Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
--SER | Serious Event | Char | (NY) | Perm | XX.–SER AESER is equired for adverse event data. |
--SEV | Severity/Intensity | Char | (AESEV) or (SEVRS) | Perm | XX.--SEV For SubClass ADVERSE EVENT, conditional on whether the --SEV variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in SDTM. |
--SEVN | Severity/Intensity (N) | Num | 1, 2, 3 | Perm | Code XX.--SEV to numeric Low intensity should correspond to low value |
ASEV | Analysis Severity/Intensity | Char |
| Perm | Apply imputation rules for missing severity of adverse events as specified in the SAP or metadata. May change case of text, such as from all uppercase in --SEV to mixed case in ASEV. |
ASEVN | Analysis Severity/Intensity (N) | Num | 1, 2, 3 | Perm | Code ASEV to numeric Low intensity should correspond to low value |
SEVGRy | Pooled Severity Group y | Char |
| Perm | Pooled grouping of AE severity for analysis (e.g., mild/moderate, severe) |
SEVGRyN | Pooled Severity Group y (N) | Num |
| Perm | Code SEVGRy to numeric Low intensity should correspond to low value |
--REL | Causality | Char |
| Perm | XX.--REL |
--RELN | Causality (N) | Num |
| Perm | Code XX.--REL to numeric Low relation should correspond to low value |
AREL | Analysis Causality | Char |
| Perm | Apply imputation rules for missing causality of study drug as specified in the SAP or metadata. May change case of text, such as from all uppercase in --REL to mixed case in AREL. |
ARELN | Analysis Causality (N) | Num |
| Perm | Code AREL to numeric |
RELGRy | Pooled Causality Group y | Char |
| Perm | Pooled grouping of causality of study drug for analysis (e.g. related, not related) |
RELGRyN | Pooled Causality Group y (N) | Num |
| Perm | Code of RELGRy to numeric Low relation should correspond to low value |
--TOXGR | Standard Toxicity Grade | Char |
| Perm | XX.--TOXGR For SubClass ADVERSE EVENT, conditional on whether the --TOXGR variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in SDTM. |
--TOXGRN | Standard Toxicity Grade (N) | Num |
| Perm | Code --TOXGR to numeric Low toxicity should correspond to low value |
ATOXGR | Analysis Toxicity Grade | Char |
| Perm | Toxicity grade for analysis. May be based on --TOXGR or an imputed or assigned value. May change case of text, such as from all uppercase in --TOXGR to mixed case in ATOXGR. |
ATOXGRN | Analysis Toxicity Grade (N) | Num |
| Perm | Code ATOXGR to numeric Low toxicity should correspond to low value |
TOXGGRy | Pooled Toxicity Grade Group y | Char |
| Perm | Pooled grouping of toxicity grade for analysis |
TOXGGRyN | Pooled Toxicity Grade Group y (N) | Num |
| Perm | Code of TOXGGRy to numeric Low toxicity should correspond to low value |
--ACN | Action Taken with Study Product | Char | ACN | Perm | XX.--ACN Required if XX.--ACN is present and populated |