Pre-specified Events Collection of adverse event, clinical events, and medical history events can follow two approaches: Were there any events? If yes, what were the events? Did event X occur? If yes, record the details of the event(s)
ADaM datasets include names that start with "AD", therefore "AD" must not be used as the name of a custom SDTM domain. Analysis datasets that are not based on ADaM may have names that start with "AX", so "AX" must not be used as the name of a custom SDTM domain. The SDTM Domain Abbreviations codelist includes "AD" and "AX" as a reminder that these domain abbreviations must not be used for SDTM custom domains.
This diagram illustrates the steps that go into assessing the causality of an adverse event. For certain kinds of adverse events, some steps are almost automatic (e.g., an infectious disease can't happen without a pathogen), but for other kinds of adverse events, there may be many possible causes, and the steps can be quite distinct.
This example shows information for all-cause death, including primary and secondary causes and location.
This example shows 24-hour urine protein results for two subjects.
This example shows a data collection form for renal replacement therapy, that is, for kidney transplant and chronic dialysis.
This example shows data collection for diabetes complications and their dates of diagnosis.
This example shows albumin excretion rate result values for the same subject at different visits.
This example shows an injection of iohexol administered prior to the GFR test.
This example shows data about the last meal before a hypoglycemic event.
This example shows data about the last meal before a hypoglycemic event.
This data shows cystatin and creatine data, with glomerular filtration rates estimated from them.