TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02727699

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 91 at risk

Adverse event: Vibration test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 91 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pulmonary cavitation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 91 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 91 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 91 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 91 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 91 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 91 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 94 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 94 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 94 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 94 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 94 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 94 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 94 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 94 at risk
Study: NCT02727751

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 312 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 312 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 312 at risk
Study: NCT02727777

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2 at risk

Adverse event: Anorexia/appetite change
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pain in extremity (right thigh)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT02727842

Adverse event: Mircrophone housing
Serious: no
Organ System: Product Issues
Notes: Intermittent sound processor. The adverse event was resolved by replacing the processor. The device was subsequently analyzed and found to have dislodged microphones from the housing.
Frequency: 1 affected / 30 at risk

Adverse event: Skin flap
Serious: no
Organ System: Product Issues
Notes: Infection or swelling at implant site. August 30, 2016 was reported date of onset, and reported to the clinic on September 3, 2016. The adverse event was resolved on September 6, 2016 by antibiotic treatment.
Frequency: 1 affected / 30 at risk
Study: NCT02727907

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: flu-like syndrom
Serious: no
Organ System: General disorders
Frequency: 15 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: increased ALT
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Local reaction
Serious: no
Organ System: General disorders
Frequency: 15 affected / 53 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 53 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: flu-like syndrom
Serious: no
Organ System: General disorders
Frequency: 16 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 55 at risk

Adverse event: increased ALT
Serious: no
Organ System: Investigations
Frequency: 4 affected / 55 at risk

Adverse event: Local reaction
Serious: no
Organ System: General disorders
Frequency: 12 affected / 55 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 55 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 55 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 55 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Notes: The patient had an albuminuria, in connection with which he was hospitalized in a hospital for treatment. It is discharged with improvement of a status. The therapy was abolished.
Frequency: 1 affected / 54 at risk

Adverse event: Left hemophthalmos
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 54 at risk

Adverse event: Chronic viral hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: flu-like syndrom
Serious: no
Organ System: General disorders
Frequency: 19 affected / 54 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 54 at risk

Adverse event: increased ALT
Serious: no
Organ System: Investigations
Frequency: 3 affected / 54 at risk

Adverse event: Local reaction
Serious: no
Organ System: General disorders
Frequency: 10 affected / 54 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 54 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 54 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 54 at risk
Study: NCT02728076

Adverse event: Thromboembolic event other - specify
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 35 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 35 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 35 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Skin and subcutaneous tissue disorders - Oher, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Fibroses
Frequency: 1 affected / 35 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk
Study: NCT02728089

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 114 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 114 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 114 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 114 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 114 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 114 at risk
Study: NCT02728102

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

Adverse event: PROLONGED QTC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: ELEVATE LIVER ENZYMES
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Lentigo maligna
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 68 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: ELEVATED ALT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 37 at risk

Adverse event: LIVER FUNCTION TESTS INCREASED
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: GRADE 2 DVT
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: GRADE 2 TRANSAMINITIS
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: INCREASED ALT > 3.0 X ULN
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Prostate cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: ELEVATED LFT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk
Study: NCT02728596

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 456 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 456 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 456 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 456 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 456 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 110 affected / 456 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 456 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 350 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 350 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 101 affected / 350 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 350 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 694 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 694 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 205 affected / 694 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 694 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 448 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 448 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 76 affected / 448 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 121 affected / 448 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 448 at risk
Study: NCT02728726

Adverse event: Cardiac Catherization post surgery - Stent placed
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Extended intubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk
Study: NCT02729038

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Suprapubic pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02729311

Adverse event: Emergency visit or hospitalization
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Falls / Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: Other AEs
Serious: no
Organ System: General disorders
Notes: Includes infections, gastrointestinal issues, and psychiatric issues
Frequency: 2 affected / 15 at risk

Adverse event: Other AEs
Serious: no
Organ System: General disorders
Notes: Includes infections, gastrointestinal issues, and psychiatric issues
Frequency: 4 affected / 15 at risk

Adverse event: Emergency visit or hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Falls / Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: Other AEs
Serious: no
Organ System: General disorders
Notes: Includes infections, gastrointestinal issues, and psychiatric issues
Frequency: 1 affected / 15 at risk

Adverse event: Falls / Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT02729545

Adverse event: Transient bruises at the sites of needle insertion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: post-treatment soreness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk
Study: NCT02729714

Adverse event: Excessive Drowsiness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Excessive Drowsiness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Compulsive behavior
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk
Study: NCT02729753

Adverse event: Post Procedure Pain
Serious: no
Organ System: General disorders
Notes: Patient experienced pain score of 3 on VAS scale 0 - 10, 24 hours post procedure.
Frequency: 1 affected / 3 at risk
Study: NCT02730234

Adverse event: Target Lesion Revascularization with Bailout Stenting
Serious: yes
Organ System: Vascular disorders
Notes: Retreatment of the index lesion (extended 1 cm proximal and distal to the lesion). At 1 Year.
Frequency: 21 affected / 60 at risk

Adverse event: Target Lesion Revascularization without Bailout Stenting
Serious: yes
Organ System: Vascular disorders
Notes: at 1 year
Frequency: 11 affected / 60 at risk

Adverse event: Distal Embolization
Serious: yes
Organ System: Vascular disorders
Notes: at 1 month
Frequency: 8 affected / 60 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: at 1 month
Frequency: 1 affected / 60 at risk

Adverse event: Nonfatal myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Notes: at 1 month
Frequency: 1 affected / 60 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Chest pain due to ischemic heart disease
Frequency: 4 affected / 60 at risk

Adverse event: worsening claudication in non affected limb
Serious: no
Organ System: Vascular disorders
Notes: worsening claudication and interventions on the non affected limb
Frequency: 11 affected / 60 at risk