Adverse Events Module

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


Ignite Creation Date: 2025-12-24 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT02459769
Description: None
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT02459769
Study Brief: Exercise Intervention for LGBT Cancer Survivors
Event Groups(If Any):

Event Groups

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
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious Adverse Event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):