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 @ 12:53 AM
Ignite Modification Date: 2025-12-25 @ 11:08 PM
NCT ID: NCT01927367
Description: Safety outcomes were monitored and reported at 12 months, including Major bleeding per ISTH criteria as well as All bleeding.
Frequency Threshold: 0
Time Frame: Adverse events were collected over 12 months for each participant's active study phase.
Study: NCT01927367
Study Brief: Integrated Management Program Advancing Community Treatment of Atrial Fibrillation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Clinical Decision Support System for AF Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool). Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care. 28 None 9 590 0 590 View
Usual Care Usual Care - providers are not eligible to access / use the CDSS. 21 None 7 543 0 543 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Major bleeding per ISTH criteria SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):