Study: NCT01753193

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hypothalamic pituitary adrenal axis suppression
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Chikungunya virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Latent tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 218 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 218 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 218 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Idiopathic intracranial hypertension
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: High risk pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 218 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 218 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cervical polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 218 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hidradenitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 218 at risk

Adverse event: Hypercoagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hyperleukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Leukaemoid reaction
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 218 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 218 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Bifascicular block
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Left atrial dilatation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Myocardial fibrosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 218 at risk

Adverse event: Eustachian tube dysfunction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 218 at risk

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hyperparathyroidism primary
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 218 at risk

Adverse event: Thyroid mass
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 218 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Blepharochalasis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 218 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 218 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Scleritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 218 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 218 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 218 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Gastric mucosa erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 218 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Internal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 218 at risk

Adverse event: Noninfective gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pancreatitis chronic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Acquired gene mutation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 218 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 218 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 218 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 218 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cholecystitis chronic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 218 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 218 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 218 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 218 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Bone abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 218 at risk

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Bronchitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Dermatophytosis of nail
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 218 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 218 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Genital herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 218 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 218 at risk

Adverse event: Latent tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 218 at risk

Adverse event: Lymphangitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 218 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 218 at risk

Adverse event: Oropharyngeal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 218 at risk

Adverse event: Papilloma viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Parotitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Pelvic inflammatory disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Peritonsillar abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 218 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Pleurisy viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 218 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Pyelonephritis acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 218 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Tinea manuum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 218 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 218 at risk

Adverse event: Urinary tract infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 218 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 218 at risk

Adverse event: Vulval abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Zika virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Burns second degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Compression fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 218 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 218 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 218 at risk

Adverse event: Injection related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 218 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 218 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Scar
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 218 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Blood immunoglobulin A decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Electrocardiogram QT shortened
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Lipids abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 218 at risk

Adverse event: Mycobacterium tuberculosis complex test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 218 at risk

Adverse event: Magnetic resonance imaging head abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Acquired mixed hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 218 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 218 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 218 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 218 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 218 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 218 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 218 at risk

Adverse event: Myofascial pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 218 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Osteochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 218 at risk

Adverse event: Scoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Spondylolisthesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Haemangioma of bone
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Squamous cell carcinoma of the cervix
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Vulvovaginal warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 218 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cerebrovascular disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 218 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 218 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Intercostal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Lumbosacral radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 218 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pineal gland cyst
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 218 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 218 at risk

Adverse event: Bipolar disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 218 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 218 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 218 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 218 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 218 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Nephritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Ureterolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Breast discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cervical polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Endometrial hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Endometrial thickening
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Endometriosis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 218 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Menometrorrhagia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Menstruation delayed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Polymenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Ectropion of cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Asthmatic crisis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 218 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Emphysema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Reflux laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Snoring
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hair growth abnormal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hypersensitivity vasculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Idiopathic urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Keratosis pilaris
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Mechanical urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Panniculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 218 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 218 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Peripheral coldness
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Raynaud's phenomenon
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk