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 |
|---|---|---|---|---|---|---|---|---|
| Arm #2 - Fed State, 2 Study Visits | 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red | None | None | 0 | 24 | 1 | 24 | View |
| Arm #1 - Fasting State, 2 Study Visits | 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red 2. Washout period of at least 7 days 3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red | None | None | 0 | 24 | 0 | 24 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |