{"denoms":[{"counts":[{"groupId":"BG000","value":"2253"},{"groupId":"BG001","value":"2256"},{"groupId":"BG002","value":"4509"}],"units":"Participants"}],"groups":[{"description":"Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.","id":"BG000","title":"Placebo"},{"description":"Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.","id":"BG001","title":"Denosumab"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10.6","value":"51.6"},{"groupId":"BG001","spread":"10.7","value":"51.4"},{"groupId":"BG002","spread":"10.7","value":"51.5"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1960"},{"groupId":"BG001","value":"1959"},{"groupId":"BG002","value":"3919"}],"title":"18 - 64 years"},{"measurements":[{"groupId":"BG000","value":"259"},{"groupId":"BG001","value":"260"},{"groupId":"BG002","value":"519"}],"title":"65 - 74 years"},{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"69"}],"title":"75 - 84 years"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}],"title":"≥ 85 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2253"},{"groupId":"BG001","value":"2256"},{"groupId":"BG002","value":"4509"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1692"},{"groupId":"BG001","value":"1676"},{"groupId":"BG002","value":"3368"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"222"},{"groupId":"BG001","value":"213"},{"groupId":"BG002","value":"435"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"134"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"269"}],"title":"Japanese"},{"measurements":[{"groupId":"BG000","value":"112"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"247"}],"title":"Hispanic/Latino"},{"measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"144"}],"title":"Black"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"38"}],"title":"Other"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1165"},{"groupId":"BG001","value":"1195"},{"groupId":"BG002","value":"2360"}],"title":"Premenopausal"},{"measurements":[{"groupId":"BG000","value":"1088"},{"groupId":"BG001","value":"1061"},{"groupId":"BG002","value":"2149"}],"title":"Postmenopausal"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Menopausal Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1913"},{"groupId":"BG001","value":"1922"},{"groupId":"BG002","value":"3835"}],"title":"0 (Fully active)"},{"measurements":[{"groupId":"BG000","value":"340"},{"groupId":"BG001","value":"329"},{"groupId":"BG002","value":"669"}],"title":"1 (Restricted but ambulatory)"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}],"title":"2 (Ambulatory, unable to work)"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}],"title":"Missing"}]}],"description":"A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"550"},{"groupId":"BG001","value":"552"},{"groupId":"BG002","value":"1102"}],"title":"Neo-adjuvant therapy / any lymph node status"},{"measurements":[{"groupId":"BG000","value":"68"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"133"}],"title":"Adjuvant therapy / lymph node negative"},{"measurements":[{"groupId":"BG000","value":"1635"},{"groupId":"BG001","value":"1639"},{"groupId":"BG002","value":"3274"}],"title":"Adjuvant therapy / lymph node positive"}]}],"description":"Breast cancer therapy / lymph node (LN) status:\n\n1. neo-adjuvant therapy / any LN status;\n2. adjuvant therapy / LN negative (based on axillary LN dissection, or based on sentinel node \\[SN\\] status);\n3. adjuvant therapy / LN positive","paramType":"COUNT_OF_PARTICIPANTS","title":"Breast Cancer Therapy / Lymph Node Status (Strata per Randomization)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1740"},{"groupId":"BG001","value":"1747"},{"groupId":"BG002","value":"3487"}],"title":"ER and/or PR positive"},{"measurements":[{"groupId":"BG000","value":"513"},{"groupId":"BG001","value":"509"},{"groupId":"BG002","value":"1022"}],"title":"ER and PR negative"}]}],"description":"Hormone receptor (estrogen receptor \\[ER\\] / progesterone receptor \\[PR\\]) status\n\n1. ER and/or PR positive\n2. ER and PR negative","paramType":"COUNT_OF_PARTICIPANTS","title":"Hormone Receptor Status (Strata per Randomization)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"490"},{"groupId":"BG001","value":"492"},{"groupId":"BG002","value":"982"}],"title":"HER-2 positive"},{"measurements":[{"groupId":"BG000","value":"1763"},{"groupId":"BG001","value":"1764"},{"groupId":"BG002","value":"3527"}],"title":"HER-2 negative"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Human Epidermal Growth Factor Receptor 2 (HER-2) Status (Strata per Randomization)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1026"},{"groupId":"BG001","value":"1029"},{"groupId":"BG002","value":"2055"}],"title":"< 50 years"},{"measurements":[{"groupId":"BG000","value":"1227"},{"groupId":"BG001","value":"1227"},{"groupId":"BG002","value":"2454"}],"title":"≥ 50 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age (Strata per Randomization)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"262"}],"title":"Japan"},{"measurements":[{"groupId":"BG000","value":"2122"},{"groupId":"BG001","value":"2125"},{"groupId":"BG002","value":"4247"}],"title":"Other"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Geographic Region (Strata per Randomization)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"288"},{"groupId":"BG001","value":"286"},{"groupId":"BG002","value":"574"}],"title":"HR positive and HER-2 positive"},{"measurements":[{"groupId":"BG000","value":"1460"},{"groupId":"BG001","value":"1458"},{"groupId":"BG002","value":"2918"}],"title":"HR positive and HER-2 negative"},{"measurements":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"168"},{"groupId":"BG002","value":"331"}],"title":"HR negative and HER-2 positive"},{"measurements":[{"groupId":"BG000","value":"341"},{"groupId":"BG001","value":"343"},{"groupId":"BG002","value":"684"}],"title":"HR negative and HER-2 negative"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}],"title":"Missing"}]}],"description":"Hormone receptor (HR; estrogen receptor \\[ER\\] / progesterone receptor \\[PR\\]); HR positive = ER and/or PR positive; HR negative = ER and PR negative","paramType":"COUNT_OF_PARTICIPANTS","title":"Molecular Subtypes of Breast Cancer","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"130"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"261"}],"title":"N0"},{"measurements":[{"groupId":"BG000","value":"1369"},{"groupId":"BG001","value":"1381"},{"groupId":"BG002","value":"2750"}],"title":"N1"},{"measurements":[{"groupId":"BG000","value":"506"},{"groupId":"BG001","value":"505"},{"groupId":"BG002","value":"1011"}],"title":"N2"},{"measurements":[{"groupId":"BG000","value":"230"},{"groupId":"BG001","value":"224"},{"groupId":"BG002","value":"454"}],"title":"N3"},{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"33"}],"title":"Nx"}]}],"description":"Clinical and pathologic regional lymph node (LN) status (by American Joint Committee on Cancer (AJCC)): N0 = no LN metastasis or pathologic (p) micrometastases \\<2.0 mm; N1 = Ipsilateral level I, II axillary (Ax) LN or p micrometastases \\>2.0mm or in internal mammary (IM) LN; N2 = fixed ipsilateral level I, II Ax LNs or clinically detected IM LNs only or pLN metastases in 4-9 Ax LNs; N3 = ipsilateral level III infraclavicular (IC) LNs or clinically detected IM LNs with other level I/II Ax LNs or supraclavicular (SC) LNs or pLN metastases in ≥10 Ax LNs; NX =LNs cannot be assessed.","paramType":"COUNT_OF_PARTICIPANTS","title":"Lymph Node Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"222"},{"groupId":"BG001","value":"209"},{"groupId":"BG002","value":"431"}],"title":"Grade 1 = Low"},{"measurements":[{"groupId":"BG000","value":"1015"},{"groupId":"BG001","value":"1079"},{"groupId":"BG002","value":"2094"}],"title":"Grade 2 = Intermediate"},{"measurements":[{"groupId":"BG000","value":"938"},{"groupId":"BG001","value":"906"},{"groupId":"BG002","value":"1844"}],"title":"Grade 3 = High"},{"measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"62"},{"groupId":"BG002","value":"140"}],"title":"Not Evaluable/Missing"}]}],"description":"Tumor grade was determined according to the Nottingham Combined Histological Grading System, based on morphological features (tubule formation, nuclear pleomorphism, and mitotic count), by assigning a value of 1 (favorable) to 3 (unfavorable) for each feature. Scores for the 3 categories were added to give a combined histopathologic grade score: Grade (G)1 (low grade; favorable) = total score of 3, 4, or 5; G2 (intermediate) = total score of 6 or 7; G3 (high; unfavorable) = total score of 8 or 9.","paramType":"COUNT_OF_PARTICIPANTS","title":"Breast Cancer Histopathologic Grade","unitOfMeasure":"Participants"}]}