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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT01288469
Description: Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants received at least one dose or partial dose of IMP.
Frequency Threshold: 5
Time Frame: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal product (IMP).
Study: NCT01288469
Study Brief: Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
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 + Atorvastatin 80mg Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks. None None 0 31 13 31 View
Alirocumab + Atorvastatin 10 mg Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks. None None 0 31 4 31 View
Alirocumab + Atorvastatin 80 mg Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks. None None 1 30 10 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View