Study: NCT00401986

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 3 affected / 14 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 5 affected / 14 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 14 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 5 affected / 14 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Vessel puncture site thrombosis
Serious: no
Organ System: General disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Gastritis viral
Serious: no
Organ System: Infections and infestations
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Sudden death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Asthma prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 7 affected / 14 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 3 affected / 14 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 4 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 14 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 14 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Asthma prophylaxis
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Respiratory
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Respiratory
Frequency: 2 affected / 12 at risk

Adverse event: Asthma prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 12 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 5 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 12 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Gastroenteritis bacterial
Serious: no
Organ System: Infections and infestations
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Respiratory
Frequency: 2 affected / 12 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Asthma prophylaxis
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 4 affected / 12 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 7 affected / 12 at risk

Adverse event: Lower respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 12 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Post-traumatic neck syndrome
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Non-Respiratory
Frequency: 1 affected / 12 at risk