{"description":"Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":34,"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":"EG000","otherNumAffected":24,"otherNumAtRisk":34,"seriousNumAffected":0,"seriousNumAtRisk":34,"title":"Supportive Care (Fluocinonide Cream)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Bullous dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":34,"numEvents":23}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Pruritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Vaginal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE Version 4.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Vaginal inflammation"}],"timeFrame":"End of study week 1, 2, 3, 4"}