Study: NCT00056472

Adverse event: worsening depression
Serious: yes
Organ System: Psychiatric disorders
Notes: worsening symptoms of depression requiring (re)hospitalization
Frequency: 9 affected / 129 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: leg pain/edema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 129 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 129 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 25 affected / 129 at risk

Adverse event: sleepiness/sedation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 129 at risk

Adverse event: increased lab values
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: triglycerides, cholesterol, LFTs
Frequency: 14 affected / 129 at risk

Adverse event: reduced sleep
Serious: no
Organ System: General disorders
Frequency: 4 affected / 129 at risk

Adverse event: pedal edema/edema
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 129 at risk

Adverse event: Increased fatigability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 129 at risk

Adverse event: increased sleep
Serious: no
Organ System: General disorders
Frequency: 4 affected / 129 at risk

Adverse event: increased dream activity
Serious: no
Organ System: General disorders
Frequency: 7 affected / 129 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 129 at risk

Adverse event: dizziness/feeling faint
Serious: no
Organ System: General disorders
Frequency: 5 affected / 129 at risk

Adverse event: nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 129 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: worsening depression
Serious: yes
Organ System: Psychiatric disorders
Notes: worsening symptoms of depression requiring (re)hospitalization
Frequency: 3 affected / 130 at risk

Adverse event: knee sepsis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 130 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 130 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 130 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 16 affected / 130 at risk

Adverse event: sleepiness/sedation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 130 at risk

Adverse event: increased lab values
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: triglycerides, cholesterol, LFTs
Frequency: 3 affected / 130 at risk

Adverse event: reduced sleep
Serious: no
Organ System: General disorders
Frequency: 7 affected / 130 at risk

Adverse event: pedal edema/edema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 130 at risk

Adverse event: Increased fatigability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 130 at risk

Adverse event: increased sleep
Serious: no
Organ System: General disorders
Frequency: 4 affected / 130 at risk

Adverse event: increased dream activity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 130 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 130 at risk

Adverse event: dizziness/feeling faint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 130 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 130 at risk

Adverse event: nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 130 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 130 at risk