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 |
|---|---|---|---|---|---|---|---|---|
| Exercise in the Workplace | Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild. Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months. Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors | None | None | 0 | 62 | 0 | 62 | View |
| Educational Intervention | This company received a quality of life software and poster with tips on health lifestyle. Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months. Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors | None | None | 0 | 39 | 0 | 39 | View |
| Control Company | No intervention. Control group received no intervention during study period | None | None | 0 | 24 | 0 | 24 | View |
| Exercise in the Workplace and Educational Intervention | Company A received exercise in the workplace, posters with tips on health and quality of life computer software Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months. Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors | None | None | 0 | 65 | 0 | 65 | View |