Study: NCT00370682

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 19 affected / 40 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 16 affected / 40 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 9 affected / 40 at risk

Adverse event: Abdonimal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 3 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 1
Frequency: 4 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 25 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 13 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 1
Frequency: 22 affected / 40 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 1
Frequency: 15 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 6 affected / 40 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Dose 1
Frequency: 15 affected / 40 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Dose 1
Frequency: 3 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 6 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 7 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 2
Frequency: 2 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 16 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 9 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 2
Frequency: 18 affected / 40 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 2
Frequency: 12 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 2 affected / 40 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Dose 2
Frequency: 8 affected / 40 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Dose 2
Frequency: 1 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 5 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 3 affected / 40 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tympanic membrane disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Consitpation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 40 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Eptopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal wall hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 10 affected / 40 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 15 affected / 40 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 6 affected / 40 at risk

Adverse event: Abdonimal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 3 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 1
Frequency: 3 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 16 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 10 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 1
Frequency: 10 affected / 40 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 1
Frequency: 9 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 1 affected / 40 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Dose 1
Frequency: 7 affected / 40 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Dose 1
Frequency: 1 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 5 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 3 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 2
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 6 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 9 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 2
Frequency: 4 affected / 40 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 2
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 1 affected / 40 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Dose 2
Frequency: 1 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 2 affected / 40 at risk

Adverse event: Vomitng
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 1 affected / 40 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 40 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 40 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Venipuncture
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 40 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 10 affected / 40 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 9 affected / 40 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 5 affected / 40 at risk

Adverse event: Abdonimal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 3 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 1
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 14 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Dose 1
Frequency: 10 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 1
Frequency: 11 affected / 40 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 1
Frequency: 9 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 3 affected / 40 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Dose 1
Frequency: 7 affected / 40 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Dose 1
Frequency: 1 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 4 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1
Frequency: 2 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 1
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 2 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 7 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Dose 2
Frequency: 6 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dose 2
Frequency: 8 affected / 40 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dose 2
Frequency: 4 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dose 2
Frequency: 1 affected / 40 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Dose 2
Frequency: 3 affected / 40 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Dose 2
Frequency: 2 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 4 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2
Frequency: 2 affected / 40 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Consitpation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tooth impacted
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 40 at risk