Study: NCT01942135

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 345 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 345 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 345 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 345 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 345 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 345 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 345 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 345 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 345 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 345 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 345 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 345 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 345 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 345 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Drug withdrawal convulsions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 345 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 345 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 345 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 345 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 345 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 345 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 345 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Hypopituitarism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 345 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 345 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 345 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 345 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Gastric volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Hiatus hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 345 at risk

Adverse event: Injection site fibrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 345 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Heat illness
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Sedation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 345 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 345 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 345 at risk

Adverse event: Skin disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 345 at risk

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 345 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 345 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 345 at risk

Adverse event: Cauda equina syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Facial spasm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 345 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 345 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 345 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 345 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 108 affected / 345 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 113 affected / 345 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 231 affected / 345 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 345 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 345 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 345 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 95 affected / 345 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 345 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 345 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 126 affected / 345 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 345 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 345 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 345 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 345 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 151 affected / 345 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 26 affected / 345 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 36 affected / 345 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 345 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 44 affected / 345 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 345 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 345 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 345 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 84 affected / 345 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 345 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 107 affected / 345 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 345 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 90 affected / 345 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 345 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 345 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 345 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 345 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 62 affected / 345 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 345 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 345 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 102 affected / 345 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 345 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 345 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 46 affected / 345 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 79 affected / 345 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 345 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 345 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 345 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 68 affected / 345 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 345 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 345 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 57 affected / 345 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 345 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 345 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 345 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 345 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 345 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 34 affected / 345 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 345 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 345 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 345 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 345 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 345 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 345 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 345 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 345 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 345 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 345 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 345 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 345 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 345 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 172 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 172 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 172 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Osteonecrosis of jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 172 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 172 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 172 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 172 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 172 at risk

Adverse event: Vocal cord paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 172 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 172 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 172 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 172 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 172 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 172 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 172 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 172 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 172 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 172 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 172 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 172 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 172 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 172 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 172 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 172 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 56 affected / 172 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 172 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 13 affected / 172 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 172 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 172 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 172 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 172 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 172 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 172 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 172 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 172 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 172 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 172 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 172 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 172 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 172 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 172 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 172 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 172 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 172 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 172 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 172 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 172 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 172 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 172 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 172 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 172 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 172 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 172 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 172 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 30 affected / 172 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 172 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 172 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 172 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 172 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 172 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 172 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 172 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 172 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 172 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 172 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 172 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 172 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 172 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 172 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 172 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 172 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 172 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 172 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 172 at risk