Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00382018
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2006-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmiao@fredhutch.org', 'phone': '2066675712', 'title': 'Breast Committee Statistician', 'organization': 'SWOG'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression', 'description': "Patients in 'Arm A (Baseline CTCs \\< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.", 'eventGroups': [{'id': 'EG000', 'title': 'Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)', 'otherNumAtRisk': 161, 'otherNumAffected': 152, 'seriousNumAtRisk': 161, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'otherNumAtRisk': 64, 'otherNumAffected': 57, 'seriousNumAtRisk': 64, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'otherNumAtRisk': 56, 'otherNumAffected': 53, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 43}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema: limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic/Laboratory-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-high (hypercalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle weakness, not d/t neuropathy - body/general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, pulmonary/upper respiratory - Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pleural effusion (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hair loss/Alopecia (scalp or body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash: hand-foot skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot flashes/flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Gastrointestinal-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/Genitourinary-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \\>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.'}, {'id': 'OG001', 'title': 'Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \\>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '14.8'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '16.3'}]}]}], 'analyses': [{'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.47', 'groupDescription': 'Hazard Ration of overall survival compared Arm C2 to Arm C1.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 3 months until progression then every 6 months for 5 years or until death', 'description': 'From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \\>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.'}, {'id': 'OG001', 'title': 'Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \\>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.7'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '6.7'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.32', 'groupDescription': 'Hazard Ratio of progression free survival compared Arm C2 to Arm C1', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients in Arm C2 were judged as progression on day 22 and were excluded from the PFS analysis but were included in the OS analysis.'}, {'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Baseline CTCs < 5, Low Risk)', 'description': "Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS)."}, {'id': 'OG001', 'title': 'Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \\< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.'}, {'id': 'OG002', 'title': 'Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \\>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '38.5'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '28.3'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 3 months until progression then every 6 months for 5 years or until death', 'description': 'From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Baseline CTCs < 5, Low Risk)', 'description': "Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS)."}, {'id': 'OG001', 'title': 'Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \\< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.'}, {'id': 'OG002', 'title': 'Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \\>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '12.5'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '10.8'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every 3 months until progression', 'description': 'From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients in Arm C were judged as progressing on day 22 and were excluded from the PFS analysis but were included in the OS analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events That Are Related to Study Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)'}, {'id': 'OG001', 'title': 'Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)'}, {'id': 'OG002', 'title': 'Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)'}], 'classes': [{'title': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'AST, SGOT', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, serum-low (hypoalbuminemia)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Allergic reaction/hypersensitivity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Allergic rhinitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Allergy/Immunology-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Ascites (non-malignant)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Auditory/Ear-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin (hyperbilirubinemia)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Blood/Bone Marrow-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CNS cerebrovascular ischemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, serum-high (hypercalcemia)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, serum-low (hypocalcemia)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Confusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Constitutional Symptoms-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Dermatology/Skin-Other (Specify)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Distention/bloating, abdominal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dry mouth/salivary gland (xerostomia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dry skin', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnea (shortness of breath)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Edema: head and neck', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Edema: limb', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue (asthenia, lethargy, malaise)', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Flushing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Glucose, serum-high (hyperglycemia)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Glucose, serum-low (hypoglycemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hair loss/Alopecia (scalp or body)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Heartburn/dyspepsia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, Respiratory tract NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, GI - Stomach', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, GU - Uterus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, pulmonary/upper respiratory - Nose', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hot flashes/flushes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hyperpigmentation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ileus, GI (functional obstruction of bowel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Induration/fibrosis (skin and subcutaneous tissue)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Blood', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Skin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - UTI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Lung', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Nose', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Sinus', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Skin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - UTI', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Up airway', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Sinus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Skin (cellulitis)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Urinary tract NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infection-Other (Specify)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Injection site reaction/extravasation changes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Left ventricular systolic dysfunction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (total WBC)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium, serum-low (hypomagnesemia)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Memory impairment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Metabolic/Laboratory-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - anxiety', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - depression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mucositis/stomatitis (functional/symp) - Oral cav', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - Extrem-lower', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - Extrem-upper', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - body/general', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal/Soft Tissue-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nail changes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Nasal cavity/paranasal sinus reactions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: motor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: sensory', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils/granulocytes (ANC/AGC)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Ocular/Visual-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Osteonecrosis (avascular necrosis)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Abdomen NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Back', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Bladder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Bone', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Breast', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Chest wall', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Chest/thorax NOS', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Extremity-limb', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Face', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Head/headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Joint', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Muscle', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Neck', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Neuralgia/peripheral nerve', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Oral cavity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Oral-gums', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Pain NOS', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Pelvis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Rectum', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Scalp', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Stomach', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Throat/pharynx/larynx', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Vagina', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Phosphate, serum-low (hypophosphatemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Pleural effusion (non-malignant)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonitis/pulmonary infiltrates', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, serum-high (hyperkalemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, serum-low (hypokalemia)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Proteinuria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pruritus/itching', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary/Upper Respiratory-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash/desquamation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Rash: acne/acneiform', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash: hand-foot skin reaction', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Renal/Genitourinary-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Restrictive cardiomyopathy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Retinopathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Rigors/chills', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SVT and nodal arrhythmia - Atrial tachycardia/PAT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SVT and nodal arrhythmia - Sinus tachycardia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, serum-high (hypernatremia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, serum-low (hyponatremia)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Sweating (diaphoresis)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Syndromes-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Taste alteration (dysgeusia)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis/thrombus/embolism', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Thyroid function, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Triglyceride, serum-high (hypertriglyceridemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Urinary frequency/urgency', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal dryness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vision-blurred vision', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Watery eye (epiphora, tearing)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight loss', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression', 'description': 'Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Patients in 'Arm A (Baseline CTCs \\< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. And only patients who were evaluable for Adverse Event Assessment were included in the following analysis results."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Correlation of CTC Levels With Breast Cancer Tumor Markers', 'timeFrame': 'Baseline, Weeks 4, 8, 13, 25, 37 and at progression', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Baseline CTCs < 5, Low Risk)', 'description': "Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS)."}, {'id': 'FG001', 'title': 'Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \\< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.'}, {'id': 'FG002', 'title': 'Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \\>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.'}, {'id': 'FG003', 'title': 'Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \\>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Patients in this group were only followed for OS and PFS. Thus, no treatment status data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'This group of patients did not receive protocol treatment.', 'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '43'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Other, not protocol specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '624 patients were registered for screening. 29 patients were excluded due to initial CTC test not completed(17) and ineligible(12). 276 did not have increased CTC levels (Arm A). 319 patients had increased CTC levels. Additional 31 patients were excluded from 319 due to no CTC values on Day 21. Thus total 288 patients in ArmB, ArmC2 and ArmC2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (Baseline CTCs < 5, Low Risk)', 'description': "Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS)."}, {'id': 'BG001', 'title': 'Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \\< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.'}, {'id': 'BG002', 'title': 'Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \\>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.'}, {'id': 'BG003', 'title': 'Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)', 'description': 'Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \\>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 55 years or older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '334', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Black Race', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Measurable disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '455', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measurable disease: Lesions that can be accurately measured in at least one dimension by 1) medical photograph (skin or oral lesion), palpation, plain x-ray, CT, MRI or other conventional technique with longest diameter 2 cm or greater in the axial plane (bone lesions not included), or 2) spiral CT with longest diameter 1 cm or greater. Ultrasound is suitable only for superficial disease (superficial palpable nodes, subcutaneous lesions, thyroid nodules).', 'unitOfMeasure': 'Participants'}, {'title': 'No. of patients classified by disease subtype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '560', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Homo receptor positive, HER2 negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '560', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '330', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only patients classified by disease subtype category will be included in the analysis.'}, {'title': 'Triple negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '560', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '134', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only patients classified by disease subtype category will be included in the analysis.'}, {'title': 'HER2 positive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '560', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only patients classified by disease subtype category will be included in the analysis.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2006-09-26', 'resultsFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2006-09-26', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-15', 'studyFirstPostDateStruct': {'date': '2006-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation of CTC Levels With Breast Cancer Tumor Markers', 'timeFrame': 'Baseline, Weeks 4, 8, 13, 25, 37 and at progression'}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Every 3 months until progression then every 6 months for 5 years or until death', 'description': 'From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.'}, {'measure': 'Progression-free Survival', 'timeFrame': 'every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}, {'measure': 'Progression Free Survival', 'timeFrame': 'every 3 months until progression', 'description': 'From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Adverse Events That Are Related to Study Drugs', 'timeFrame': 'Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression', 'description': 'Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24888818', 'type': 'DERIVED', 'citation': "Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression.\n\nPURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine whether women with metastatic breast cancer and elevated circulating tumor cells (CTCs) (≥ 5 per 7.5 mL of whole blood) after 3 weeks of first-line chemotherapy derive increased overall survival from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen.\n* Determine whether these patients derive increased progression-free survival (PFS) from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen.\n* Confirm previous findings that patients with \\< 5 CTCs per 7.5 mL of whole blood on initial screening have longer median OS and PFS than patients with ≥ 5 CTCs per 7.5 mL of whole blood.\n* Determine the prognostic value of sequentially collected CTC values in these patients.\n* Compare toxicity between patients with and without elevated CTCs after 3 weeks of first-line chemotherapy AND between the two randomized treatment arms.\n\nSecondary\n\n* Compare the prognostic and predictive value of CTC number vs breast cancer tumor markers, including CA 15-3 and carcinoembryonic antigen.\n* Create a serum specimen bank for future biologic investigation.\n\nOUTLINE: This is a partially blinded, partially randomized, multicenter study. Patients are assigned to 1 of 3 groups based on circulating tumor cells (CTCs) after 1 course of chemotherapy.\n\nAll patients undergo blood collection before their first dose of first-line chemotherapy\\* to determine baseline CTC count. Patients with \\< 5 CTCs at baseline are assigned to group I. Patients with ≥ 5 CTCs at baseline undergo a second blood draw on day 22 (after completion of 1 course of chemotherapy). Patients with \\< 5 CTCs after completing 1 course of chemotherapy are assigned to group 2. Patients with ≥ 5 CTCs after completion of 1 course of chemotherapy are assigned to group 3.\n\nNOTE: \\*Chemotherapy may be initiated while waiting for the baseline CTC result.\n\n* Group 1 (low risk of early progression): Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.\n* Group 2 (moderate risk of early progression): Patients continue to receive their current chemotherapy regimen without change.\n* Group 3 (high risk of early progression): Patients are stratified according to HER-2 status (positive vs negative) and disease type (bone-only vs measurable disease). Patients are randomized to 1 of 2 treatment arms.\n\n * Arm I: Patients continue with their current chemotherapy regimen without change.\n * Arm II: Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.\n\nPatients receiving hormonal therapy or biologic therapy and chemotherapy continue to receive the hormonal or biologic therapy unchanged regardless of CTC level.\n\nIn groups 2 and 3, blood is collected periodically during chemotherapy and then at the completion of chemotherapy. Samples are examined for CTCs via the CellSearch™ blood test. Blood is also tested for CA 15-3 and carcinoembryonic antigen (CEA).\n\nAfter completion of study therapy, patients are followed for up to 5 years.\n\nPROJECTED ACCRUAL: A total of 500 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n * Clinical evidence of metastatic disease (stage IV disease)\n * Newly metastatic disease OR progressive metastatic disease while on hormonal therapy\n* Meets 1 of the following criteria:\n\n * Measurable disease\n * Bone-only disease\\* NOTE: \\*Patients with nonmeasurable disease that does not include bone are not eligible\n* HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay\n\n * HER-2 positivity is defined as IHC 3+ or FISH+\n * If IHC is indeterminate (2+), FISH must be performed to classify disease\n* Planning to undergo first-line chemotherapy for metastatic disease\n* Patients with brain metastases must have stable disease for \\> 90 days after completion of prior radiotherapy to the brain\n* No leptomeningeal disease\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n* Zubrod performance status 0-2\n* Not pregnant or nursing\n* Negative pregnancy test\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed\n\n * Any number of exogenous hormonal therapies for metastatic disease and/or as adjuvant therapy allowed\n* At least 1 year since prior adjuvant chemotherapy\n* At least 2 weeks since prior minor surgery and recovered\n* At least 4 weeks since prior major surgery and recovered\n* No prior chemotherapy for metastatic disease\n* Concurrent hormonal therapy and/or bisphosphonate therapy allowed\n* Concurrent trastuzumab and/or bevacizumab allowed'}, 'identificationModule': {'nctId': 'NCT00382018', 'briefTitle': 'S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment', 'orgStudyIdInfo': {'id': 'CDR0000504319'}, 'secondaryIdInfos': [{'id': 'S0500', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.', 'interventionNames': ['Drug: chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Patients continue to receive their current chemotherapy regimen without change.', 'interventionNames': ['Drug: chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3, Arm I', 'description': 'Patients continue with their current chemotherapy regimen without change.', 'interventionNames': ['Drug: chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3, Arm II', 'description': "Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.", 'interventionNames': ['Drug: chemotherapy']}], 'interventions': [{'name': 'chemotherapy', 'type': 'DRUG', 'description': 'No administration details available', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3, Arm I', 'Group 3, Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Regional Medical Center', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Regional Hospital Cancer Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Cancer Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Medical Center - Stadium Boulevard', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Memorial Hospital Comprehensive Cancer Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Care, Incorporated - Greenbrae', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Cancer Institute at Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Camino Medical Group - Treatment Center', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94305-5824', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '81101', 'city': 'Alamosa', 'state': 'Colorado', 'country': 'United States', 'facility': 'San Luis Valley Regional Medical Center', 'geoPoint': {'lat': 37.46945, 'lon': -105.87002}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center at UC Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81632', 'city': 'Edwards', 'state': 'Colorado', 'country': 'United States', 'facility': 'Shaw Regional Cancer Center', 'geoPoint': {'lat': 39.64499, 'lon': -106.5942}}, {'zip': '81601', 'city': 'Glenwood Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Valley View Hospital Cancer Center', 'geoPoint': {'lat': 39.55054, 'lon': -107.32478}}, {'zip': '81502', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '81401', 'city': 'Montrose', 'state': 'Colorado', 'country': 'United States', 'facility': 'Montrose Memorial Hospital Cancer Center', 'geoPoint': {'lat': 38.47832, 'lon': -107.87617}}, {'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06520-8028', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32803-1273', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute at Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '31602', 'city': 'Valdosta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pearlman Comprehensive Cancer Center at South Georgia Medical Center', 'geoPoint': {'lat': 30.83334, 'lon': -83.28032}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Cancer Research Center of Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'OnCare Hawaii, Incorporated - Lusitana', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "Queen's Cancer Institute at Queen's Medical Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Straub Clinic and Hospital, Incorporated', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Medical Center - East', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'OnCare Hawaii, Incorporated - Kuakini', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kapiolani Medical Center for Women and Children', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96859', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Tripler Army Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96793', 'city': 'Wailuku', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Maui Memorial Medical Center', 'geoPoint': {'lat': 20.89133, 'lon': -156.50604}}, {'zip': '96793', 'city': 'Wailuku', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Pacific Cancer Institute - Maui', 'geoPoint': {'lat': 20.89133, 'lon': -156.50604}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kapiolani Medical Center at Pali Momi', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60504', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush-Copley Cancer Care Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '60631', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Resurrection Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Louis A. 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