Study: NCT00489827

Adverse event: Stroke < 24 hours
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke within 24 hours of surgery
Frequency: 4 affected / 428 at risk

Adverse event: Severe circulatory failure
Serious: yes
Organ System: Cardiac disorders
Notes: Postoperative heart failure according to prespecified criteria
Frequency: 10 affected / 428 at risk

Adverse event: Perioperative myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Troponin-T \> 2.0 μg/L on the third or fourth postoperative day
Frequency: 11 affected / 428 at risk

Adverse event: Cardiac mortality
Serious: yes
Organ System: Cardiac disorders
Notes: Death within 30 days or in hospital due to cardiac cause as determined by a blinded end-point committee
Frequency: 1 affected / 428 at risk

Adverse event: Postoperative dialysis
Serious: yes
Organ System: Renal and urinary disorders
Notes: New onset dialysis postoperatively
Frequency: 2 affected / 428 at risk

Adverse event: Reoperation for bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Reoperation for bleeding during the postoperative course
Frequency: 22 affected / 428 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection requiring surgery (mainly deep sternal wound infections)
Frequency: 4 affected / 428 at risk

Adverse event: Postoperative mortality
Serious: yes
Organ System: Surgical and medical procedures
Notes: All-cause mortality within 30 days of surgery
Frequency: 4 affected / 428 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Postoperative nausea as reported by attending nurse
Frequency: 139 affected / 428 at risk

Adverse event: Postoperative atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Postoperative atrial fibrillation recorded in the institutional database
Frequency: 147 affected / 428 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Postoperative infection not requiring surgery or extending hospital stay
Frequency: 33 affected / 428 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory problems (atelectasis, pleural effusion, respiratory discomfort, need for oxygen etc) reported but not extending hospital stay
Frequency: 39 affected / 428 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, itching or other skin reaction reported by attending nurse
Frequency: 3 affected / 428 at risk

Adverse event: Stroke < 24 hours
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke within 24 hours of surgery
Frequency: 6 affected / 433 at risk

Adverse event: Severe circulatory failure
Serious: yes
Organ System: Cardiac disorders
Notes: Postoperative heart failure according to prespecified criteria
Frequency: 18 affected / 433 at risk

Adverse event: Perioperative myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Troponin-T \> 2.0 μg/L on the third or fourth postoperative day
Frequency: 6 affected / 433 at risk

Adverse event: Cardiac mortality
Serious: yes
Organ System: Cardiac disorders
Notes: Death within 30 days or in hospital due to cardiac cause as determined by a blinded end-point committee
Frequency: 4 affected / 433 at risk

Adverse event: Postoperative dialysis
Serious: yes
Organ System: Renal and urinary disorders
Notes: New onset dialysis postoperatively
Frequency: 6 affected / 433 at risk

Adverse event: Reoperation for bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Reoperation for bleeding during the postoperative course
Frequency: 21 affected / 433 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection requiring surgery (mainly deep sternal wound infections)
Frequency: 8 affected / 433 at risk

Adverse event: Postoperative mortality
Serious: yes
Organ System: Surgical and medical procedures
Notes: All-cause mortality within 30 days of surgery
Frequency: 5 affected / 433 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Postoperative nausea as reported by attending nurse
Frequency: 114 affected / 433 at risk

Adverse event: Postoperative atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Postoperative atrial fibrillation recorded in the institutional database
Frequency: 152 affected / 433 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Postoperative infection not requiring surgery or extending hospital stay
Frequency: 27 affected / 433 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory problems (atelectasis, pleural effusion, respiratory discomfort, need for oxygen etc) reported but not extending hospital stay
Frequency: 45 affected / 433 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, itching or other skin reaction reported by attending nurse
Frequency: 7 affected / 433 at risk