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: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2025-12-26 @ 12:18 PM
NCT ID: NCT01709500
Description: Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Frequency Threshold: 5
Time Frame: From Baseline up to Week 78
Study: NCT01709500
Study Brief: Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alirocumab 75 mg/up to 150 mg Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. None None 10 167 65 167 View
Placebo Placebo matched to alirocumab SC injection for 78-week treatment duration. None None 7 81 35 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders meddra (17.0) View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders meddra (17.0) View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders meddra (17.0) View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders meddra (17.0) View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders meddra (17.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders meddra (17.0) View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra (17.0) View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders meddra (17.0) View
Non-Cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders meddra (17.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations meddra (17.0) View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations meddra (17.0) View
Hepatitis a SYSTEMATIC_ASSESSMENT Infections and infestations meddra (17.0) View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations meddra (17.0) View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations meddra (17.0) View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications meddra (17.0) View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications meddra (17.0) View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra (17.0) View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra (17.0) View
Rectal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) meddra (17.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders meddra (17.0) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra (17.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations meddra (17.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra (17.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders meddra (17.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra (17.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders meddra (17.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations meddra (17.0) View