{"analyses":[{"groupDescription":"In order to compare the response between groups, Kruskal-Wallis ANOVA was used.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.7395","pValueComment":"No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons","statisticalComment":"Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.","statisticalMethod":"ANOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1","upperLimit":"0","value":"-0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"}],"units":"Participants"}],"title":"Anastrazole"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.5","upperLimit":"-0.5","value":"-1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"title":"Exemestane"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2","upperLimit":"0","value":"-0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"}],"units":"Participants"}],"title":"Letrozole"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.75","upperLimit":"-1","value":"-1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"title":"Tamoxifen"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.","dispersionType":"Inter-Quartile Range","groups":[{"description":"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.\n\nAll subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.","id":"OG000","title":"Supportive Care (Fluocinonide Cream)"}],"paramType":"MEDIAN","populationDescription":"The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.","reportingStatus":"POSTED","timeFrame":"Baseline and 4 weeks","title":"Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics","type":"SECONDARY","unitOfMeasure":"units on a scale"}