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 @ 11:57 PM
Ignite Modification Date: 2025-12-25 @ 9:54 PM
NCT ID: NCT03207451
Description: None
Frequency Threshold: 0
Time Frame: Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).
Study: NCT03207451
Study Brief: Vorapaxar on Thrombin Generation and Coagulability
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vorapaxar and Aspirin Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy. 0 None 0 29 0 29 View
Vorapaxar, Aspirin, and Clopidogrel Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy. 0 None 1 23 7 23 View
Vorapaxar Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects. 0 None 0 21 0 21 View
Vorapaxar and Clopidogrel Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy. 0 None 0 8 2 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
minor bleeding SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View