Study: NCT00946998

Adverse event: Dialysis initiation
Serious: yes
Organ System: Renal and urinary disorders
Notes: Initiation of chronic dialysis
Frequency: 7 affected / 97 at risk

Adverse event: Hospitalization other than for dialysis initiation
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 97 at risk

Adverse event: Bleeding requiring a blood transfusion or hospitalization
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Nausea, indigestion, or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 97 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 97 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 9 affected / 97 at risk

Adverse event: Decreased memory or confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Dizziness, syncope, or fall
Serious: no
Organ System: General disorders
Frequency: 8 affected / 97 at risk

Adverse event: Anxiety, irritability, or agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 97 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 97 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 97 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 97 at risk

Adverse event: Decrease libido or erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 97 at risk

Adverse event: Dialysis initiation
Serious: yes
Organ System: Renal and urinary disorders
Notes: Initiation of chronic dialysis
Frequency: 5 affected / 96 at risk

Adverse event: Hospitalization other than for dialysis initiation
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 96 at risk

Adverse event: acute suicidal intent
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Bleeding requiring a blood transfusion or hospitalization
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 96 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Nausea, indigestion, or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 96 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 96 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 96 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 96 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 5 affected / 96 at risk

Adverse event: Decreased memory or confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 96 at risk

Adverse event: Dizziness, syncope, or fall
Serious: no
Organ System: General disorders
Frequency: 4 affected / 96 at risk

Adverse event: Anxiety, irritability, or agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 96 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 96 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 96 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Decrease libido or erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 96 at risk