Study: NCT00254488

Adverse event: Psychiatric condition worsening
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychiatric Hospitalization due to worsening condition
Frequency: 9 affected / 112 at risk

Adverse event: Circulatory condition
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 112 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Medical intervention for Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Increased creatine level
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Unsteady gait with a subsequent fall, increased confusion and tremulousness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 112 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 112 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Nausea and vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Elevated glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 112 at risk

Adverse event: Cardiac change
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 112 at risk

Adverse event: Calcium deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Change in Thyroid level
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 112 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 112 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 112 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 112 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 112 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 112 at risk

Adverse event: Change in Amylase and Lipase lab values
Serious: no
Organ System: Investigations
Frequency: 6 affected / 112 at risk

Adverse event: Increased creatine level in lab work
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 112 at risk

Adverse event: Worsening psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 112 at risk

Adverse event: Urinary dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 112 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 112 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 112 at risk

Adverse event: Vision disturbance
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 112 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 112 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 112 at risk

Adverse event: Decreased need for sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Memory Change
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 112 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 112 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Sinus tension
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Psychiatric condition worsening
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychiatric Hospitalization due to worsening condition
Frequency: 11 affected / 112 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Circulatory condition
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 112 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Notes: One completed suicide after study completion
Frequency: 1 affected / 112 at risk

Adverse event: Hospitalization for rectal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hospitalization for cellulitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hospitalization for Urinary Tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Medical intervention for Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Medical complications due to alcohol abuse
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Decrease in sodium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Cardiac change
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 112 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 112 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 112 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 112 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 112 at risk

Adverse event: Change in pre existing high blood pressure
Serious: no
Organ System: Investigations
Frequency: 2 affected / 112 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 112 at risk

Adverse event: laboratory finding Increased liver enzymes
Serious: no
Organ System: Investigations
Frequency: 3 affected / 112 at risk

Adverse event: laboratory findings increased white blood count
Serious: no
Organ System: Investigations
Frequency: 3 affected / 112 at risk

Adverse event: Worsening psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 112 at risk

Adverse event: Elevated blood levels
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 112 at risk

Adverse event: Urinary dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 112 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 112 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 112 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 112 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 112 at risk

Adverse event: Decreased need for sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Memory Change
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 112 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Sinus tension
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk