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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:45 PM
NCT ID: NCT02320903
Description: Since the study was non-medical, participants were NOT at risk of a mortality event, i.e., the intervention involved use of a phone app only. Participants were also not at risk for a serious adverse event involving "a life-threatening event, hospitalization, or incapacity/disability." As a social science study, our participants may have had some risk of Other including Not Serious Adverse events, such as embarrassment or discomfort answering psychologically- and behaviorally-oriented questions.
Frequency Threshold: 0
Time Frame: Adverse events were informally monitored throughout the 4-week period during which time parents and teens were using the app. Also, most families had their baseline assessment sessions 1-2 weeks prior to the start of app use, and their post-assessment 1-2 weeks after finishing their use of the app. Thus, adverse events were informally monitored for the entire study period, for most families, approximately 8 weeks.
Study: NCT02320903
Study Brief: Using Mobile Technology to Enhance Multisystemic Therapy (MST) Outcomes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Use of VillageWhere App Prototype In this single-arm study design, all enrolled caregivers and teens used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day. Thus, the risk was identical for both parents and teens, since both experienced the app as the only intervention (i.e., there was no comparison group who did not use the app). 0 None 0 32 0 32 View
Serious Events(If Any):
Other Events(If Any):