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 |
|---|---|---|---|---|---|---|---|---|
| Intervention: Heart Rate Variability Biofeedback | Participants in this intervention group completed at-home heart rate variability biofeedback (HRVB) training using a wrist-worn heart rate monitor and a smartphone app. They were asked to complete at least 10 minutes per day of HRVB training on at least 5 days per week for 3 weeks. Heart Rate Variability Biofeedback Training: First, participants were taught how to do relaxed, abdominal breathing. Second, they were taught how to breathe at a slow rate of 0.1 Hz (i.e., one completed breath cycle every 10 seconds). Third, they were taught how to monitor their heart rate variability (HRV) in real time using the smartphone app, which received data wirelessly via Bluetooth from the heart rate monitor. Participants were instructed that their goal was to increase their HRV during the three weeks of at-home practice. | 0 | None | 0 | 10 | 0 | 10 | View |