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: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT03706794
Description: Adverse Events were assessed in accordance with HHS/NIH/NCI Common Terminology Criteria for Adverse Events (Version 4.0)
Frequency Threshold: 0
Time Frame: Participants were contacted bi-weekly by the research coordinator and monthly by the research assistant throughout the study to assess for adverse events. The PI also monitored each participant's recorded headache diaries monthly to assess for adverse events. Adverse events were monitored/collected over a period of 3 months during the interventional phase of the study.
Study: NCT03706794
Study Brief: Clinical Decision Support for Patient Migraine Management
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Headache Education Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application. 0 None 0 10 1 10 View
Clinical Decision Support Tool Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application. 0 None 0 8 0 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View