Adverse Events Module

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

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 @ 1:36 PM

Ignite Modification Date: 2025-12-25 @ 12:35 PM

NCT ID: NCT01790295

Description: None

Frequency Threshold: 0

Time Frame: up to 4 years

Study: NCT01790295

Study Brief: Ruxolitinib Prior to Transplant in Patients With Myelofibrosis

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT)	Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets.	4	None	13	21	20	21	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Drug-induced hyperglycemia	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Diverticulitis NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea post chemotherapy	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Death sudden	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Neutropenic fever	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Graft failure	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Elevated liver enzyme levels	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lymphocyte count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hyponatremia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Intracranial hemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Spinal epidural hematoma	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Acute renal failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Disease Progression	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Activated partial thromboplastin time	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Acute myeloid leukemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Acute renal failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Allergic rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Allergic rhinitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Alloimmunization	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Anal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Ankle edema	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Anorexia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Back pain (without radiation)	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Bloating	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blurred vision	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Bone pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Bronchospasm	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Bruising	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Burning from urination	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Burning sensation	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
C.difficile diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
CMV infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cardiac neoplasm unspecified	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Cardiomyopathy	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cataract	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Catheter site erythema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chest congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Chest pain - cardiac	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chronic kidney disease	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Clostridium difficile test positive	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Confusion	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Confusion	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Conjunctivitis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Contusion	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Cytokine release syndrome	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Diaphoresis	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Double vision	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Drug-induced liver disease	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Dry eye	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Dry mouth	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dysgeusia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Edema extremities	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Erythema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Facial swelling	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Febrile neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Fecal incontinence	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Fever	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fibrinogen decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Flatulence	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Folliculitis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Foot injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
GGT Increased	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Generalized muscle weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Gout	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Gynecomastia	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
HSV infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hearing impaired	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Hematoma	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hemolysis	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hemorrhoidal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Hiccups	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hoarseness	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hyperglycemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperkalemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypermagnesemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypertriglyceridemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperuricemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoalbuminemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypocalcemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatremia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophosphatemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Increased TSH	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Infusion site cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Insufficiency adrenal	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Iron deficiency anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Irritation lips	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Itching	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Laboratory test abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Left lower quadrant pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Lethargy	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Leukopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Lightheadedness	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Lung infection	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Lymphocyte count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lymphocyte count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Maculopapular rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Malaise	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Middle ear inflammation	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Muscle weakness lower limb	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea and vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Night blindness	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Night sweats	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Non-cardiac chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Open wound of foot except toe(s) alone	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Oral hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Orthostatic hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Painful urination	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Palpitations	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Paraplegia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Perianal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Peripheral sensory neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Petechiae	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Pharyngitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Plasma creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleuritic pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Polymyalgia rheumatica	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Post procedural discomfort	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Postnasal drip	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pressure sore	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Presyncope	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pseudogout	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Rash acneiform	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Renal calculi	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Scleral hemorrhage	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sinus tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Skin desquamation	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin hyperpigmentation	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Skin lesion	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Sneezing	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Sleep apnea	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Sore throat	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Sore throat	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Upper respiratory tract infection bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary incontinence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Urinary hesitancy	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary incontinence	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urticaria	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Weakness	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Weight gain	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight loss	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Wheezing	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
White blood cell decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Autoimmune hemolytic anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Edema periorbital	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Edematous weight gain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypoalbuminemia	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Macular Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
White blood cell count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Hemoglobin decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
INR increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Mucositis oral	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Periocular rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Peripheral motor neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory syncytial virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Rigors	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Tooth pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Petechiae	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View