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 @ 10:08 PM
Ignite Modification Date: 2025-12-25 @ 7:44 PM
NCT ID: NCT05223335
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected from baseline to end of study, approximately 90 days
Study: NCT05223335
Study Brief: Clopidogrel Monotherapy in Patients With High Bleeding Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Genotype-Guided Therapy Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy. Prasugrel: 60 mg bolus then 10 mg daily Tricagrelor: 180 mg bolus then 90 mg twice daily 0 None 0 29 0 29 View
Conventional Therapy Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers continued with clopidogrel monotherapy. Clopidogrel: 75 mg/day 0 None 1 69 3 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Possible Stent Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BARC 3 bleeding event SYSTEMATIC_ASSESSMENT Vascular disorders None View