Study: NCT01897766

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 482 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 482 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Bone neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 482 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 482 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 482 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 482 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 482 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 482 at risk

Adverse event: Upper respiratory tract inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 482 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Scoliosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 482 at risk

Adverse event: Synovial disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 482 at risk

Adverse event: Condition aggravated
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 482 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 482 at risk

Adverse event: Snake bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 482 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 482 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 482 at risk

Adverse event: Arnold-Chiari malformation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 482 at risk

Adverse event: Congenital musculoskeletal disorder of spine
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 482 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 482 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 482 at risk

Adverse event: Thyroiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 482 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 482 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 482 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 482 at risk

Adverse event: Pigmentation lip
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 482 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 482 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 482 at risk

Adverse event: Injection site urticaria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 482 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 482 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 482 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Adenoviral upper respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 482 at risk

Adverse event: Bronchitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Dermatitis infected
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Erythema infectiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 482 at risk

Adverse event: H1N1 influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 482 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 482 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 482 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 482 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 482 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Parotitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 482 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 482 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 482 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Tracheobronchitis mycoplasmal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 482 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 482 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 482 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 482 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 482 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 482 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 482 at risk

Adverse event: Blood thyroid stimulating hormone decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Body mass index increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Glucose urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Insulin-like growth factor increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 482 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 482 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 482 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 482 at risk

Adverse event: Hyperinsulinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 482 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 482 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 482 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 482 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 482 at risk

Adverse event: Scoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 482 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 482 at risk

Adverse event: Neurofibroma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 482 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Orthostatic intolerance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 482 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 482 at risk

Adverse event: Autism spectrum disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 482 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 482 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 482 at risk

Adverse event: Orthostatic proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 482 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 482 at risk

Adverse event: Renal glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 482 at risk

Adverse event: Renal haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 482 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 482 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 482 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 482 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 482 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 482 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 482 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 482 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 482 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 482 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 482 at risk

Adverse event: Oral surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 482 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 482 at risk