Study: NCT03006848

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Vascular disorders
Notes: Thromboembolic event
Frequency: 1 affected / 18 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Neoplasms benign, malignant and unspecified
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea
Frequency: 2 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchopulmonary hemorrhage
Frequency: 1 affected / 18 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lung infection
Frequency: 1 affected / 18 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain
Frequency: 1 affected / 18 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia
Frequency: 1 affected / 18 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Notes: Aspartate aminotransferase increased
Frequency: 1 affected / 18 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Notes: Alanine aminotransferase increased
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Pericardial effusion
Frequency: 1 affected / 18 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 18 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood and lymphatic system disorders - Other
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Notes: Sinus tachycardia
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Notes: Pericardial tamponade
Frequency: 1 affected / 18 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hyperthyroidism
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 2 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastritis
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 3 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 3 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hemorrhoids
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Rectal pain
Frequency: 1 affected / 18 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Fever
Frequency: 1 affected / 18 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Pain
Frequency: 3 affected / 18 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 1 affected / 18 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Non-cardiac chest pain
Frequency: 1 affected / 18 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Gait disturbance
Frequency: 1 affected / 18 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: Autoimmune disorder
Frequency: 1 affected / 18 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Lung infection
Frequency: 2 affected / 18 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Urinary tract infection
Frequency: 1 affected / 18 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 2 affected / 18 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Alkaline phosphatase increased
Frequency: 2 affected / 18 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Aspartate aminotransferase increased
Frequency: 1 affected / 18 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Alanine aminotransferase increased
Frequency: 2 affected / 18 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Blood bilirubin increased
Frequency: 1 affected / 18 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperglycemia
Frequency: 1 affected / 18 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypokalemia
Frequency: 1 affected / 18 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia
Frequency: 1 affected / 18 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain
Frequency: 3 affected / 18 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Paresthesia
Frequency: 1 affected / 18 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Peripheral sensory neuropathy
Frequency: 1 affected / 18 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 18 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Proteinuria
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleuritic pain
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Allergic rhinitis
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonitis
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchopulmonary hemorrhage
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 1 affected / 18 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash acneiform
Frequency: 1 affected / 18 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Alopecia
Frequency: 1 affected / 18 at risk