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 @ 11:51 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT04313751
Description: Adverse events were collected throughout the duration of the study (i.e., Baseline through Month 12). Although Wait-list control participants were offered the opportunity to receive education sessions after all participants had completed Month 12 visits and the study was closed, this occurred after study completion and outside of the scope of the study. Thus, no adverse events were collected for Wait-list control participants who decided to receive education sessions after study completion.
Frequency Threshold: 0
Time Frame: From the time of signing informed consent through study completion, a total of approximately 18 months.
Study: NCT04313751
Study Brief: Reducing Cardiovascular Disease Risk in Perimenopausal Latinas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Education, Physical Activity, and Stress Management Program Classes for the intervention group will be run by a bilingual interventionist and will last 120 minutes weekly for 12 weeks and then monthly for 3 months. Education, Physical Activity, and Stress Management Program: Twelve weekly classes for one hour focused on CVD risk factor education using the Su Corazón Su Vida curriculum and coping skills training followed by a 45 minute exercise class and 15 minute stress management session. Then they will return for one hour for continued support, a forty-five minute exercise class, and fifteen minute stress management session. 0 None 0 26 0 26 View
Wait-list Control Data in the wait-list control group will be collected at the same time intervals as the intervention group. After Time 3 data collection, they will be offered the Phase I intervention (12 weekly sessions). Wait-list: The wait-list control group will receive 12 weekly one hour education and coping skills training sessions followed by a 45 minute exercise class and a 15 minute stress management session. 0 None 0 23 0 23 View
Serious Events(If Any):
Other Events(If Any):