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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT04463069
Description: Possible adverse effects (e.g., sports injury, underweight, binge eating) suggested by previous studies will be prevented via diverse means (e.g., to inform children and parents of the possible adverse consequences in advance and provide feasible and practical preventive strategies to them). They can reach the research team via a hotline on an ad hoc basis. The adverse events will be monitored among participants who completed the baseline assessments.
Frequency Threshold: 5
Time Frame: 9 months
Study: NCT04463069
Study Brief: School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
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 Group Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week. Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months. 0 None 0 41 0 41 View
Control Group Participants in the control group received no intervention in the study time period. 0 None 0 29 0 29 View
Serious Events(If Any):
Other Events(If Any):