Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 6:24 PM
Study NCT ID:
NCT00790335
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2008-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011186', 'term': 'Postphlebitic Syndrome'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D054070', 'term': 'Postthrombotic Syndrome'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010689', 'term': 'Phlebitis'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D013923', 'term': 'Thromboembolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vedanthams@mir.wustl.edu', 'phone': '3143622900', 'title': 'Dr. Suresh Vedantham, Principal Investigator', 'phoneExt': '314', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were collected throughout the study - i.e. through 24 months post-randomization. Non-serious adverse events were collected through 30 days post-randomization, and through 30 days after any subsequent PCDT procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.', 'otherNumAtRisk': 336, 'deathsNumAtRisk': 336, 'otherNumAffected': 0, 'seriousNumAtRisk': 336, 'deathsNumAffected': 7, 'seriousNumAffected': 109}, {'id': 'EG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed', 'otherNumAtRisk': 355, 'deathsNumAtRisk': 355, 'otherNumAffected': 0, 'seriousNumAtRisk': 355, 'deathsNumAffected': 8, 'seriousNumAffected': 86}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal lab results secondary to undetermined infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute and progressive cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute arterial limb ischemia of left lower extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute CHF with atrial fibrillation and rapid ventricular response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute gallstone pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute on chronic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute on chronic respiratory insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute oxycodone and doxylamine intoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute phencyclidine intoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute rejection (heart transplant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute right lower extremity DVT and acute bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Acute short bowel obstruction versus Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute viral gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenocarcinoma of unknown primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol intoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol Withdrawal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered mental state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angioedema, unclear etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Antral gastritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter with rapid ventricular response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atypical chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral lower extremity cellulitis and CHF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biliary diskinesia and sludge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding at sheath puncture site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding from wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding gums', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision and diffuse itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast intraductal papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken ribs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'C5 on C6 retrolisthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain/asthma exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain and shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain, shortness of breath, hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer - adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complex gouty septic olecranon bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease and hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death secondary to metastatic gastric carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Debridement of right below-the-knee amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Degenerative joint disease with total right hip replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic 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'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral arterial disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleuritic chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia and pulmonary hypertension likely due to PE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-operative infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-percardiotomy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 36, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal vein obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reversible cerebral vasoconstriction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right foot amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right hand abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right knee hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right knee tear of medial meniscus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ruptured ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis and pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Serum sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe bilateral knee degenerative joint disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Short-term memory impairment of uncertain etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma of unknown primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staph infection in right shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation and alcohol withdrawal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical excision of squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected infection to stump from right below-knee amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope and head contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemia attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Type A ascending aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection and cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomoting and diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.11', 'estimateComment': 'Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for extent of DVT and for clinical center'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between 6 and 24 months after randomization', 'description': 'Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Major Non-post-thrombotic Syndrome Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.98', 'estimateComment': 'Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 24 months', 'description': 'A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Any Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.09', 'estimateComment': 'No statistically significant difference was seen.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for thrombus extent and clinical center'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 24 months', 'description': 'Composite of PTS and major non-PTS treatment failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Moderate-to-severe Post-thrombotic Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.98', 'estimateComment': 'Numerator: PCDT Arm; Denominator: Control Arm', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of DVT and clinical center'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between 6 and 24 months after randomization', 'description': 'Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set, intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.18', 'ciLowerLimit': '0.78', 'ciUpperLimit': '49.2', 'estimateComment': 'Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 10 days after randomization', 'description': 'Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set, intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.76', 'ciUpperLimit': '3.01', 'estimateComment': 'Numerator: PCDT Arm; Denominator: Control Arm', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 months after randomization', 'description': 'Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Any (Minor + Major) Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.64', 'ciLowerLimit': '1.04', 'ciUpperLimit': '6.68', 'estimateComment': 'Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 10 days after randomization', 'description': 'Clinically overt bleeding that occurred through 10 days post-randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set, intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Any (Major + Minor) Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.89', 'estimateComment': 'Numerator: PCDT Arm; Denominator: Control Arm', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 months after randomization', 'description': 'Clinically overt bleeding that occurred within 24 months post-randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set, intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Recurrent Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.44', 'ciUpperLimit': '5.28', 'estimateComment': 'Numerator = PCDT Arm; Denominator = Control Arm', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 10 days after randomization', 'description': 'Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrent Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.94', 'ciUpperLimit': '2.29', 'estimateComment': 'Numerator: PCDT Arm; Denominator: Control Arm', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 months after randomization', 'description': 'Symptomatic recurrent venous thromboembolism (DVT and/or PE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 10 days after randomization', 'description': 'All-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.33', 'ciUpperLimit': '2.44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 months after randomization', 'description': 'All-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Severity of Post-thrombotic Syndrome (Villalta)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '3.11', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '4.33', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months', 'description': 'Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Severity of Post-thrombotic Syndrome (Villalta)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '3.22', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '4.38', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 12 months', 'description': 'Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Severity of Post-thrombotic Syndrome (Villalta)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '3.32', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 18 months', 'description': 'Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Severity of Post-thrombotic Syndrome (Villalta)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '3.43', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 24 months', 'description': 'Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Venous Clinical Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.73', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months', 'description': 'Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Venous Clinical Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.80', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 12 months', 'description': 'Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Venous Clinical Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 18 months', 'description': 'Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Venous Clinical Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.87', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'estimateComment': 'Lower (better) mean scores in the PCDT Arm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates'}], 'paramType': 'MEAN', 'timeFrame': 'At 24 months', 'description': 'Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Change in General Quality of Life - Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '11.18', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '10.06', 'spread': '2.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.26', 'estimateComment': 'No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 months post-randomization', 'description': 'Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Change in General Quality of Life - Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.16', 'estimateComment': 'No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 months post-randomization', 'description': 'Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Venous Disease-specific Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '27.67', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '23.47', 'spread': '17.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.39', 'estimateComment': 'No significant difference in the change from baseline to 24 months between the two treatment arms.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 months post-randomization', 'description': 'Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Change in Leg Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.62', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 10 days post-randomization', 'description': 'Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Change in Leg Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.17', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 30 days post-randomization', 'description': 'Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Change in Leg Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 10 days post-randomization', 'description': 'Mean calf circumference measured 10 cm below the tibial tuberosity', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}, {'type': 'SECONDARY', 'title': 'Change in Leg Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'OG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by extent of thrombus and clinical center'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 30 days post-randomization', 'description': 'Mean calf circumference measured 10 cm below the tibial tuberosity', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set; intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A-Intervention', 'description': 'Pharmacomechanical catheter-directed thrombolysis (PCDT) with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'FG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio \\[INR} 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '355'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '243'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '112'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '355', 'groupId': 'BG001'}, {'value': '691', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm\n\nRecombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.'}, {'id': 'BG001', 'title': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '62'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '43', 'upperLimit': '62'}, {'value': '53', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '319', 'groupId': 'BG001'}, {'value': '629', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body-mass index', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '36'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '35'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms per square meter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Symptom severity score', 'classes': [{'categories': [{'title': 'None or very mild (0-4)', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Mild (5-9)', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': 'Moderate (10-14)', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Severe (> 14)', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Not documented', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Villalta scale was used to define baseline symptom severity', 'unitOfMeasure': 'Participants'}, {'title': 'Side of index DVT', 'classes': [{'categories': [{'title': 'Left leg', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}, {'title': 'Right leg', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous DVT or PE', 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'DVT = deep vein thrombosis; PE = pulmonary embolism', 'unitOfMeasure': 'Participants'}, {'title': 'Previous ipsilateral DVT', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'DVT = deep vein thrombosis', 'unitOfMeasure': 'Participants'}, {'title': 'DVT extends into iliac or common femoral vein', 'classes': [{'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients with DVT extending into the iliac or common femoral vein are termed "iliofemoral DVT" and those whose DVT did not extend that high are termed "femoropopliteal DVT".', 'unitOfMeasure': 'Participants'}, {'title': 'DVT risk factors', 'classes': [{'categories': [{'title': 'Major surgery', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Hospitalization', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Plaster cast immobilization', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Childbirth', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'None of the above risk factors', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Outpatient', 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '568', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from symptom start to randomization', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Aspirin use within past 7 days', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estimated glomerular filtration rate', 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000', 'lowerLimit': '70', 'upperLimit': '102'}, {'value': '86', 'groupId': 'BG001', 'lowerLimit': '71', 'upperLimit': '102'}, {'value': '86', 'groupId': 'BG002', 'lowerLimit': '71', 'upperLimit': '102'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'milliliters per minute', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'High cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Asthma', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic obstructive pulmonary disease', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'COPD = chronic obstructive pulmonary disease', 'unitOfMeasure': 'Participants'}, {'title': 'Angina or myocardial infarction', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'MI = myocardial infarction', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive heart failure', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '174', 'spread': '11', 'groupId': 'BG000'}, {'value': '174', 'spread': '10', 'groupId': 'BG001'}, {'value': '174', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '97', 'spread': '25', 'groupId': 'BG000'}, {'value': '96', 'spread': '24', 'groupId': 'BG001'}, {'value': '97', 'spread': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'One patient was found not to meet the study inclusion criterion, and was excluded from all analyses by the adjudication committee.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 692}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2008-10-15', 'resultsFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-28', 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)', 'timeFrame': 'Between 6 and 24 months after randomization', 'description': 'Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.'}], 'secondaryOutcomes': [{'measure': 'Major Non-post-thrombotic Syndrome Treatment Failure', 'timeFrame': 'Through 24 months', 'description': 'A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.'}, {'measure': 'Any Treatment Failure', 'timeFrame': 'Through 24 months', 'description': 'Composite of PTS and major non-PTS treatment failure'}, {'measure': 'Moderate-to-severe Post-thrombotic Syndrome', 'timeFrame': 'Between 6 and 24 months after randomization', 'description': 'Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.'}, {'measure': 'Major Bleeding', 'timeFrame': 'Within 10 days after randomization', 'description': 'Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).'}, {'measure': 'Major Bleeding', 'timeFrame': 'Within 24 months after randomization', 'description': 'Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).'}, {'measure': 'Any (Minor + Major) Bleeding', 'timeFrame': 'Within 10 days after randomization', 'description': 'Clinically overt bleeding that occurred through 10 days post-randomization'}, {'measure': 'Any (Major + Minor) Bleeding', 'timeFrame': 'Within 24 months after randomization', 'description': 'Clinically overt bleeding that occurred within 24 months post-randomization'}, {'measure': 'Recurrent Venous Thromboembolism', 'timeFrame': 'Within 10 days after randomization', 'description': 'Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)'}, {'measure': 'Recurrent Venous Thromboembolism', 'timeFrame': 'Within 24 months after randomization', 'description': 'Symptomatic recurrent venous thromboembolism (DVT and/or PE)'}, {'measure': 'Death', 'timeFrame': 'Within 10 days after randomization', 'description': 'All-cause mortality'}, {'measure': 'Death', 'timeFrame': 'Within 24 months after randomization', 'description': 'All-cause mortality'}, {'measure': 'Severity of Post-thrombotic Syndrome (Villalta)', 'timeFrame': 'At 6 months', 'description': 'Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.'}, {'measure': 'Severity of Post-thrombotic Syndrome (Villalta)', 'timeFrame': 'At 12 months', 'description': 'Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.'}, {'measure': 'Severity of Post-thrombotic Syndrome (Villalta)', 'timeFrame': 'At 18 months', 'description': 'Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.'}, {'measure': 'Severity of Post-thrombotic Syndrome (Villalta)', 'timeFrame': 'At 24 months', 'description': 'Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.'}, {'measure': 'Venous Clinical Severity Score', 'timeFrame': 'At 6 months', 'description': 'Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse'}, {'measure': 'Venous Clinical Severity Score', 'timeFrame': 'At 12 months', 'description': 'Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)'}, {'measure': 'Venous Clinical Severity Score', 'timeFrame': 'At 18 months', 'description': 'Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)'}, {'measure': 'Venous Clinical Severity Score', 'timeFrame': 'At 24 months', 'description': 'Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)'}, {'measure': 'Change in General Quality of Life - Physical', 'timeFrame': 'Baseline to 24 months post-randomization', 'description': 'Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.'}, {'measure': 'Change in General Quality of Life - Mental', 'timeFrame': 'Baseline to 24 months post-randomization', 'description': 'Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.'}, {'measure': 'Change in Venous Disease-specific Quality of Life', 'timeFrame': 'Baseline to 24 months post-randomization', 'description': 'Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.'}, {'measure': 'Change in Leg Pain Severity', 'timeFrame': 'Baseline to 10 days post-randomization', 'description': 'Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain'}, {'measure': 'Change in Leg Pain Severity', 'timeFrame': 'Baseline to 30 days post-randomization', 'description': 'Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain'}, {'measure': 'Change in Leg Circumference', 'timeFrame': 'Baseline to 10 days post-randomization', 'description': 'Mean calf circumference measured 10 cm below the tibial tuberosity'}, {'measure': 'Change in Leg Circumference', 'timeFrame': 'Baseline to 30 days post-randomization', 'description': 'Mean calf circumference measured 10 cm below the tibial tuberosity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['deep vein thrombosis', 'deep venous thrombosis', 'post thrombotic syndrome', 'blood clot', 'thrombolysis', 'tissue plasminogen activator', 'rt-PA', 'Activase', 'mechanical thrombectomy', 'pharmacomechanical', 'ATTRACT'], 'conditions': ['Deep Vein Thrombosis', 'Venous Thrombosis', 'Postphlebitic Syndrome', 'Venous Thromboembolism', 'Post Thrombotic Syndrome']}, 'referencesModule': {'references': [{'pmid': '18574272', 'type': 'BACKGROUND', 'citation': 'Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):454S-545S. doi: 10.1378/chest.08-0658.'}, {'pmid': '16475040', 'type': 'BACKGROUND', 'citation': 'Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006 Feb;21(1):41-8. doi: 10.1007/s11239-006-5574-9.'}, {'pmid': '16614142', 'type': 'BACKGROUND', 'citation': 'Vedantham S, Millward SF, Cardella JF, Hofmann LV, Razavi MK, Grassi CJ, Sacks D, Kinney TB; Society of Interventional Radiology. Society of Interventional Radiology position statement: treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis. J Vasc Interv Radiol. 2006 Apr;17(4):613-6. doi: 10.1097/01.RVI.0000203802.35689.66. No abstract available.'}, {'pmid': '15178716', 'type': 'BACKGROUND', 'citation': 'Vedantham S, Vesely TM, Sicard GA, Brown D, Rubin B, Sanchez LA, Parti N, Picus D. Pharmacomechanical thrombolysis and early stent placement for iliofemoral deep vein thrombosis. J Vasc Interv Radiol. 2004 Jun;15(6):565-74. doi: 10.1097/01.rvi.0000127894.00553.02.'}, {'pmid': '39968829', 'type': 'DERIVED', 'citation': 'Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.'}, {'pmid': '33445952', 'type': 'DERIVED', 'citation': 'Li W, Kessinger CW, Orii M, Lee H, Wang L, Weinberg I, Jaff MR, Reed GL, Libby P, Tawakol A, Henke PK, Jaffer FA. Time-Restricted Salutary Effects of Blood Flow Restoration on Venous Thrombosis and Vein Wall Injury in Mouse and Human Subjects. Circulation. 2021 Mar 23;143(12):1224-1238. doi: 10.1161/CIRCULATIONAHA.120.049096. Epub 2021 Jan 15.'}, {'pmid': '31843251', 'type': 'DERIVED', 'citation': 'Kahn SR, Julian JA, Kearon C, Gu CS, Cohen DJ, Magnuson EA, Comerota AJ, Goldhaber SZ, Jaff MR, Razavi MK, Kindzelski AL, Schneider JR, Kim P, Chaer R, Sista AK, McLafferty RB, Kaufman JA, Wible BC, Blinder M, Vedantham S; ATTRACT Trial Investigators. Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):8-23.e18. doi: 10.1016/j.jvsv.2019.03.023.'}, {'pmid': '31592728', 'type': 'DERIVED', 'citation': 'Magnuson EA, Chinnakondepalli K, Vilain K, Kearon C, Julian JA, Kahn SR, Goldhaber SZ, Jaff MR, Kindzelski AL, Herman K, Brady PS, Sharma K, Black CM, Vedantham S, Cohen DJ. Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial. Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005659. doi: 10.1161/CIRCOUTCOMES.119.005659. Epub 2019 Oct 8.'}, {'pmid': '31354089', 'type': 'DERIVED', 'citation': 'Weinberg I, Vedantham S, Salter A, Hadley G, Al-Hammadi N, Kearon C, Julian JA, Razavi MK, Gornik HL, Goldhaber SZ, Comerota AJ, Kindzelski AL, Schainfeld RM, Angle JF, Misra S, Schor JA, Hurst D, Jaff MR; ATTRACT Trial Investigators. Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial. Vasc Med. 2019 Oct;24(5):442-451. doi: 10.1177/1358863X19862043. Epub 2019 Jul 27.'}, {'pmid': '30699446', 'type': 'DERIVED', 'citation': 'Kearon C, Gu CS, Julian JA, Goldhaber SZ, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Kahn SR, Kindzelski AL, Slater D, Geary R, Winokur R, Natarajan K, Dietzek A, Leung DA, Kim S, Vedantham S. Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial. Thromb Haemost. 2019 Apr;119(4):633-644. doi: 10.1055/s-0039-1677795. Epub 2019 Jan 30.'}, {'pmid': '30586751', 'type': 'DERIVED', 'citation': 'Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.'}, {'pmid': '29211671', 'type': 'DERIVED', 'citation': 'Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066.'}, {'pmid': '23537968', 'type': 'DERIVED', 'citation': 'Vedantham S, Goldhaber SZ, Kahn SR, Julian J, Magnuson E, Jaff MR, Murphy TP, Cohen DJ, Comerota AJ, Gornik HL, Razavi MK, Lewis L, Kearon C. Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis. Am Heart J. 2013 Apr;165(4):523-530.e3. doi: 10.1016/j.ahj.2013.01.024. Epub 2013 Mar 5.'}, {'pmid': '20047905', 'type': 'DERIVED', 'citation': 'Comerota AJ. The ATTRACT trial: rationale for early intervention for iliofemoral DVT. Perspect Vasc Surg Endovasc Ther. 2009 Dec;21(4):221-4; quiz 224-5. doi: 10.1177/1531003509359311. Epub 2010 Jan 3.'}], 'seeAlsoLinks': [{'url': 'http://www.patient.co.uk/showdoc/23068982', 'label': 'Deep Vein Thrombosis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.', 'detailedDescription': 'Activase, the study drug, is a fibrinolytic drug that is indicated for use in acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults. Previous studies have established the ability of rt-PA to lyse venous thrombus in patients with deep vein thrombosis (DVT), and suggest that successful rt-PA mediated thrombolysis can prevent the post-thrombotic syndrome (PTS), a morbid, late complication of DVT that occurs in nearly 50% of patients.\n\nrt-PA is delivered directly into venous thrombus using a catheter/device which is embedded within the thrombus by a physician under imaging guidance. This method of rt-PA delivery, pharmacomechanical catheter-directed intrathrombus thrombolysis (PCDT),is thought to be safer, more effective, and more efficient than previous methods. The question of whether PCDT using rt-PA improves long-term DVT patient outcomes with acceptable risk and cost has not yet been addressed.\n\nThe rationale for performing the ATTRACT Trial is based upon:\n\n* the major burden of PTS on DVT patients and the U.S. healthcare system\n* the association between rapid clot lysis and prevention of PTS\n* the proven ability of rt-PA to dissolve venous thrombus in proximal DVT\n* recent advances in CDT methods which may lower bleeding risk\n* the major clinical controversy on whether CDT should be routinely used for first-line DVT therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.\n\nExclusion Criteria:\n\n* Age less than 16 years or greater than 75 years.\n* Symptom duration \\> 14 days for the DVT episode in the index leg (i.e., non-acute DVT).\n* In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.\n* In the contralateral (non-index) leg: symptomatic acute DVT a) involving the iliac and/or common femoral vein; or b) for which thrombolysis is planned as part of the initial therapy.\n* Limb-threatening circulatory compromise.\n* Pulmonary embolism with hemodynamic compromise (i.e., hypotension).\n* Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.\n* Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.\n* Hemoglobin \\< 9.0 mg/dl, INR \\> 1.6 before warfarin was started, or platelets \\< 100,000/ml.\n* Moderate renal impairment in diabetic patients (estimated glomerular filtration rate \\[GFR\\] \\< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR \\< 30 ml/min).\n* Active bleeding, recent (\\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.\n* Recent (\\< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (\\< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure.\n* History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.\n* Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.\n* Severe hypertension on repeated readings (systolic \\> 180 mmHg or diastolic \\> 105 mmHg).\n* Pregnant (positive pregnancy test, women of childbearing potential must be tested).\n* Recently (\\< 1 mo) had thrombolysis or is participating in another investigational drug study.\n* Use of a thienopyridine antiplatelet drug (except clopidogrel) in the last 5 days.\n* Life expectancy \\< 2 years or chronic non-ambulatory status.\n* Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).'}, 'identificationModule': {'nctId': 'NCT00790335', 'acronym': 'ATTRACT', 'briefTitle': 'Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial', 'orgStudyIdInfo': {'id': '22326953211'}, 'secondaryIdInfos': [{'id': 'U01HL088476-01A1', 'link': 'https://reporter.nih.gov/quickSearch/U01HL088476-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-Intervention', 'description': 'PCDT with intrathrombus delivery of recombinant tissue plasminogen activator (rt-PA, maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm', 'interventionNames': ['Drug: Recombinant tissue plasminogen activator (rt-PA)']}, {'type': 'NO_INTERVENTION', 'label': 'B-Control', 'description': 'Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio 2.0 - 3.0). Elastic compression stockings will be prescribed'}], 'interventions': [{'name': 'Recombinant tissue plasminogen activator (rt-PA)', 'type': 'DRUG', 'otherNames': ['rt-PA', 'recombinant tissue plasminogen activator', 'Activase', 'Alteplase'], 'description': 'Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.', 'armGroupLabels': ['A-Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arrowhead Hospital/Phoenix Heart, PLLC', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Danbury Hospital', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Eastern Connecticut Hematology and Oncology Associates', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Systems', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Mease Countryside Hospital', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cardiac & Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. 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