Study: NCT00611130

Adverse event: Drug Abuse & Major Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 92 at risk

Adverse event: Gun shot wound, road traffic accident & tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 92 at risk

Adverse event: Hepatitis, acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 92 at risk

Adverse event: Meningitis & Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 92 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 92 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 92 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 92 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 92 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 92 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 92 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 92 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 92 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 92 at risk

Adverse event: Alanine aminotransferase decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 92 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 92 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 92 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 92 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 92 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 92 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 92 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 92 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 94 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 94 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 94 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 94 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 94 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 94 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 94 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 94 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 94 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 94 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 94 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 94 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 94 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 94 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 94 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 94 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 94 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 94 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 94 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 94 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 94 at risk