Start of Adverse Event
• AENDY (Float64): Analysis End Relative Day
• AEENDY (Float64): Study Day of End of Adverse Event
• ADURN (Float64): Analysis Duration (N)
• ADURU (String): Analysis Duration Units
• TRTEMFL (String): Treatment Emergent Analysis Flag
• AOCCIFL (String): 1st Max Sev./Int. Occurrence Flag
• AESER (String): Serious Event
• AESDTH (String): Results in Death
• AESLIFE (String): Is Life Threatening
• AESHOSP (String): Requires or Prolongs Hospitalization
• AESDISAB (String): Persist or Signif Disability/Incapacity
• AESCONG (String): Congenital Anomaly or Birth Defect
• AESEV (String): Severity/Intensity
• ASEV (String): Analysis Severity/Intensity
• ASEVN (Int32): Analysis Severity/Intensity (N)
• AEREL (String): Causality
• AREL (String): Analysis Causality
• AEACN (String): Action Taken with Study Treatment
• AESPID (String): Sponsor-Defined Identifier
• AEOUT (String): Outcome of Adverse Event
• AESCAN (String): Involves Cancer
• AESOD (String): Occurred with Overdose
• AEDTC (String): Date/Time of Collection
• LDOSEDTM (Datetime): End Date/Time of Last Dose
• DOSEON (Float64): Treatment Dose
• DOSEU (String): Treatment Dose Unit