Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | None | None | 0 | 0 | 0 | 0 | View |
| No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. | None | None | 0 | 0 | 0 | 0 | View |
| Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count \<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \>15% beginning within 5-10 days after starting heparin), without a thrombotic event. | None | None | 0 | 0 | 0 | 0 | View |