Study: NCT02892955

Adverse event: Protocol defined bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 802 affected / 1685 at risk

Adverse event: Protocol defined hemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 6 affected / 1685 at risk

Adverse event: Protocol defined cardiac arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 473 affected / 1685 at risk

Adverse event: Protocol defined myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 15 affected / 1685 at risk

Adverse event: Protocol defined pericardial fluid collection
Serious: yes
Organ System: Cardiac disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 96 affected / 1685 at risk

Adverse event: Protocol defined right heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 541 affected / 1685 at risk

Adverse event: Protocol defined other adverse event
Serious: yes
Organ System: General disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 1084 affected / 1685 at risk

Adverse event: Protocol defined hepatic dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 58 affected / 1685 at risk

Adverse event: Protocol defined major infection
Serious: yes
Organ System: Infections and infestations
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 862 affected / 1685 at risk

Adverse event: Protocol defined stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 153 affected / 1685 at risk

Adverse event: Protocol defined other neurological event
Serious: yes
Organ System: Nervous system disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 202 affected / 1685 at risk

Adverse event: Protocol defined suspected device thrombosis
Serious: yes
Organ System: Product Issues
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 18 affected / 1685 at risk

Adverse event: Protocol defined psychiatric episode
Serious: yes
Organ System: Psychiatric disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 73 affected / 1685 at risk

Adverse event: Protocol defined renal dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 231 affected / 1685 at risk

Adverse event: Protocol defined respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 325 affected / 1685 at risk

Adverse event: Protocol defined wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 10 affected / 1685 at risk

Adverse event: Protocol defined arterial non-CNS thromboembolism
Serious: yes
Organ System: Vascular disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 21 affected / 1685 at risk

Adverse event: Protocol defined hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 45 affected / 1685 at risk

Adverse event: Protocol defined venous thromboembolism
Serious: yes
Organ System: Vascular disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 30 affected / 1685 at risk

Adverse event: Protocol defined bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 107 affected / 1685 at risk

Adverse event: Protocol defined cardiac arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 135 affected / 1685 at risk

Adverse event: Protocol defined major infection
Serious: no
Organ System: Infections and infestations
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 267 affected / 1685 at risk

Adverse event: Protocol defined psychiatric episode
Serious: no
Organ System: Psychiatric disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 94 affected / 1685 at risk

Adverse event: Protocol defined right heart failure
Serious: no
Organ System: Cardiac disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 107 affected / 1685 at risk

Adverse event: Protocol defined other adverse event
Serious: no
Organ System: General disorders
Notes: Events categorized based on detailed definition specified in the study protocol.
Frequency: 617 affected / 1685 at risk