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 @ 2:03 AM
Ignite Modification Date: 2025-12-26 @ 12:27 AM
NCT ID: NCT02228460
Description: Reported AEs are TEAEs that is AEs developed/worsened during "on treatment period" (from first administration through last administration of study drug + 30 days or end of study participation for participant, whichever occurs first). Analysis was performed on safety population that included all enrolled participants who received at least 1 dose of study drug.
Frequency Threshold: 0
Time Frame: Baseline up to 212 days
Study: NCT02228460
Study Brief: Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GZ/SAR402671 GZ/SAR402671 15 mg once daily, orally for 26 weeks. 0 None 3 11 9 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Floppy infant SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Haemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Retinal vascular disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Oesophageal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Electrocardiogram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Vibration test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Angiokeratoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Lenticular opacities SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Nuclear magnetic resonance imaging brain abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
White matter lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View