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 |
|---|---|---|---|---|---|---|---|---|
| Standard Care | Observations were in the clinical encounter via video, audio or observational notes. | 19 | None | 52 | 459 | 0 | 459 | View |
| Standard Care + Decision Aid | Observation were in the clinical encounter using the decision aid via video, audio, or observational notes. Decision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient. | 15 | None | 52 | 463 | 0 | 463 | View |
| Clinicians | Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites | 0 | None | 0 | 244 | 0 | 244 | View |