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 |
|---|---|---|---|---|---|---|---|---|
| Bubble CPAP- BabiPlus, Respiralogics | Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\&B Bubbler device Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B\&B Bubbler at time of extubation | None | None | 0 | 22 | 0 | 22 | View |
| Bubble CPAP - B&B Bubbler, B&B Medical Technologies | Infants randomized to the B\&B Bubbler device will be extubated to B\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device Bubble CPAP- B\&B Bubbler, B\&B Medical devices: Infant will be randomized to BabiPlus verses B\&B Bubbler at time of extubation | None | None | 0 | 21 | 0 | 21 | View |