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 @ 7:19 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT03627403
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
Study: NCT03627403
Study Brief: Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Selinexor, All Patients Single Arm Study, all patients received selinexor. Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first. For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly. Participants experienced dose escalations and reductions based on their individual responses. Subjects were not assigned to fixed-dosing cohorts as dosing ranged from 20mg once weekly to 80 mg once weekly. Adverse Events were not collected specific to dose. 6 None 7 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Peritoneal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system 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
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal 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
Body odor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flashing lights SYSTEMATIC_ASSESSMENT Eye disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders None View
Gum infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Herpes simplex reactivation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Iron overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Periorbital edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Surgical and medical procedures - Other, specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Testosterone deficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary frequency 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
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mitral valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View