{"description":"Participants were assessed for toxicity at each study visit. All events at least possibly related to the study intervention will be collected. Participants were instructed to call the study team for adverse events that occurred between visits. The study team or an on-call physician were available 24 hours a day.","eventGroups":[{"description":"Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.","id":"EG000","otherNumAffected":4,"otherNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"title":"Vaginal Renewal Program"},{"description":"This will consist of still vaginal dilator and/or lubricant.\n\nVaginal Dilator: Still vaginal dilator with lubricant.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":13,"seriousNumAffected":0,"seriousNumAtRisk":13,"title":"Standard of Care"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13}],"term":"Bladder irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13}],"term":"Bladder pressure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":3}],"term":"Urinary tract infections (UTI)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Yeast","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13}],"term":"Vaginal irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13}],"term":"Vulvar fissures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Wrist pain"}],"timeFrame":"Adverse event data were collected for 1 year, 8 months."}