Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 4:53 AM
Study NCT ID:
NCT01566461
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arslan.malik@medtronic.com', 'title': 'Arslan Malik, Sr. Clinical Research Manager', 'organization': 'Medtronic Endovascular Therapies'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'Paclitaxel drug-coated angioplasty balloon\n\nIN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm', 'otherNumAtRisk': 220, 'otherNumAffected': 104, 'seriousNumAtRisk': 220, 'seriousNumAffected': 102}, {'id': 'EG001', 'title': 'Standard PTA', 'description': 'Standard angioplasty balloon without Paclitaxel drug-coating\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm', 'otherNumAtRisk': 111, 'otherNumAffected': 62, 'seriousNumAtRisk': 111, 'seriousNumAffected': 62}], 'otherEvents': [{'term': 'Artery Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 37, 'numAffected': 36}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral Artery Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intermittent Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Artery Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vessel Puncture Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Adverse Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MedDRA 13.0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aorto-Duodenal Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial Stenosis Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial Thrombosis Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arteriovenous Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Artery Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthritis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bile Duct Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Biliary Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Carotid Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Colon Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Device Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetic Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetic Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Embolic Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Facial Bones Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral Arterial Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral Artery Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fractured Coccyx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhage Intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhagic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Iliac Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Iliac Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Impaired Healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Implant Site Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'In-Stent Arterial Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'In-Stent Coronary Artery Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infected Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intermittent Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Joint Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Large Intestine Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Liver Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Localised Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lumbar Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lumbar Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Malignant Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neuropathic Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peptic Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Arterial Reocclusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Artery Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Revascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Postmenopausal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostatic Specific Antigen Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Shock Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Spinal Column Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Spinal Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Subclavian Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Synovial Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Therapeutic Embolisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tonsil Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vascular Graft Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vascular Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vessel Puncture Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'West Nile Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'PRIMARY', 'title': 'Primary Safety Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '76.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.', 'unitOfMeasure': 'Percentage of particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Event (MAE) Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'All-cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.926', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Revascularization (TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '144.6', 'spread': '159.6', 'groupId': 'OG000'}, {'value': '201.9', 'spread': '90.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.859', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 month', 'description': 'Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \\>0.15 when compared to post procedure baseline.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who experienced a CD-TLR.'}, {'type': 'SECONDARY', 'title': 'Major Target Limb Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Thrombosis at the Target Lesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Primary Sustained Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000'}, {'value': '68.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Secondary Sustained Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.121', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'Freedom from target amputation and increase in Rutherford class.', 'unitOfMeasure': 'Percentage of particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '33.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1059', 'spread': '0.2089', 'groupId': 'OG000'}, {'value': '0.0730', 'spread': '0.1951', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.095', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 month', 'description': "Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.\n\nEQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '92.1', 'groupId': 'OG000'}, {'value': '59.1', 'spread': '102.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.878', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 12 month', 'description': 'Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe. Data not collected in IN.PACT SFA I phase.'}, {'type': 'SECONDARY', 'title': 'Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '73.6', 'spread': '29.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.590', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 month', 'description': 'Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.\n\nClinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}, {'units': 'Devices', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '98.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.302', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).', 'unitOfMeasure': 'Percentage of devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Devices', 'denomUnitsSelected': 'Devices', 'populationDescription': 'Total number of devices used in the ITT population (n=331).'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}, {'value': '98.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (n=331)'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '97.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (n=331)'}, {'type': 'SECONDARY', 'title': 'Days of Hospitalization Due to the Index Lesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty\n\nIN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA Balloon: Balloon Angioplasty\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 month', 'description': 'Days of hospitalization from procedure through 12 month.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'Paclitaxel drug-coated angioplasty balloon\n\nIN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm'}, {'id': 'FG001', 'title': 'Standard PTA', 'description': 'Standard angioplasty balloon without Paclitaxel drug-coating\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm'}], 'periods': [{'title': 'IN.PACT SFA I Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'IN.PACT SFA II Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'The IN.PACT SFA Trial was designed as a two-phase randomized trial. IN.PACT SFA I, the first phase, was conducted in Europe with 150 subjects enrolled. IN.PACT SFA II, the second phase, was conducted in the US with 181 subjects enrolled. The randomized data from both phases are pooled and comprise the pivotal trial data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug-Coated Balloon (DCB)', 'description': 'Paclitaxel drug-coated angioplasty balloon\n\nIN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm'}, {'id': 'BG001', 'title': 'Standard PTA', 'description': 'Standard angioplasty balloon without Paclitaxel drug-coating\n\nStandard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '68.0', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '67.6', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The randomized data (n=331) from both phases have been pooled and comprise the pivotal trial data.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2012-03-27', 'resultsFirstSubmitDate': '2015-02-18', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-18', 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency', 'timeFrame': '12 month', 'description': 'Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.'}, {'measure': 'Primary Safety Composite', 'timeFrame': '12 month', 'description': 'Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Event (MAE) Composite', 'timeFrame': '12 month', 'description': 'Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.'}, {'measure': 'All-cause Death', 'timeFrame': '12 month'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '12 month'}, {'measure': 'Target Lesion Revascularization (TLR)', 'timeFrame': '12 month'}, {'measure': 'Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)', 'timeFrame': '12 month', 'description': 'Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \\>0.15 when compared to post procedure baseline.'}, {'measure': 'Major Target Limb Amputation', 'timeFrame': '12 month'}, {'measure': 'Thrombosis at the Target Lesion', 'timeFrame': '12 month'}, {'measure': 'Primary Sustained Clinical Improvement', 'timeFrame': '12 month', 'description': 'Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.'}, {'measure': 'Secondary Sustained Clinical Improvement', 'timeFrame': '12 month', 'description': 'Freedom from target amputation and increase in Rutherford class.'}, {'measure': 'Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)', 'timeFrame': '12 month'}, {'measure': 'Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)', 'timeFrame': '12 month'}, {'measure': 'Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)', 'timeFrame': '12 month', 'description': "Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.\n\nEQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."}, {'measure': 'Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)', 'timeFrame': 'From baseline to 12 month', 'description': 'Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.'}, {'measure': 'Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)', 'timeFrame': '12 month', 'description': 'Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.\n\nClinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).'}, {'measure': 'Device Success', 'timeFrame': 'Day 1', 'description': 'Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).'}, {'measure': 'Procedural Success', 'timeFrame': 'Day 1', 'description': 'Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.'}, {'measure': 'Clinical Success', 'timeFrame': 'Day 1', 'description': 'Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.'}, {'measure': 'Days of Hospitalization Due to the Index Lesion', 'timeFrame': '12 month', 'description': 'Days of hospitalization from procedure through 12 month.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug-Coated Angioplasty Balloon', 'Drug Coated Angioplasty Balloon', 'Peripheral Artery Disease', 'Experimental', 'Percutaneous Transluminal Angioplasty (PTA)'], 'conditions': ['Femoral Artery Stenosis', 'Popliteal Artery Stenosis', 'Femoral Artery Occlusion', 'Popliteal Artery Occlusion']}, 'referencesModule': {'references': [{'pmid': '36137674', 'type': 'DERIVED', 'citation': 'Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.'}, {'pmid': '31543165', 'type': 'DERIVED', 'citation': 'Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.'}, {'pmid': '31195825', 'type': 'DERIVED', 'citation': 'Laird JA, Schneider PA, Jaff MR, Brodmann M, Zeller T, Metzger DC, Krishnan P, Scheinert D, Micari A, Wang H, Masters M, Tepe G. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. 2019 Jun;12(6):e007702. doi: 10.1161/CIRCINTERVENTIONS.118.007702. Epub 2019 Jun 14.'}, {'pmid': '30690141', 'type': 'DERIVED', 'citation': 'Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25.'}, {'pmid': '29326153', 'type': 'DERIVED', 'citation': 'Schneider PA, Laird JR, Tepe G, Brodmann M, Zeller T, Scheinert D, Metzger C, Micari A, Sachar R, Jaff MR, Wang H, Hasenbank MS, Krishnan P; IN.PACT SFA Trial Investigators. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. 2018 Jan;11(1):e005891. doi: 10.1161/CIRCINTERVENTIONS.117.005891.'}, {'pmid': '26476467', 'type': 'DERIVED', 'citation': 'Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.'}, {'pmid': '25472980', 'type': 'DERIVED', 'citation': 'Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR; IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015 Feb 3;131(5):495-502. doi: 10.1161/CIRCULATIONAHA.114.011004. Epub 2014 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.', 'detailedDescription': 'The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\> or equal to 18 years and \\< or equal to 85 years\n* Documented ischemia with Rutherford classification 2, 3, or 4\n* Target lesion in the SFA and/or PPA\n* Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:\n\n 1. 70 - 99% occlusion by visual estimate with lesion length \\> or equal to 4 cm and \\< or equal to 18 cm\n 2. 100% occlusion by visual estimate with lesion length \\< or equal to 10 cm\n 3. Combination lesions must have a total lesion length of \\> or equal to 4 cm and \\< or equal to 18 cm with an occluded segment that is \\< or equal to 10 cm (by visual estimate)\n* Target vessel diameter \\> or equal to 4 mm and \\< or equal to 7 mm\n* Angiographic evidence of adequate distal run-off to the ankle\n* Able to walk without assistive devices\n\nExclusion Criteria:\n\n* Stroke or heart attack within 3 months prior to enrollment\n* Enrolled in another investigational drug, device or biologic study\n* Any surgical procedure or intervention performed within 30 days prior to or post index procedure\n* SFA or PPA disease in the opposite leg that requires treatment at the index procedure\n* Failure to successfully cross the target lesion\n* Angiographic evidence of severe calcification\n* Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)\n* Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure\n* Chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT01566461', 'acronym': 'INPACT SFA II', 'briefTitle': 'IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)', 'orgStudyIdInfo': {'id': '10031540DOC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-Coated Balloon (DCB)', 'description': 'IN.PACT Admiral: Balloon Angioplasty', 'interventionNames': ['Device: Drug-Coated Balloon (DCB)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard PTA', 'description': 'Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty', 'interventionNames': ['Device: PTA Balloon: Balloon Angioplasty']}], 'interventions': [{'name': 'Drug-Coated Balloon (DCB)', 'type': 'DEVICE', 'description': 'Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm', 'armGroupLabels': ['Drug-Coated Balloon (DCB)']}, {'name': 'PTA Balloon: Balloon Angioplasty', 'type': 'DEVICE', 'description': 'Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm', 'armGroupLabels': ['Standard PTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Washington Hospital', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '96819', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}