{"description":"AEs are to be reported in a routine fashion at scheduled times during the trial. Certain AEs must be reported in an expedited fashion to allow for timely monitoring of subject safety and care.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).","id":"EG000","otherNumAffected":4,"otherNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"title":"Intrarosa & Standard of Care Aromatase Inhibitor"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).","id":"EG001","otherNumAffected":1,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Replens & Standard of Care Aromatase Inhibitor"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Burning with vaginal Intrarosa application"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dyspareunia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Herpes simplex reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Hirsutism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Other, specify: Vaginal pulsing sensation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Other, specify: Vulva swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Other: Vaginal fullness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Vaginal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Vaginal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Vaginal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Vitamin D deficiency"}],"timeFrame":"12 weeks (+/- 1 week)"}