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 |
|---|---|---|---|---|---|---|---|---|
| Participants Received Acthar | All participants in the study received Acthar. | 1 | None | 2 | 6 | 1 | 6 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cramps of hands and fingers | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Tightness of Chest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Elevated Blood Pressure | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Dizziness and Vertigo | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Irritablility | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moon Face (Swelling of face) | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |