Study: NCT01171989

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 137 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 137 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 44 affected / 136 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 69 affected / 136 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 50 affected / 136 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 40 affected / 136 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 65 affected / 136 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 31 affected / 136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 34 affected / 136 at risk

Adverse event: Upper respiratory tract infection (unsolicited)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 137 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 137 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 137 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 68 affected / 133 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 77 affected / 133 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 58 affected / 133 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 39 affected / 133 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 65 affected / 133 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 32 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 30 affected / 133 at risk

Adverse event: Upper respiratory tract infection (unsolicited)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 133 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 133 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 133 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 121 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 58 affected / 120 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 69 affected / 120 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 50 affected / 120 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 39 affected / 120 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 66 affected / 120 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 43 affected / 120 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 31 affected / 120 at risk

Adverse event: Upper respiratory tract infection (unsolicited)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 121 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 121 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 121 at risk