Study: NCT02869295

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Lipase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypotension Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 4 at risk

Adverse event: Headache Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 4 at risk

Adverse event: Anemia Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 4 at risk

Adverse event: Constipation Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Abdominal Pain Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pleural Effusion Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 4 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Flu-Like Symptoms Grade 1-2
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 4 at risk

Adverse event: Pruritus Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Decreased Appetite Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4 at risk

Adverse event: Arthralgia Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cough Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Diarrhea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Dyspnea Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Nasal Congestion Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Vomiting Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Weight Decreased Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Anxiety Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dry Skin Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Muscular Weakness Grade 1-2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Constipation Grade 3-5
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pleural Effusion Grade 3-5
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Lipase Increased Grade 3-5
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Ascites
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Gastroduodenal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 11 at risk

Adverse event: Headache Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Anemia Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Peripheral Edema Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 11 at risk

Adverse event: Abdominal Pain Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pleural Effusion Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Infusion Related Reaction Grade 1-2
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Presyncope Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 11 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 9 affected / 11 at risk

Adverse event: Flu-Like Symptoms Grade 1-2
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 11 at risk

Adverse event: Pruritus Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 11 at risk

Adverse event: Decreased Appetite Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 6 affected / 11 at risk

Adverse event: Rash Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 11 at risk

Adverse event: Arthralgia Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Cough Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Nausea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Diarrhea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dyspnea Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Nasal Congestion Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dizziness Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Myalgia Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Vomiting Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Weight Decreased Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Flushing Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anxiety Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Blood creatine increased Grade 1-2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dry Skin Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Generalized Edema Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Muscular Weakness Grade 1-2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain Extremity Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Syncope Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache Grade 3-5
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anemia Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Metastases to Central Nervous System Grade 3-5
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Confusional State Grade 3-5
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Presyncope Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Brain Edema Grade 3-5
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Gastroduodenal Hemorrhage Grade 3-5
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hemiparesis Grade 3-5
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Metastases to Meninges Grade 3-5
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypotension Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Headache Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Peripheral Edema Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal Pain Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Confusional State Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 6 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 5 affected / 6 at risk

Adverse event: Flu-Like Symptoms Grade 1-2
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 6 at risk

Adverse event: Pruritus Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 6 at risk

Adverse event: Decreased Appetite Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

Adverse event: Rash Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 6 at risk

Adverse event: Arthralgia Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 5 affected / 6 at risk

Adverse event: Cough Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Nausea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Diarrhea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnea Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasal Congestion Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Dizziness Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Flushing Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Blood creatine increased Grade 1-2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspepsia Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Generalized Edema Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Muscular Weakness Grade 1-2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain Extremity Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Syncope Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Peripheral Edema Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal Pain Grade 3-5
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Disease Progression Grade 3-5
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lower Gastrointestinal Hemorrhage Grade 3-5
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sepsis Grade 3-5
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Anemia Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Peripheral Edema Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pleural Effusion Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 6 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 5 affected / 6 at risk

Adverse event: Flu-Like Symptoms Grade 1-2
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 6 at risk

Adverse event: Pruritus Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 6 at risk

Adverse event: Decreased Appetite Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

Adverse event: Rash Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Arthralgia Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Cough Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Nausea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Diarrhea Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Nasal Congestion Grade 1-2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Dizziness Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Vomiting Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Weight Decreased Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Flushing Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety Grade 1-2
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatine increased Grade 1-2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cytokine Release Syndrome Grade 1-2
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Dyspepsia Grade 1-2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain Extremity Grade 1-2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache Grade 3-5
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anemia Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Metastases to Central Nervous System Grade 3-5
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infusion Related Reaction Grade 3-5
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Hypovolemic Shock Grade 3-5
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Liver Function Test Abnormal Grade 3-5
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: Fatigue Grade 1-2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Pruritus Grade 1-2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Cytokine Release Syndrome Grade 1-2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Syncope Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypotension Grade 3-5
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk