{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.89","value":"-5.9"},{"groupId":"OG001","spread":"13.72","value":"-7.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"description":"Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.","dispersionType":"Standard Deviation","groups":[{"description":"Fulvestrant 250 mg Intramuscular Injection every 28 days","id":"OG000","title":"Fulvestrant 250 mg"},{"description":"Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14","id":"OG001","title":"Fulvestrant 500 mg"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)","title":"Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}