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 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:15 PM
NCT ID: NCT00283959
Description: None
Frequency Threshold: 5
Time Frame: Day 1 after dosing through Week 48 (end of extension period).
Study: NCT00283959
Study Brief: A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants 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 Participants received migalastat 150 mg orally QOD during the 12-week treatment period and the optional 36-week extension period. None None 1 4 3 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 8.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 8.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.0 View
Bifascicular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 8.0 View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 8.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.0 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.0 View
QRS axis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.0 View
Venous pressure jugular increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.0 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 8.0 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 8.0 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.0 View
Poor peripheral circulation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 8.0 View