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 |
|---|---|---|---|---|---|---|---|---|
| Information/Attention Without Counseling CONTROL | Received informational/educational material on physical activity from the NIH (Physical Activity \& You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of "overall health" (without counseling). This is the Control Group | 0 | None | 1 | 62 | 0 | 62 | View |
| Physical Activitiy Motiviational Interviewing Counseling INTER | Received educational material on physical activity from the NIH (Physical Activity \& You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency. This is the active intervention group | 0 | None | 0 | 59 | 0 | 59 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back Injury | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |