{"description":"AE: Any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":50,"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration","id":"EG000","otherNumAffected":3,"otherNumAtRisk":50,"seriousNumAffected":1,"seriousNumAtRisk":50,"title":"0.005% Estriol Vaginal Gel"},{"deathsNumAffected":0,"deathsNumAtRisk":11,"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration\n\nPlacebo","id":"EG001","otherNumAffected":1,"otherNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"title":"Placebo Vaginal Gel"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":50},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Urinary tract infection"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"An unrelated Serious adverse event (lymphoma) was reported but before study treatment administration","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Lymphoma"}],"timeFrame":"From baseline to last visit (up to 16 weeks)"}