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 |
|---|---|---|---|---|---|---|---|---|
| Control Group | no daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device | 0 | None | 0 | 42 | 0 | 42 | View |
| Active Soocial Engagement Group | Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention | 0 | None | 0 | 41 | 0 | 41 | View |