Study: NCT01761292

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 12 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Non cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk

Adverse event: Autoimmune thyroiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 19 at risk

Adverse event: Secondary adrenocartical insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 19 at risk

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Non cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Legament injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Legament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 19 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 19 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 12 at risk

Adverse event: Lens discolouration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 12 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Tendinous contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Tendon pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Solar dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cushing's syndrome
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Femural fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Left ventricular dilatation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Left ventricular disfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gilbert's syndrome
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 20 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Autoimmune thyroiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Delayed puberty
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 20 at risk

Adverse event: Secondary adrenocartical insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk

Adverse event: Lens discolouration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 20 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 20 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 20 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Non cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 20 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 20 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 20 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 20 at risk

Adverse event: Femur fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Legament injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Legament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 20 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 20 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Compression fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Spinal cord injury sacral
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Tendon injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Tibia fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 20 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 20 at risk

Adverse event: Hypertryglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fracture pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Tendinous contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Tendon pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Erythema annulare
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nail dystrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Solar dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 20 at risk