Study: NCT01628159

Adverse event: Infection, local
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 657 at risk

Adverse event: Infection (systemic)
Serious: yes
Organ System: Infections and infestations
Notes: Infection (systemic) requiring antibiotics.
Frequency: 1 affected / 657 at risk

Adverse event: Significant hemorrhage
Serious: yes
Organ System: General disorders
Notes: Access site: Significant hemorrhagic event requiring transfusion.
Frequency: 1 affected / 657 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Notes: Access site: Pseudoaneurysm
Frequency: 1 affected / 657 at risk

Adverse event: Target vessel injury
Serious: yes
Organ System: Vascular disorders
Notes: Angiographic event: Target vessel injury:/dissection with study treatment.
Frequency: 21 affected / 657 at risk

Adverse event: Distal embolization with study treatment
Serious: yes
Organ System: Vascular disorders
Notes: Angiographic event.
Frequency: 3 affected / 657 at risk

Adverse event: Distal embolization with post treatment
Serious: yes
Organ System: Vascular disorders
Notes: Angiographic event
Frequency: 1 affected / 657 at risk

Adverse event: Clot/Thrombus formation
Serious: yes
Organ System: Vascular disorders
Notes: Angiographic event: Thrombosis.
Frequency: 1 affected / 657 at risk

Adverse event: Other angiographic event
Serious: yes
Organ System: Vascular disorders
Notes: Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 1 affected / 657 at risk

Adverse event: Restenosis of study lesion
Serious: yes
Organ System: Vascular disorders
Notes: Vascular event
Frequency: 3 affected / 657 at risk

Adverse event: Arterial revascularisation
Serious: yes
Organ System: Vascular disorders
Notes: Vascular event: Clinically-driven target (study) lesion revascularization (TLR)
Frequency: 26 affected / 657 at risk

Adverse event: Target (study) vessel revascularization (TVR)
Serious: yes
Organ System: Vascular disorders
Notes: Vascular event
Frequency: 2 affected / 657 at risk

Adverse event: Target (study) limb ishchemia
Serious: yes
Organ System: Vascular disorders
Notes: Vascular event
Frequency: 1 affected / 657 at risk

Adverse event: Other vascular event
Serious: yes
Organ System: Vascular disorders
Notes: Not specified. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 1 affected / 657 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Notes: Vascular event
Frequency: 11 affected / 657 at risk

Adverse event: Arrhytmia
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 657 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 657 at risk

Adverse event: Other cardiovascular events
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular events, not specified. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 67 affected / 657 at risk

Adverse event: Gastrointestinal events (other)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal events, not specified. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 79 affected / 657 at risk

Adverse event: Local Infection
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 657 at risk

Adverse event: Neurological events (other)
Serious: no
Organ System: Nervous system disorders
Notes: Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 54 affected / 657 at risk

Adverse event: Respiratory (other)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 52 affected / 657 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 657 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 657 at risk

Adverse event: Skeletal, spine and muscular events (Other)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 155 affected / 657 at risk

Adverse event: Restenosis
Serious: no
Organ System: Vascular disorders
Notes: Target Lesion: Restenosis event.
Frequency: 35 affected / 657 at risk

Adverse event: Renal failure/ insufficiency
Serious: no
Organ System: Renal and urinary disorders
Notes: Genito-urinary system event.
Frequency: 35 affected / 657 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Genito-urinary system event.
Frequency: 46 affected / 657 at risk

Adverse event: Various
Serious: no
Organ System: General disorders
Notes: Not otherwise described. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 241 affected / 657 at risk

Adverse event: Vessel specific events (Other)
Serious: no
Organ System: General disorders
Notes: Vessel specific events in the leg (not target lesion or target vessel). Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.
Frequency: 41 affected / 657 at risk