Study: NCT01809691

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 627 at risk

Adverse event: Blood and lymphatic system disorders - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 627 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 627 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 627 at risk

Adverse event: Cardiac disorders-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 627 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 627 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 627 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 627 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 627 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 627 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 627 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 627 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 627 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 627 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 627 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 627 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 627 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Gastrointestinal disorders-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 627 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 627 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 627 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 627 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 627 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 627 at risk

Adverse event: Face oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 627 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 627 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 627 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 627 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 627 at risk

Adverse event: General disorders and admin site conditions - Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 627 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 627 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 627 at risk

Adverse event: Gallbladder obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Anorectal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 627 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Infections and infestations-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 627 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 627 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Prostate infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 627 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 627 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 627 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 627 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 627 at risk

Adverse event: Aortic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 627 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 627 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 627 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 627 at risk

Adverse event: Injury, poison and procedural complications - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 627 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 627 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 627 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 627 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 627 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 627 at risk

Adverse event: Troponin I increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 627 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 627 at risk

Adverse event: Ejection fraction decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 627 at risk

Adverse event: Investigations-Other
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 627 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 627 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 627 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 627 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 627 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 627 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 627 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 627 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 627 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Metabolism and nutrition disorders - Other, specify
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 627 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 627 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 627 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 627 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 627 at risk

Adverse event: Musculoskeletal and connective tiss disorder - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 627 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 627 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 627 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 627 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 627 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 627 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 627 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 627 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 627 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 627 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 627 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 627 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 627 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 627 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 627 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 627 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 627 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 627 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 627 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 627 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 627 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 627 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 627 at risk

Adverse event: Cystitis noninfective
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 627 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 627 at risk

Adverse event: Renal and urinary disorders-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 627 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 627 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 627 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 627 at risk

Adverse event: Erectile dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 627 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 627 at risk

Adverse event: Reproductive system and breast disorders - Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 627 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 627 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 627 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 627 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 627 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 627 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Resp, thoracic and mediastinal disorders - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 627 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 627 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 627 at risk

Adverse event: Surgical and medical procedures-Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 627 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 44 affected / 627 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 627 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 627 at risk

Adverse event: Vascular disorders-Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 627 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 340 affected / 627 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 627 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 88 affected / 627 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 228 affected / 627 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 181 affected / 627 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 627 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 627 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 627 at risk

Adverse event: Gastrointestinal disorders-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 627 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 214 affected / 627 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 120 affected / 627 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 33 affected / 627 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 150 affected / 627 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 445 affected / 627 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 41 affected / 627 at risk

Adverse event: General disorders and admin site conditions - Other
Serious: no
Organ System: General disorders
Frequency: 61 affected / 627 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 47 affected / 627 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 208 affected / 627 at risk

Adverse event: Infections and infestations-Other
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 627 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 627 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 627 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 62 affected / 627 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 179 affected / 627 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 135 affected / 627 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 182 affected / 627 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 627 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 51 affected / 627 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 151 affected / 627 at risk

Adverse event: Investigations-Other
Serious: no
Organ System: Investigations
Frequency: 49 affected / 627 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 128 affected / 627 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 627 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 95 affected / 627 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 66 affected / 627 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 130 affected / 627 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 90 affected / 627 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 134 affected / 627 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 627 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 244 affected / 627 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 73 affected / 627 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 627 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 85 affected / 627 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 627 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 63 affected / 627 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 130 affected / 627 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 87 affected / 627 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 157 affected / 627 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 627 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 213 affected / 627 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 627 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 103 affected / 627 at risk

Adverse event: Musculoskeletal and connective tiss disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 85 affected / 627 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 101 affected / 627 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 627 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 627 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 220 affected / 627 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 32 affected / 627 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 152 affected / 627 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 627 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 190 affected / 627 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 627 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 103 affected / 627 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 90 affected / 627 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 118 affected / 627 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 169 affected / 627 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 627 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 58 affected / 627 at risk

Adverse event: Renal and urinary disorders-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 58 affected / 627 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 155 affected / 627 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 69 affected / 627 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 627 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 62 affected / 627 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 43 affected / 627 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 627 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 152 affected / 627 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 147 affected / 627 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 627 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 627 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 627 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 627 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 77 affected / 627 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 68 affected / 627 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 448 affected / 627 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 364 affected / 627 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 627 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 629 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 629 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 629 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 629 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 629 at risk

Adverse event: Infections and infestations-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 629 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 629 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 629 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 629 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 629 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 629 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 629 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 629 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 629 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 629 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 271 affected / 629 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 629 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 629 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 133 affected / 629 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 90 affected / 629 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 629 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 629 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 629 at risk

Adverse event: Gastrointestinal disorders-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 629 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 629 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 629 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 19 affected / 629 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 110 affected / 629 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 346 affected / 629 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 34 affected / 629 at risk

Adverse event: General disorders and admin site conditions - Other
Serious: no
Organ System: General disorders
Frequency: 47 affected / 629 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 629 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 156 affected / 629 at risk

Adverse event: Infections and infestations-Other
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 629 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 629 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 629 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 34 affected / 629 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 85 affected / 629 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 107 affected / 629 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 86 affected / 629 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 629 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 52 affected / 629 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 99 affected / 629 at risk

Adverse event: Investigations-Other
Serious: no
Organ System: Investigations
Frequency: 21 affected / 629 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 52 affected / 629 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 629 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 60 affected / 629 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 103 affected / 629 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 629 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 55 affected / 629 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 60 affected / 629 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 629 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 172 affected / 629 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 629 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 629 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 629 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 629 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 629 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 629 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 59 affected / 629 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 101 affected / 629 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 629 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 194 affected / 629 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 74 affected / 629 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 629 at risk

Adverse event: Musculoskeletal and connective tiss disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 62 affected / 629 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 629 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 629 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 629 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 147 affected / 629 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 19 affected / 629 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 99 affected / 629 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 629 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 629 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 629 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 70 affected / 629 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 51 affected / 629 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 80 affected / 629 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 96 affected / 629 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 629 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 38 affected / 629 at risk

Adverse event: Renal and urinary disorders-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 37 affected / 629 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 114 affected / 629 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 53 affected / 629 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 629 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 70 affected / 629 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 72 affected / 629 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 629 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 85 affected / 629 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 90 affected / 629 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 629 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 629 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 629 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 629 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 629 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 629 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 453 affected / 629 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 222 affected / 629 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 629 at risk