Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-01 @ 5:12 PM
Study NCT ID:
NCT02338492
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gdipoto@illuminoss.com', 'phone': '401-714-0008', 'title': 'Gene DiPoto', 'phoneExt': '202', 'organization': 'IlluminOss Medical Inc.'}, 'certainAgreement': {'otherDetails': "The PI shall submit copies of any material to sponsor for review at least 30 days in advance of submission to a publisher or other third party. The sponsor shall review the data provided for consistency and reserves the right to delete any confidential information or other proprietary information from the proposed material. Sponsor may extend such review period for another 60 days to allow for filing of patent applications or take other steps to protect the sponsor's IP interests.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 49, 'seriousNumAtRisk': 81, 'deathsNumAffected': 32, 'seriousNumAffected': 58}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Medical device site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Medical device site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bone lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Medical device site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Post procedural pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Postoperative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fracture nonunion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bone cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chondrosarcoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Endotheliomatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Large cell lung cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Leiomyosarcoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': "Non-Hodgkin's lymphoma metastatic", 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oesophageal adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Activities of daily living impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.7', 'spread': '3.62', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.615', 'groupIds': ['OG000'], 'pValueComment': 'P-value not adjusted for multiple comparisons as the second co-primary endpoint will only be tested if the p-value for VAS improvement is \\<0.05.', 'groupDescription': 'Null hypothesis: Mean improvement in VAS over 90 days \\<= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures (MMRM) model employed, including the baseline VAS score. Missing values will be imputed.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 90 days', 'description': 'Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects who had a Day 90 visit'}, {'type': 'PRIMARY', 'title': 'Change in Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'categories': [{'measurements': [{'value': '39.23', 'spread': '2.929', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 90 days', 'description': 'Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had 90 Day data'}, {'type': 'PRIMARY', 'title': 'Summary of Clinical Safety Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'title': 'Up to D7-14 : No serious dev rel complications', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Up to D7-14 : No additional surgical intervention', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Up to D7-14 : No device fracture, migration', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Up to D7-14 : Safety Success', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Up to D30 : No serious dev rel complications', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Up to D30 : No additional surgical intervention', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Up to D30 : No device fracture, migration', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Up to D30 : Safety Success', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Up to D90 : No serious dev rel complications', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Up to D90 : No additional surgical intervention', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Up to D90 : No device fracture, migration', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Up to D90 : Safety Success', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Up to D180 : No serious dev rel complications', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Up to D180 : No additional surgical intervention', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Up to D180 : No device fracture, migration', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Up to D180 : Safety Success', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Up to D360 : No serious dev rel complications', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Up to D360 : No additional surgical intervention', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Up to D360 : No device fracture, migration', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Up to D360 : Safety Success', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.0', 'ciLowerLimit': '96', 'ciUpperLimit': '100', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '96', 'ciUpperLimit': '100', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.8', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.8', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.8', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.8', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '96.3', 'ciLowerLimit': '90', 'ciUpperLimit': '99', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '96.3', 'ciLowerLimit': '90', 'ciUpperLimit': '99', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '96.3', 'ciLowerLimit': '90', 'ciUpperLimit': '99', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.8', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.8', 'ciLowerLimit': '86', 'ciUpperLimit': '98', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.6', 'ciLowerLimit': '85', 'ciUpperLimit': '97', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.8', 'ciLowerLimit': '86', 'ciUpperLimit': '98', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95.1', 'ciLowerLimit': '88', 'ciUpperLimit': '99', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '86.4', 'ciLowerLimit': '77', 'ciUpperLimit': '93', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '86.4', 'ciLowerLimit': '77', 'ciUpperLimit': '93', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '91.4', 'ciLowerLimit': '83', 'ciUpperLimit': '96', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '91.4', 'ciLowerLimit': '83', 'ciUpperLimit': '96', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '82.7', 'ciLowerLimit': '73', 'ciUpperLimit': '90', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '82.7', 'ciLowerLimit': '73', 'ciUpperLimit': '90', 'groupDescription': '95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360', 'description': 'No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain at Palpation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'title': '90 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Pain on palpation Yes Clinically Si', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation Yes Not Clinically Sig', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation No', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation Not Done', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Pain on palpation Yes Clinically Si', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation Yes Not Clinically Sig', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation No', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation Not Done', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Pain on palpation Yes Clinically Si', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation Yes Not Clinically Sig', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation No', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Pain on palpation Not Done', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90, 180 and 360 days', 'description': 'Pain on palpation and clinical significance', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.'}, {'type': 'SECONDARY', 'title': 'Duration of Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '1.221', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': 'Duration of index procedure (hours)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Activities of Daily Living Score Through All Follow-up Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'title': 'Functional Interference, 90 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.41', 'spread': '29.362', 'groupId': 'OG000'}]}]}, {'title': 'Functional Interference, 180 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.86', 'spread': '33.357', 'groupId': 'OG000'}]}]}, {'title': 'Functional Interference, 360 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.12', 'spread': '31.625', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Aspects, 90 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.73', 'spread': '22.316', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Aspects, 180 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.48', 'spread': '25.522', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Aspects, 360 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.36', 'spread': '26.056', 'groupId': 'OG000'}]}]}, {'title': 'Painful Sites, 90 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.55', 'spread': '17.093', 'groupId': 'OG000'}]}]}, {'title': 'Painful Sites, 180 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '17.029', 'groupId': 'OG000'}]}]}, {'title': 'Painful Sites, 360 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.19', 'spread': '18.248', 'groupId': 'OG000'}]}]}, {'title': 'Pain Characteristics, 90 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.12', 'spread': '29.988', 'groupId': 'OG000'}]}]}, {'title': 'Pain Characteristics, 180 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.94', 'spread': '33.115', 'groupId': 'OG000'}]}]}, {'title': 'Pain Characteristics, 360 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-37.35', 'spread': '32.655', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 90, 180 and 360 days', 'description': 'Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.'}, {'type': 'SECONDARY', 'title': 'MSTS Upper Extremity Functional Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'title': '90 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.13', 'spread': '23.607', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.15', 'spread': '26.507', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.75', 'spread': '22.608', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90, 180, 360 days', 'description': 'Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.'}, {'type': 'SECONDARY', 'title': 'Assessment of Post-Surgery Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'title': 'Surgery/Discharge: Physical therapy prescribed', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Surgery/Discharge: Supportive orth dev recommend', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'SurgeryDischarge: Analgesic med prescribed', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Surgery/Discharge: Completed physical therapy', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable for this visit', 'groupId': 'OG000'}]}]}, {'title': 'Surgery/Discharge: Used supportive orth devices', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable for this visit', 'groupId': 'OG000'}]}]}, {'title': 'Surgery/Discharge: Used analgesic medication', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable for this visit', 'groupId': 'OG000'}]}]}, {'title': '7-14 Day F/U: Physical therapy prescribed', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': '7-14 Day F/U: Supportive orth dev recommend', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': '7-14 Day F/U: Analgesic medication prescribed', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '7-14 Day F/U: Completed physical therapy', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': '7-14 Day F/U: Used supportive orthopedic devices', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': '7-14 Day F/U: Used analgesic medication', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': '30 Day F/U: Physical therapy prescribed', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': '30 Day F/U: Supportive orth recommend', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '30 Day F/U: Analgesic medication prescribed', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '30 Day F/U: Completed physical therapy', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': '30 Day F/U: Used supportive orthopedic devices', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': '30 Day F/U: Used analgesic medication', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U: Physical therapy prescribed', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U: Supportive orthopedic dev recommend', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U: Analgesic medication prescribed', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U: Completed physical therapy', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U: Used supportive orthopedic devices', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U : Used analgesic medication', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U: Physical therapy prescribed', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U: Supportive orth device recommend', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U: Analgesic medication prescribed', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U: Completed physical therapy', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U: Used supportive orthopedic devices', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U: Used analgesic medication', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U: Physical therapy prescribed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U: Supportive orth device recommended', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U: Analgesic medication prescribed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U: Completed physical therapy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U: Used supportive orthopedic devices', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U: Used analgesic medication', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Surgery & Discharge, 7-14, 30, 90, 180, 360 days', 'description': 'Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Summary of Procedure and Device-Related Complications Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'title': 'Procedure & device-related complications up to D90', 'categories': [{'title': 'During device preparation', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'During device implantation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Post-implantation', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'None', 'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Proc & dev-related comp rate up D180 since D90', 'categories': [{'title': 'During device preparation', 'measurements': [{'value': 'NA', 'comment': 'Post-op visit', 'groupId': 'OG000'}]}, {'title': 'During device implantation', 'measurements': [{'value': 'NA', 'comment': 'Post-op visit', 'groupId': 'OG000'}]}, {'title': 'Post-implantation', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'None', 'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Proc & dev-related comp rate up to D360 since D180', 'categories': [{'title': 'During device preparation', 'measurements': [{'value': 'NA', 'comment': 'Post-op visit', 'groupId': 'OG000'}]}, {'title': 'During device implantation', 'measurements': [{'value': 'NA', 'comment': 'Post-op visit', 'groupId': 'OG000'}]}, {'title': 'Post-implantation', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'None', 'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to day 90, up to day180 since day 90, up to 360 since day 180', 'description': 'Procedure and device-related complications rate presented at follow-up visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Summary of Change From Baseline Range of Motion by Visit and Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'title': '90 Day F/U, Abduction, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '33.36', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Abduction, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.1', 'spread': '38.22', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Abduction, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': '36.04', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U Abduction, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.2', 'spread': '37.71', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Abduction, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.9', 'spread': '44.42', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Abduction, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.3', 'spread': '51.24', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Abduction, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '32.14', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Abduction, Pass ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '29.19', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Abduction, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '33.29', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Abduction, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '32.46', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Abduction, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '43.62', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Abduction, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '42.13', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Extension, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'spread': '14.88', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Extension, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '17.01', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Extension, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '16.17', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Extension, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '17.15', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Extension, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '19.75', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Extension, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '21.83', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Extension, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '13.87', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Extension, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '14.12', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Extension, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '17.96', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Extension, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '17.41', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Extension, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '19.90', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Extension, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '27.24', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Flexion, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.7', 'spread': '36.61', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Flexion, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.5', 'spread': '45.27', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Flexion, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.1', 'spread': '39.90', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Flexion, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '45.35', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Flexion, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.6', 'spread': '51.17', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Flexion, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.7', 'spread': '52.28', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Flexion, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '29.85', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Flexion, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '29.02', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Flexion, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '35.86', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Flexion, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '34.72', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Flexion, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '42.01', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Flexion, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 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[{'measurements': [{'value': '6.5', 'spread': '30.69', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Lat Rotate, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '22.79', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Lat Rotate, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '20.99', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Lat Rotate, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '14.95', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Lat Rotate, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '14.18', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Lat Rotate, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '18.67', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Lat Rotate, Passive ROM unaffect arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '19.14', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Lat Rotate, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '20.25', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Lat Rotate, Passive ROM unaffect arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '25.656', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Med Rotate, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '28.78', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Med Rotate, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '25.90', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Med Rotate, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '31.21', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Med Rotate, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '34.14', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Med Rotate, Active ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '27.46', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Med Rotate, Passive ROM affected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '24.28', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Med Rotate, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '14.43', 'groupId': 'OG000'}]}]}, {'title': '90 Day F/U, Med Rotate, Passive ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.89', 'spread': '20.939', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Med Rotate, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '14.72', 'groupId': 'OG000'}]}]}, {'title': '180 Day F/U, Med Rotate, Passive ROM unaffect arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '9.85', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Med Rotate, Active ROM unaffected arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '19.15', 'groupId': 'OG000'}]}]}, {'title': '360 Day F/U, Med Rotate, Passive ROM unaffect arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '18.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 90, 180 and 360 Days', 'description': 'Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '6.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day of procedure until the day of hospital discharge (up to 36 days)', 'description': 'Length of hospital stay (from day of procedure to day of discharge)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'Device Implanted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'Treatment Failure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Reason not captured above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Photodynamic Bone Stabilization System (PBSS)', 'description': 'The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone\n\nIlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.9', 'spread': '11.91', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], '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': '9', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Actual Bone Fracture Characteristics - Location of Target Fracture', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Left Humerus', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Right Humerus', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects with Actual Bone Fracture'}, {'title': 'Actual Bone Fracture Characteristics - Location', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Proximal', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Diaphyseal', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Distal', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects with Actual Bone Fracture'}, {'title': 'Actual Bone Fracture Characteristics - AO Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': '11-A1', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '11-A2', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '11-A3', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '12-A1', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '12-A2', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '12-A3', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '12-B1', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '12-B2', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '12-C3', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'NA', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Classification system of fractures. 11 is the proximal humerus, 12 is the humeral shaft, and 13 is the distal humerus. For the proximal humerus, A is an extra-articular unifocal fracture, B is an extra-articular bifocal fracture and C is an articular fracture. For the humeral shaft, A is a simple fracture, B is a wedge fracture and C is a complex fracture. For the distal humerus, A is an extra articular fracture, B is partial articular fracture and C is a complete articular fracture. These are further classified as 1, 2, 3 with the higher number indicating a more complex fracture.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects with Actual Bone Fracture'}, {'title': 'Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Closed Fracture', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Type I', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Soft tissue grading. It ranges from Type I (wound \\< 1 cm) to Type III C (vascular injury requiring vascular repair), with the wound damage getting more severe as the type increases. A closed fracture does not have any soft tissue damage. The grading system considers the energy of the injury, the wound size, amount of soft tissue damage, contamination, fracture pattern, periosteal stripping, skin coverage, neovascular injury and antibiotic use.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects with Actual Bone Fracture'}, {'title': 'Impending Bone Fracture Characteristics - Location of Target Fracture', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Left Humerus', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Right Humerus', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects with Impending Bone Fracture'}, {'title': 'Impending Bone Fracture Characteristics - Location', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Proximal', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Diaphyseal', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Distal', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subjects with Impending Bone Fracture'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-06', 'size': 997714, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-03T13:09', 'hasProtocol': True}, {'date': '2016-11-15', 'size': 607329, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-03T17:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2017-11-13', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2015-01-07', 'dispFirstSubmitQcDate': '2017-11-13', 'resultsFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2015-01-13', 'dispFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-18', 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': 'Baseline and 90 days', 'description': 'Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).'}, {'measure': 'Change in Function', 'timeFrame': 'Baseline and 90 days', 'description': 'Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.'}, {'measure': 'Summary of Clinical Safety Success', 'timeFrame': 'Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360', 'description': 'No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation'}], 'secondaryOutcomes': [{'measure': 'Pain at Palpation', 'timeFrame': '90, 180 and 360 days', 'description': 'Pain on palpation and clinical significance'}, {'measure': 'Duration of Index Procedure', 'timeFrame': '1 Day', 'description': 'Duration of index procedure (hours)'}, {'measure': 'Activities of Daily Living Score Through All Follow-up Intervals', 'timeFrame': 'Baseline, 90, 180 and 360 days', 'description': 'Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning.'}, {'measure': 'MSTS Upper Extremity Functional Outcome', 'timeFrame': '90, 180, 360 days', 'description': 'Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.'}, {'measure': 'Assessment of Post-Surgery Status', 'timeFrame': 'Surgery & Discharge, 7-14, 30, 90, 180, 360 days', 'description': 'Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication'}, {'measure': 'Summary of Procedure and Device-Related Complications Rate', 'timeFrame': 'up to day 90, up to day180 since day 90, up to 360 since day 180', 'description': 'Procedure and device-related complications rate presented at follow-up visits'}, {'measure': 'Summary of Change From Baseline Range of Motion by Visit and Test', 'timeFrame': 'Baseline, 90, 180 and 360 Days', 'description': 'Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'From day of procedure until the day of hospital discharge (up to 36 days)', 'description': 'Length of hospital stay (from day of procedure to day of discharge)'}]}, 'conditionsModule': {'conditions': ['Humerus Fracture Metastatic Bone Disease']}, 'descriptionModule': {'briefSummary': 'This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.', 'detailedDescription': 'This is a prospective, multi-center, open label study to evaluate the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic malignancy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- General Inclusion Criteria\n\n1. Skeletally mature adult males and females 18 years of age or older.\n2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.\n3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:\n\n 1. Postmenopausal for at least 1 year OR\n 2. Documented oophorectomy or hysterectomy\n 3. Surgically sterile OR\n 4. If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening\n4. Patient, or his/her legally authorized representative, is able to understand and provide informed consent.\n5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.\n6. VAS Pain Score \\> 60mm on 100mm scale.\n\n -Impending Fracture-Specific Inclusion Criteria\n7. Documented presence of at least one metastatic lesion of the humerus.\n8. Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements)\n9. Destruction of cortical bone at impending fracture site \\> 50%.\n\n -Actual Fracture-Specific Inclusion Criteria\n10. Fracture is closed, Gustilo Type I or II.\n\nExclusion Criteria:\n\n\\- General Exclusion Criteria\n\n1. Primary tumor (osteogenic origin, etc.) at site.\n2. Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.\n3. Active or incompletely treated infections that could involve the device implant site.\n4. Distant foci of infection that may spread to the implant site.\n5. Allergy to implant materials or dental glue.\n6. In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).\n7. In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.\n8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).\n9. Prisoner\n\n -Impending Fracture-Specific Exclusion Criteria\n10. Mirels Score \\< 8 (specific to target humeral lesion).\n11. Destruction of cortical bone at impending fracture site \\< 50%.\n12. Prior surgery and/or prior fracture of affected site.\n13. Any articular component to impending fracture site.\n\n -Actual Fracture-Specific Exclusion Criteria\n14. Open fractures with severe contamination.\n15. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.\n16. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided."}, 'identificationModule': {'nctId': 'NCT02338492', 'briefTitle': 'Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus', 'organization': {'class': 'INDUSTRY', 'fullName': 'IlluminOss Medical, Inc.'}, 'officialTitle': 'A Prospective, Multi-Center Study of the IlluminOss® Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease', 'orgStudyIdInfo': {'id': '14-03-PATHOLHUM-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photodynamic Bone Stabilization System', 'description': 'Photodynamic Bone Stabilization System (PBSS) is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone', 'interventionNames': ['Device: Photodynamic Bone Stabilization System']}], 'interventions': [{'name': 'Photodynamic Bone Stabilization System', 'type': 'DEVICE', 'description': 'Treatment of impending and actual pathological fractures of the humerus', 'armGroupLabels': ['Photodynamic Bone Stabilization System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford School of Medicine', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Orthopaedics at Rush', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Franklin Square Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Physicians', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'University Orthopedics Inc.', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '25701', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Marshall University', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IlluminOss Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}