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 |
|---|---|---|---|---|---|---|---|---|
| Fatigued Group | Subjects held in a modify pushup plus position. Like an all four position, subjects hold with right arm with elbow flexion and full shoulder protraction. Male subjects had to hold three minutes for ten repetitions, and female subjects were two minutes for five repetitions. There was thirty second rest between repetitions. The end of fatigue task was: subjects finished all the repetition, or could not do one more repetition. Female subjects could do more than five repetitions if they felt ok, and the maximum repetitions were ten. The muscle activation of upper trapezius, lower trapezius, and serratus would record for analysis of median frequency. As long as finished fatigue task, the post measurements would start. | 0 | None | 0 | 30 | 0 | 30 | View |