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 |
|---|---|---|---|---|---|---|---|---|
| Reactive | Written education material (basic) Additional education material PELICAN-Reactive \[In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)\] Written education material (basic): Education material on COPD distributed to all participants. Additional education material: Additional education material sent to participants in the proactive and reactive arms. PELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. | None | None | 0 | 148 | 0 | 148 | View |
| Proactive | Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\] Written education material (basic): Education material on COPD distributed to all participants. Additional education material: Additional education material sent to participants in the proactive and reactive arms. PELICAN-Proactive: In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy. | None | None | 0 | 154 | 0 | 154 | View |
| Usual Care | Written education material (basic) Written education material (basic): Education material on COPD distributed to all participants. | None | None | 0 | 142 | 0 | 142 | View |