{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Stomatitis all grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Not evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"}],"units":"Participants"}],"description":"The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. 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":"The FAS, consisting 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), was considered for the analysis. However, only those participants, who were evaluable for stomatitis grade, were analyzed.","reportingStatus":"POSTED","timeFrame":"56 days","title":"Number of Participants With All Grades of Stomatitis","type":"SECONDARY","unitOfMeasure":"Participants"}