Study: NCT00853099

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 96 at risk

Adverse event: Rectal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 96 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 96 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 96 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 96 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 96 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 96 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 96 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 96 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 96 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 96 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 96 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 96 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 96 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 96 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 96 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 96 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 96 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 96 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 87 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 87 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 87 at risk

Adverse event: Drug level
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 87 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Parathyroid tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 87 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 87 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 87 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 87 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 87 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 87 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 87 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 87 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 87 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 87 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 87 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 87 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 87 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 87 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 87 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 87 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 87 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 87 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 87 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 87 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Gastrointestinal dysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Gingivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 90 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 6 affected / 90 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 90 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 90 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 90 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 90 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 266 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 266 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 266 at risk

Adverse event: Sudden hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 266 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 266 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 266 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 266 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 266 at risk

Adverse event: Gastrointestinal dysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 266 at risk

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 266 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 266 at risk

Adverse event: Rectal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 266 at risk

Adverse event: Rectal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 266 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 266 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 266 at risk

Adverse event: Drug intolerance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 266 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 266 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 266 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 266 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 266 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 266 at risk

Adverse event: Bursitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 266 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 266 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Gingivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 266 at risk

Adverse event: Pseudomembranous colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 266 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 266 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 266 at risk

Adverse event: Heat illness
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 266 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 266 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 266 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 266 at risk

Adverse event: Drug level
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 266 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 266 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 266 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Joint range of motion decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Muscle haemorrhage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 266 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 266 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 266 at risk

Adverse event: Parathyroid tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 266 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 266 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 266 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 266 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 266 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 266 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 266 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 266 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 266 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 266 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 266 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 266 at risk

Adverse event: Erythema nodosum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 266 at risk

Adverse event: Immunosuppressant drug therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 266 at risk

Adverse event: Takayasu's arteritis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 266 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 266 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 266 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 266 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 266 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 266 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 266 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 25 affected / 266 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 266 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 266 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 266 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 266 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 266 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 162 affected / 266 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 266 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 266 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 266 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 266 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 266 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 266 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 266 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 266 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 266 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 266 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 266 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 266 at risk