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 @ 1:52 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT04294095
Description: serious adverse event - miscarriage.
Frequency Threshold: 1
Time Frame: 16 months
Study: NCT04294095
Study Brief: My Baby My Move A Community Wellness Intervention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. Please note that all in-person sessions were moved to an online platform due to Covid. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain. 0 None 1 25 0 26 View
Control Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Please note that all in-person sessions were moved to an online platform due to Covid. Control: This is a 12-week basic prenatal education class. 0 None 0 24 0 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions serious View
Other Events(If Any):