Study: NCT00824850

Adverse event: Lymphoid tissue hyperplasia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Gastritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 38 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 38 at risk

Adverse event: Tenderness: Significant
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Redness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Fever ≥38 degrees C but ≤39 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Decreased appetite: Mild
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Frequency: 10 affected / 38 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Increased sleep: Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Decreased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Decreased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Rash: Mild
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Congenital flat feet
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 36 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Avulsion fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Patellofemoral pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 36 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Tenderness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 36 at risk

Adverse event: Tenderness: Significant
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 36 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Redness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Decreased appetite: Mild
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Decreased appetite: Moderate
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Irritability: Mild
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Irritability: Moderate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Frequency: 12 affected / 36 at risk

Adverse event: Increased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Increased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Decreased sleep: Mild
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Decreased sleep: Moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk