adae {pharmaverseadam}

Adverse Events Analysis

Description

An example of ADAE ADaM dataset

Usage

adae

Format

A data frame with 101 columns:

STUDYID

Study Identifier

DOMAIN

Domain Abbreviation

USUBJID

Unique Subject Identifier

AESEQ

Sequence Number

AESPID

Sponsor-Defined Identifier

AETERM

Reported Term for the Adverse Event

AELLT

Lowest Level Term

AELLTCD

Lowest Level Term Code

AEDECOD

Dictionary-Derived Term

AEPTCD

Preferred Term Code

AEHLT

High Level Term

AEHLTCD

High Level Term Code

AEHLGT

High Level Group Term

AEHLGTCD

High Level Group Term Code

AEBODSYS

Body System or Organ Class

AEBDSYCD

Body System or Organ Class Code

AESOC

Primary System Organ Class

AESOCCD

Primary System Organ Class Code

AESEV

Severity/Intensity

AESER

Serious Event

AEACN

Action Taken with Study Treatment

AEREL

Causality

AEOUT

Outcome of Adverse Event

AESCAN

Involves Cancer

AESCONG

Congenital Anomaly or Birth Defect

AESDISAB

Persist or Signif Disability/Incapacity

AESDTH

Results in Death

AESHOSP

Requires or Prolongs Hospitalization

AESLIFE

Is Life Threatening

AESOD

Occurred with Overdose

AEDTC

Date/Time of Collection

AESTDTC

Start Date/Time of Adverse Event

AEENDTC

End Date/Time of Adverse Event

AESTDY

Study Day of Start of Adverse Event

AEENDY

Study Day of End of Adverse Event

TRTSDT

Date of First Exposure to Treatment

TRTEDT

Date of Last Exposure to Treatment

DTHDT

Date of Death

EOSDT

End of Study Date

ASTDTM

Analysis Start Date/Time

ASTDTF

Analysis Start Date Imputation Flag

ASTTMF

Analysis Start Time Imputation Flag

AENDTM

Analysis End Date/Time

AENDTF

Analysis End Date Imputation Flag

AENTMF

Analysis End Time Imputation Flag

ASTDT

Analysis Start Date

AENDT

Analysis End Date

ASTDY

Analysis Start Relative Day

AENDY

Analysis End Relative Day

ADURN

Analysis Duration (N)

ADURU

Analysis Duration Units

LDOSEDTM

End Date/Time of Last Dose

ASEV

Analysis Severity/Intensity

AREL

Analysis Causality

TRTEMFL

Treatment Emergent Analysis Flag

ASEVN

Analysis Severity/Intensity (N)

AOCCIFL

1st Max Sev./Int. Occurrence Flag

SUBJID

Subject Identifier for the Study

RFSTDTC

Subject Reference Start Date/Time

RFENDTC

Subject Reference End Date/Time

RFXSTDTC

Date/Time of First Study Treatment

RFXENDTC

Date/Time of Last Study Treatment

RFICDTC

Date/Time of Informed Consent

RFPENDTC

Date/Time of End of Participation

DTHDTC

Date/Time of Death

DTHFL

Subject Death Flag

SITEID

Study Site Identifier

AGE

Age

AGEU

Age Units

SEX

Sex

RACE

Race

ETHNIC

Ethnicity

ARMCD

Planned Arm Code

ARM

Description of Planned Arm

ACTARMCD

Actual Arm Code

ACTARM

Description of Actual Arm

COUNTRY

Country

DMDTC

Date/Time of Collection

DMDY

Study Day of Collection

TRT01P

Planned Treatment for Period 01

TRT01A

Actual Treatment for Period 01

TRTSDTM

Datetime of First Exposure to Treatment

TRTSTMF

Time of First Exposure Imput. Flag

TRTEDTM

Datetime of Last Exposure to Treatment

TRTETMF

Time of Last Exposure Imput. Flag

TRTDURD

Total Treatment Duration (Days)

SCRFDT

Screen Failure Date

EOSSTT

End of Study Status

FRVDT

Final Retrievel Visit Date

RANDDT

Date of Randomization

DTHADY

Relative Day of Death

LDDTHELD

Elapsed Days from Last Dose to Death

LSTALVDT

Date Last Known Alive

AGEGR1

Pooled Age Group 1

SAFFL

Safety Population Flag

RACEGR1

Pooled Race Group 1

REGION1

Geographic Region 1

LDDTHGR1

Last Dose to Death - Days Elapsed Grp 1

DTH30FL

Death Within 30 Days of Last Trt Flag

DTHA30FL

Death After 30 Days from Last Trt Flag

DTHB30FL

Death Within 30 Days of First Trt Flag

Source

Generated from admiral package (template ad_adae.R).

References

None

Examples

data("adae")