Study: NCT00666224

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 238 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 238 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 238 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 238 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 238 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 238 at risk

Adverse event: Fistula
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 238 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 238 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 238 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Cluster headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 238 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 238 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 238 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 238 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 238 at risk

Adverse event: Anal fissure excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 238 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 238 at risk

Adverse event: Breast reconstruction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 238 at risk

Adverse event: Endometrial ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 238 at risk

Adverse event: Nail operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 238 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 238 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 238 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 238 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 238 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 238 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 238 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 22 affected / 238 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 238 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 238 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 238 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 238 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 238 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 238 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 238 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 238 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 238 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 238 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 238 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 238 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 238 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 238 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 238 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 238 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 238 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 238 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 238 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 238 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 238 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 238 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 238 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 238 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 238 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 238 at risk

Adverse event: Abdominal tenderness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 243 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 243 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 243 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 243 at risk

Adverse event: Visual field tests abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 243 at risk

Adverse event: Cholesteatoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 243 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 243 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 243 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 243 at risk

Adverse event: Cholesteatoma removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 243 at risk

Adverse event: Skin neoplasm excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 243 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 243 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 243 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 243 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 243 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 243 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 13 affected / 243 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 243 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 72 affected / 243 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 16 affected / 243 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 25 affected / 243 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 54 affected / 243 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 31 affected / 243 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 25 affected / 243 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 24 affected / 243 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 243 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 243 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 243 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 243 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 243 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 243 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 243 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 243 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 243 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 243 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 243 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 243 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 243 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 243 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 243 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 243 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 243 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 243 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 243 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 243 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 243 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 454 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 454 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 454 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 454 at risk

Adverse event: Abdominal tenderness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 454 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 454 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 454 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 454 at risk

Adverse event: Feeling hot
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 454 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 454 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 454 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 454 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 454 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 454 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 454 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 454 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Avulsion fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 454 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 454 at risk

Adverse event: Visual field tests abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 454 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 454 at risk

Adverse event: Cholesteatoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 454 at risk

Adverse event: Rectal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 454 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 454 at risk

Adverse event: Cerebral venous sinus thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 454 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 454 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 454 at risk

Adverse event: Imminent abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 454 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 454 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 454 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 454 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 454 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 454 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 454 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 454 at risk

Adverse event: Bladder neoplasm surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 454 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 454 at risk

Adverse event: Cholesteatoma removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 454 at risk

Adverse event: Haemorrhoid operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 454 at risk

Adverse event: Lipoma excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 454 at risk

Adverse event: Proctectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 454 at risk

Adverse event: Skin neoplasm excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 454 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 454 at risk

Adverse event: Flushing
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 454 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 454 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 454 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 454 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 454 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 454 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 454 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 25 affected / 454 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 454 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 140 affected / 454 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 22 affected / 454 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 45 affected / 454 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 105 affected / 454 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 58 affected / 454 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 41 affected / 454 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 53 affected / 454 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 454 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 454 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 454 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 94 affected / 454 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 454 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 454 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 454 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 454 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 454 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 454 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 454 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 454 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 454 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 80 affected / 454 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 454 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 454 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 454 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 454 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 454 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 454 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 454 at risk