{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.11","pValueComment":"Two-sided test of values at 4 months.","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.31","pValueComment":"Two-sided test of values at 6 months.","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.21","pValueComment":"Two-sided test of values at 15 months.","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.6","upperLimit":"0","value":"-0.27"},{"groupId":"OG001","lowerLimit":"-0.8","upperLimit":"-0.13","value":"-0.47"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"52"}],"units":"Participants"}],"title":"4 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.73","upperLimit":"-0.2","value":"-0.33"},{"groupId":"OG001","lowerLimit":"-0.87","upperLimit":"-0.14","value":"-0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"6 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.87","upperLimit":"-0.07","value":"-0.47"},{"groupId":"OG001","lowerLimit":"-1","upperLimit":"-0.2","value":"-0.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"15 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.","dispersionType":"Inter-Quartile Range","groups":[{"description":"5mg pilocarpine by mouth 3 times a day for 12 weeks","id":"OG000","title":"Pilocarpine: Phase III"},{"description":"Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit","id":"OG001","title":"ALTENS: Phase III"}],"paramType":"MEDIAN","populationDescription":"Eligible patients with both baseline and respective follow-up (4,6,15 months) XeQOLS scores.","reportingStatus":"POSTED","timeFrame":"Baseline, 4, 6, and 15 months from randomization","title":"Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III)","type":"SECONDARY","unitOfMeasure":"units on a scale"}