Study: NCT00968201

Adverse event: Drug Overdose (Period II)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 228 at risk

Adverse event: Dehydration (Period II)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 228 at risk

Adverse event: Bipolar Disorder (Period II)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 228 at risk

Adverse event: Asthma (Period II)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 228 at risk

Adverse event: Infection, Respiratory, Upper (Period II)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 228 at risk

Adverse event: Infiltrate, Pulmonary (Period II)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 228 at risk

Adverse event: Fever (Period II)
Serious: no
Organ System: General disorders
Frequency: 61 affected / 228 at risk

Adverse event: Pain, Abdominal (Period II)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 228 at risk

Adverse event: Diarrhea (Period II)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 228 at risk

Adverse event: Vomiting (Period II)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 228 at risk

Adverse event: Headache (Period II)
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 228 at risk

Adverse event: Asthma (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 228 at risk

Adverse event: Bronchitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 228 at risk

Adverse event: Cough (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 228 at risk

Adverse event: Infection, Respiratory (Period II)
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 228 at risk

Adverse event: Infection, Respiratory, Upper (Period II)
Serious: no
Organ System: Infections and infestations
Frequency: 63 affected / 228 at risk

Adverse event: Pharyngitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 228 at risk

Adverse event: Rhinitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 228 at risk

Adverse event: Rhinitis, Allergic (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 228 at risk

Adverse event: Rhinorrhea (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 228 at risk

Adverse event: Sinusitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 228 at risk

Adverse event: Tonsillitis (Period II)
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 228 at risk

Adverse event: Otitis (Period II)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 228 at risk

Adverse event: Otitis Media (Period II)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 228 at risk

Adverse event: Infection, Viral (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Allergy (Period III)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Asthma (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 157 at risk

Adverse event: Bronchoconstriction (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 157 at risk

Adverse event: Hypoxemia (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Pneumonia (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 157 at risk

Adverse event: Pneumonia, Bacterial (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Sinusitis (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Fever (Period III)
Serious: no
Organ System: General disorders
Frequency: 60 affected / 157 at risk

Adverse event: Infection, Viral (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 157 at risk

Adverse event: Pain, Abdominal (Period III)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 157 at risk

Adverse event: Trauma (Period III)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 157 at risk

Adverse event: Dental Caries (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 157 at risk

Adverse event: Diarrhea (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 157 at risk

Adverse event: Gastroenteritis (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 157 at risk

Adverse event: Vomiting (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 157 at risk

Adverse event: Allergy (Period III)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 157 at risk

Adverse event: Headache (Period III)
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 157 at risk

Adverse event: Asthma (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 96 affected / 157 at risk

Adverse event: Bronchitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 157 at risk

Adverse event: Congestion, Nasal (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 157 at risk

Adverse event: Cough (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 157 at risk

Adverse event: Epistaxis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 157 at risk

Adverse event: Infection, Respiratory (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 157 at risk

Adverse event: Infection, Respiratory, Upper (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 81 affected / 157 at risk

Adverse event: Influenza (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 157 at risk

Adverse event: Laryngitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 157 at risk

Adverse event: Pharyngitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 157 at risk

Adverse event: Pneumonia (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 157 at risk

Adverse event: Rhinitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 157 at risk

Adverse event: Rhinitis, Allergic (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 157 at risk

Adverse event: Rhinorrhea (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 157 at risk

Adverse event: Sinus Disorder (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 157 at risk

Adverse event: Sinusitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 157 at risk

Adverse event: Tonsillitis (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 157 at risk

Adverse event: Rash (Period III)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 157 at risk

Adverse event: Urticaria (Period III)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 157 at risk

Adverse event: Varicella (Period III)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 157 at risk

Adverse event: Conjunctivitis (Period III)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 157 at risk

Adverse event: Otitis (Period III)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 33 affected / 157 at risk

Adverse event: Otitis Media (Period III)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 35 affected / 157 at risk

Adverse event: Pain, Ear (Period III)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 157 at risk

Adverse event: Drug Overdose (Period II)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 461 at risk

Adverse event: Drug Overdose (Period III)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 364 at risk

Adverse event: Infection, Viral (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Pain, Abdominal (Period III)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 364 at risk

Adverse event: Trauma (Period III)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 364 at risk

Adverse event: Tachycardia (Period III)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 364 at risk

Adverse event: Appendicitis (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Gastroenteritis (Period II)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 461 at risk

Adverse event: Gastroenteritis, Infectious (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 364 at risk

Adverse event: Gastroesophageal Reflux (Period III)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 364 at risk

Adverse event: Infection, Intra-Abdominal (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Thirst (Period II)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 461 at risk

Adverse event: Thirst (Period III)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 364 at risk

Adverse event: Vomiting (Period III)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 364 at risk

Adverse event: Alkaline Phosphatase Increased (Period III)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 364 at risk

Adverse event: Dehydration (Period III)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 364 at risk

Adverse event: Hypokalemia (Period III)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 364 at risk

Adverse event: Concussion (Period III)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 364 at risk

Adverse event: Headache (Period III)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 364 at risk

Adverse event: Hyperkinesia (Period III)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 364 at risk

Adverse event: Hypersomnia (Period III)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 364 at risk

Adverse event: Meningitis (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Seizure Disorder (Period III)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 364 at risk

Adverse event: Somnolence (Period II)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 461 at risk

Adverse event: Somnolence (Period III)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 364 at risk

Adverse event: Tremor (Period III)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 364 at risk

Adverse event: Apnea (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 364 at risk

Adverse event: Asthma (Period II)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 461 at risk

Adverse event: Asthma (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 364 at risk

Adverse event: Bronchoconstriction (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 364 at risk

Adverse event: Hypoxemia (Period III)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 364 at risk

Adverse event: Infection, Respiratory, Upper (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Pneumonia (Period II)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 461 at risk

Adverse event: Pneumonia (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 364 at risk

Adverse event: Pneumonia, Viral (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Pallor (Period III)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 364 at risk

Adverse event: Infection, Eyelid (Period III)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Mydriasis (Period II)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 461 at risk

Adverse event: Anomaly, Urogenital (Period III)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 364 at risk

Adverse event: Fever (Period II)
Serious: no
Organ System: General disorders
Frequency: 125 affected / 461 at risk

Adverse event: Fever (Period III)
Serious: no
Organ System: General disorders
Frequency: 164 affected / 364 at risk

Adverse event: Infection, Viral (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 364 at risk

Adverse event: Pain, Abdominal (Period II)
Serious: no
Organ System: General disorders
Frequency: 51 affected / 461 at risk

Adverse event: Pain, Abdominal (Period III)
Serious: no
Organ System: General disorders
Frequency: 46 affected / 364 at risk

Adverse event: Trauma (Period III)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 364 at risk

Adverse event: Dental Caries (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 364 at risk

Adverse event: Diarrhea (Period II)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 461 at risk

Adverse event: Diarrhea (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 364 at risk

Adverse event: Gastroenteritis (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 364 at risk

Adverse event: Vomiting (Period II)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 461 at risk

Adverse event: Vomiting (Period III)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 364 at risk

Adverse event: Allergy (Period III)
Serious: no
Organ System: Immune system disorders
Frequency: 22 affected / 364 at risk

Adverse event: Headache (Period II)
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 461 at risk

Adverse event: Headache (Period III)
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 364 at risk

Adverse event: Asthma (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 130 affected / 461 at risk

Adverse event: Asthma (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 217 affected / 364 at risk

Adverse event: Bronchitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 461 at risk

Adverse event: Bronchitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 364 at risk

Adverse event: Congestion, Nasal (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 364 at risk

Adverse event: Cough (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 461 at risk

Adverse event: Cough (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 97 affected / 364 at risk

Adverse event: Epistaxis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 364 at risk

Adverse event: Infection, Respiratory (Period II)
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 461 at risk

Adverse event: Infection, Respiratory (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 364 at risk

Adverse event: Infection, Respiratory, Upper (Period II)
Serious: no
Organ System: Infections and infestations
Frequency: 123 affected / 461 at risk

Adverse event: Infection, Respiratory, Upper (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 192 affected / 364 at risk

Adverse event: Influenza (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 364 at risk

Adverse event: Laryngitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 364 at risk

Adverse event: Pharyngitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 461 at risk

Adverse event: Pharyngitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 120 affected / 364 at risk

Adverse event: Pneumonia (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 364 at risk

Adverse event: Rhinitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 461 at risk

Adverse event: Rhinitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 364 at risk

Adverse event: Rhinitis, Allergic (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 461 at risk

Adverse event: Rhinitis, Allergic (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 364 at risk

Adverse event: Rhinorrhea (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 461 at risk

Adverse event: Rhinorrhea (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 364 at risk

Adverse event: Sinus Disorder (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 364 at risk

Adverse event: Sinusitis (Period II)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 461 at risk

Adverse event: Sinusitis (Period III)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 364 at risk

Adverse event: Tonsillitis (Period II)
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 461 at risk

Adverse event: Tonsillitis (Period III)
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 364 at risk

Adverse event: Rash (Period III)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 364 at risk

Adverse event: Urticaria (Period III)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 364 at risk

Adverse event: Varicella (Period III)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 364 at risk

Adverse event: Conjunctivitis (Period III)
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 364 at risk

Adverse event: Otitis (Period II)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 29 affected / 461 at risk

Adverse event: Otitis (Period III)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 62 affected / 364 at risk

Adverse event: Otitis Media (Period II)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 36 affected / 461 at risk

Adverse event: Otitis Media (Period III)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 84 affected / 364 at risk

Adverse event: Pain, Ear (Period III)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 25 affected / 364 at risk