Study: NCT00340834

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 420 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 420 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 420 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 420 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 420 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 420 at risk

Adverse event: Supraventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 420 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 420 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 420 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 420 at risk

Adverse event: Anal skin tags
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 420 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 420 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 420 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 420 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 420 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 420 at risk

Adverse event: Encephalitis herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 420 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 420 at risk

Adverse event: Helicobacter gastritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 420 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 420 at risk

Adverse event: Herpes zoster disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 420 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 420 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 420 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 420 at risk

Adverse event: Human papilloma virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 420 at risk

Adverse event: Abnormal loss of weight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 420 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 420 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 420 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 420 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 420 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 420 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Dural arteriovenous fistula
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Spinal cord ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 420 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 420 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 420 at risk

Adverse event: Hyperventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 420 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 420 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 420 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 420 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 420 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 420 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 420 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 420 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 420 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 60 affected / 420 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 420 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 420 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 420 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 420 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 420 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 93 affected / 420 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 420 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 420 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 420 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 420 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 420 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 420 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 420 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 420 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 420 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 420 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 420 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 420 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 420 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 42 affected / 420 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 420 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 96 affected / 420 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 420 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 420 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 420 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 420 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 420 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 420 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 429 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 429 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 429 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 429 at risk

Adverse event: Congenital anomaly in offspring
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Ear disorder
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 429 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 429 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 429 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 429 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 429 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 429 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 429 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 429 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 429 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 429 at risk

Adverse event: Electrocardiogram ST segment elevation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 429 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 429 at risk

Adverse event: Sjogren's syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 429 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 429 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 429 at risk

Adverse event: Breast cancer in situ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 429 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 429 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 429 at risk

Adverse event: Ovarian neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 429 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 429 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 429 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 429 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 429 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 429 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 429 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 429 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 429 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 429 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 44 affected / 429 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 429 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 429 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 429 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 429 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 429 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 88 affected / 429 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 429 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 429 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 429 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 429 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 429 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 429 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 429 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 429 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 429 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 429 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 429 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 429 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 429 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 28 affected / 429 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 429 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 99 affected / 429 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 429 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 429 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 429 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 429 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 429 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 429 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 431 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 431 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 431 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 431 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Administration site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Bartholin's abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Incision site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 431 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 431 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 431 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 431 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 431 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 45 affected / 431 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 158 affected / 431 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 76 affected / 431 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 431 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 431 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 431 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 88 affected / 431 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 431 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 431 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 431 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 431 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 431 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 431 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 431 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 431 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 431 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 431 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 431 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 24 affected / 431 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 431 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 431 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 431 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 431 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 431 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 431 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 431 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 431 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 504 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 504 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 504 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 504 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 504 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 504 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 504 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 504 at risk

Adverse event: Tolosa-Hunt syndrome
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 504 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 504 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 504 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 504 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Chronic tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 504 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 504 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Papilloma viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 504 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Salpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 504 at risk

Adverse event: Complicated fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 504 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 504 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 504 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 504 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 504 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 504 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 504 at risk

Adverse event: Benign mediastinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Benign neoplasm of thyroid gland
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Bone cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Testis cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Demyelination
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 504 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Progressive relapsing multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Sensorimotor disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 504 at risk

Adverse event: Complication of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 504 at risk

Adverse event: Unintended pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 504 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 504 at risk

Adverse event: Acquired hydrocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 504 at risk

Adverse event: Adenomyosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 504 at risk

Adverse event: Infertility
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 504 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 504 at risk

Adverse event: Spermatocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 504 at risk

Adverse event: Testicular pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 504 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 504 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 108 affected / 504 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 504 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 504 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 504 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 39 affected / 504 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 24 affected / 504 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 33 affected / 504 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 504 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 504 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 504 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 158 affected / 504 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 504 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 504 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 504 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 504 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 504 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 504 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 504 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 72 affected / 504 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 504 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 504 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 60 affected / 504 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 504 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 504 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 53 affected / 504 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 504 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 86 affected / 504 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 504 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 504 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 504 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 504 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 504 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 504 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 523 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 523 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 523 at risk

Adverse event: Congenital absence of cranial vault
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 523 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 523 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 523 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 523 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 523 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 523 at risk

Adverse event: Gait inability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 523 at risk

Adverse event: Complication of device insertion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 523 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 523 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 523 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 523 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 523 at risk

Adverse event: Abscess sweat gland
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Bartholin's abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 523 at risk

Adverse event: Gastrointestinal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Herpes ophthalmic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Herpes zoster disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Salpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Septic encephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 523 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 523 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 523 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 523 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 523 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 523 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 523 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 523 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 523 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 523 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 523 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 523 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 523 at risk

Adverse event: Plica syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 523 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 523 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 523 at risk

Adverse event: Ovarian epithelial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 523 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 523 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 523 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 523 at risk

Adverse event: Central nervous system lesion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Intensive care unit acquired weakness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Trigeminal neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 523 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Tension headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 523 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 523 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 523 at risk

Adverse event: Generalised anxiety disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 523 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 523 at risk

Adverse event: Acquired hydrocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 523 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 523 at risk

Adverse event: Haemorrhagic ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 523 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 523 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 523 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 523 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 523 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 523 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 523 at risk

Adverse event: Skin lesion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 523 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 523 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 77 affected / 523 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 523 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 523 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 523 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 523 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 18 affected / 523 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 523 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 523 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 523 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 523 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 162 affected / 523 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 523 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 523 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 523 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 523 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 523 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 523 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 523 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 523 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 523 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 523 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 523 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 523 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 523 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 51 affected / 523 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 523 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 107 affected / 523 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 44 affected / 523 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 523 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 523 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 523 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 523 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 523 at risk