Study: NCT03016169

Adverse event: MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 358 at risk

Adverse event: MAJOR BLEEDING - OTHER BLEEDING
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 358 at risk

Adverse event: Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 358 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 358 at risk

Adverse event: MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 358 at risk

Adverse event: NONSTRUCTURAL DYSFUNCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 83 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 358 at risk

Adverse event: Prosthetic cardiac valve malfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NEUROVASCULAR
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 358 at risk

Adverse event: MAJOR BLEEDING - GASTROINTESTINAL BLEED
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 358 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 358 at risk

Adverse event: MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 358 at risk

Adverse event: MAJOR BLEEDING - OTHER BLEEDING
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 358 at risk

Adverse event: OTHER NEUROVASCULAR
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 26 affected / 358 at risk

Adverse event: Embolism
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 358 at risk

Adverse event: MAJOR BLEEDING - OTHER BLEEDING
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NEUROVASCULAR
Serious: yes
Organ System: Nervous system disorders
Frequency: 20 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 358 at risk

Adverse event: OTHER NEUROVASCULAR
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 358 at risk

Adverse event: MAJOR BLEEDING - UROLOGIC BLEEDING
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 18 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 358 at risk

Adverse event: MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 358 at risk

Adverse event: MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 358 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 358 at risk

Adverse event: MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 358 at risk

Adverse event: MAJOR BLEEDING - OTHER BLEEDING
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 358 at risk

Adverse event: OTHER NEUROVASCULAR
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 358 at risk

Adverse event: NONSTRUCTURAL DYSFUNCTION
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 358 at risk

Adverse event: Prosthetic cardiac valve malfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 358 at risk

Adverse event: MAJOR BLEEDING - GASTROINTESTINAL BLEED
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: no
Organ System: General disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: General disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 358 at risk

Adverse event: Embolism
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NEUROVASCULAR
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 358 at risk

Adverse event: NONSTRUCTURAL DYSFUNCTION
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 358 at risk

Adverse event: MAJOR BLEEDING - OTHER BLEEDING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 358 at risk

Adverse event: OTHER CARDIOVASCULAR
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 358 at risk

Adverse event: OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 358 at risk