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 @ 3:33 PM
Ignite Modification Date: 2025-12-25 @ 1:46 PM
NCT ID: NCT01523392
Description: Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Frequency Threshold: 1
Time Frame: Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant).
Study: NCT01523392
Study Brief: A Pharmacodynamic Study With Ticagrelor in African American Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ticagrelor Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days None None 1 34 5 34 View
Clopidogrel Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days None None 0 31 2 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA V16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemorroidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA V16.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA V16.0 View
Application site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA V16.0 View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA V16.0 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA V16.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA V16.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA V16.0 View
Vaginal haemmorhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V16.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA V16.0 View