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 |
|---|---|---|---|---|---|---|---|---|
| Walking: No Intervention in Diabetics | Subjects will be instructed to continue their usual lifestyle for 8 weeks. | 0 | None | 0 | 13 | 0 | 13 | View |
| Walking: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. | 0 | None | 0 | 15 | 0 | 15 | View |
| Lower Body Heating: Intervention Arm in Healthy Subjects | This intervention consists of 60 minutes of lower body heating (40-42 degree C). | 0 | None | 0 | 18 | 1 | 18 | View |
| Lower Body Heating: Intervention Arm in Diabetics | This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. | 0 | None | 0 | 20 | 0 | 20 | View |
| Lower Body Heating: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. | 0 | None | 0 | 20 | 0 | 20 | View |
| Walking: Intervention Arm in Diabetics | The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. | 0 | None | 0 | 13 | 1 | 13 | View |