Study: NCT01205152

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Congenital bowing of long bones
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 10 at risk

Adverse event: Craniosynostosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 10 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 10 at risk

Adverse event: Conductive deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Papilloedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Immediate post-injection reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chronic hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bacterial tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Stress fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Blood urea increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: CSF pressure
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Investigation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Selective eating disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Scoliosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Adenoidal disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Apnoeic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Restrictive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tonsillar disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Central venous catheter removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Tracheal fistula repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Tracheostomy tube removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 10 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Microcytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Craniosynostosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 10 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eustachian tube dysfunction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Middle ear disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Precocious puberty
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Conjunctival deposit
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Optic disc drusen
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Papilloedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gingival swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tooth loss
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Catheter site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site atrophy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site calcification
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Injection site hypertrophy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Injection site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

Adverse event: Vaccination site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abscess jaw
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: H1N1 influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Injection site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Lice infestation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 10 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 10 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Atypical pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 10 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Adverse event following immunisation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Foreign body
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Periorbital haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Procedural site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Scapula fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Tibia fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Tracheal haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood alkaline phosphatase abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Staphylococcus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Urine calcium/creatinine ratio increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Vitamin D decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Vitamin D increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Abnormal weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypophosphataemic osteomalacia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Mobility decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 10 at risk

Adverse event: Scoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Speech disorder developmental
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Abnormal behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anticipatory anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fear of injection
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nephrocalcinosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 10 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Renal pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Breast enlargement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Adenoidal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Increased upper airway secretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasal polyps
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Tonsillar disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tonsillar hypertrophy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Excessive granulation tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lipohypertrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 10 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urticaria contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 10 at risk