{"analyses":[{"groupDescription":"A test of the incidence rate R was performed with null hypothesis H0: R\\>= 0.33 and alternative hypothesis Ha: R\\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \\<0.33), the one-sided p-value for the null hypothesis R\\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \\<0.5.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Incidence rate R","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Stomatitis grade >=2: Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83"}]}],"title":"Stomatitis grade >=2: No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Stomatitis grade >=2: Not evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"}],"units":"Participants"}],"description":"The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.","groups":[{"description":"Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.","id":"OG000","title":"Dexamethasone Based Mouthwash"}],"paramType":"NUMBER","populationDescription":"Full analysis set (FAS): The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).","reportingStatus":"POSTED","timeFrame":"56 days","title":"Number of Participants With Stomatitis Grade ≥ 2","type":"PRIMARY","unitOfMeasure":"Participants"}