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 |
|---|---|---|---|---|---|---|---|---|
| Terbutaline Arm | During turbutaline intervention night | None | None | 0 | 16 | 0 | 16 | View |
| 20% Basal Reduction Arm | During 20% basal reduction night | None | None | 0 | 16 | 0 | 16 | View |
| All Study Subjects | Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. | None | None | 0 | 16 | 0 | 16 | View |
| Control Arm | during control intervention night | None | None | 0 | 16 | 0 | 16 | View |