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 |
|---|---|---|---|---|---|---|---|---|
| Study Volunteers | Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. | None | None | 0 | 13 | 4 | 13 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear pain and tinnitus associated with sinusitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Migraine headaches with prior history of headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vesicular rash following vaccination | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rash on face, neck, upper trunk, and back with peeling skin on palms of hands on both sides | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |