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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dyadic Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program | 3 | None | 1 | 32 | 0 | 32 | View |
| Individual Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program | 2 | None | 0 | 31 | 0 | 31 | View |
| Dyadic Exercise Intervention for Caregivers | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program | 1 | None | 0 | 32 | 0 | 32 | View |
| Individual Caregivers-No Intervention | A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members | 1 | None | 0 | 31 | 0 | 31 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Serious Adverse Event | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |