Study: NCT02241655

Adverse event: Bleeding/anemia requiring unexpected transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 614 at risk

Adverse event: Embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Thrombosis without embolus
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Other hematologic event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 614 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 614 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 614 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 614 at risk

Adverse event: Unexpected atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 614 at risk

Adverse event: Unexpected cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 614 at risk

Adverse event: Unexpected heart block
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 614 at risk

Adverse event: Unexpected hypo or hyperkelemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 614 at risk

Adverse event: Other endocrine or metabolic event
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 614 at risk

Adverse event: Nausea and/or vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 614 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 614 at risk

Adverse event: Ileus/bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 614 at risk

Adverse event: Other GI event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 614 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 614 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Immune system disorders
Frequency: 9 affected / 614 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 614 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Immune system disorders
Frequency: 11 affected / 614 at risk

Adverse event: Other immune or infectious event
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 614 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 614 at risk

Adverse event: Other neurological event
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 614 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 614 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 614 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 614 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 614 at risk

Adverse event: Respiratory Failures
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 614 at risk

Adverse event: Other respiratory event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 614 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 614 at risk

Adverse event: Renal failure requiring dialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 614 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 614 at risk

Adverse event: Other renal event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 614 at risk

Adverse event: Non-cardiogenic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 614 at risk

Adverse event: Unexpected hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 614 at risk

Adverse event: Other vascular event
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 614 at risk

Adverse event: Other body system event
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 614 at risk

Adverse event: Bleeding/anemia requiring unexpected transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 121 affected / 614 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 614 at risk

Adverse event: Thrombosis without embolus
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 614 at risk

Adverse event: Other hematologic event
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 614 at risk

Adverse event: Unexpected atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 73 affected / 614 at risk

Adverse event: Unexpected cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 614 at risk

Adverse event: Unexpected heart block
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 614 at risk

Adverse event: Other unexpected abnormal heart rhythms
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 614 at risk

Adverse event: Other cardiac event
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 614 at risk

Adverse event: Unexpected hypo or hyperkalemia
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 614 at risk

Adverse event: Unexpected hypo or hypernatremia
Serious: no
Organ System: Endocrine disorders
Frequency: 13 affected / 614 at risk

Adverse event: Other endocrine event
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 614 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 614 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 614 at risk

Adverse event: Ileus/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 614 at risk

Adverse event: Other GI event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 614 at risk

Adverse event: Large intestine infection
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 614 at risk

Adverse event: Non-anaphylactic allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 614 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Immune system disorders
Frequency: 20 affected / 614 at risk

Adverse event: Wound infection
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 614 at risk

Adverse event: Other immune event
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 614 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 614 at risk

Adverse event: Other neurological event
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 614 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 614 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 614 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 614 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 614 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 614 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 614 at risk

Adverse event: Respiratory Failures
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 614 at risk

Adverse event: Other respiratory event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 614 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 614 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 614 at risk

Adverse event: Other renal event
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 614 at risk

Adverse event: Non-cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 614 at risk

Adverse event: Unexpected hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 614 at risk

Adverse event: Unexpected hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 614 at risk

Adverse event: Other vascular event
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 614 at risk

Adverse event: Other body system event
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 614 at risk

Adverse event: Bleeding/anemia requiring unexpected transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 618 at risk

Adverse event: Embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 618 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Thrombosis without embolus
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 618 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 618 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 618 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 618 at risk

Adverse event: Unexpected atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 618 at risk

Adverse event: Unexpected cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 618 at risk

Adverse event: Unexpected heart block
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 618 at risk

Adverse event: Other unexpected abnormal heart rhythms
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 618 at risk

Adverse event: Unexpected hypo or hypernatremia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 618 at risk

Adverse event: Other endocrine or metabolic event
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 618 at risk

Adverse event: Anastomotic leak
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 618 at risk

Adverse event: Nausea and/or vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 618 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 618 at risk

Adverse event: Ileus/bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 618 at risk

Adverse event: Other GI event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 618 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 618 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Immune system disorders
Frequency: 11 affected / 618 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Immune system disorders
Frequency: 13 affected / 618 at risk

Adverse event: Other immune or infectious event
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 618 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 618 at risk

Adverse event: Other neurological event
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 618 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 618 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 618 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 618 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 618 at risk

Adverse event: Respiratory Failures
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 618 at risk

Adverse event: Other respiratory event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 618 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 618 at risk

Adverse event: Renal failure requiring dialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 618 at risk

Adverse event: Other renal event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 618 at risk

Adverse event: Non-cardiogenic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 618 at risk

Adverse event: Unexpected hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 618 at risk

Adverse event: Other vascular event
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 618 at risk

Adverse event: Other body system event
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 14 affected / 618 at risk

Adverse event: Bleeding/anemia requiring unexpected transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 126 affected / 618 at risk

Adverse event: Embolism
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 618 at risk

Adverse event: Thrombosis without embolus
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 618 at risk

Adverse event: Other hematologic event
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 618 at risk

Adverse event: Unexpected atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 97 affected / 618 at risk

Adverse event: Unexpected cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 618 at risk

Adverse event: Unexpected heart block
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 618 at risk

Adverse event: Other unexpected abnormal heart rhythms
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 618 at risk

Adverse event: Other cardiac event
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 618 at risk

Adverse event: unexpected hypo or hyperglycemia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 618 at risk

Adverse event: Unexpected hypo or hyperkalemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 618 at risk

Adverse event: Unexpected hypo or hypernatremia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 618 at risk

Adverse event: Other endocrine event
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 618 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 618 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 618 at risk

Adverse event: Ileus/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 618 at risk

Adverse event: Other GI event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 618 at risk

Adverse event: Large intestine infection
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 618 at risk

Adverse event: Non-anaphylactic allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Sepsis
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 618 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 618 at risk

Adverse event: Wound infection
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 618 at risk

Adverse event: Other immune event
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 618 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 618 at risk

Adverse event: Other neurological event
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 618 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 618 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 618 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 618 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 618 at risk

Adverse event: Respiratory Failures
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 618 at risk

Adverse event: Other respiratory event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 618 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 618 at risk

Adverse event: Renal failure requiring dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 618 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 618 at risk

Adverse event: Other renal event
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 618 at risk

Adverse event: Non-cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 618 at risk

Adverse event: Unexpected hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 618 at risk

Adverse event: Unexpected hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 618 at risk

Adverse event: Other vascular event
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 618 at risk

Adverse event: Other body system event
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 618 at risk