Study: NCT02921061

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Cardiogenic shock/heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: acute kidney injury, grade 3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: aortic valve disease, grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: AST increased, grade 3
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 28 at risk

Adverse event: atrial fibrillation, grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 28 at risk

Adverse event: atrial fibrillation, grade 4
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: back pain, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: delirium, grade 3
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: diarrhea, grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: duodenal hemorrhage, grade 4
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: dyspnea, grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: encephalopathy, grade 4
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: fatigue, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: febrile neutropenia, grade 3
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 28 at risk

Adverse event: hyperbilirubinemia, grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: hypertension, grade 3
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: hypokalemia, grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: hypotension, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: hypoxemia, grade 3
Serious: no
Organ System: General disorders
Frequency: 7 affected / 28 at risk

Adverse event: infective endocarditis, grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: LV systolic dysfunction, grade 4
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: maculopapular rash, grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: myocardial infarction, grade 4
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: nausea, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: phlebitis infective, grade 3
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: pleural effusions, grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: pulmonary nodules, grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 28 at risk

Adverse event: sinusitis, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: syncope, grade 3
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: tumor lysis syndrome, grade 3
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk