Summary
This article covers the adverse events dataset.
Table of Contents
Mapping
| Form Type Id | Question Id | Instruction | Value | Column Number | Column Title | Data Type |
|---|---|---|---|---|---|---|
| ae,AE | macro | STUDYID | 0 | STUDYID | String | |
| const | AE | 1 | DOMAIN | String | ||
| macro | USUBJID | 2 | USUBJID | String | ||
| macro | SUBJID | 3 | SUBJID | String | ||
| nextSequenceID | STUDYID,DOMAIN,USUBJID | 4 | AESEQ | Integer | ||
| 5 | AEGRPID | String | ||||
| 6 | AEREFID | String | ||||
| formUniqueID | 7 | AESPID | String | |||
| aeterm | uppercase | 8 | AETERM | String | ||
| 9 | AEMODIFY | String | ||||
| aeterm $> | codeTerm $>uppercase | PT $> | 10 | AEDECOD | String | |
| 11 | AECAT | String | ||||
| 12 | AESCAT | String | ||||
| 13 | AEPRESP | String | ||||
| aeterm $> | codeTerm $>uppercase | SOC $> | 14 | AEBODSYS | String | |
| 15 | AELOC | String | ||||
| aesev | paramListLookup | aesevSDTM | 16 | AESEV | String | |
| aeser | paramListLookup | nySDTM | 17 | AESER | String | |
| aeacn | paramListLookup | acnSDTM | 18 | AEACN | String | |
| aeacnoth | uppercase | 19 | AEACNOTH | String | ||
| aerel | paramListLookup | aerelEx | 20 | AEREL | String | |
| 21 | AERELNST | String | ||||
| 22 | AEPATT | String | ||||
| aeout | paramListLookup | outSDTM | 23 | AEOUT | String | |
| 24 | AESCAN | String | ||||
| aescong | paramListLookup | nySDTM | 25 | AESCONG | String | |
| aesdisab | paramListLookup | nySDTM | 26 | AESDISAB | String | |
| aesdth | paramListLookup | nySDTM | 27 | AESDTH | String | |
| aeshosp | if $>then $>else $>fi | aeacnoth CONTAINS 3 $>Y $>N | 19 | AESHOSP | String | |
| aeslife | paramListLookup | nySDTM | 29 | AESLIFE | String | |
| 30 | AESOD | String | ||||
| aesmie | paramListLookup | nySDTM | 31 | AESMIE | String | |
| 32 | AECONTRT | String | ||||
| aetoxgr | paramListLookup | aetoxgrEx | 33 | AETOXGR | String | |
| const $>setVar $>const $>setVar $>toISO8601 | aestdat $>dateVar $>aesttim $>timeVar $>dateVar,timeVar | 34 | AESTDTC | String | ||
| const $>setVar $>const $>setVar $>toISO8601 | aeendat $>dateVar $>aeentim $>timeVar $>dateVar,timeVar | 35 | AEENDTC | String | ||
| aestdat | studyDay | 36 | AESTDY | Integer | ||
| aeendat | studyDay | 37 | AEENDY | Integer | ||
| 38 | AEDUR | String | ||||
| aeout $> $> $>aeendat | setVarQst $>const $>setVar $>observationRelativeToReferencePeriod | ongoingQst $>0 $>ongoingYes $> | 39 | AEENRF | String | |
| 40 | AEENRTPT | String | ||||
| 41 | AEENTPT | String |
Summary of Questions
| questionTypeId | Question Text | Data Type | Answer Options / Default Value |
|---|---|---|---|
| aeyn | Were any Adverse Events experienced? | Integer | 1||Yes::2||No |
| aespid | Adverse Event Number: | Integer | sequenceNumber |
| aeterm | Adverse Event: | String | |
| aestdat | Start Date (dd-MMM-yyyy): | Date | |
| aesttim | Start Time (HH:mm): | Date | |
| aeendat | End Date (dd-MMM-yyyy): | Date | |
| aeentim | End Time (HH:mm): | Date | |
| aeongo | Ongoing? | Integer | 1||Yes::2||No |
| aesev | Severity: | Integer | 1||Mild::2||Moderate::3||Severe |
| aetoxgr | Severity CTCAE Grade: | Integer | 1||Mild::2||Moderate::3||Severe::4||Life Threatening::5||Fatal |
| aeser | Serious Event? | Integer | 1||Yes::2||No |
| aescong | Serious Event Type – Congenital Anomaly or Birth Defect? | Integer | 1||Yes::2||No |
| aesdisab | Serious Event Type – Persistent or Significant Disability or Incapacity? | Integer | 1||Yes::2||No |
| aesdth | Serious Event Type – Death? | Integer | 1||Yes::2||No |
| aeshosp | Serious Event Type – Initial or Prolonged Hospitalization? | Integer | 1||Yes::2||No |
| aeslife | Serious Event Type – Life Threatening? | Integer | 1||Yes::2||No |
| aesmie | Serious Event Type – Other Serious or Important Medical Events? | Integer | 1||Yes::2||No |
| aerel | Relationship to Study Treatment: | Integer | 1||Not Related::2||Unlikely Related::3||Possibly Related::4||Related |
| aeacn | Action Taken with Study Treatment: | Integer | 1||Dose Increased::2||Dose Not Changed::3||Dose Reduced::4||Drug Interrupted::5||Drug Withdrawn::78||Not Applicable::98||Unknown |
| aeacnoth | Other Action Taken: | String | |
| aeout | Outcome: | Integer | 1||Fatal::2||Not Recovered/Not Resolved::3||Recovered/Resolved::4||Recovered/Resolved With Sequelae::5||Recovering/Resolving::98||Unknown |
| aedis | Adverse Event that Caused Study Discontinuation? | Integer | 1||Yes::2||No |
paramListLookup Formats
| Name | Value |
|---|---|
| nySDTM | 2||N::78||NA::98||U::1||Y |
| aesevSDTM | 1||MILD::2||MODERATE::3||SEVERE |
| aetoxgrEx | 1||MILD::2||MODERATE::3||SEVERE::4||LIFE threatening::5||FATAL |
| aerelEx | 1||NOT RELATED::2||UNLIKELY RELATED::3||POSSIBLY RELATED::4||RELATED |
| acnSDTM | 1||DOSE INCREASED::2||DOSE NOT CHANGED::3||DOSE REDUCED::4||DRUG INTERRUPTED::5||DRUG WITHDRAWN::78||NOT APPLICABLE::98||UNKNOWN |
| outSDTM | 1||FATAL::2||NOT RECOVERED/NOT RESOLVED::3||RECOVERED/RESOLVED::4||RECOVERED/RESOLVED WITH SEQUELAE::5||RECOVERING/RESOLVING::98||UNKNOWN |
Downloadable Link
To download an example Excel File of this export click on the attachment at the bottom of the page.
Summary of AE
The Adverse Events dataset includes clinical data describing “any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment” (ICH E2A). In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pre-treatment events related to trial conduct, not collecting events that are assessed as efficacy endpoints). The events included in the AE dataset should be consistent with the protocol requirements. Adverse events may be captured either as free text or via a pre-specified list of terms.
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