Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT00109967
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2005-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C401859', 'term': 'temsirolimus'}, {'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ansell.stephen@mayo.edu', 'title': 'Stephen M. Ansell, M.D., Ph.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'temsirolimus: 25 mg given IV', 'otherNumAtRisk': 48, 'otherNumAffected': 48, 'seriousNumAtRisk': 48, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Group II: Rituximab Refractory', 'description': 'temsirolimus: 25 mg given IV', 'otherNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 143, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 88, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Endocrine disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dry eye syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal exam abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 21, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 51, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ear, nose and throat examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Esophageal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Gastric mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Gastroscopy abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 47, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 25, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 50, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 18, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 170, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 74, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Gingival infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Small intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 30, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 19, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Leukocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 174, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 68, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 64, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 20, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 97, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 38, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 176, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 75, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 136, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 45, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 27, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 26, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 27, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 22, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 45, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 38, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 28, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum phosphate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 151, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 63, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Muscle weakness upper limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 30, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 41, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 17, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Reproductive tract disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 12, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Laryngoscopy abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hand-and-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 31, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 13, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rash desquamating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 88, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 40, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Leukocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Serum calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}, {'id': 'OG001', 'title': 'Group II: Rituximab Refractory', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '47.4', 'upperLimit': '76.1'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '74.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12, 28-day cycles.', 'description': 'Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.\n\nPartial Response (PR) requires a \\>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses.\n\nOverall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients.\n\nWe report the Overall Response Rate here.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}, {'id': 'OG001', 'title': 'Group II: Rituximab Refractory', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '12.8'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '9.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients were followed up to five years after registration.', 'description': 'Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}, {'id': 'OG001', 'title': 'Group II: Rituximab Refractory', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '13.2'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '20.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Response duration is followed up to 5 years from registration.', 'description': 'Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 48 Rituximab Sensitive patients, 30 patients had a response. Of the 21 Rituximab Refractory patients, 11 patients had a response. Therefore, this endpoint uses 30 patients from the Rituximab Sensitive group and 11 patients from the Rituximab Refractory group in the analysis.'}, {'type': 'SECONDARY', 'title': 'Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}, {'id': 'OG001', 'title': 'Group II: Rituximab Refractory', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}], 'classes': [{'title': 'Grade 3 or Higher', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4 or Higher', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed during treatment (up to 12, 28-day cycles)', 'description': "As per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician.\n\nIn this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event.", 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}, {'id': 'OG001', 'title': 'Group II: Rituximab Refractory', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '24.9', 'upperLimit': '39.7'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '30.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients were followed for survival status for up to 5 years.', 'description': 'Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}, {'id': 'FG001', 'title': 'Group II: Rituximab Refractory', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV\n\ntemsirolimus: 25 mg given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Cancel Prior to Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Seventy-one patients seen at 35 sites were enrolled on this trial between May 6, 2005 and March 6, 2009. Two patients canceled before receiving treatment and 69 patients were therefore included in the analysis. There were 48 patients in group 1 (rituximab-sensitive) and 21 (rituximab-refractory) in group 2.', 'preAssignmentDetails': 'The patients were stratified by their previous response to rituximab into rituximab sensitive (group 1) or rituximab refractory (group 2) groups. Rituximab refractory was defined as no response (stable disease or progression) or a response that lasted \\<6 months the last time the patient received rituximab alone or rituximab with chemotherapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I: Rituximab Sensitive', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV temsirolimus: 25 mg given IV'}, {'id': 'BG001', 'title': 'Group II: Rituximab Refractory', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nrituximab: 375 mg/m\\^2 Given IV temsirolimus: 25 mg given IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '86'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '85'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-21', 'studyFirstSubmitDate': '2005-05-03', 'resultsFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2005-05-03', 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-03', 'studyFirstPostDateStruct': {'date': '2005-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria', 'timeFrame': 'Up to 12, 28-day cycles.', 'description': 'Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.\n\nPartial Response (PR) requires a \\>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses.\n\nOverall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients.\n\nWe report the Overall Response Rate here.'}], 'secondaryOutcomes': [{'measure': 'Time to Progression', 'timeFrame': 'Patients were followed up to five years after registration.', 'description': 'Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.'}, {'measure': 'Duration of Response', 'timeFrame': 'Response duration is followed up to 5 years from registration.', 'description': 'Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.'}, {'measure': 'Toxicity', 'timeFrame': 'Assessed during treatment (up to 12, 28-day cycles)', 'description': "As per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician.\n\nIn this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event."}, {'measure': 'Overall Survival', 'timeFrame': 'Patients were followed for survival status for up to 5 years.', 'description': 'Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Recurrent Mantle Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '21440503', 'type': 'DERIVED', 'citation': 'Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, Ziesmer SC, Feldman AL, Rao R, Gupta M, Erlichman C, Witzig TE. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011 Apr;12(4):361-8. doi: 10.1016/S1470-2045(11)70062-6.'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab.\n\nII. Determine the tolerability of this regimen in these patients by assessing toxicity.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the time to disease progression and overall survival of patients treated with this regimen.\n\nII. Determine the duration of response in patients treated with this regimen.\n\nOUTLINE: Patients are stratified according to prior response to rituximab (sensitive \\[partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last treatment with rituximab alone or in combination with chemotherapy\\] vs refractory \\[stable or progressive disease OR a PR or CR that lasted \\< 6 months after the last treatment with rituximab alone or in combination with chemotherapy\\]).\n\nPatients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.\n\nAfter completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed\\* mantle cell lymphoma (MCL)\n\n * Relapsed, refractory, or stable disease after prior treatment\n * Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics\n* Measurable disease, defined as ≥ 1 of the following:\n\n * Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI\n * Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin\n * Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry\n* No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)\n* Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2\n* At least 3 months\n* No other concurrent treatment for MCL\n* Absolute neutrophil count ≥ 1,000/mm\\^3\n* Platelet count ≥ 75,000/mm\\^3\n* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* Direct bilirubin \\< 1.5 times ULN\n* Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)\n* Creatinine ≤ 2 times ULN\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after completion of study treatment\n* Cholesterol ≤ 350 mg/dL\n* Fasting triglycerides \\< 400 mg/dL\n* No known HIV positivity\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n* No other uncontrolled illness\n* No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs\n* Prior biologic response modifiers allowed\n* Prior immunotherapy allowed\n* Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed\n* No concurrent prophylactic growth factor to support neutrophils\n* Prior chemotherapy allowed\n* No other concurrent chemotherapy\n* No concurrent corticosteroids to induce an antitumor response\n\n * Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed\n* Prior radiotherapy allowed\n* No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor\n* No other concurrent investigational or commercial agents or therapies for MCL\n* No other concurrent immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT00109967', 'briefTitle': "CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'NCI-2009-00644'}, 'secondaryIdInfos': [{'id': 'N038H'}, {'id': 'U10CA025224', 'link': 'https://reporter.nih.gov/quickSearch/U10CA025224', 'type': 'NIH'}, {'id': 'CDR0000425334', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.', 'interventionNames': ['Biological: rituximab', 'Drug: temsirolimus']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['IDEC-C2B8', 'IDEC-C2B8 monoclonal antibody', 'Mabthera', 'MOAB IDEC-C2B8', 'Rituxan'], 'description': '375 mg/m\\^2 Given IV', 'armGroupLabels': ['Arm I']}, {'name': 'temsirolimus', 'type': 'DRUG', 'otherNames': ['CCI-779', 'cell cycle inhibitor 779', 'Torisel'], 'description': '25 mg given IV', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Medical Center of Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose-Saint Francis Healthcare', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Saint Anthony Central Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Exempla Saint Joseph Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Presbyterian - Saint Lukes Medical Center - Health One', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rose Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80224-2522', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Cancer Research Program CCOP', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '81502', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "Saint Mary's Hospital and Regional Medical Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '80631', 'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Colorado Medical Center', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sky Ridge Medical Center', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Longmont United Hospital', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '80539', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'McKee Medical Center', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '81004', 'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'facility': 'Saint Mary Corwin Medical Center', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'zip': '80229', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Suburban Medical Center', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Exempla Lutheran Medical Center', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '60504', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush - Copley Medical Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Saint Joseph Medical Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '61520', 'city': 'Canton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Graham Hospital Association', 'geoPoint': {'lat': 40.55809, 'lon': -90.03512}}, {'zip': '62321', 'city': 'Carthage', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 40.41643, 'lon': -91.13625}}, {'zip': '61530', 'city': 'Eureka', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eureka Hospital', 'geoPoint': {'lat': 40.72143, 'lon': -89.27286}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Clinic', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Cottage Hospital', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '62644', 'city': 'Havana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mason District Hospital', 'geoPoint': {'lat': 40.30004, 'lon': -90.06095}}, {'zip': '61747', 'city': 'Hopedale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hopedale Medical Complex - Hospital', 'geoPoint': {'lat': 40.42087, 'lon': -89.41454}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology-Hematology Associates Limited', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '61443', 'city': 'Kewanee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Kewanee Hospital', 'geoPoint': {'lat': 41.24559, 'lon': -89.92483}}, {'zip': '61455', 'city': 'Macomb', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mcdonough District Hospital', 'geoPoint': {'lat': 40.45921, 'lon': -90.6718}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Bromenn Regional Medical Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Community Cancer Center Foundation', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '61350', 'city': 'Ottawa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare-Ottawa Clinic', 'geoPoint': {'lat': 41.34559, 'lon': -88.84258}}, {'zip': '61350', 'city': 'Ottawa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ottawa Regional Hospital and Healthcare Center', 'geoPoint': {'lat': 41.34559, 'lon': -88.84258}}, {'zip': '61554', 'city': 'Pekin', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pekin Cancer Treatment Center', 'geoPoint': {'lat': 40.56754, 'lon': -89.64066}}, {'zip': '61554', 'city': 'Pekin', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pekin Hospital', 'geoPoint': {'lat': 40.56754, 'lon': -89.64066}}, {'zip': '61603', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Methodist Medical Center of Illinois', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Proctor Hospital', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare-Peoria', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Oncology Research Association CCOP', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF Saint Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61354', 'city': 'Peru', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Valley Hospital', 'geoPoint': {'lat': 41.32753, 'lon': -89.12897}}, {'zip': '61356', 'city': 'Princeton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Perry Memorial Hospital', 'geoPoint': {'lat': 41.36809, 'lon': -89.46481}}, {'zip': '61362', 'city': 'Spring Valley', 'state': 'Illinois', 'country': 'United States', 'facility': "Saint Margaret's Hospital", 'geoPoint': {'lat': 41.32754, 'lon': -89.19981}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Clinic-Urbana Main', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Foundation dba Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'Saint Francis Hospital and Health Centers', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '46360', 'city': 'Michigan City', 'state': 'Indiana', 'country': 'United States', 'facility': 'Saint Anthony Memorial Health Center', 'geoPoint': {'lat': 41.70754, 'lon': -86.89503}}, {'zip': '47374', 'city': 'Richmond', 'state': 'Indiana', 'country': 'United States', 'facility': 'Reid Hospital and Health Care Services', 'geoPoint': {'lat': 39.82894, 'lon': -84.89024}}, {'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': 'McFarland Clinic', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '52402', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': "Saint Luke's Hospital", 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Cedar Rapids Oncology Association', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Oncology Associates', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '50325', 'city': 'Clive', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medical Oncology and Hematology Associates-West Des Moines', 'geoPoint': {'lat': 41.60304, 'lon': -93.72411}}, {'zip': '50307', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Capitol', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Methodist Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Oncology Research Association CCOP', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medical Oncology and Hematology Associates-Des Moines', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medical Oncology and Hematology Associates', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center - Des Moines', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50316', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Lutheran Hospital', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50401', 'city': 'Mason City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center - North Iowa', 'geoPoint': {'lat': 43.15357, 'lon': -93.20104}}, {'zip': '51101-1733', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Regional Cancer Center', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology - Oncology Associates', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center-Sioux City', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': "Saint Luke's Regional Medical Center", 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '67003', 'city': 'Anthony', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hospital District Sixth of Harper County', 'geoPoint': {'lat': 37.15336, 'lon': -98.03117}}, {'zip': '66720', 'city': 'Chanute', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Chanute', 'geoPoint': {'lat': 37.67921, 'lon': -95.4572}}, {'zip': '67801', 'city': 'Dodge City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Dodge City', 'geoPoint': {'lat': 37.7528, 'lon': -100.01708}}, {'zip': '67042', 'city': 'El Dorado', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - El Dorado', 'geoPoint': {'lat': 37.81724, 'lon': -96.86225}}, {'zip': '66701', 'city': 'Fort Scott', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Fort Scott', 'geoPoint': {'lat': 37.83976, 'lon': -94.7083}}, {'zip': '67301', 'city': 'Independence', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas-Independence', 'geoPoint': {'lat': 37.22424, 'lon': -95.70831}}, {'zip': '67068', 'city': 'Kingman', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas-Kingman', 'geoPoint': {'lat': 37.64585, 'lon': -98.11367}}, {'zip': '66044', 'city': 'Lawrence', 'state': 'Kansas', 'country': 'United States', 'facility': 'Lawrence Memorial Hospital', 'geoPoint': {'lat': 38.97167, 'lon': -95.23525}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Newton', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67357', 'city': 'Parsons', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Parsons', 'geoPoint': {'lat': 37.34034, 'lon': -95.26108}}, {'zip': '67124', 'city': 'Pratt', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Pratt', 'geoPoint': {'lat': 37.64391, 'lon': -98.73759}}, {'zip': '67401', 'city': 'Salina', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Salina', 'geoPoint': {'lat': 38.84028, 'lon': -97.61142}}, {'zip': '67152', 'city': 'Wellington', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Wellington', 'geoPoint': {'lat': 37.2653, 'lon': -97.37171}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Associates In Womens Health', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas-Wichita Medical Arts Tower', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Main Office', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Wichita CCOP', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67156', 'city': 'Winfield', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Winfield', 'geoPoint': {'lat': 37.23975, 'lon': -96.99559}}, {'zip': '49221', 'city': 'Adrian', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bixby Medical Center', 'geoPoint': {'lat': 41.89755, 'lon': -84.03717}}, {'zip': '49221', 'city': 'Adrian', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hickman Cancer Center', 'geoPoint': {'lat': 41.89755, 'lon': -84.03717}}, {'zip': '48106-0995', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint Joseph Mercy Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Cancer Research Consortium Community Clinical Oncology Program', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48123', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakwood Hospital', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint John Hospital and Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48502', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hurley Medical Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48532', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Regional Medical Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49201', 'city': 'Jackson', 'state': 'Michigan', 'country': 'United States', 'facility': 'Allegiance Health', 'geoPoint': {'lat': 42.24587, 'lon': -84.40135}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48154', 'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint Mary Mercy Hospital', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'zip': '48162', 'city': 'Monroe', 'state': 'Michigan', 'country': 'United States', 'facility': 'Community Cancer Center of Monroe', 'geoPoint': {'lat': 41.91643, 'lon': -83.39771}}, {'zip': '48162', 'city': 'Monroe', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mercy Memorial Hospital', 'geoPoint': {'lat': 41.91643, 'lon': -83.39771}}, {'zip': '48341-2985', 'city': 'Pontiac', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint Joseph Mercy Oakland', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}, {'zip': '48060', 'city': 'Port Huron', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint Joseph Mercy Port Huron', 'geoPoint': {'lat': 42.97086, 'lon': -82.42491}}, {'zip': '48601', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': "Saint Mary's of Michigan", 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '48093', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint John Macomb-Oakland Hospital', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '56601', 'city': 'Bemidji', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Merit Care Clinic Bemidji', 'geoPoint': {'lat': 47.47356, 'lon': -94.88028}}, {'zip': '55337', 'city': 'Burnsville', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Ridges Hospital', 'geoPoint': {'lat': 44.76774, 'lon': -93.27772}}, {'zip': '55433', 'city': 'Coon Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 45.11997, 'lon': -93.28773}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Duluth Clinic CCOP', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Miller-Dwan Hospital', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': "Saint Mary's Medical Center", 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview-Southdale Hospital', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Unity Hospital', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '55109', 'city': 'Maplewood', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology PA-Maplewood', 'geoPoint': {'lat': 44.95302, 'lon': -92.99522}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott-Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55422', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'North Memorial Medical Health Center', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro-Minnesota CCOP', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet Clinic - Saint Louis Park', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '55379', 'city': 'Shakopee', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Saint Francis Regional Medical Center', 'geoPoint': {'lat': 44.79802, 'lon': -93.5269}}, {'zip': '55387', 'city': 'Waconia', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Ridgeview Medical Center', 'geoPoint': {'lat': 44.8508, 'lon': -93.78691}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology and Hematology PA-Woodbury', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Hematology-Oncology Centers of the Northern Rockies PC', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Cancer Consortium CCOP', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Northern Rockies Radiation Oncology Center', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Saint Vincent Healthcare', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59107-7000', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Clinic', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59107', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Deaconess Medical Center', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59715', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Bozeman Deaconess Cancer Center', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '59715', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Bozeman Deaconess Hospital', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Saint James Community Hospital and Cancer Treatment Center', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Berdeaux, Donald MD (UIA Investigator)', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Great Falls Clinic', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '59501', 'city': 'Havre', 'state': 'Montana', 'country': 'United States', 'facility': 'Northern Montana Hospital', 'geoPoint': {'lat': 48.55, 'lon': -109.68409}}, {'zip': '59601', 'city': 'Helena', 'state': 'Montana', 'country': 'United States', 'facility': "Saint Peter's Community Hospital", 'geoPoint': {'lat': 46.59271, 'lon': -112.03611}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Glacier Oncology PLLC', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Kalispell Medical Oncology', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Kalispell Regional Medical Center', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '59801', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Community Medical Hospital', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Cancer Specialists', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Saint Patrick Hospital - Community Hospital', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '59804', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Guardian Oncology and Center for Wellness', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '28139', 'city': 'Rutherfordton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rutherford Hospital', 'geoPoint': {'lat': 35.36929, 'lon': -81.95677}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Bismarck Cancer Center', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Medcenter One Health Systems', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Mid Dakota Clinic', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Saint Alexius Medical Center', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Meritcare Hospital', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'MeritCare Medical Group', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43402', 'city': 'Bowling Green', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wood County Oncology Center', 'geoPoint': {'lat': 41.37477, 'lon': -83.65132}}, {'zip': '45405', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Grandview Hospital', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45406', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital - Dayton', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Miami Valley Hospital', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45415', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Samaritan North Health Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45428', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Veteran Affairs Medical Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45429', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton CCOP', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44035', 'city': 'Elyria', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hematology Oncology Center Incorporated', 'geoPoint': {'lat': 41.36838, 'lon': -82.10765}}, {'zip': '45840', 'city': 'Findlay', 'state': 'Ohio', 'country': 'United States', 'facility': 'Blanchard Valley Hospital', 'geoPoint': {'lat': 41.04422, 'lon': -83.64993}}, {'zip': '45005-1066', 'city': 'Franklin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Atrium Medical Center-Middletown Regional Hospital', 'geoPoint': {'lat': 39.55895, 'lon': -84.30411}}, {'zip': '43420', 'city': 'Fremont', 'state': 'Ohio', 'country': 'United States', 'facility': 'Fremont Memorial Hospital', 'geoPoint': {'lat': 41.35033, 'lon': -83.12186}}, {'zip': '45331', 'city': 'Greenville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wayne Hospital', 'geoPoint': {'lat': 40.10283, 'lon': -84.63301}}, {'zip': '43326', 'city': 'Kenton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cole, Sharon, K. M.D. (UIA Investigator)', 'geoPoint': {'lat': 40.647, 'lon': -83.60965}}, {'zip': '45429', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kettering Medical Center', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '45804', 'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lima Memorial Hospital', 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'zip': '43537-1839', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northwest Ohio Oncology Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': "Saint Luke's Hospital", 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Radiation Oncology at Northwest Ohio Onocolgy Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '43616', 'city': 'Oregon', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bayview Oncology Associates', 'geoPoint': {'lat': 41.64366, 'lon': -83.48688}}, {'zip': '43616', 'city': 'Oregon', 'state': 'Ohio', 'country': 'United States', 'facility': 'Saint Charles Hospital', 'geoPoint': {'lat': 41.64366, 'lon': -83.48688}}, {'zip': '44870', 'city': 'Sandusky', 'state': 'Ohio', 'country': 'United States', 'facility': 'Firelands Regional Medical Center', 'geoPoint': {'lat': 41.44894, 'lon': -82.70796}}, {'zip': '44870', 'city': 'Sandusky', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Coast Cancer Care', 'geoPoint': {'lat': 41.44894, 'lon': -82.70796}}, {'zip': '43560', 'city': 'Sylvania', 'state': 'Ohio', 'country': 'United States', 'facility': 'Flower Memorial Hospital', 'geoPoint': {'lat': 41.71894, 'lon': -83.71299}}, {'zip': '44883', 'city': 'Tiffin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Hospital of Tiffin', 'geoPoint': {'lat': 41.1145, 'lon': -83.17797}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Saint Vincent Mercy Medical Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Community Hospital Oncology Program CCOP', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Cancer Center at Saint Anne Mercy Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Stark, Michael, Edward. M.D. (UIA Investigator)', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Clinic', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '45373', 'city': 'Troy', 'state': 'Ohio', 'country': 'United States', 'facility': 'Upper Valley Medical Center', 'geoPoint': {'lat': 40.0395, 'lon': -84.20328}}, {'zip': '43567', 'city': 'Wauseon', 'state': 'Ohio', 'country': 'United States', 'facility': 'Fulton County Health Center', 'geoPoint': {'lat': 41.54922, 'lon': -84.14161}}, {'zip': '45177', 'city': 'Wilmington', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinton Memorial Hospital', 'geoPoint': {'lat': 39.44534, 'lon': -83.82854}}, {'zip': '45385', 'city': 'Xenia', 'state': 'Ohio', 'country': 'United States', 'facility': 'Greene Memorial Hospital', 'geoPoint': {'lat': 39.68478, 'lon': -83.92965}}, {'zip': '18105', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '17822-2001', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Group', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '18711', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Wyoming Valley', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AnMed Health Hospital', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Upstate Carolina CCOP', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Cancer Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera McKennan Hospital and University Health Center', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '22401', 'city': 'Fredericksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fredericksburg Oncology Inc', 'geoPoint': {'lat': 38.30318, 'lon': -77.46054}}, {'zip': '82801', 'city': 'Sheridan', 'state': 'Wyoming', 'country': 'United States', 'facility': 'Welch Cancer Center', 'geoPoint': {'lat': 44.79719, 'lon': -106.95618}}], 'overallOfficials': [{'name': 'Stephen Ansell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Central Cancer Treatment Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}