{"analyses":[{"ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.009620","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.68","paramType":"Slope","paramValue":"-0.00394","statisticalComment":"Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.14","value":"2.06"},{"groupId":"OG001","spread":"0.14","value":"2.09"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"882"},{"groupId":"OG001","value":"884"}],"units":"Participants"}],"description":"To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below.","dispersionType":"Standard Error","groups":[{"description":"Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm I (Zoledronic Acid Every 4 Weeks)"},{"description":"Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm II (Zoledronic Acid Every 12 Weeks)"}],"paramType":"MEAN","populationDescription":"1766 patients completed treatment and were analyzed.","reportingStatus":"POSTED","timeFrame":"from baseline up to 2 years","title":"Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire","type":"SECONDARY","unitOfMeasure":"score on a scale"}