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 |
|---|---|---|---|---|---|---|---|---|
| Abdominal Binder Intervention Group | Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy. Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device | 0 | None | 0 | 173 | 0 | 173 | View |
| Sham Group | Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device | 0 | None | 0 | 173 | 0 | 173 | View |