Study: NCT00117325

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 173 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 173 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 173 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 173 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 173 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 173 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 173 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 173 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 173 at risk

Adverse event: Nasal septum ulceration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Nasal ulcer
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 173 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Tongue haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 173 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 173 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 173 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 173 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 173 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 173 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 173 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 173 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 173 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 173 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 173 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 173 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 173 at risk

Adverse event: Tympanic membrane disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 173 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 173 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 173 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 173 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 173 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 173 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 173 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 173 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 173 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 173 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 173 at risk

Adverse event: Biliary colic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 173 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 173 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 179 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 179 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 179 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 179 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 179 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 179 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 179 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 179 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 179 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 179 at risk

Adverse event: Anal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 179 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 179 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 179 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 179 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Nasal mucosal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Nasal polyps
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 179 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Tongue ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 179 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 179 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 179 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 179 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 179 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 179 at risk

Adverse event: Lacrimation decreased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 179 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 179 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 179 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 179 at risk

Adverse event: Ill-defined disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 179 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 179 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 179 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 179 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 179 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 179 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 179 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 179 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: no
Organ System: Investigations
Frequency: 1 affected / 179 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 179 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 179 at risk