Study: NCT03531918

Adverse event: Grade 3 Left Ventricular Systolic Dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Febrile Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Esophageal Hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Grade 3 Chest Pain - Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Grade 3 Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Skin Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3 Lung Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Grade 4 Bronchopulmonary Hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 4 Aspartate Aminotransferase Increase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Reversible Posterior Leukoencephalopathy Syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Intercranial Hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 4 Tumor Lysis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Hip Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Grade 4 Upper Gastrointestinal Hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Encephalitis Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 4 Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 4 Respiratory Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 4 Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Febrile Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 60 at risk

Adverse event: Grade 3 Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 60 at risk

Adverse event: Grade 4 Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Grade 3 Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 60 at risk

Adverse event: Grade 3 Skin Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Grade 3 Lung Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 60 at risk

Adverse event: Grade 3 Perineal Pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Vaginal Hemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Alanine Aminotransferase Increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 60 at risk

Adverse event: Grade 4 Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Tumor Lysis Syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 60 at risk

Adverse event: Grade 3 Upper Gastrointestinal Hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Grade 3 Lower Gastrointestinal Hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Grade 3 Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Disseminated Intravascular Coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 60 at risk

Adverse event: Grade 3 Urinary Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Intracranial Hemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Aspartate Aminotransferase Increase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Grade 3 Hepatic Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Typhlitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Left Ventricular Systolic Dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 60 at risk

Adverse event: Grade 3 Ejection Fraction Decrease
Serious: no
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Pulmonary Edema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 60 at risk

Adverse event: Grade 3 Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 60 at risk

Adverse event: Grade 3 Myocardial Infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Acute Kidney Injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 4 Acute Kidney Injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 60 at risk

Adverse event: Grade 3 Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Mucositis Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Grade 3 Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Grade 4 Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Hyperphosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Generalized Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Catheter Related Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Grade 3 Rash Maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Grade 3 Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 4 Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Anorexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Shingles
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Bronchopulmonary Hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Dental Caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Colonic Perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Colonic Hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Anorectal Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Menorrhagia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Grade 3 Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk