{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.43","upperLimit":"2.65","value":"17"},{"groupId":"OG001","lowerLimit":"0.43","upperLimit":"2.65","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"84"}],"units":"Participants"}],"description":"The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.","groups":[{"description":"Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.","id":"OG000","title":"15 - Minute Infusion"},{"description":"Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.","id":"OG001","title":"30 - Minute Infusion"}],"paramType":"NUMBER","populationDescription":"Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.","reportingStatus":"POSTED","timeFrame":"Baseline and 12 Months","title":"The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months","type":"PRIMARY","unitOfMeasure":"Participants"}