Study: NCT00360009

Adverse event: Confusion/Disorientation/Difficulty Concentrating/Distractability
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pneumonia Resulting in Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hemorrhage Resulting in Death
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Depression/Tearful/Decreased Confidence/Loss of Motivation/Feelings of Guilt
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 26 at risk

Adverse event: Anxiety/Fearfulness/Preoccupation with Health
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 26 at risk

Adverse event: Difficulty with Speech and Language/Increased Speech
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 26 at risk

Adverse event: Confusion/Disorientation/Difficulty Concentrating/Distractibility
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 26 at risk

Adverse event: Irritability/Disruptive of Aggressive Behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 26 at risk

Adverse event: Obsessive-Compulsive Tendencies
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 26 at risk

Adverse event: Manic Tendencies
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 26 at risk

Adverse event: Worsening of Memory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Sleep Disturbance/Vivid Dreaming/Increased Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 26 at risk

Adverse event: Fatigue/Tired
Serious: no
Organ System: General disorders
Frequency: 11 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 26 at risk

Adverse event: Worsening of Balance/Gait Disturbance/Freezing
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 26 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dizziness/Lightheadedness/Orthostasis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Difficulty with Urination/Urinary Urgency/Distended Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain/Discomfort/Pruritus/Erythema at Sight of Incision
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Stomach Cramps/Constipation/Indegestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Cold/Low-grade Fever
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Confusion/Disorientation/Difficulty Concentrating/Distractability
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Symptomatic Hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Symptomatic Venous Hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Air Embolus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Anxiety/Feafulness/Preocupation with Health
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Depression/Tearful/Decreased Confidence/Loss of Motivation/Feelings of Guilt
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 26 at risk

Adverse event: Anxiety/Fearfulness/Preoccupation with Health
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 26 at risk

Adverse event: Difficulty with Speech and Language/Increased Speech
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 26 at risk

Adverse event: Confusion/Disorientation/Difficulty Concentrating/Distractibility
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 26 at risk

Adverse event: Irritability/Disruptive of Aggressive Behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 26 at risk

Adverse event: Obsessive-Compulsive Tendencies
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 26 at risk

Adverse event: Manic Tendencies
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Worsening of Memory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Sleep Disturbance/Vivid Dreaming/Increased Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Fatigue/Tired
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Worsening of Balance/Gait Disturbance/Freezing
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 26 at risk

Adverse event: Dizziness/Lightheadedness/Orthostasis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Difficulty with Urination/Urinary Urgency/Distended Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 26 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 26 at risk

Adverse event: Pain/Discomfort/Pruritus/Erythema at Sight of Incision
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Stomach Cramps/Constipation/Indegestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cold/Low-grade Fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk