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 |
|---|---|---|---|---|---|---|---|---|
| General Rheumatoid Arthritis Education | Arm 1 participants will receive general information about RA. General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis. | 0 | None | 0 | 80 | 0 | 80 | View |
| PRE-RA | Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool. PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. | 0 | None | 0 | 78 | 0 | 78 | View |
| PRE-RA Plus | Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator. PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator. | 0 | None | 0 | 80 | 0 | 80 | View |