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 |
|---|---|---|---|---|---|---|---|---|
| Exercise and Weight Loss | Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months. | 0 | None | 2 | 9 | 4 | 9 | View |
| Exercise | Individuals assigned to this group will be asked to complete the exercise intervention for xic months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. | 0 | None | 3 | 9 | 2 | 9 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| angina | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary Artery Bypass Graft (CABG) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal (GI) bleed | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |