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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT04152603
Description: AEs are identified by self-report from study participants to the research team. SAEs and specific procedure-associated AEs are reported to the sponsor and IRB within 24 hours. In addition, all AEs are reported according to the University of Washington IRB AE reporting guidelines. Adverse events data were not collected from Neonates as that component of our study was limited to secondary data collection.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT04152603
Study Brief: Better Research Interactions for Every Family
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Arm Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment before implementation of the BRIEF intervention. Adverse events data were not collected from Neonates as that component of our study was limited to secondary data collection. 0 None 0 28 0 28 View
BRIEF Arm Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention. BRIEF Educational Module: The BRIEF Educational Module for research recruitment team members is intended to teach evidence-based approaches to improving participant experiences with research recruitment. It has three components: (1) asynchronous pre-work, including multimedia materials and an individual worksheet (approx. 30 min); (2) one synchronous in-person (or virtual if necessary) session, including didactics, discussions, and practice scenarios (approx. 90 min); and (3) an asynchronous, individual follow-up phone call to review individual questions (approx. 15 min). Adverse events data were not collected from Neonates as that component of our study was limited to secondary data collection. 0 None 0 30 0 30 View
Serious Events(If Any):
Other Events(If Any):