{"analyses":[{"ciLowerLimit":"0.60","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.17","estimateComment":"Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3039","paramType":"Cox Proportional Hazard","paramValue":"0.84","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"84.0","upperLimit":"95.1","value":"91.0"},{"groupId":"OG001","lowerLimit":"70.8","upperLimit":"86.1","value":"79.7"}]}],"title":"12 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"66.7","upperLimit":"83.0","value":"76.0"},{"groupId":"OG001","lowerLimit":"52.6","upperLimit":"71.2","value":"62.7"}]}],"title":"24 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"51.4","upperLimit":"69.9","value":"61.4"},{"groupId":"OG001","lowerLimit":"40.0","upperLimit":"59.4","value":"50.1"}]}],"title":"36 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.5","upperLimit":"58.6","value":"49.5"},{"groupId":"OG001","lowerLimit":"31.8","upperLimit":"51.4","value":"41.8"}]}],"title":"48 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.8","upperLimit":"46.4","value":"37.1"},{"groupId":"OG001","lowerLimit":"25.7","upperLimit":"45.2","value":"35.4"}]}],"title":"60 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"Survival estimates were collected every 12 Months up to 60 Months to compare OS between the two treatment groups.","dispersionType":"95% Confidence Interval","groups":[{"description":"* 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died.\n* Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi).\n* Concomitant amino acids were given with each administration for kidney protection.\n* 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.\n* In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.","id":"OG000","title":"177Lu-DOTA0-Tyr3-Octreotate"},{"description":"* 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.\n* In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.","id":"OG001","title":"Octreotide LAR"}],"paramType":"NUMBER","populationDescription":"Full Analysis Set (FAS).","reportingStatus":"POSTED","timeFrame":"12 months, 24 months, 36 months, 48 months, 60 months","title":"Rate of Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Percentage of Survival Estimates"}