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 |
|---|---|---|---|---|---|---|---|---|
| Cognitive-Behavioral Therapy | The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques. Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques. | None | None | 0 | 19 | 0 | 19 | View |
| Wait-list | A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'. Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'. | None | None | 0 | 14 | 0 | 14 | View |