Study: NCT02077140

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 36 at risk

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

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 36 at risk

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

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

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

Adverse event: Post procedural cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

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

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

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

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

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

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

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

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

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 36 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

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

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

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

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

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

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

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

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

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

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 36 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 36 at risk

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

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

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

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

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

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

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

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

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

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

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

Adverse event: Nasopharyngitis
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: 1 affected / 36 at risk

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

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

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

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

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

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 36 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

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

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

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 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: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 36 at risk

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

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 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: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 36 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 36 at risk

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

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

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

Adverse event: Allergy to animal
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 36 at risk

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

Adverse event: Post procedural cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

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

Adverse event: Incision site haemorrhage
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: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

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

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

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

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 36 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Urinary tract disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal 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: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

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

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

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

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

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 36 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 36 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 36 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 36 at risk

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

Adverse event: Hyperaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system 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: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

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

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

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

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

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 36 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 36 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 48 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Infusion site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Post procedural cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 48 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 48 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 48 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 48 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk