Study: NCT01790243

Adverse event: Arterial occlusion puncture site
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1029 at risk

Adverse event: Hematoma / bleeding puncture site - major
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1029 at risk

Adverse event: Hematoma / bleeding puncture site - minor
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1029 at risk

Adverse event: Pseudo aneurysm
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1029 at risk

Adverse event: Puncture site infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1029 at risk

Adverse event: Vascular perforation / rupture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1029 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1029 at risk

Adverse event: Significant blood loss
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1029 at risk

Adverse event: Other Access site complication
Serious: yes
Organ System: General disorders
Notes: This category of SAEs is not broken down further in the Clinical Study Report.
Frequency: 7 affected / 1029 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 23 affected / 1029 at risk

Adverse event: Angina, stable
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 65 affected / 1029 at risk

Adverse event: Angina, unstable
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 58 affected / 1029 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 22 affected / 1029 at risk

Adverse event: Arrhythmia - Tachycardia
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 20 affected / 1029 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report. This category is not broken down further in the Clinical Study Report.
Frequency: 45 affected / 1029 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 1 affected / 1029 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 9 affected / 1029 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 59 affected / 1029 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 17 affected / 1029 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 2 affected / 1029 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 33 affected / 1029 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 14 affected / 1029 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 69 affected / 1029 at risk

Adverse event: Other Cardiovascular
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 152 affected / 1029 at risk

Adverse event: Diabetes Mellitus, Type I
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 1029 at risk

Adverse event: Diabetes Mellitus, Type II
Serious: yes
Organ System: Endocrine disorders
Frequency: 12 affected / 1029 at risk

Adverse event: Hyperthroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1029 at risk

Adverse event: Hypothroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1029 at risk

Adverse event: Other Endocrine system
Serious: yes
Organ System: Endocrine disorders
Notes: These SAEs are not broken down further in the Clinical Study Report.
Frequency: 16 affected / 1029 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 1029 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1029 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 1029 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1029 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1029 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 1029 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1029 at risk

Adverse event: Other infections / inflammatory
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Category of SAE not otherwise broken down in the Clinical Study Report.
Frequency: 11 affected / 1029 at risk

Adverse event: Other infectious / inflammatory
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Category of SAE not otherwise broken down in the Clinical Study Report.
Frequency: 3 affected / 1029 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1029 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1029 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1029 at risk

Adverse event: Other Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Category of SAE not otherwise broken down in the Clinical Study Report.
Frequency: 68 affected / 1029 at risk

Adverse event: Local infection
Serious: yes
Organ System: Infections and infestations
Frequency: 30 affected / 1029 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1029 at risk

Adverse event: Septicemia / bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 1029 at risk

Adverse event: Other Infectious
Serious: yes
Organ System: Infections and infestations
Notes: Category of SAE not otherwise broken down in the Clinical Study report.
Frequency: 23 affected / 1029 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 8 affected / 1029 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 1 affected / 1029 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 6 affected / 1029 at risk

Adverse event: Dizziness / vertigo
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 8 affected / 1029 at risk

Adverse event: Fainting / syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 17 affected / 1029 at risk

Adverse event: Peripheral nervous system complication
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 4 affected / 1029 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 4 affected / 1029 at risk

Adverse event: Stroke - hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 6 affected / 1029 at risk

Adverse event: Stroke - ischemic
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 36 affected / 1029 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 26 affected / 1029 at risk

Adverse event: Other Neurological / nervous system
Serious: yes
Organ System: Nervous system disorders
Notes: Category of SAE not otherwise broken down in the Clinical Study Report. Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 43 affected / 1029 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 1029 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 1029 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 1029 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1029 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1029 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 1029 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1029 at risk

Adverse event: Other respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Category of SAE not otherwise broken down in Clinical Study Report.
Frequency: 43 affected / 1029 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 75 affected / 1029 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1029 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1029 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1029 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Category "Skeletal, Spine and Muscular System" in Clinical Study Report.
Frequency: 7 affected / 1029 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 1029 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 1029 at risk

Adverse event: Fracture (bone)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 1029 at risk

Adverse event: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 1029 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 1029 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1029 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 1029 at risk

Adverse event: Other Skeletal, spine and muscular system
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Category of SAE not otherwise broken down in Clinical Study report.
Frequency: 89 affected / 1029 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Notes: SAE entered as part of a Category titled "Systematic Complication" in Clinical Study Report.
Frequency: 1 affected / 1029 at risk

Adverse event: Anaphylatic reaction
Serious: yes
Organ System: General disorders
Notes: SAE entered as part of a Category titled "Systematic Complication" in Clinical Study Report.
Frequency: 3 affected / 1029 at risk

Adverse event: Other Systematic complication
Serious: yes
Organ System: General disorders
Notes: Category of SAE not further broken down in Clinical Study Report. SAE entered as part of a Category titled "Systematic Complication" in Clinical Study Report.
Frequency: 6 affected / 1029 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 1 affected / 1029 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 15 affected / 1029 at risk

Adverse event: Dissection
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 3 affected / 1029 at risk

Adverse event: Embolism
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 1 affected / 1029 at risk

Adverse event: Occlusion / closure
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 18 affected / 1029 at risk

Adverse event: Perforation
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 2 affected / 1029 at risk

Adverse event: Restenosis
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 65 affected / 1029 at risk

Adverse event: Thrombus - in-lesion
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 1 affected / 1029 at risk

Adverse event: Other Target vessel
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report. SAE not otherwise broken down in the Clinical Study Report.
Frequency: 10 affected / 1029 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 4 affected / 1029 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 5 affected / 1029 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 5 affected / 1029 at risk

Adverse event: Prostate hypertrophy
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 7 affected / 1029 at risk

Adverse event: Renal failure / insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 54 affected / 1029 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 21 affected / 1029 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 2 affected / 1029 at risk

Adverse event: Other Genito-urinary system
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report. SAE entry not otherwise broken down in Clinical Study Report.
Frequency: 48 affected / 1029 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 6 affected / 1029 at risk

Adverse event: Amputation
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 8 affected / 1029 at risk

Adverse event: Atypical chest pain
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 7 affected / 1029 at risk

Adverse event: Carcinoma (not specified elsewhere)
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 58 affected / 1029 at risk

Adverse event: Death (non-cardiac or neurological)
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 23 affected / 1029 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 2 affected / 1029 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 4 affected / 1029 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 1 affected / 1029 at risk

Adverse event: Haematuria
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 3 affected / 1029 at risk

Adverse event: Rash
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 1 affected / 1029 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 7 affected / 1029 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. SAE "other" is not otherwise broken down in the Clinical Study Report.
Frequency: 163 affected / 1029 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 7 affected / 1029 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 36 affected / 1029 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 6 affected / 1029 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 36 affected / 1029 at risk

Adverse event: Dissection
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 3 affected / 1029 at risk

Adverse event: Embolism
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 7 affected / 1029 at risk

Adverse event: Hematoma / bleeding
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 2 affected / 1029 at risk

Adverse event: Perforation
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 1 affected / 1029 at risk

Adverse event: Restenosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 112 affected / 1029 at risk

Adverse event: Stent thrombosis (definite)
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 4 affected / 1029 at risk

Adverse event: Stent thrombosis (possible)
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 2 affected / 1029 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 2 affected / 1029 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 7 affected / 1029 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 5 affected / 1029 at risk

Adverse event: Stenosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 126 affected / 1029 at risk

Adverse event: Other Vessel Specific
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.

SAE not otherwise broken down in the Clinical Study report.
Frequency: 22 affected / 1029 at risk

Adverse event: Hematoma / bleeding puncture site - minor
Serious: no
Organ System: General disorders
Notes: AE entered in category "Access Site Complication" in the Clinical Study Report.
Frequency: 51 affected / 1029 at risk

Adverse event: Angina, Stable
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report.
Frequency: 46 affected / 1029 at risk

Adverse event: Arrhythmia - Other
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report. AE (other) not otherwise broken down in Clinical Study Report.
Frequency: 47 affected / 1029 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report.
Frequency: 64 affected / 1029 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report.
Frequency: 32 affected / 1029 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report. AE "Other" not otherwise broken down in the Clinical Study report.
Frequency: 110 affected / 1029 at risk

Adverse event: Diabetes Mellitus, Type II
Serious: no
Organ System: Endocrine disorders
Frequency: 35 affected / 1029 at risk

Adverse event: Other Endocrine system
Serious: no
Organ System: Endocrine disorders
Notes: AE (Other) not otherwise broken down in Clinical Study Report.
Frequency: 33 affected / 1029 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 1029 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE (other) not otherwise broken down in Clinical Study Report.
Frequency: 118 affected / 1029 at risk

Adverse event: Local infection
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 1029 at risk

Adverse event: Other infectious
Serious: no
Organ System: Infections and infestations
Notes: AE (Other) not otherwise broken down in the Clinical Study Report.
Frequency: 43 affected / 1029 at risk

Adverse event: Dizziness / vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 1029 at risk

Adverse event: Other Neurological / nervous system
Serious: no
Organ System: Nervous system disorders
Notes: AE (Other) not otherwise broken down in the Clinical Study Report.
Frequency: 92 affected / 1029 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 1029 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 1029 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 44 affected / 1029 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 1029 at risk

Adverse event: Other respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 88 affected / 1029 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 1029 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 1029 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 112 affected / 1029 at risk

Adverse event: Fracture (bone)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 1029 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 79 affected / 1029 at risk

Adverse event: Other skeletal, spine and muscular system
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: AE (Other) not otherwise broken down in Clinical Study Report.
Frequency: 272 affected / 1029 at risk

Adverse event: Dissection
Serious: no
Organ System: General disorders
Notes: AE entered in "Target Lesion" Category of Clinical Study Report.
Frequency: 26 affected / 1029 at risk

Adverse event: Restenosis
Serious: no
Organ System: General disorders
Frequency: 53 affected / 1029 at risk

Adverse event: Renal failure / insufficiency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 57 affected / 1029 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 72 affected / 1029 at risk

Adverse event: Other Genito-urinary system
Serious: no
Organ System: General disorders
Notes: AE (Other) not otherwise broken down in the Clinical Study Report.
Frequency: 52 affected / 1029 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: AE reported in category "Various" in the Clinical Study Report.
Frequency: 41 affected / 1029 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: AE "Other" not otherwise broken down in the Clinical Study Report.
Frequency: 399 affected / 1029 at risk

Adverse event: Restenosis
Serious: no
Organ System: General disorders
Notes: AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report.
Frequency: 31 affected / 1029 at risk

Adverse event: Stenosis
Serious: no
Organ System: General disorders
Notes: AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report.
Frequency: 40 affected / 1029 at risk

Adverse event: Other Vessel Specific
Serious: no
Organ System: General disorders
Notes: AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report.

AE (Other) not otherwise broken down in clinical Study Report.
Frequency: 55 affected / 1029 at risk

Adverse event: Hematoma / bleeding puncture site - major
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pseudo aneurysm
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 160 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Angina, stable
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 8 affected / 160 at risk

Adverse event: Angina, unstable
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 5 affected / 160 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 3 affected / 160 at risk

Adverse event: Arrhythmia - Tachycardia
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 6 affected / 160 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report. This category is not broken down further in the Clinical Study Report.
Frequency: 10 affected / 160 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 8 affected / 160 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 10 affected / 160 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 17 affected / 160 at risk

Adverse event: Other Cardiovascular
Serious: yes
Organ System: Vascular disorders
Notes: Category "Cardiovascular" in Clinical Study Report.
Frequency: 20 affected / 160 at risk

Adverse event: Diabetes Mellitus, Type II
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 160 at risk

Adverse event: Other Endocrine system
Serious: yes
Organ System: Endocrine disorders
Notes: These SAEs are not broken down further in the Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 160 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 160 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 160 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 160 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Other infectious / inflammatory
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Category of SAE not otherwise broken down in the Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 160 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Other Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Category of SAE not otherwise broken down in the Clinical Study Report.
Frequency: 11 affected / 160 at risk

Adverse event: Local infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 160 at risk

Adverse event: Septicemia / bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Other Infectious
Serious: yes
Organ System: Infections and infestations
Notes: Category of SAE not otherwise broken down in the Clinical Study report.
Frequency: 3 affected / 160 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 3 affected / 160 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Dizziness / vertigo
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Fainting / syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 3 affected / 160 at risk

Adverse event: Peripheral nervous system complication
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Stroke - hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Stroke - ischemic
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 3 affected / 160 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Other Neurological / nervous system
Serious: yes
Organ System: Nervous system disorders
Notes: Category of SAE not otherwise broken down in the Clinical Study Report. Category "Neurological/Nervous System" in Clinical Study Report.
Frequency: 7 affected / 160 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 160 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Other respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Category of SAE not otherwise broken down in Clinical Study Report.
Frequency: 6 affected / 160 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 160 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 160 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 160 at risk

Adverse event: Fracture (bone)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 160 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 160 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 160 at risk

Adverse event: Other Skeletal, spine and muscular system
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Category of SAE not otherwise broken down in Clinical Study report.
Frequency: 12 affected / 160 at risk

Adverse event: Anaphylatic reaction
Serious: yes
Organ System: General disorders
Notes: SAE entered as part of a Category titled "Systematic Complication" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 4 affected / 160 at risk

Adverse event: Occlusion / closure
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 5 affected / 160 at risk

Adverse event: Restenosis
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 18 affected / 160 at risk

Adverse event: Thrombus - in-lesion
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Other Target vessel
Serious: yes
Organ System: General disorders
Notes: This SAE was entered in "Target Vessel" category in Clinical Study Report. SAE not otherwise broken down in the Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 1 affected / 160 at risk

Adverse event: Renal failure / insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 9 affected / 160 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 5 affected / 160 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report.
Frequency: 1 affected / 160 at risk

Adverse event: Other Genito-urinary system
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE part of a category titled "Genito-urinary" in Clinical Study report. SAE entry not otherwise broken down in Clinical Study Report.
Frequency: 5 affected / 160 at risk

Adverse event: Amputation
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 1 affected / 160 at risk

Adverse event: Atypical chest pain
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 2 affected / 160 at risk

Adverse event: Carcinoma (not specified elsewhere)
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 5 affected / 160 at risk

Adverse event: Death (non-cardiac or neurological)
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 1 affected / 160 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 2 affected / 160 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category.
Frequency: 1 affected / 160 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. SAE "other" is not otherwise broken down in the Clinical Study Report.
Frequency: 21 affected / 160 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 9 affected / 160 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 11 affected / 160 at risk

Adverse event: Restenosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 22 affected / 160 at risk

Adverse event: Stent thrombosis (definite)
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Stent thrombosis (possible)
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 1 affected / 160 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 2 affected / 160 at risk

Adverse event: Stenosis
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.
Frequency: 23 affected / 160 at risk

Adverse event: Other Vessel Specific
Serious: yes
Organ System: General disorders
Notes: SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report.

SAE not otherwise broken down in the Clinical Study report.
Frequency: 2 affected / 160 at risk

Adverse event: Hematoma / bleeding puncture site - minor
Serious: no
Organ System: General disorders
Notes: AE entered in category "Access Site Complication" in the Clinical Study Report.
Frequency: 4 affected / 160 at risk

Adverse event: Angina, Stable
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report.
Frequency: 11 affected / 160 at risk

Adverse event: Arrhythmia - Other
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report. AE (other) not otherwise broken down in Clinical Study Report.
Frequency: 10 affected / 160 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report.
Frequency: 9 affected / 160 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report.
Frequency: 3 affected / 160 at risk

Adverse event: Other Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: AE entered in category "Cardiovascular" in clinical Study report. AE "Other" not otherwise broken down in the Clinical Study report.
Frequency: 23 affected / 160 at risk

Adverse event: Diabetes Mellitus, Type II
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 160 at risk

Adverse event: Other Endocrine system
Serious: no
Organ System: Endocrine disorders
Notes: AE (Other) not otherwise broken down in Clinical Study Report.
Frequency: 3 affected / 160 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE (other) not otherwise broken down in Clinical Study Report.
Frequency: 11 affected / 160 at risk

Adverse event: Local infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 160 at risk

Adverse event: Other infectious
Serious: no
Organ System: Infections and infestations
Notes: AE (Other) not otherwise broken down in the Clinical Study Report.
Frequency: 4 affected / 160 at risk

Adverse event: Dizziness / vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 160 at risk

Adverse event: Other Neurological / nervous system
Serious: no
Organ System: Nervous system disorders
Notes: AE (Other) not otherwise broken down in the Clinical Study Report.
Frequency: 13 affected / 160 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 160 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 160 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 160 at risk

Adverse event: Other respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 160 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 160 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 160 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 160 at risk

Adverse event: Fracture (bone)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 160 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 160 at risk

Adverse event: Other skeletal, spine and muscular system
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: AE (Other) not otherwise broken down in Clinical Study Report.
Frequency: 35 affected / 160 at risk

Adverse event: Dissection
Serious: no
Organ System: General disorders
Notes: AE entered in "Target Lesion" Category of Clinical Study Report.
Frequency: 6 affected / 160 at risk

Adverse event: Restenosis
Serious: no
Organ System: General disorders
Frequency: 11 affected / 160 at risk

Adverse event: Renal failure / insufficiency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 160 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 160 at risk

Adverse event: Other Genito-urinary system
Serious: no
Organ System: General disorders
Notes: AE (Other) not otherwise broken down in the Clinical Study Report.
Frequency: 13 affected / 160 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: AE reported in category "Various" in the Clinical Study Report.
Frequency: 5 affected / 160 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: AE "Other" not otherwise broken down in the Clinical Study Report.
Frequency: 67 affected / 160 at risk

Adverse event: Restenosis
Serious: no
Organ System: General disorders
Notes: AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report.
Frequency: 3 affected / 160 at risk

Adverse event: Stenosis
Serious: no
Organ System: General disorders
Notes: AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report.
Frequency: 5 affected / 160 at risk

Adverse event: Other Vessel Specific
Serious: no
Organ System: General disorders
Notes: AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report.

AE (Other) not otherwise broken down in clinical Study Report.
Frequency: 13 affected / 160 at risk