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 @ 3:04 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT02545933
Description: None
Frequency Threshold: 0
Time Frame: Duration of the study (30 days)
Study: NCT02545933
Study Brief: Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DAPT Plus Vorapaxar Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily) Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily Aspirin: Aspirin will be administered at the dose of 81mg once daily Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily) 0 None 0 44 9 44 View
Prasugrel/Ticagrelor Plus Vorapaxar Prasugrel or ticagrelor plus vorapaxar 2.5mg od Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily) Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily) 0 None 0 43 6 43 View
DAPT Aspirin in addition to prasugrel or ticagrelor Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily) Aspirin: Aspirin will be administered at the dose of 81mg once daily Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily) 0 None 0 43 4 43 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BARC 1 bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dizziness SYSTEMATIC_ASSESSMENT General disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View