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 |
|---|---|---|---|---|---|---|---|---|
| Amitriptyline | Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period. | 0 | None | 0 | 1 | 1 | 1 | View |
| Placebo | Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period. | 0 | None | 0 | 1 | 0 | 1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |