Study: NCT01797965

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 597 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 597 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 597 at risk

Adverse event: Lymphoid tissue hyperplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 597 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Pernicious anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 597 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 597 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 597 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 597 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 597 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 597 at risk

Adverse event: Iritis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 597 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 597 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 597 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 597 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 597 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 597 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 597 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 597 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 597 at risk

Adverse event: Chronic hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 597 at risk

Adverse event: Hepatic necrosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Hepatitis cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Serum sickness
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Chronic hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Genitourinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Hepatitis E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 597 at risk

Adverse event: Pneumonia cytomegaloviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 597 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 597 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 597 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 597 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 597 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 597 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 597 at risk

Adverse event: Snake bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 597 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 597 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 597 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 597 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 597 at risk

Adverse event: Diagnostic procedure
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 597 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 597 at risk

Adverse event: Protein urine present
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 597 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 597 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 597 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 597 at risk

Adverse event: Hyperamylasaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 597 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 597 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 597 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 597 at risk

Adverse event: Ligament laxity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Still's disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 597 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 597 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 597 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 597 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Encephalitis autoimmune
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 597 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 597 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 597 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 597 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 61 affected / 597 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 597 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 597 at risk

Adverse event: Anembryonic gestation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 597 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 597 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 597 at risk

Adverse event: Acute stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 597 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 597 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 597 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 597 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 597 at risk

Adverse event: Somatic symptom disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 597 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 597 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 597 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 597 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 597 at risk

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 597 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 597 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 597 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 597 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 597 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Nasal polyps
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Tracheal fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Alopecia scarring
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Dermatitis contact
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 597 at risk

Adverse event: Drug reaction with eosinophilia and systemic symptoms
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 597 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Erythema nodosum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Pemphigoid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 597 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 597 at risk

Adverse event: Seborrhoeic dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Toxic epidermal necrolysis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Toxic skin eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 597 at risk

Adverse event: Mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 597 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 597 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 597 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 47 affected / 597 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 597 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 597 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 597 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 597 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 597 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 597 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 121 affected / 597 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 597 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 597 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 597 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 597 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 116 affected / 597 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 597 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 45 affected / 597 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 597 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 32 affected / 597 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 597 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 597 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 597 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 597 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 179 affected / 597 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 45 affected / 597 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 597 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 597 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 597 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 597 at risk

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 606 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Granulocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 606 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 606 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 606 at risk

Adverse event: Lymphoid tissue hyperplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 606 at risk

Adverse event: Pseudolymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 606 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 606 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 606 at risk

Adverse event: Left ventricular hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 606 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 606 at risk

Adverse event: Acute vestibular syndrome
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 606 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 606 at risk

Adverse event: Hyperparathyroidism primary
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 606 at risk

Adverse event: Eye haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 606 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 606 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Coeliac disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 606 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 606 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Functional gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Gingivitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 606 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Peptic ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Stomatitis necrotising
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Tongue necrosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 606 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 606 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 606 at risk

Adverse event: Multi-organ disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 606 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 606 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 606 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 606 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 606 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 606 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 606 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 606 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Bartholin's abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Brucellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Chlamydial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Hepatitis E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 606 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 606 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 606 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 606 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 606 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 606 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 606 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 606 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 606 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 606 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Traumatic intracranial haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 606 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 606 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 606 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Fibromyalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Psoriatic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Seronegative arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Synovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Systemic scleroderma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Tenosynovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Anorectal human papilloma virus infection
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 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 / 606 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Fibroadenoma of breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Metaplastic breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Testicular neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 606 at risk

Adverse event: Uterine leiomyosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 606 at risk

Adverse event: Brain compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Cerebellar syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Cerebral venous thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 606 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 606 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 65 affected / 606 at risk

Adverse event: Muscle spasticity
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Myasthenia gravis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Neurological symptom
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 606 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 606 at risk

Adverse event: Personality disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 606 at risk

Adverse event: Hypertonic bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 606 at risk

Adverse event: Renal cyst
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Urogenital fistula
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Vesicoureteric reflux
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 606 at risk

Adverse event: Adnexal torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 606 at risk

Adverse event: Endometrial hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 606 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 606 at risk

Adverse event: Ovarian adhesion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 606 at risk

Adverse event: Ovarian cyst ruptured
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 606 at risk

Adverse event: Pelvic organ prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 606 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Pharyngeal necrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Pulmonary sarcoidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 606 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 606 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Erythema nodosum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Hidradenitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Pemphigoid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Superficial inflammatory dermatosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Pityriasis rosea
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 606 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 606 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Rosacea
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Toxic skin eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 606 at risk

Adverse event: Abdominoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 606 at risk

Adverse event: Female sterilisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 606 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 606 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 606 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 606 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 606 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 606 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 606 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 43 affected / 606 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 606 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 606 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 125 affected / 606 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 606 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 606 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 606 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 606 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 114 affected / 606 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 606 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 48 affected / 606 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 48 affected / 606 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 30 affected / 606 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 606 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 606 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 606 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 606 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 169 affected / 606 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 38 affected / 606 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 606 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 606 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 606 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 606 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Anorectal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Lyme disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Erythema nodosum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Granulomatosis with polyangiitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 70 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 70 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 70 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 70 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 70 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 70 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 70 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 70 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 227 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 227 at risk

Adverse event: Inflammatory bowel disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Arthritis reactive
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 227 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 227 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 227 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Psoriatic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 227 at risk

Adverse event: Fibroadenoma of breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 227 at risk

Adverse event: Ovarian fibroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 227 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 227 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 227 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Toxic skin eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Immunosuppressant drug therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 227 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 227 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 227 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 227 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 227 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 227 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 227 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 227 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 227 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 227 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 227 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 227 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 227 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 227 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 227 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 227 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 6 affected / 227 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 227 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 227 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 227 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 227 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 227 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 227 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 227 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 227 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 227 at risk