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 |
|---|---|---|---|---|---|---|---|---|
| Respiration Rate Sensor | All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45. Actual: Age 18 to 30 - quantity 12 31 to 49 - quantity 5 50 to 65 - quantity 3 BMI 18.5 to 24.9 (normal) - quantity 8 25 to 29.9 (overweight) - quantity 9 30 to 45 (obese) - quantity 3 | 0 | None | 0 | 20 | 0 | 20 | View |