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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT04049760
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 181 to 1457 days).
Study: NCT04049760
Study Brief: Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) 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
Migalastat HCl 150 mg One migalastat 123 mg capsule (equivalent to 150 mg migalastat HCl) administered every other day (QOD) during the treatment period. 0 None 1 16 13 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Raynaud's phenomenon SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Electrocardiogram T wave biphasic SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Left ventricular mass index SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Left ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Tooth impacted SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View