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 |
|---|---|---|---|---|---|---|---|---|
| Paper Asthma Action Plan | Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage. Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage. | None | None | 0 | 17 | 0 | 17 | View |
| Mobile Phone | Participants will record asthma symptoms, medication usage, and peak flow data on their phones. Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app. | None | None | 0 | 17 | 0 | 17 | View |