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 @ 4:42 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT02325466
Description: data collected for participants who return for any subsequent visits
Frequency Threshold: 0
Time Frame: 16 weeks
Study: NCT02325466
Study Brief: Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aspirin/Ticagrelor Placebo aspirin 81 mg daily and ticagrelor placebo twice daily crossover order was never unblinded to PI and study team 0 None 0 70 0 70 View
Aspirin/Ticagrelor aspirin 81 mg daily and ticagrelor 90 mg twice daily crossover order was never unblinded to PI and study team 0 None 1 70 0 70 View
Aspirin Placebo/Ticagrelor aspirin placebo daily and ticagrelor 90 mg twice daily crossover order was never unblinded to PI and study team 0 None 0 70 1 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GI Bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View