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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions. Usual Care: Standard Healthcare Services | 7 | None | 69 | 120 | 0 | 120 | View |
| BREATHE Program | Study participants randomized to this arm will be offered the BREATHE program an integrated multifaceted intervention that includes comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services . BREATHE program: A patient and family- centered transitional care intervention that includes a comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services . | 8 | None | 76 | 120 | 0 | 120 | View |