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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 (Study Product) | Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days. Famotidine: 80 mg tablet, QID for 14 days Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days | 0 | None | 0 | 2 | 1 | 2 | View |
| Group 2 (Reference Therapy) | Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days. Placebo: tablet, QID for 14 days; capsule, BID for 5 days | 0 | None | 0 | 2 | 0 | 2 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sinus Headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |