Study: NCT00498628

Adverse event: Alcohol detoxification
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 105 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 105 at risk

Adverse event: Ruptured Spleen
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 105 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 105 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 105 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 105 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 105 at risk

Adverse event: Somnelence
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 105 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 105 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 105 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 105 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 105 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 105 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 105 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 105 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 105 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 105 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 105 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 10 affected / 105 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 105 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 105 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 105 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 105 at risk

Adverse event: Oropharynageal Pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 105 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 105 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 105 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 105 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 105 at risk

Adverse event: Mylagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 105 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 105 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 105 at risk

Adverse event: Alcohol detoxification
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 113 at risk

Adverse event: Behavioral Disturbance while intoxicated
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 113 at risk

Adverse event: Pre-ventricular contractions
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 113 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 113 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 113 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 113 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 113 at risk

Adverse event: Somnelence
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 113 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 49 affected / 113 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 113 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 113 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 113 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 113 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 113 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 113 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 113 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 113 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 113 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 113 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 113 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 8 affected / 113 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 113 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 113 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 113 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 113 at risk

Adverse event: Oropharynageal Pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 113 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 113 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 113 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 113 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 113 at risk

Adverse event: Mylagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 113 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 113 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 113 at risk