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 |
|---|---|---|---|---|---|---|---|---|
| CPAP-therapy | Positive airway pressure therapy (CPAP) | 0 | None | 6 | 53 | 0 | 53 | View |
| Control Group | No sleep apnea treatment | 0 | None | 2 | 54 | 0 | 54 | View |
| ASV Therapy | Adaptive Servo Ventilation (ASV) | 0 | None | 0 | 1 | 0 | 1 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization due to hemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Pacemaker implantation due to syncope and prolonged pauses | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization due to syncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization due to symptomatic atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization due to chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |