{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6"}]}],"title":"Patient #1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Patient #2"},{"categories":[{"measurements":[{"comment":"Patient did not report a baseline pain score, so an AUC adjusted for baseline could not be calculated.","groupId":"OG000","value":"NA"}]}],"title":"Patient #3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"description":"Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.","groups":[{"description":"Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.","id":"OG000","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"5 were accrued but only 3 provided data. Since only 1 patient was accrued \\& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \\& only for placebo intervention.","reportingStatus":"POSTED","timeFrame":"Baseline and 5, 15, 30, 60, 120, and 240 minutes after treatment on day 1","title":"Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment","type":"PRIMARY","unitOfMeasure":"units on a scale"}