Study: NCT00666757

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 372 at risk

Adverse event: Temporal lobe epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 372 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 372 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 372 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 372 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 372 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 372 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 372 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 372 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 372 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 372 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 372 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 372 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 372 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 372 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 372 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 372 at risk

Adverse event: Anorgasmia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 372 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 372 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 372 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 157 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 157 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 157 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 157 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 157 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 157 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 157 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 157 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 157 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 157 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 157 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 157 at risk

Adverse event: Anorgasmia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 157 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 157 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 57 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 57 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 57 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 57 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 57 at risk

Adverse event: Anorgasmia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 57 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Anorgasmia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 119 at risk

Adverse event: Post-traumatic stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 119 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 119 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 119 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 119 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 119 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 119 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 119 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 119 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 119 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 119 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 119 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 119 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 119 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 119 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 119 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 119 at risk