Study: NCT02915744

Adverse event: Colitis Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Brain Edema Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Leukopenia Grade 4
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Neutropenia Grade 4
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Esophagitis Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Device Related Infection Grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Neutropenic Sepsis Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Hyponatremia Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Malaise Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Atrial Fibrillation Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Viral Gastroenteritis Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Vomiting Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Diarrhea Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Dehydration Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: Hip Fracture Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Urinary Tract Infection Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Intestinal Obstruction Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Colitis Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Neutropenic Colitis Grade 4
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Generalized Physical Health Deterioration Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Generalized Physical Health Deterioration Grade 5
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Asthenia Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Bile Duct Stone Grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cholecystitis Grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hepatic Function Abnormal Grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia Grade 5
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Cellulitis Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Device Related Sepsis Grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Lung Infection Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Groin Pain Grade 2
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Muscle Spasm Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pathological Fracture Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dizziness Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Epilepsy Grade 2
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Fine motor skill dysfunction Grade 2
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypoesthesia Grade 2
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Paresthesia Grade 2
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Seizure Grade 2
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Syncope Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Confusional State Grade 2
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Mental Status Changes Grade 3
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pleural Effusion Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumothorax Grade 2
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Influenza Grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 54 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 34 affected / 90 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 90 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 90 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 90 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 36 affected / 90 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 90 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 90 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 90 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 90 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 90 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 90 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 90 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 90 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Dygeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 90 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 90 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 90 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 90 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 90 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 90 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 90 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Platelet Count Decresed
Serious: no
Organ System: Investigations
Frequency: 3 affected / 90 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 90 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 90 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 90 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 90 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 90 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 90 at risk

Adverse event: Pneumonia Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Hyponatremia Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Vomiting Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hip Fracture Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Urinary Tract Infection Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Nausea Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Fatigue Grade 2
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Abdominal Pain Grade 2
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dysphagia Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Esophageal Candidiasis Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Bacteremia Grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Contusion Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 77 at risk

Adverse event: Febrile Neutropenia Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Normochromic normocytic Anemia Grade 3
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cardiac Tamponade Grade 4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Blindness Grade 3
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 77 at risk

Adverse event: Vomiting Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Abdominal Pain Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Fatigue Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hepatic Failure Grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hyperbilirubinemia Grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 77 at risk

Adverse event: Escherichia Sepsis Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Pyoderma Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Fall Grade 3
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Neutrophil Count Decrease Grade 4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Failure to Thrive Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypercalcemia Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Back Pain Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Seizure Grade 2
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Status Epilepticus Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Confusional State Grade 3
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hallucination Grade 4
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pleural Effusion Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dyspnea Grade 2
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dyspnea Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Deep Vein Thrombosis Grade 4
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 31 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 17 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 77 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 77 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 77 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 77 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 77 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 77 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 77 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 77 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 77 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 77 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 77 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 77 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 77 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 77 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 77 at risk

Adverse event: Dygeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 77 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 77 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 77 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 77 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 77 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 77 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 77 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 77 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 77 at risk

Adverse event: Platelet Count Decresed
Serious: no
Organ System: Investigations
Frequency: 4 affected / 77 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 77 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 77 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 77 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 77 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 77 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 77 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 77 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 77 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 77 at risk