Adverse Events Module

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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: 2025-12-25 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT04259905
Description: PI review of screening call logs, group session documentation, and data collection was used to systematically assess instances of adverse events.
Frequency Threshold: 1
Time Frame: 12 weeks
Study: NCT04259905
Study Brief: Pink Warrior 2: Teleconference-based Gaming Support
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Video Game Teleconference Support Group Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag. Active video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device 0 None 0 10 0 10 View
Standard Support Group + Pedometer Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag. Standard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):