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 |
|---|---|---|---|---|---|---|---|---|
| LAMA Arm | The 4-week treatment period with once daily inhaled umeclidinium (125 mcg). | None | None | 0 | 17 | 1 | 17 | View |
| LABA/LAMA Arm | The 4-week treatment period with once daily inhaled fixed-dose combination of umeclidinium (125 mcg) and vilanterol (25 mcg). | None | None | 0 | 17 | 0 | 17 | View |
| Washout Period | There was a 2 week washout period between the two treatment arms. | None | None | 0 | 17 | 1 | 17 | View |