Viewing Study NCT03998566

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Ignite Creation Date: 2025-12-24 @ 4:18 PM
Ignite Modification Date: 2025-12-28 @ 7:04 AM
Study NCT ID: NCT03998566
Status: COMPLETED
Last Update Posted: 2023-02-27
First Post: 2019-06-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeya.satheesh@bsci.com', 'phone': '6124490870', 'title': 'Jeya Satheesh', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit.', 'description': "Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected.\n\nAll AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.", 'eventGroups': [{'id': 'EG000', 'title': 'TraceIT Tissue Spacer', 'description': 'TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders - Other', 'notes': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders - Other', 'notes': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Leukocytes - Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Neutrophils - Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Platelet Count - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythmatous Injection Sites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders - Other', 'notes': 'inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders - Other', 'notes': 'Paraesophageal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions - Other', 'notes': 'Temperature regulation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions - Other', 'notes': 'localized edema - lower extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary disorders - Other', 'notes': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations - Other', 'notes': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kyphosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Chest Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'notes': 'Throracolumbar Spondylosis without Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'notes': 'generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'notes': 'abnormalities of gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'notes': 'decreased mobility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'notes': 'left ankle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 15, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occasional Leg Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occasional Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occasional Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain Near Incision Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruiritic Injection Sites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders - Other', 'notes': 'Glucosuria Present Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders - Other', 'notes': 'chronic renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'notes': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'notes': 'reactive airway disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'notes': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders - Other', 'notes': 'swelling of leg (left)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bile Duct Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to Disease progression/worsening of Pancreatic Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disease recurrence in the pancreas and metastasis to the lower lobe of the right lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder- Other', 'notes': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders- Other', 'notes': 'Obstructive hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders- Other', 'notes': 'Liver Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations- Other', 'notes': 'bacterial peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations- Other', 'notes': 'Influenza B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations- Other', 'notes': 'Coronavirus HKU1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations - Other,', 'notes': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder- Other', 'notes': 'Right Thoracic Facet Spondylosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other,', 'notes': 'distant metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders- Other', 'notes': 'Cancer-Related Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'notes': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'notes': 'hypercapnic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'notes': 'bacterial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'notes': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures - Other', 'notes': 'Drain site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All TIPS Participant', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 week assessment post-procedure', 'description': 'Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'Radio-Therapy Benefits of TraceIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All TIPS Participants', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 week assessment', 'description': 'Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'Feasibility of TraceIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All TIPS Participant', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 week assessment post-procedure', 'description': 'Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'TraceIT Persistence (at 6-months Post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2-3 Weeks Follow-up Post Radiation Therapy', 'description': 'Number of subjects showing persistence and migration.'}, {'id': 'OG001', 'title': '6 Month Follow-up Post Radiation Therapy', 'description': 'Number of subjects showing persistence and migration.'}], 'classes': [{'title': 'Persistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Migration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 weeks and 6 month post procedure', 'description': 'Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'Theoretical Dose Escalation From Post-TraceIT Treatment Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All TIPS Participants', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '19.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-6 week assessment Post-procedure', 'description': 'Maximum dose to the GTV while maintaining duodenal dose constraints', 'unitOfMeasure': 'Gy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Total number of subjects'}, {'id': 'OG001', 'title': 'One or More Acute (<=3 Months)', 'description': 'Subjects who have experienced one or more acute AEs within 3 months of index procedure.'}, {'id': 'OG002', 'title': 'One or More Late (>3 Months)', 'description': 'Subjects who have experienced one or more AEs more than 3 months after index procedure.'}], 'classes': [{'title': 'Subjects who have one or more grade 1 duodenal AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Subjects who have one or more grade 2 duodenal AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Subjects who have one or more grade 3 duodenal AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Subjects who have one or more grade 4 duodenal AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects who have one or more grade 5 duodenal AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects who only have grade N/A duodenal AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects who have one or more duodenal AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months post procedure', 'description': 'Number of subject with Duodenal AE summarized by CTCAE grade and timing', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'Incidence of Resection Following the Completion of Radiation Therapy (RT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All TIPS Participants', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-6 weeks post procedure', 'description': 'Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'Progression Free and Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All TIPS Participants', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}], 'classes': [{'title': 'Progression free survival (subjects with tumor progression event)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Overall survival in subjects who died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': '10.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months post procedure', 'description': 'Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Final RT', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}, {'id': 'OG001', 'title': '3 Months', 'description': 'Subject outcomes at 3 month follow-up visit'}, {'id': 'OG002', 'title': '6 Month', 'description': 'Subject outcome at 6 month follow-up visit'}, {'id': 'OG003', 'title': '12 Month', 'description': 'Subject outcomes at 12 Month follow-up visit'}, {'id': 'OG004', 'title': '18 Month', 'description': 'Subject outcome at 18 month follow-up visit'}], 'classes': [{'title': 'Change of Global health status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-25', 'upperLimit': '0'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-25', 'upperLimit': '8.3'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '25'}, {'value': '-29.2', 'groupId': 'OG003', 'lowerLimit': '-33.3', 'upperLimit': '-25'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6.7'}, {'value': '-17.8', 'groupId': 'OG001', 'lowerLimit': '-46.7', 'upperLimit': '0'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '-13.3', 'upperLimit': '20'}, {'value': '-10.0', 'groupId': 'OG003', 'lowerLimit': '-20', 'upperLimit': '0'}, {'value': '-13.3', 'groupId': 'OG004', 'lowerLimit': '-13.3', 'upperLimit': '-13.3'}]}]}, {'title': 'Role Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-13.3', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '-50.0', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '-8.3', 'groupId': 'OG003', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '-66.7', 'groupId': 'OG004', 'lowerLimit': '-66.7', 'upperLimit': '-66.7'}]}]}, {'title': 'Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '8.3'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8.3'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '-25', 'upperLimit': '25'}, {'value': '-20.8', 'groupId': 'OG003', 'lowerLimit': '-25', 'upperLimit': '-16.7'}, {'value': '-33.3', 'groupId': 'OG004', 'lowerLimit': '-33.3', 'upperLimit': '-33.3'}]}]}, {'title': 'Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-16.7', 'upperLimit': '33.3'}, {'value': '-16.7', 'groupId': 'OG001', 'lowerLimit': '-50', 'upperLimit': '0'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16.7'}, {'value': '-8.3', 'groupId': 'OG003', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '-33.3', 'groupId': 'OG004', 'lowerLimit': '-33.3', 'upperLimit': '-33.3'}]}]}, {'title': 'Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '-5.6', 'groupId': 'OG001', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '-16.7', 'upperLimit': '50'}, {'value': '-16.7', 'groupId': 'OG003', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '-66.7', 'groupId': 'OG004', 'lowerLimit': '-66.7', 'upperLimit': '-66.7'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '66.7'}, {'value': '11.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16.7'}, {'value': '-6.7', 'groupId': 'OG002', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '16.7', 'upperLimit': '16.7'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '-16.7', 'upperLimit': '16.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '-10', 'groupId': 'OG002', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '-8.3', 'groupId': 'OG003', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '50', 'groupId': 'OG004', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-13.3', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '-20', 'groupId': 'OG002', 'lowerLimit': '-66.7', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-66.7', 'upperLimit': '33.3'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '66.7'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '66.7', 'upperLimit': '66.7'}]}]}, {'title': 'Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '66.7'}, {'value': '-22.2', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '-13.3', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '-6.7', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Financial Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month', 'description': "The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All TIPS Participants', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}], 'classes': [{'title': 'Fiducial marker visibility scoring', 'categories': [{'title': '1-Not visualized', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2-Faint or trace visibility (shadow or haze)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3-Visibility but indistinct borders (definable entity)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4-Partially distinct border, partial haze', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '5- Clearly visualized, unequivocal', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'TraceIT hydrogel visibility scoring', 'categories': [{'title': '1-Not visualized', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2-Faint or trace visibility (shadow or haze)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3-Visibility but indistinct borders (definable entity)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '4-Partially distinct border, partial haze', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '5- Clearly visualized, unequivocal', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-5 weeks assessment post procedure', 'description': 'Scores for the visualization of the fiducial marker and TraceIT hydrogel.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'TraceIT Stability and Space Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-TraceIT', 'description': 'Space measurements taken before TraceIT was injected.'}, {'id': 'OG001', 'title': 'Post- TraceIT', 'description': 'Stability measured as the minimum distance from the fiducial maker to TraceIT gel.\n\nSpace measurement taken after TraceIT was injected.'}, {'id': 'OG002', 'title': '2-6 Weeks Follow-up Post Radiation Therapy', 'description': 'Stability measured as the minimum distance from the fiducial maker to TraceIT gel.'}], 'classes': [{'title': 'Stability - Minimum distance from fiducial to TraceIT gel (mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'TraceIT Space Measurement (mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy', 'description': 'The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Final RT', 'description': 'Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.'}, {'id': 'OG001', 'title': '3 Months', 'description': 'Subject outcomes at 3 month follow-up visit'}, {'id': 'OG002', 'title': '6 Month', 'description': 'Subject outcome at 6 month follow-up visit'}, {'id': 'OG003', 'title': '12 Month', 'description': 'Subject outcomes at 12 Month follow-up visit'}, {'id': 'OG004', 'title': '18 Month', 'description': 'Subject outcome 18 month follow-up visit'}], 'classes': [{'title': 'Pancreatic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-8.3', 'upperLimit': '25'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8.3'}, {'value': '-10', 'groupId': 'OG002', 'lowerLimit': '-25', 'upperLimit': '0'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '8.3', 'upperLimit': '8.3'}, {'value': '8.3', 'groupId': 'OG004', 'lowerLimit': '8.3', 'upperLimit': '8.3'}]}]}, {'title': 'Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '-6.7', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '33.3', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Digestive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '44.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '66.7'}, {'value': '-16.7', 'groupId': 'OG003', 'lowerLimit': '-16.7', 'upperLimit': '-16.7'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '66.7', 'upperLimit': '66.7'}]}]}, {'title': 'Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '33.3', 'upperLimit': '100'}, {'value': '-6.7', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '66.7'}, {'value': '-33.3', 'groupId': 'OG003', 'lowerLimit': '-33.3', 'upperLimit': '-33.3'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Indigestion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '-26.7', 'groupId': 'OG002', 'lowerLimit': '-66.7', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Flatulence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '66.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '13.3', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '66.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '33.3', 'upperLimit': '33.3'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Weakness arms and legs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '13.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '33.3', 'upperLimit': '33.3'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '100'}, {'value': '-13.3', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '33.3', 'upperLimit': '33.3'}, {'value': '-33.3', 'groupId': 'OG004', 'lowerLimit': '-33.3', 'upperLimit': '-33.3'}]}]}, {'title': 'Hepatic Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '-5.6', 'groupId': 'OG001', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '-3.3', 'groupId': 'OG002', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '50', 'groupId': 'OG003', 'lowerLimit': '50', 'upperLimit': '50'}, {'value': '-16.7', 'groupId': 'OG004', 'lowerLimit': '-16.7', 'upperLimit': '-16.7'}]}]}, {'title': 'Altered Bowel Habit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-83.3', 'upperLimit': '66.7'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '-3.3', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '16.7'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '33.3', 'upperLimit': '33.3'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '16.7', 'upperLimit': '16.7'}]}]}, {'title': 'Body Image', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-50', 'upperLimit': '16.7'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '16.7'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '-50', 'upperLimit': '83.3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '50', 'groupId': 'OG004', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Trouble with side-effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-20', 'groupId': 'OG000', 'lowerLimit': '-66.7', 'upperLimit': '33.3'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '66.7'}, {'value': '-6.7', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '66.7', 'upperLimit': '66.7'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Future Worries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '66.7'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '66.7', 'upperLimit': '66.7'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Planning of activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-13.3', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '33.3'}, {'value': '44.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '66.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '33.3'}]}]}, {'title': 'Satisfaction with health care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '50'}, {'value': '-5.6', 'groupId': 'OG001', 'lowerLimit': '-16.7', 'upperLimit': '0'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '-16.7', 'groupId': 'OG004', 'lowerLimit': '-16.7', 'upperLimit': '-16.7'}]}]}, {'title': 'Sexuality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-33.3', 'upperLimit': '33.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '50'}, {'value': '-33.3', 'groupId': 'OG003', 'lowerLimit': '-33.3', 'upperLimit': '-33.3'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26', 'description': 'The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TraceIT Tissue Spacer', 'description': 'TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TraceIT Tissue Spacer', 'description': 'TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified Intent to Treat (MITT)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-27', 'size': 3720255, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-12T11:47', 'hasProtocol': True}, {'date': '2021-03-25', 'size': 284219, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-15T11:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2019-06-13', 'resultsFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2019-06-24', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-22', 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel', 'timeFrame': '2-5 weeks assessment post procedure', 'description': 'Scores for the visualization of the fiducial marker and TraceIT hydrogel.'}, {'measure': 'TraceIT Stability and Space Measurements', 'timeFrame': 'Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy', 'description': 'The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP.'}, {'measure': 'Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26', 'timeFrame': 'Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26', 'description': 'The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning.'}], 'primaryOutcomes': [{'measure': 'Safety Endpoint', 'timeFrame': '2-6 week assessment post-procedure', 'description': 'Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).'}], 'secondaryOutcomes': [{'measure': 'Radio-Therapy Benefits of TraceIT', 'timeFrame': '2-6 week assessment', 'description': 'Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.'}, {'measure': 'Feasibility of TraceIT', 'timeFrame': '2-6 week assessment post-procedure', 'description': 'Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).'}, {'measure': 'TraceIT Persistence (at 6-months Post-treatment)', 'timeFrame': '2-6 weeks and 6 month post procedure', 'description': 'Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.'}, {'measure': 'Theoretical Dose Escalation From Post-TraceIT Treatment Plan', 'timeFrame': '2-6 week assessment Post-procedure', 'description': 'Maximum dose to the GTV while maintaining duodenal dose constraints'}, {'measure': 'Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing', 'timeFrame': '18 months post procedure', 'description': 'Number of subject with Duodenal AE summarized by CTCAE grade and timing'}, {'measure': 'Incidence of Resection Following the Completion of Radiation Therapy (RT)', 'timeFrame': '2-6 weeks post procedure', 'description': 'Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).'}, {'measure': 'Progression Free and Overall Survival', 'timeFrame': '18 months post procedure', 'description': 'Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.'}, {'measure': 'Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)', 'timeFrame': 'Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month', 'description': "The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiotherapy', 'Radiation', 'SBRT'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines\n3. Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.\n4. Subject is able to comply with motion management guidelines.\n5. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.\n6. In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.\n7. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:\n\n 1. White blood cell count: ≥ 3.0 x 109/L\n 2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L\n 3. Platelets: ≥ 100 x 109/L\n 4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)\n 5. AST and ALT: ≤ 3.0 times institutional upper normal limit\n 6. Serum creatinine: \\< 1.5 times ULN e\n 7. INR: \\< 1.5\n 8. Serum pregnancy: Negative\n 9. Hemoglobin: ≥ 8.0 g/dl\n8. Zubrod Performance Status 0-2\n9. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.\n10. Life expectancy of at least 9 months\n\nExclusion Criteria:\n\n1. Patients for whom radiotherapy is contraindicated\n2. Previous thoracic or abdominal radiotherapy\n3. Any GI abnormality that would interfere with the ability to access the injection site\n4. Presence of tumor invasion of the duodenum detected on EUS at time of biopsy\n5. Previous Whipple procedure or other resection of pancreatic tumor prior to screening\n6. Active gastroduodenal ulcer or uncontrolled watery diarrhea\n7. History of Chronic Renal Failure.\n8. Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)\n9. Currently enrolled in another investigational drug or device trial that clinically interferes with this study.\n10. Unable to comply with the study requirements or follow-up schedule.\n11. Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject.\n12. Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives."}, 'identificationModule': {'nctId': 'NCT03998566', 'briefTitle': 'Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Early Feasibility Study For Evaluation Of The TraceIT® Tissue Spacer For Creating Space Between The Duodenum And Pancreas In Patients With Localized Pancreatic Cancer Undergoing Radiation Therapy', 'orgStudyIdInfo': {'id': 'AGX17-001-US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TraceIT Tissue Spacer', 'interventionNames': ['Device: TraceIT Tissue Spacer implantation']}], 'interventions': [{'name': 'TraceIT Tissue Spacer implantation', 'type': 'DEVICE', 'description': 'The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.', 'armGroupLabels': ['TraceIT Tissue Spacer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}