Study: NCT03472586

Adverse event: grade 3 thromboembolic event that resulted in a hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: hepatic hemorrhage - grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dyspnea - Grade 5
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dyspnea - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Paresthesia - Grade 1
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhea - grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Colitis - grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: death - disease progression
Serious: no
Organ System: General disorders
Frequency: 6 affected / 14 at risk

Adverse event: Tachycardia - Grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vertigo - Grade 0
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 14 at risk

Adverse event: Chills - 0
Serious: no
Organ System: General disorders
Frequency: 10 affected / 14 at risk

Adverse event: Fatigue - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 14 at risk

Adverse event: Edema - extremities - grade 0
Serious: no
Organ System: General disorders
Frequency: 12 affected / 14 at risk

Adverse event: Pericardial Effusion - Grade 0
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 14 at risk

Adverse event: Tachycardia - Grade 0
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 14 at risk

Adverse event: Vertigo - Grade 1
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hyperthyroidism - Grade 0
Serious: no
Organ System: Endocrine disorders
Frequency: 14 affected / 14 at risk

Adverse event: Hypothyroidism - Grade 0
Serious: no
Organ System: Endocrine disorders
Frequency: 14 affected / 14 at risk

Adverse event: Blurred vision - Grade 0
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 14 at risk

Adverse event: Decreased vision - grade 0
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 14 at risk

Adverse event: Chills - Grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Chills - Grade 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Fatigue - Grade 1
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Fatigue - Grade 2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Edema - extremities - Grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Fever - Grade 0
Serious: no
Organ System: General disorders
Frequency: 7 affected / 14 at risk

Adverse event: Fever - Grade 1
Serious: no
Organ System: General disorders
Frequency: 5 affected / 14 at risk

Adverse event: Fever - Grade 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Flu-like symptoms - Grade 0
Serious: no
Organ System: General disorders
Frequency: 12 affected / 14 at risk

Adverse event: Flu-like symptoms - Grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Edema - Localized - Grade 0
Serious: no
Organ System: General disorders
Frequency: 12 affected / 14 at risk

Adverse event: Edema - Localized - Grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Non-cardiac chest pain - Grade 0
Serious: no
Organ System: General disorders
Frequency: 10 affected / 14 at risk

Adverse event: Non-cardiac chest pain - Grade 1
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Pain - Grade 0
Serious: no
Organ System: General disorders
Frequency: 11 affected / 14 at risk

Adverse event: Pain - Grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain - Grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rigors - Grade 0
Serious: no
Organ System: General disorders
Frequency: 12 affected / 14 at risk

Adverse event: Rigors - Grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal bloating - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Abdominal distension - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Abdominal pain - grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Abdominal pain - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 14 at risk

Adverse event: Abdominal pain - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain - Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Colitis - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Constipation - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Diarrhea - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Dry Mouth - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Dyspepsia - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 14 at risk

Adverse event: Dysphagia - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Dyspepsia - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Flatulence - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Nausea - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Nausea - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 14 at risk

Adverse event: Nausea - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Vomiting - Grade 0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 14 at risk

Adverse event: Vomiting - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Vomiting - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Hepatic Pain - Grade 0
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 14 at risk

Adverse event: Hepatic Pain - Grade 2
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 14 at risk

Adverse event: ALT increased - Grade 0
Serious: no
Organ System: Investigations
Frequency: 10 affected / 14 at risk

Adverse event: ALT increased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 3 affected / 14 at risk

Adverse event: ALT increased - Grade 4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: AST increased - Grade 0
Serious: no
Organ System: Investigations
Frequency: 10 affected / 14 at risk

Adverse event: AST increased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 3 affected / 14 at risk

Adverse event: AST increased - Grade 4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Blood bilirubin increased - Grade 0
Serious: no
Organ System: Investigations
Frequency: 13 affected / 14 at risk

Adverse event: Blood bilirubin increased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Creatinine increased - Grade 0
Serious: no
Organ System: Investigations
Frequency: 13 affected / 14 at risk

Adverse event: Creatinine increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Creatinine Kinase increased - Grade 0
Serious: no
Organ System: Investigations
Frequency: 14 affected / 14 at risk

Adverse event: Troponin Increased - Grade 0
Serious: no
Organ System: Investigations
Frequency: 14 affected / 14 at risk

Adverse event: Arthralgia - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Back pain - grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 14 at risk

Adverse event: Back pain - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Back pain - Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Back pain - Grade 3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Gait disturbance - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 14 at risk

Adverse event: Gait disturbance - Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Generalized Muscle Weakness - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Hand pain - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 14 at risk

Adverse event: Hand pain - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hip Pain - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 14 at risk

Adverse event: Hip Pain - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Knee pain - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Muscle cramps - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 14 at risk

Adverse event: Muscle cramps - Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Myalgia - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Neck pain - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Shoulder pain - Grade 0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 14 at risk

Adverse event: Shoulder pain - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Anorexia - Grade 0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 14 at risk

Adverse event: Anorexia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Hyperglycemia - Grade 0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 14 at risk

Adverse event: Hypoalbuminia - Grade 0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 14 at risk

Adverse event: Hyponatremia - Grade 0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 14 at risk

Adverse event: Hypophosphatemia - Grade 0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 14 at risk

Adverse event: Hypophosphatemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Weight loss - Grade 0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 14 at risk

Adverse event: Weight loss - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness - Grade 0
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 14 at risk

Adverse event: Dysgeusia - Grade 0
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 14 at risk

Adverse event: Dysgeusia - Grade 2
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Headache - Grade 0
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 14 at risk

Adverse event: Larynsophageal Dysthesia - Grade 0
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 14 at risk

Adverse event: Paresthesia - Grade 0
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 14 at risk

Adverse event: Paresthesia - Grade 3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Peripheral Neuropathy - Grade 0
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 14 at risk

Adverse event: Postoperative hemorrhage - Grade 0
Serious: no
Organ System: Surgical and medical procedures
Frequency: 11 affected / 14 at risk

Adverse event: Postoperative hemorrhage - Grade 1
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 14 at risk

Adverse event: Postoperative hemorrhage - Grade 2
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 14 at risk

Adverse event: Confusion - Grade 0
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 14 at risk

Adverse event: Scrotal edema - Grade 0
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 14 at risk

Adverse event: Urinary incontinence - Grade 0
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 14 at risk

Adverse event: Cough - Grade 0
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Dyspnea - Grade 0
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Pleural Effusion - Grade 0
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 14 at risk

Adverse event: Erythematous Papule - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Pain at cath. site - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 14 at risk

Adverse event: Pain at cath. site - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain at cath. site - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Periorbital Edema - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 14 at risk

Adverse event: Periorbital Edema - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pruritus - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Rash - Maculopapular - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Rash - Pustular - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Skin Ulceration - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Uticaria - Grade 0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 14 at risk

Adverse event: Hematoma - Grade 0
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 14 at risk

Adverse event: Hematoma - Grade 1
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypotension - Grade 0
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 14 at risk

Adverse event: Hypotension - Grade 1
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypotension - Grade 2
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Thromboembolic event - Grade 0
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 14 at risk

Adverse event: Thromboembolic event - Grade 3
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk