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 |
|---|---|---|---|---|---|---|---|---|
| Patient Subject Usual Care | Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit). | 1 | None | 0 | 231 | 0 | 231 | View |
| Patient-Subject Intervention | Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit. | 0 | None | 0 | 171 | 0 | 171 | View |