Study: NCT01790659

Adverse event: Second degree burn: scalding water
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 201 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 201 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 201 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 201 at risk

Adverse event: Abdominal pain (upper)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 201 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 201 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 201 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 201 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 21 affected / 201 at risk

Adverse event: Application site erosion
Serious: no
Organ System: General disorders
Frequency: 4 affected / 201 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Application site injury
Serious: no
Organ System: General disorders
Frequency: 22 affected / 201 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 201 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 11 affected / 201 at risk

Adverse event: Mucosal erosion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 201 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 201 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 201 at risk

Adverse event: Cutaneous leishmaniasis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 201 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 201 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 201 at risk

Adverse event: Lymphangitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 201 at risk

Adverse event: Mucocutaneous leishmaniasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 126 affected / 201 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 201 at risk

Adverse event: Pyoderma
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 201 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 201 at risk

Adverse event: Superinfection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 201 at risk

Adverse event: Arthrpod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 201 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 201 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 201 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 201 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 201 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 201 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 201 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 201 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 201 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 201 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 201 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 99 affected / 201 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 60 affected / 201 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 201 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 201 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Infection of surgical site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 198 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 198 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 198 at risk

Adverse event: Abdominal pain (upper)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 198 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 198 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 198 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 13 affected / 198 at risk

Adverse event: Application site erosion
Serious: no
Organ System: General disorders
Frequency: 7 affected / 198 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 198 at risk

Adverse event: Application site injury
Serious: no
Organ System: General disorders
Frequency: 38 affected / 198 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 198 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 198 at risk

Adverse event: Mucosal erosion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 198 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 198 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 198 at risk

Adverse event: Cutaneous leishmaniasis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 198 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 198 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 198 at risk

Adverse event: Lymphangitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 198 at risk

Adverse event: Mucocutaneous leishmaniasis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 198 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 112 affected / 198 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 198 at risk

Adverse event: Pyoderma
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 198 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 198 at risk

Adverse event: Superinfection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 198 at risk

Adverse event: Arthrpod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 198 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 198 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 198 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 198 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 198 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 198 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 198 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 198 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 198 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 198 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 198 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 198 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 198 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 97 affected / 198 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 198 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 198 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 198 at risk