Study: NCT00689611

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Deaths due to: coronary dissection, cardiac arrest (2), multisystem organ failure post-CABG, complications related to duodenal perforation and recurrent septic shock, ischemic event in the bowel or spinal cord.
Frequency: 6 affected / 200 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 200 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 200 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk

Adverse event: Psychiatric event
Serious: yes
Organ System: Psychiatric disorders
Notes: Includes delirium, hallucination, and suicidal ideation
Frequency: 1 affected / 200 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: Specific adverse event terms by treatment group are unknown.
Frequency: 17 affected / 200 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 200 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 18 affected / 200 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 17 affected / 200 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 200 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 200 at risk

Adverse event: Dream abnormality
Serious: no
Organ System: General disorders
Frequency: 17 affected / 200 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 200 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Deaths due to: coronary dissection, cardiac arrest (2), multisystem organ failure post-CABG, complications related to duodenal perforation and recurrent septic shock, ischemic event in the bowel or spinal cord.
Frequency: 9 affected / 192 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 192 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 192 at risk

Adverse event: Psychiatric event
Serious: yes
Organ System: Psychiatric disorders
Notes: Includes delirium, hallucination, and suicidal ideation
Frequency: 2 affected / 192 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: Specific adverse event terms by treatment group are unknown.
Frequency: 9 affected / 192 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 192 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 26 affected / 192 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 192 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 192 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 192 at risk

Adverse event: Dream abnormality
Serious: no
Organ System: General disorders
Frequency: 7 affected / 192 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 192 at risk