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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT00546260
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00546260
Study Brief: Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo Comparator None None 8 36 15 36 View
Experimental Experimental Cohorts (10, 20, 40, 60 mg) None None 2 34 21 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.1) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Thrombosis in device SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.1) View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.1) View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.1) View
Peripheral artery dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.1) View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.1) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.1) View