Study: NCT01467661

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Prinzmetal angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cytogenetic abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 53 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Angioimmunoblastic T-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Basilar artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 53 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 53 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 53 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 53 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Red blood cell abnormality
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Aortic valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 53 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Coronary artery stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Long QT syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 53 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 53 at risk

Adverse event: Prinzmetal angina
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Supraventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 53 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cytogenetic abnormality
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 53 at risk

Adverse event: Eustachian tube dysfunction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 53 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 53 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 53 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 53 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 53 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pterygium
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 53 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Colitis ischaemic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 53 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 53 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 53 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastric polyps
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 53 at risk

Adverse event: Gingival hypertrophy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 53 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 53 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 53 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 53 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 16 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 53 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cholestasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gallbladder polyp
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 53 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 53 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Chronic sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 53 at risk

Adverse event: Dermatophytosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 53 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Haemophilus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 53 at risk

Adverse event: Infected skin ulcer
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 53 at risk

Adverse event: Oesophageal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Pericoronitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 53 at risk

Adverse event: Pharyngitis mycoplasmal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 53 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Abdomen crushing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 53 at risk

Adverse event: Deafness traumatic
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 53 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 53 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Frostbite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 53 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 53 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Traumatic haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 53 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Crystal urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Differential white blood cell count abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 53 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Haptoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Metamyelocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Myelocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Red blood cell nucleated morphology present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 53 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 53 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 53 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 53 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 53 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 53 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 53 at risk

Adverse event: Metabolic disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 53 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 53 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 53 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Periostitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Tendon calcification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Acoustic neuroma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Angioimmunoblastic T-cell lymphoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Lung neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Myelofibrosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 53 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Prostate cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Altered state of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 53 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 53 at risk

Adverse event: Hyperaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 53 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Palatal palsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Subarachnoid haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 53 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 53 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Haemorrhage urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hydroureter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 53 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 53 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 53 at risk

Adverse event: Renal tubular disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cystocele
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Genital haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 53 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 53 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Interstitial lung disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pulmonary sarcoidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Chronic pigmented purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 53 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 53 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Eczema nummular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 53 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 53 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 53 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Skin lesion removal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 53 at risk

Adverse event: Arteriosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 53 at risk

Adverse event: Basilar artery thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cerebral infarction
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 53 at risk

Adverse event: Erythromelalgia
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 53 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 53 at risk

Adverse event: Lacunar infarction
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 53 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 53 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 53 at risk

Adverse event: Peripheral circulatory failure
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Peripheral coldness
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Raynaud's phenomenon
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Haemophilus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Acoustic neuroma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 33 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Genital haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 33 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk