SDTM Subject Domains Related Using Observation Other Dataset Dataset Label RELREC Class Efficacy – Safety SUPP- X X CM Events X X AE Interventions DM Demographics X Special Purpose – X Events EG ECG Test Results X Findings – X FAEX Interventions FA Findings About X Findings – FAEX Findings About Exposure X EX Findings – FAMH Findings About Medical – X MH Findings History X X Findings X FAMH Events X X Interventions QS Questionnaires X Findings – X Findings X Findings SE Subject Elements X Special Purpose – SV Subject Visits X Special Purpose – X TU Findings TU Tumor Identification X TR Findings – VS Vital Signs X Findings –
SDTM Subject Domains Dataset – Dataset Label Efficacy Safety Other SUPP- Related Using RELREC Observation Class X X CM Events X X AE Interventions DM – Demographics X Special Purpose X Events EG – ECG Test Results X Findings X FAEX Interventions FA – Findings About X Findings FAEX – Findings About Exposure X EX Findings FAMH – Findings About Medical History X MH Findings X X Findings X FAMH Events X X Interventions QS – Questionnaires X Findings X Findings X Findings SE – Subject Elements X Special Purpose SV – Subject Visits X Special Purpose X TU Findings TU – Tumor Identification X TR Findings VS – Vital Signs X Findings