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: 2025-12-24 @ 3:17 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT02688192
Description: Project Coordinator maintains the adverse event log. All unexpected and/or serious adverse events occurring during the active portion of the intervention or up to 30 days after the last fitness program session, are reported to the Rutgers Cancer Institute of New Jersey Human Research Services and the Institutional Review Board. Adverse even log is also presented to Data Safety Monitoring Board for review.
Frequency Threshold: 5
Time Frame: From the time first participant signed consent form until completion of all study related procedures. 3 years, 8 months.
Study: NCT02688192
Study Brief: Mobile Health Fitness Program for Adolescent and Young Adult Childhood 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
Arm I (FitSurvivor Intervention) Assessment including 1. Wear an electronic accelerometer 2. Quality of life assessment 3. Physical fitness evaluation 4. Participate in a fitness program which includes: * 8 group meetings of 90 minutes weekly * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies 0 None 0 25 0 25 View
Arm II (Waitlist Control [WLC]) Assessment including 1. Wear an electronic accelerometer 2. Quality of life assessment 3. Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies 0 None 0 24 0 24 View
Serious Events(If Any):
Other Events(If Any):