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 @ 4:18 PM
Ignite Modification Date: 2025-12-25 @ 2:15 PM
NCT ID: NCT05020366
Description: Participants were encouraged to report adverse events experienced as part of data collection. We are reporting on adverse events reported for child and parent participants.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT05020366
Study Brief: Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PrO-PEAR This group will receive the optimized PrO-PEAR intervention (in addition to usual care). Preventing Obesity through Parent Empowerment and the Activation of Routines: Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play. 0 None 0 30 1 30 View
Enhanced Usual Care This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data. Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline. 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View