Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00127205
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2005-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, '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': 'D004002', 'term': 'Clodronic Acid'}, {'id': 'D000077557', 'term': 'Ibandronic Acid'}, {'id': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmiao@fredhutch.org', 'phone': '2066674263', 'title': 'SWOG statistician', 'organization': 'SWOG Statistics & Data Management Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.', 'description': 'For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I Zoledronic Acid', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n\nzoledronic acid: Given IV', 'otherNumAtRisk': 2125, 'deathsNumAtRisk': 2231, 'otherNumAffected': 1854, 'seriousNumAtRisk': 2125, 'deathsNumAffected': 238, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Arm II Clodronate', 'description': 'Patients receive oral clodronate once daily for 35 months.\n\nclodronate disodium: Given orally', 'otherNumAtRisk': 2186, 'deathsNumAtRisk': 2235, 'otherNumAffected': 1942, 'seriousNumAtRisk': 2186, 'deathsNumAffected': 263, 'seriousNumAffected': 190}, {'id': 'EG002', 'title': 'Arm III Ibandronate', 'description': 'Patients receive oral ibandronate once daily for 35 months.\n\nibandronate sodium: Given orally', 'otherNumAtRisk': 1530, 'deathsNumAtRisk': 1552, 'otherNumAffected': 1366, 'seriousNumAtRisk': 1530, 'deathsNumAffected': 182, 'seriousNumAffected': 141}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 376}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 326}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 251}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 230}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 259}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 180}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 288}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 447}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 223}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Heartburn/dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 332}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 280}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 454}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 555}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 307}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 146}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 100}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 243}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 123}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema: limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 243}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 212}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 163}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 851}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 749}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 560}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 261}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 70}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 149}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 122}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash: dermatitis associated w/radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 70}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 290}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 540}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 170}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 308}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 581}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 190}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 166}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 77}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 230}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 127}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 366}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 370}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 205}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 209}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 181}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 125}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic/Laboratory-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 132}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 67}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 213}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 51}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 137}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 81}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-high (hypercalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 61}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 196}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 162}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 111}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 484}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 429}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 283}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-low (hypoglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Magnesium, serum-low (hypomagnesemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 82}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Phosphate, serum-low (hypophosphatemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 80}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 189}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 88}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 106}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 78}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Arthritis (non-septic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 206}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 197}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 143}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 295}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 253}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 213}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 614}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 390}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 303}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 260}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 231}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 173}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 1071}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 968}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 756}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 488}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 339}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 294}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 196}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 157}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 134}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 464}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 447}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 311}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 310}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 270}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 205}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 345}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 310}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 204}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 159}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 106}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 236}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 227}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 151}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 102}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 137}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 90}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 216}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 143}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 133}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 116}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hair loss/Alopecia (scalp or body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 120}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 90}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 306}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 307}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 194}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sweating (diaphoresis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 79}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot flashes/flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 795}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 808}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 579}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 127}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 60}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac General-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 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'EG001', 'numAtRisk': 2186, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Phlebitis (including superficial thrombosis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2186, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1530, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2231', 'groupId': 'OG000'}, {'value': '2235', 'groupId': 'OG001'}, {'value': '1552', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Zoledronate', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n\nzoledronic acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II Clodronate', 'description': 'Patients receive oral clodronate once daily for 35 months.\n\nclodronate disodium: Given orally'}, {'id': 'OG002', 'title': 'Arm III Ibandronate', 'description': 'Patients receive oral ibandronate once daily for 35 months.\n\nibandronate sodium: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '90'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '89'}, {'value': '87', 'groupId': 'OG002', 'lowerLimit': '86', 'upperLimit': '89'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.26', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.50', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.24', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence', 'description': 'Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.', 'unitOfMeasure': 'percentage of analyzed participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible patients will be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2231', 'groupId': 'OG000'}, {'value': '2235', 'groupId': 'OG001'}, {'value': '1552', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Zoledronate', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n\nzoledronic acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II Clodronate', 'description': 'Patients receive oral clodronate once daily for 35 months.\n\nclodronate disodium: Given orally'}, {'id': 'OG002', 'title': 'Arm III Ibandronate', 'description': 'Patients receive oral ibandronate once daily for 35 months.\n\nibandronate sodium: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '94'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '94'}, {'value': '93', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '94'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'follow up completed every 6 months for 5 years and then annually for 5 years or until death', 'description': 'Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.', 'unitOfMeasure': 'percentage of analyzable patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible patients will be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Distributions of Sites of First Recurrence on the Three Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2231', 'groupId': 'OG000'}, {'value': '2235', 'groupId': 'OG001'}, {'value': '1552', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Zoledronate', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n\nzoledronic acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II Clodronate', 'description': 'Patients receive oral clodronate once daily for 35 months.\n\nclodronate disodium: Given orally'}, {'id': 'OG002', 'title': 'Arm III Ibandronate', 'description': 'Patients receive oral ibandronate once daily for 35 months.\n\nibandronate sodium: Given orally'}], 'classes': [{'title': 'Local/Regional only', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Contralateral only', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Distant recurrence', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}]}, {'title': 'Unknown location of recurrence', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Bone as 1st site of distant recurrence', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}, {'title': 'Bone only', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Bone and nodes only', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Bone and other distant sites (beside nodes)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Liver/lung/other visceral without bone recurrence', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Brain/other CNS (+/- any other site)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Statistical analysis for recurrence to bone', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence', 'description': 'All sites of invasive disease documented within 30 days of first documentation of invasive recurrence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2113', 'groupId': 'OG000'}, {'value': '2169', 'groupId': 'OG001'}, {'value': '1518', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Zoledronic Acid', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n\nzoledronic acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II Clodronate', 'description': 'Patients receive oral clodronate once daily for 35 months.\n\nclodronate disodium: Given orally'}, {'id': 'OG002', 'title': 'Arm III Ibandronate', 'description': 'Arm III Ibandronate\n\nPatients receive oral ibandronate once daily for 35 months.\n\nibandronate sodium: Given orally'}], 'classes': [{'title': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AST, SGOT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Allergic reaction/hypersensitivity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Arthritis (non-septic)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Auditory/Ear-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin (hyperbilirubinemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood/Bone Marrow-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'CNS cerebrovascular ischemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, serum-low (hypocalcemia)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Cardiac General-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Confusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dental: periodontal disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dental: teeth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', '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': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dysphagia (difficulty swallowing)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnea (shortness of breath)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Edema: limb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Endocrine-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Esophagitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Extremity-upper (function)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue (asthenia, lethargy, malaise)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Flu-like syndrome', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fracture', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Gastritis (including bile reflux gastritis)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Glucose, serum-high (hyperglycemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Heartburn/dyspepsia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, GI - Rectum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, GI - Stomach', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hot flashes/flushes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'INR (of prothrombin time)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Incontinence, urinary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Skin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Bone', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Dental', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Appendix', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Liver', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Skin (cellulitis)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Irregular menses (change from baseline)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (children lt3 years of age)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Joint-function', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Left ventricular systolic dysfunction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (total WBC)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium, serum-high (hypermagnesemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium, serum-low (hypomagnesemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Masculinization of female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Memory impairment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Metabolic/Laboratory-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - anxiety', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - depression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - euphoria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - Extrem-lower', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - Extrem-upper', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - body/general', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: motor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: sensory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils/granulocytes (ANC/AGC)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Obesity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Opportunistic inf associated w/gt=Gr 2 lymphopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Osteonecrosis (avascular necrosis)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Abdomen NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Back', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Bone', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Chest wall', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Chest/thorax NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Extremity-limb', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Head/headache', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Joint', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Muscle', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Neck', 'categories': [{'measurements': [{'value': '1', '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': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Pain NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Stomach', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Throat/pharynx/larynx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Vagina', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Other (Specify)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pancreatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Perforation, GI - Duodenum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phosphate, serum-low (hypophosphatemia)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, serum-high (hyperkalemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, serum-low (hypokalemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Proteinuria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pruritus/itching', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash/desquamation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Renal failure', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Renal/Genitourinary-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Retinal detachment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rigors/chills', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Secondary Malignancy-poss rel to cancer Tx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sexual/Reproductive Function-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, serum-low (hyponatremia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Soft tissue necrosis - Head', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Syncope (fainting)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis/embolism (vascular access-related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis/thrombus/embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Tinnitus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Urticaria (hives, welts, wheals)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Weight gain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight loss', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.', 'description': 'Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received at least one dose of protocol treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I Zoledronate', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n\nzoledronic acid: Given IV'}, {'id': 'FG001', 'title': 'Arm II Clodronate', 'description': 'Patients receive oral clodronate once daily for 35 months.\n\nclodronate disodium: Given orally'}, {'id': 'FG002', 'title': 'Arm III Ibandronate', 'description': 'Patients receive oral ibandronate once daily for 35 months.\n\nibandronate sodium: Given orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2262'}, {'groupId': 'FG001', 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'reasons': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'Data not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '84'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2231', 'groupId': 'BG000'}, {'value': '2235', 'groupId': 'BG001'}, {'value': '1552', 'groupId': 'BG002'}, {'value': '6018', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I Zoledronate', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n\nzoledronic acid: Given IV'}, {'id': 'BG001', 'title': 'Arm II Clodronate', 'description': 'Patients receive oral clodronate once daily for 35 months.\n\nclodronate disodium: Given orally'}, {'id': 'BG002', 'title': 'Arm III Ibandronate', 'description': 'Patients receive oral ibandronate once daily for 35 months.\n\nibandronate sodium: Given orally'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'groupId': 'BG000', 'lowerLimit': '24.8', 'upperLimit': '85.7'}, {'value': '52.6', 'groupId': 'BG001', 'lowerLimit': '21.2', 'upperLimit': '86.1'}, {'value': '52.7', 'groupId': 'BG002', 'lowerLimit': '26.1', 'upperLimit': '85.8'}, {'value': '52.7', 'groupId': 'BG003', 'lowerLimit': '21.2', 'upperLimit': '86.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, Categorized', 'categories': [{'title': 'Age < 55', 'measurements': [{'value': '1270', 'groupId': 'BG000'}, {'value': '1304', 'groupId': 'BG001'}, {'value': '894', 'groupId': 'BG002'}, {'value': '3468', 'groupId': 'BG003'}]}, {'title': 'Age >= 55', 'measurements': [{'value': '961', 'groupId': 'BG000'}, {'value': '931', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}, {'value': '2550', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2231', 'groupId': 'BG000'}, {'value': '2235', 'groupId': 'BG001'}, {'value': '1552', 'groupId': 'BG002'}, {'value': '6018', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '1975', 'groupId': 'BG000'}, {'value': '1976', 'groupId': 'BG001'}, {'value': '1374', 'groupId': 'BG002'}, {'value': '5325', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nodal Status', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '1089', 'groupId': 'BG000'}, {'value': '1152', 'groupId': 'BG001'}, {'value': '784', 'groupId': 'BG002'}, {'value': '3025', 'groupId': 'BG003'}]}]}, {'title': '1~3', 'categories': [{'measurements': [{'value': '722', 'groupId': 'BG000'}, {'value': '685', 'groupId': 'BG001'}, {'value': '489', 'groupId': 'BG002'}, {'value': '1896', 'groupId': 'BG003'}]}]}, {'title': '>=4', 'categories': [{'measurements': [{'value': '404', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}, {'value': '1056', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ER/PR', 'classes': [{'title': 'Negative (ER-, PR-)', 'categories': [{'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '487', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}, {'value': '1286', 'groupId': 'BG003'}]}]}, {'title': 'Positive (ER+ or PR+)', 'categories': [{'measurements': [{'value': '1747', 'groupId': 'BG000'}, {'value': '1747', 'groupId': 'BG001'}, {'value': '1231', 'groupId': 'BG002'}, {'value': '4725', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HER2 status', 'classes': [{'title': 'HER2 negative', 'categories': [{'measurements': [{'value': '1787', 'groupId': 'BG000'}, {'value': '1786', 'groupId': 'BG001'}, {'value': '1247', 'groupId': 'BG002'}, {'value': '4820', 'groupId': 'BG003'}]}]}, {'title': 'HER2 positive/equivocal', 'categories': [{'measurements': [{'value': '418', 'groupId': 'BG000'}, {'value': '427', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '1133', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breast disease subtype', 'classes': [{'title': 'ER+ or PR+, HER2-', 'categories': [{'measurements': [{'value': '1437', 'groupId': 'BG000'}, {'value': '1419', 'groupId': 'BG001'}, {'value': '1015', 'groupId': 'BG002'}, {'value': '3871', 'groupId': 'BG003'}]}]}, {'title': 'ER+ or PR+, HER2+', 'categories': [{'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '809', 'groupId': 'BG003'}]}]}, {'title': 'ER/PR-, HER2- (triple neg)', 'categories': [{'measurements': [{'value': '350', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '949', 'groupId': 'BG003'}]}]}, {'title': 'ER/PR-, HER2+ (triple neg)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '324', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage', 'classes': [{'title': 'Stage I', 'categories': [{'measurements': [{'value': '721', 'groupId': 'BG000'}, {'value': '770', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}, {'value': '2000', 'groupId': 'BG003'}]}]}, {'title': 'Stage II', 'categories': [{'measurements': [{'value': '992', 'groupId': 'BG000'}, {'value': '954', 'groupId': 'BG001'}, {'value': '694', 'groupId': 'BG002'}, {'value': '2640', 'groupId': 'BG003'}]}]}, {'title': 'Stage III', 'categories': [{'measurements': [{'value': '472', 'groupId': 'BG000'}, {'value': '460', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}, {'value': '1236', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Staging criterial is per AJCC 6th Edition, 2002. Higher staging means worse disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Chemotherapy', 'classes': [{'title': 'Not given or planned', 'categories': [{'measurements': [{'value': '446', 'groupId': 'BG000'}, {'value': '454', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}, {'value': '1219', 'groupId': 'BG003'}]}]}, {'title': 'Given or planned', 'categories': [{'measurements': [{'value': '1779', 'groupId': 'BG000'}, {'value': '1778', 'groupId': 'BG001'}, {'value': '1232', 'groupId': 'BG002'}, {'value': '4789', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hormonal Therapy', 'classes': [{'title': 'Not given or planned', 'categories': [{'measurements': [{'value': '542', 'groupId': 'BG000'}, {'value': '535', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}, {'value': '1444', 'groupId': 'BG003'}]}]}, {'title': 'Given or planned', 'categories': [{'measurements': [{'value': '1670', 'groupId': 'BG000'}, {'value': '1686', 'groupId': 'BG001'}, {'value': '1170', 'groupId': 'BG002'}, {'value': '4526', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Only eligible patients are included in the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-12-19', 'size': 3682390, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-05-10T13:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6097}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2005-08-03', 'resultsFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2005-08-03', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-15', 'studyFirstPostDateStruct': {'date': '2005-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival', 'timeFrame': 'Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence', 'description': 'Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'follow up completed every 6 months for 5 years and then annually for 5 years or until death', 'description': 'Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.'}, {'measure': 'Distributions of Sites of First Recurrence on the Three Arms.', 'timeFrame': 'Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence', 'description': 'All sites of invasive disease documented within 30 days of first documentation of invasive recurrence.'}, {'measure': 'Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs', 'timeFrame': 'Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.', 'description': 'Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38979716', 'type': 'DERIVED', 'citation': 'Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.'}, {'pmid': '32929540', 'type': 'DERIVED', 'citation': 'Kizub DA, Miao J, Schubert MM, Paterson AHG, Clemons M, Dees EC, Ingle JN, Falkson CI, Barlow WE, Hortobagyi GN, Gralow JR. Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307). Support Care Cancer. 2021 May;29(5):2509-2517. doi: 10.1007/s00520-020-05748-8. Epub 2020 Sep 15.'}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer.\n\nPURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate.\n* Compare the distributions of sites of first disease recurrence in patients treated with these drugs.\n* Compare adverse events in patients treated with these drugs.\n* Correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients treated with these drugs.\n* Investigate whether there is an association between inherited germ-line single nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate synthase (FDPS) and the adverse event of acute phase reactions in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I: Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.\n* Arm II: Patients receive oral clodronate once daily for 35 months.\n* Arm III: Patients receive oral ibandronate once daily for 35 months. Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed every 6 months until disease recurrence and then annually for up to 10 years.\n\nPROJECTED ACCRUAL: A total of 5,400 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 primary adenocarcinoma of the breast\n\n * Stage I-III disease\n * No evidence of metastatic disease\n* Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks\n\n * Axillary evaluation per institutional standards\n* Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer\n\n * Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible\n * Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible\n * Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab \\[Herceptin\\^®\\], bevacizumab, or hematopoietic growth factors)\n * Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs ≥ 12 weeks after completion of surgery\n* Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease\n\n * Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* Zubrod 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Creatinine ≤ 2 times upper limit of normal\n* Creatinine clearance ≥ 30 mL/min\n* No renal failure\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No history of esophageal stricture or motility disorders\n\n * Gastroesophageal reflux disorder allowed\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Prior or concurrent hematopoietic growth factors allowed\n* HER-2-targeted therapies allowed\n* Antiangiogenics allowed\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* See Disease Characteristics\n\nRadiotherapy\n\n* Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* Prior neoadjuvant therapy allowed\n* Prior bisphosphonates for bone density allowed\n* No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis\n* No concurrent enrollment in clinical trials with bone density as an endpoint\n\n * Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed'}, 'identificationModule': {'nctId': 'NCT00127205', 'briefTitle': 'S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000437061'}, 'secondaryIdInfos': [{'id': 'S0307', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.', 'interventionNames': ['Drug: zoledronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive oral clodronate once daily for 35 months.', 'interventionNames': ['Drug: clodronate disodium']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III', 'description': 'Patients receive oral ibandronate once daily for 35 months.', 'interventionNames': ['Drug: ibandronate sodium']}], 'interventions': [{'name': 'clodronate disodium', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Arm II']}, {'name': 'ibandronate sodium', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Arm III']}, {'name': 'zoledronic acid', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Julie R. Gralow, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seattle Cancer Care Alliance'}, {'name': 'Robert B. Livingston, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Arizona'}, {'name': 'James N. Ingle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}, {'name': 'Carla I. Falkson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Alexander H Paterson, MD, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Tom Baker Cancer Centre - Calgary'}, {'name': 'Elizabeth C. Dees, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}, {'name': 'Mark J. Clemons, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Toronto Sunnybrook Regional Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'North Central Cancer Treatment Group', 'class': 'NETWORK'}, {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, {'name': 'NSABP Foundation Inc', 'class': 'NETWORK'}, {'name': 'Cancer and Leukemia Group B', 'class': 'NETWORK'}, {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}