myCSG © |Area: ADaM| Concept: ADAE : Full ADAE - Adverse Events Analysis Dataset | Lesson: L1101 : ADAE dataset for a parallel arm study - statschoice-001 |
Creation of Adverse Events Analysis dataset covering:
Treatment emergent flag
Start date imputation
End date imputation
Pre and follow-up flags
Three occurrence flags
| VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT |
|---|---|---|---|
| STUDYID | Study Identifier | _ | AE.STUDYID |
| USUBJID | Unique Subject Identifier | _ | AE.USUBJID |
| AESEQ | Sequence Number | _ | AE.AESEQ |
| AETERM | Reported Term for the Adverse Event | _ | AE.AETERM |
| AEDECOD | Dictionary-Derived Term | _ | AE.AEDECOD |
| AEBODSYS | Body System or Organ Class | _ | AE.AEBODSYS |
| TRTEMFL | Treatment Emergent Analysis Flag | _ | If ADSL.TRTSDT <= ASTDT<=(ADSL.TRTEDT +14) then TRTEMFL="Y" |
| PREFL | Pre-treatment Flag | _ | If ASTDT < ADSL.TRTSDT then PREFL="Y" |
| FUPFL | Follow-up Flag | _ | If ASTDT > ADSL.TRTEDT+14 then FUPFL="Y" |
| AESTDTC | Start Date/Time of Adverse Event | _ | AE.AESTDTC |
| ASTDT | Analysis Start Date | _ | Populate using AE.AESTDTC. When AESTDTC is full, convert it to numeric format. When only day component is missing use first day of the month When month component is missing use "January" When full date is missing, use treatment start date (ADSL.TRTSDT) |
| ASTDTF | Analysis Start Date Imputation Flag | _ | If start date is completely missing or missing the year then ASTDTF="Y" Else if start date has month missing then ASTDTF="M" Else if start date has day missing then ASTDTF="D" |
| ASTDY | Analysis Start Relative Day | _ | If ASTDT>=TRTSDT, populate as ASTDT-TRTSDT+1. Else if ASTDT < TRTSDT, populate as ASTDT-TRTSDT. |
| AEENDTC | End Date/Time of Adverse Event | _ | AE.AEENDTC |
| AENDT | Analysis End Date | _ | Populate using AE.AEENDTC. When AEENDTC is full, convert it to numeric format. When only day component is missing use last day of the month When month component is missing and if the year is same as treatment end date, then use the treatment end date (ADSL.TRTEDT). Else if it is a different year, use 31st December of that year. When full date is missing, use treatment end date (ADSL.TRTEDT). |
| AENDTF | Analysis End Date Imputation Flag | _ | If end date is completely missing or missing the year then AENDTF="Y". Else if end date has month missing then AENDTF="M" Else if end date has day missing then AENDTF="D" |
| AENDY | Analysis End Relative Day | _ | If AENDT>=TRTSDT, populate as AENDT-TRTSDT+1. Else if AENDT |
| AESER | Serious Event | _ | AE.AESER |
| APHASE | Phase | _ | If ASTDT LT ADSL.TRTSDT, then APHASE="PRE-TREATMENT" Else if ASTDT GT ADSL.TRTEDT + 14 days then APHASE="FOLLOW-UP", Else APHASE="TREATMENT" |
| AESEV | Severity/Intensity | _ | AE.AESEV |
| ASEV | Analysis Severity/Intensity | _ | If AE.AESEV="MILD" then ASEV="Mild" Else if AE.AESEV="MODERATE" then ASEV="Moderate" Else if AE.AESEV is equal to "SEVERE" or Severity/Intensity is missing then ASEV="Severe" |
| ASEVN | Analysis Severity/Intensity (N) | _ | Map ASEV to ASEVN in the following manner: "Mild" = 1, "Moderate" = 2, "Severe" = 3 |
| AEREL | Causality | _ | AE.AEREL |
| RELGR1 | Pooled Causality Group 1 | _ | If AE.AEREL is equal to "NOT RELATED" or "UNLIKELY RELATED" then RELGR1="Not Related" Else if AE.AEREL is equal to "POSSIBLY RELATED" or "PROBABLY RELATED" or "DEFINITELY RELATED" or Causality is missing then RELGR1="Related" |
| RELGR1N | Pooled Causality Group 1 (N) | _ | Map RELGR1 to RELGR1N in the following manner: "Not Related" = 0, "Related" = 1 |
| SAFFL | Safety Population Flag | _ | ADSL.SAFFL |
| AOCCFL | 1st Occurrence within Subject Flag | _ | Subset ADAE to Treatment Emergent Adverse Events (TRTEMFL="Y") Sort by Subject (USUBJID), Analysis Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL="Y") within each Subject |
| AOCCSFL | 1st Occurrence of SOC Flag | _ | Subset ADAE to Treatment Emergent Adverse Events (TRTEMFL="Y") Sort by Subject (USUBJID), System Organ Class (AEBODSYS), Analysis Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL ="Y") within each Subject and SOC |
| AOCCPFL | 1st Occurrence of Preferred Term Flag | _ | Subset ADAE to Treatment Emergent Adverse Events (TRTEMFL="Y") Sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD) Analysis Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL ="Y") within each Subject, SOC, and PT |
| TRTA | Actual Treatment | _ | ADSL.TRT01A |
| TRTAN | Actual Treatment (N) | _ | ADSL.TRT01AN Drug A = 1, Drug B = 2 |
| TRTSDT | Date of First Exposure to Treatment | _ | ADSL.TRTSDT |
| TRTEDT | Date of Last Exposure to Treatment | _ | ADSL.TRTEDT |
| AGE | Age | _ | ADSL.AGE |
| AGEGR1 | Pooled Age Group 1 | _ | ADSL. AGEGR1 |
| SEX | Sex | _ | ADSL.SEX |
| RACE | Race | _ | ADSL.RACE |
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