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 |
|---|---|---|---|---|---|---|---|---|
| 2: Galantamine | Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks. | None | None | 1 | 20 | 1 | 20 | View |
| 1: Oxytocin | Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks | None | None | 0 | 17 | 4 | 17 | View |
| 3: Placebo | Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day. | None | None | 0 | 21 | 0 | 21 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| hospitalization due to unrelated pneumonia | None | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Enuresis | None | Renal and urinary disorders | None | View |