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 |
|---|---|---|---|---|---|---|---|---|
| Experimental First Then Standard | 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight). Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily). | None | None | 0 | 2 | 0 | 2 | View |
| Standard First Then Experimental | 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily). Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight). | None | None | 0 | 2 | 0 | 2 | View |