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 |
|---|---|---|---|---|---|---|---|---|
| Indomethacin | Indomethacin 100 mg PR x 1 in peri-procedural period Indomethacin: 100 mg Indomethacin PR x 1 | None | None | 0 | 223 | 4 | 223 | View |
| Placebo | Placebo suppositories (#2) Placebo | None | None | 3 | 226 | 6 | 226 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to Death | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Aspiration Post-Procedure Leading to Death | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Severe Acute Pancreatitis Leading to Death | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |