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 |
|---|---|---|---|---|---|---|---|---|
| Anti-D | Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D. Anti-D: 30-minute infusion administered in an outpatient setting | None | None | 3 | 6 | 6 | 6 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Post infusion reactions | None | Vascular disorders | None | View |
| Hyperbilirubinemia Gr 3-4 | None | Hepatobiliary disorders | None | View |
| Anemia Gr 1 | None | Blood and lymphatic system disorders | None | View |
| Dyspnea on exertion | None | Cardiac disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Hypothyroidism | None | Endocrine disorders | None | View |