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 @ 11:19 PM
Ignite Modification Date: 2025-12-25 @ 9:01 PM
NCT ID: NCT01642056
Description: None
Frequency Threshold: 0
Time Frame: 14 Months
Study: NCT01642056
Study Brief: EPI-743 for Metabolism or Mitochondrial Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EPI-743 Received EPI-743, 15mg/kg up to a maximum dose of 200 mg orally or via gastric tube three times daily with meals. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant. 1 None 3 20 17 20 View
Placebo Received Placebo three times daily orally or via gastric tube with meals. 0 None 4 19 18 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Psychomotor hyperactivity SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Polycythaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders None View
Hyperammonaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations None View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Red blood cell sedimentation rate increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Violence-related symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View