Study: NCT02163694

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 174 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 174 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 174 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 174 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Colitis microscopic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 174 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: Hyperthermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 174 at risk

Adverse event: Contrast media allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 174 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Bronchitis moraxella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 174 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 174 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 174 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 174 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 174 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 174 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 174 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 174 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 174 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 174 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 174 at risk

Adverse event: Joint lock
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Osteonecrosis of jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 174 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 174 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 174 at risk

Adverse event: Metastases to bone marrow
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 174 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 174 at risk

Adverse event: Metastases to meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 174 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 174 at risk

Adverse event: Cervical cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 174 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 174 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Vascular encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 174 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 174 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 174 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 174 at risk

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pulmonary artery thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 174 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 174 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 174 at risk

Adverse event: Poor venous access
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 174 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 117 affected / 174 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 65 affected / 174 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 174 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 156 affected / 174 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 118 affected / 174 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 174 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 174 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 174 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 14 affected / 174 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 174 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 174 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 174 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 174 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 174 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 174 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 174 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 174 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 174 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 174 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 174 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 118 affected / 174 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 174 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 174 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 174 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 174 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 174 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 90 affected / 174 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 174 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 174 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 20 affected / 174 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 174 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 174 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 174 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 32 affected / 174 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 174 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 174 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 174 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 174 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 174 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 174 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 174 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 174 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 174 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 174 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 174 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 174 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 174 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 174 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 174 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 174 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 174 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 174 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 174 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 174 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 174 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 174 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 174 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 174 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 174 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 174 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 174 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 174 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 174 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 174 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 174 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 174 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 174 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 174 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 89 affected / 174 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 174 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 174 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 174 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 174 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 174 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 174 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 174 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 174 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 174 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 174 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 174 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 174 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 87 affected / 174 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 174 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 174 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 174 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 174 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 174 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 174 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 174 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 339 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 339 at risk

Adverse event: Haemorrhagic disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 339 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 339 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 339 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 339 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 339 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 339 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 339 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 339 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 339 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 339 at risk

Adverse event: Noninfective sialoadenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Toothache
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 339 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 339 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 339 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 339 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 339 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 339 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 339 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 339 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Haemophagocytic lymphohistiocytosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Abscess jaw
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 339 at risk

Adverse event: Breast cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 339 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 339 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Infected dermal cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Infected lymphocele
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 339 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Neutropenic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 339 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Parotid abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 339 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 339 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 339 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 339 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 339 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 339 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 339 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 339 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 339 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 339 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 339 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 339 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 339 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 339 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 339 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 339 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 339 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Gastric neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 19 affected / 339 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Metastases to lymph nodes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Metastases to meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 339 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 339 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 339 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 339 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 339 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Meningeal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 339 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 339 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 339 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 339 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 339 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 339 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 339 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 339 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 339 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 339 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 339 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 339 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 339 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 256 affected / 339 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 133 affected / 339 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 339 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 292 affected / 339 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 257 affected / 339 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 339 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 339 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 21 affected / 339 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 24 affected / 339 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 339 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 339 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 339 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 339 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 339 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 339 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 151 affected / 339 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 339 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 339 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 339 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 339 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 240 affected / 339 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 339 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 339 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 118 affected / 339 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 339 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 339 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 168 affected / 339 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 27 affected / 339 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 30 affected / 339 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 69 affected / 339 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 339 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 18 affected / 339 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 59 affected / 339 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 58 affected / 339 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 339 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 339 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 339 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 339 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 339 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 339 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 339 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 339 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 339 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 59 affected / 339 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 50 affected / 339 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 339 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 339 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 81 affected / 339 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 339 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 339 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 339 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 339 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 83 affected / 339 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 339 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 339 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 339 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 339 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 339 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 339 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 339 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 60 affected / 339 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 339 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 71 affected / 339 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 339 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 339 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 124 affected / 339 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 339 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 339 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 158 affected / 339 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 339 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 339 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 339 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 63 affected / 339 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 339 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 77 affected / 339 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 71 affected / 339 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 339 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 62 affected / 339 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 339 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 339 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 339 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 182 affected / 339 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 339 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 339 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 339 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 339 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 41 affected / 339 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 339 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 339 at risk