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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT03755518
Description: Adverse events will be analyzed in terms of TEAEs that are defined to be any event that begins or worsens in grade after the start of fedratinib through 30 days after the last dose.
Frequency Threshold: 5
Time Frame: Adverse Events: From first dose up to 30 days post last dose. (An average of 50.3 weeks up to a maximum of 124 weeks) All-Cause Mortality: From first dose up to LPLV PE final Database lock: approximately 56 Months.
Study: NCT03755518
Study Brief: A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fedratinib 400 mg/day PO (4 x 100 mg capsules) 16 None 22 38 38 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 26.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 26.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 26.1 View
Laryngeal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 26.1 View
Lymphoproliferative disorder SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 26.1 View
Neuroendocrine carcinoma of the skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 26.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders 26.1 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders 26.1 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 26.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 26.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders 26.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders 26.1 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 26.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Early satiety SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 26.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 26.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 26.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 26.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 26.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Blast cell count increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Vitamin B1 decreased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations 26.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 26.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 26.1 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders 26.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 26.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders 26.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 26.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders 26.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 26.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 26.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 26.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 26.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders 26.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 26.1 View