Study: NCT00763971

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 111 at risk

Adverse event: Abdominal upper pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 111 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 111 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 111 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 111 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 111 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 4 affected / 111 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 111 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 111 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 111 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 111 at risk

Adverse event: Wrong product administered
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 111 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 111 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 111 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 111 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 111 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 111 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 111 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 111 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 111 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 111 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 111 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 111 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 111 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 111 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 111 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 111 at risk

Adverse event: Abdominal upper pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 111 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 111 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 111 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 111 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 111 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 4 affected / 111 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 111 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 111 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 111 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 111 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 111 at risk

Adverse event: Wrong product administered
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 111 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 111 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 111 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 111 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 111 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 111 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 111 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 111 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 111 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 111 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 111 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 111 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 111 at risk

Adverse event: Loss of conciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 110 at risk

Adverse event: Abdominal upper pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 110 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 110 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 110 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 110 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 110 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Wrong product administered
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 110 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 110 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 110 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 110 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 110 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 110 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 110 at risk