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 @ 12:42 PM
Ignite Modification Date: 2025-12-25 @ 12:13 PM
NCT ID: NCT03734861
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT03734861
Study Brief: The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BreatheSmart System * BreatheSmart mobile application that tracks medication usage and sends real time reminders * HeroTracker sensor that counts dosage and monitors real-time medication adherence * CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm) * BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders * HeroTracker sensor that counts dosage and monitors real-time medication adherence * CoheroConnect provider portal that allows the Investigator to monitor adherence 0 None 0 50 3 50 View
Standard of Care These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness. Standard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness. 0 None 0 25 4 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Caregiver-reported emergency department visit for asthma exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View