| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | | USUBJID | AETERM | AEMODIFY | AEDECOD | AEBODSYS | ASTDT | AENDT | ASTDY | AENDY | PREFL | TRTEMFL | FUPFL | AETRTEM | AOCCFL | AOCCPFL | AOCCSFL | AESER | AEREL | AERLDEV | RELGR1 | AESEV | AEACN | AEACNDEV | AEOUT | TRTA | SAFFL | TRTSDT | TRTEDT | AESEQ | AESTDTC | AEENDTC | AESTDY | AEENDY | AEENRF |
|---|
| 1 | A123 | A2001 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | 21JAN2021 | 21JAN2021 | 14 | 14 |
| Y |
|
|
|
|
| N | DEFINITELY NOT RELATED |
| NOT RELATED | SEVERE | DOSE NOT CHANGED |
| RECOVERED/RESOLVED | Placebo | Y | 08JAN2021 | 28JAN2021 | 1 | 2021-01-21 | 2021-01-21 | 14 | 14 |
| | 2 | A123 | A2008 | SKIN REDNESS | SKIN REDNESS | Skin Redness |
| 16FEB2021 | 21FEB2021 | 9 | 14 |
| Y |
| Y | Y | Y | Y | N | PROBABLY RELATED | RELATED | RELATED | MODERATE | DOSE NOT CHANGED | DEVICE REPLACED | RECOVERED/RESOLVED | Placebo | Y | 08FEB2021 | 01MAR2021 | 2 | 2021-02-16 | 2021-02-21 | 9 | 14 |
| | 3 | A123 | A3009 | INFLUENZA | INFLUENZA | Influenza | Infections and infestations | 21JUN2021 | 26JUN2021 | 13 | 18 |
| Y | Y | Y |
| Y | Y | Y | PROBABLY NOT RELATED |
| NOT RELATED | SEVERE | TRIAL INTERVENTION DISCONTINUED |
| RECOVERING/RESOLVING | Placebo | Y | 09JUN2021 | 21JUN2021 | 3 | 2021-06-21 | 2021-06-26 | 13 | 18 |
|
|
|
| Definexmltable |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
| Name | ADAE |
|---|
|
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|
| ADAE | Adverse Events Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per adverse event | Analysis | STUDYID, USUBJID, AEBODSYS, AEDECOD, AETERM | ADAE.xpt | ADAE.SAS/SAP | |
| Definexmltable |
|---|
| Dataset | ADAE |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| OID | ADAE |
|---|
| Name | ADAE |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| Study Identifier | text |
| Req | AE.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Req | AE.USUBJID |
|
...
Created from converting AE.AESTDTC from character ISO8601 format to numeric date format,
...
| AETERM | Reported Term for the Adverse Experience | text |
| Req | AE.AETERM | | AEMODIFY | Modified Reported Term | text |
| Perm | AE.MODIFY | | AEBODSYS | Body System or Organ Class | text |
| Req | AE.AEBODSYS | | AEDECOD | Dictionary-Derived Term | text |
| Req | AE.AEDECOD | | ASTDT | Analysis Start |
|
...
| Date | integer |
| Cond | Created from converting |
|
...
...
AESTDTC from character ISO8601 format to numeric date format |
|
...
...
...
| integer |
| Cond | Created from converting |
|
...
...
AEENDTC from character ISO8601 format to numeric |
|
...
date format | | ASTDY | Analysis Start Relative Day | integer |
| Cond |
|
...
| ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT |
|
...
...
| AENDY | Analysis End Relative Day | integer |
| Cond |
|
...
| AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT |
|
...
...
| product Flag | text | Y | Cond | If ASTDT < ADSL.TRTSDT then PREFL=’Y’ | | TRTEMFL |
|
...
Product | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-787 |
|---|
|
Emergent Analysis Flag | text | Y | Cond | If ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’ | | FUPFL | Follow-up Flag | text | Y | Cond | If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
| | AETRTEM |
|
...
| Product Emergent Flag | text | (NY) | Perm | SUPPAE.QVAL where QNAM=’AETRTEM’. | | AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | Sort the data in the required order and flag the first |
|
...
| product emergent record for each subject. | | AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | Sort the data in the required order and flag the first |
|
...
| product emergent record for each AEDECOD for each subject. | | AOCCSFL | 1st Occurrence of SOC Flag | text | Y | Perm | Sort the data in the required order and flag the first |
|
...
| product emergent record for each body system for each subject. | | AESER | |
|
...
Experience | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-788 |
|---|
|
| text | (NY) | Req | AE.AESER | | AEREL | Causality | text |
| Perm | AE.AEREL | | AERLDEV | Relationship of Event to Device | text | * | Perm | AE.AERLDEV | | RELGR1 | Pooled Causality Group y | text |
| Perm |
|
...
| set to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT) | | AEACN | Action Taken with Study |
|
...
...
...
| AEACNDEV | Action Taken with Device | text |
| Perm | AE.AEACNDEV |
|---|
| AEOUT | Outcome of Adverse Experience | text |
|---|
|
...
| (OUT) | Perm | AE.AEOUT |
|---|
| TRTA | Actual |
|
...
| Product | text |
| Cond | ADSL.TRT01A | | SAFFL | Safety Population Flag | text |
| Cond | ADSL.SAFFL | | TRTSDT | Date of First Exposure to |
|
...
| Product | integer |
| Perm | ADSL.TRTSDT | | TRTEDT | Date of Last Exposure to |
|
...
| Product | integer |
| Perm | ADSL.TRTEDT |
|
...
...
...
| experience | text |
| Perm | AE.AEOUT | | AESEQ | Sequence Number | integer |
| Perm | AE.AESEQ | | AESTDTC | Start Date/Time of
Adverse |
|
...
| Experience | text |
| Perm | AE.AESTDTC | | AEENDTC | End Date/Time of
Adverse |
|
...
| Experience | text |
| Perm | AE.AEENDTC | | AESTDY | Study Day of Start of
Adverse |
|
...
| text |
| Perm | AE.AESTDY | | AEENDY | Study Day of End of
Adverse |
|
...
| Experience | text |
| Perm | AE.AEENDY | | AEENRF | End Relative to
Reference Period | text |
| Perm | AE.AEENRF |
|
...
...