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 @ 4:14 PM
Ignite Modification Date: 2025-12-25 @ 2:12 PM
NCT ID: NCT01523366
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: 2.5
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: NCT01523366
Study Brief: A Pharmacodynamic Study With Ticagrelor in Hispanic 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 Arm Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days. None None 0 40 5 40 View
Clopidogrel Arm Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days. None None 0 39 6 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Burning Sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Heart rate irregular SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View