Study: NCT00894556

Adverse event: Vision blurred - Treatment Phase
Serious: no
Organ System: Eye disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Abdominal pain upper - Treatment Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 2 affected / 102 at risk

Adverse event: Diarrhoea - Treatment Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Nausea - Treatment Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 4 affected / 102 at risk

Adverse event: Fatigue - Treatment Phase
Serious: no
Organ System: General disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Feeling of relaxation - Treatment Phase
Serious: no
Organ System: General disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Influenza like illness - Treatment Phase
Serious: no
Organ System: General disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Sensation of pressure - Treatment Phase
Serious: no
Organ System: General disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Facial bones fracture - Treatment Phase
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Wrist fracture - Treatment Phase
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Myokymia - Treatment Phase
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Melanocytic naevus - Treatment Phase
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Dizziness - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 4 affected / 102 at risk

Adverse event: Dysgeusia - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Paraesthesia - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 2 affected / 102 at risk

Adverse event: Sinus headache - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Somnolence - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 2 affected / 102 at risk

Adverse event: Syncope - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Insomnia - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Hot flush - Treatment Phase
Serious: no
Organ System: Vascular disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 102 at risk

Adverse event: Eyelid ptosis - Treatment Phase
Serious: no
Organ System: Eye disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 100 at risk

Adverse event: Abdominal pain upper - Treatment Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 100 at risk

Adverse event: Gait disturbance - Treatment Phase
Serious: no
Organ System: General disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 100 at risk

Adverse event: Cognitive disorder - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 100 at risk

Adverse event: Dizziness - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 100 at risk

Adverse event: Paraesthesia - Treatment Phase
Serious: no
Organ System: Nervous system disorders
Notes: Post-Randomization reported Adverse Event
Frequency: 1 affected / 100 at risk

Adverse event: Tachycardia - Baseline Phase
Serious: no
Organ System: Cardiac disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Motion Sickness - Baseline Phase
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Eyelid Pain - Baseline Phase
Serious: no
Organ System: Eye disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Abdominal pain - Baseline Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Abdominal pain upper - Baseline Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 2 affected / 194 at risk

Adverse event: Dry mouth - Baseline Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 2 affected / 194 at risk

Adverse event: Nausea - Baseline Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 4 affected / 194 at risk

Adverse event: Paraesthesia oral - Baseline Phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 2 affected / 194 at risk

Adverse event: Asthenia - Baseline Phase
Serious: no
Organ System: General disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Chest discomfort - Baseline Phase
Serious: no
Organ System: General disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 3 affected / 194 at risk

Adverse event: Fatigue - Baseline Phase
Serious: no
Organ System: General disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 2 affected / 194 at risk

Adverse event: Oedema peripheral - Baseline Phase
Serious: no
Organ System: General disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Pain - Baseline Phase
Serious: no
Organ System: General disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Hordeolum - Baseline Phase
Serious: no
Organ System: Infections and infestations
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Nasopharyngitis - Baseline Phase
Serious: no
Organ System: Infections and infestations
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Rhinitis - Baseline Phase
Serious: no
Organ System: Infections and infestations
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Foot fracture - Baseline Phase
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Heart rate increased - Baseline Phase
Serious: no
Organ System: Investigations
Notes: Pre-Randomization reported Adverse Event
Frequency: 2 affected / 194 at risk

Adverse event: Back pain - Baseline Phase
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Muscle spasms - Baseline Phase
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Muscle tightness - Baseline Phase
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Neck pain - Baseline Phase
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Cognitive disorder - Baseline Phase
Serious: no
Organ System: Nervous system disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Dizziness - Baseline Phase
Serious: no
Organ System: Nervous system disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 9 affected / 194 at risk

Adverse event: Headache - Baseline Phase
Serious: no
Organ System: Nervous system disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 3 affected / 194 at risk

Adverse event: Migraine - Baseline Phase
Serious: no
Organ System: Nervous system disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Paraesthesia - Baseline Phase
Serious: no
Organ System: Nervous system disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 3 affected / 194 at risk

Adverse event: Sinus headache - Baseline Phase
Serious: no
Organ System: Nervous system disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Anxiety - Baseline Phase
Serious: no
Organ System: Psychiatric disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Insomnia - Baseline Phase
Serious: no
Organ System: Psychiatric disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Metrorrhagia - Baseline Phase
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Dyspnoea - Baseline Phase
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk

Adverse event: Throat tightness - Baseline Phase
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 2 affected / 194 at risk

Adverse event: Hot flush - Baseline Phase
Serious: no
Organ System: Vascular disorders
Notes: Pre-Randomization reported Adverse Event
Frequency: 1 affected / 194 at risk