Study: NCT00518713

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Sedation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Metapneumovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 58 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 58 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 58 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 58 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 58 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 58 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 58 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 58 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 58 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 58 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 58 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 58 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 62 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Product administration error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Myoclonic epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 62 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 62 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 62 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 62 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 62 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 62 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 62 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 62 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 62 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 62 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 62 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 62 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ultrasound abdomen abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 59 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 59 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 59 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 59 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 59 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 59 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 59 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 59 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 59 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 59 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 59 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 59 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 59 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 59 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 59 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 59 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 59 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 59 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 59 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 59 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 59 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 59 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 59 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 59 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 59 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 59 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 59 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 59 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 59 at risk