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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT03515304
Description: None
Frequency Threshold: 0
Time Frame: from enrollment through 30-day follow-up
Study: NCT03515304
Study Brief: Evolocumab in Acute Coronary Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Evolocumab 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. 0 None 2 30 13 30 View
Placebo Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. 0 None 6 30 6 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury requiring intermittent hemodialysis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gastrointestinal bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Recurrent non-ST elevation myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Transient myocardial ischemia prompting hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization for planned vascular surgery NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hospitalization for neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Transient ischemic attack, slurred speech NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Retinal artery occlusion NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pre-syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ecchymosis injection site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-infarction pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View