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Personal/Psychological Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.67","upperLimit":"0.66","value":"-0.33"},{"groupId":"OG001","lowerLimit":"-0.67","upperLimit":"0","value":"-0.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"6-month Social Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.25","upperLimit":"0","value":"-0.5"},{"groupId":"OG001","lowerLimit":"-1","upperLimit":"-0.25","value":"-0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"title":"9-month Physical 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Pain/Discomfort"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1","upperLimit":"0","value":"-0.5"},{"groupId":"OG001","lowerLimit":"-1.25","upperLimit":"-0.25","value":"-0.75"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"15-month Personal/Psychological Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1","upperLimit":"0.33","value":"0"},{"groupId":"OG001","lowerLimit":"-0.67","upperLimit":"0","value":"-0.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"15-month Social Functioning"}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"Symptom 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 domain score is the average of all responses on a given domain and can range from 0 to 4, with higher scores indicating increased symptom burden. Change in symptom burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the symptom 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, 9,15 months) XeQOLS scores.","reportingStatus":"POSTED","timeFrame":"Baseline, 4, 6, 9 and 15 months from randomization","title":"Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III)","type":"SECONDARY","unitOfMeasure":"units on a scale"}