{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0141","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.8","upperLimit":"21.6","value":"14.7"},{"groupId":"OG001","lowerLimit":"0.2","upperLimit":"7.8","value":"4.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"100"}],"units":"Participants"}],"description":"Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) according to RECIST 1.1.","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). Only participants with available post-baseline CT scans were considered.","reportingStatus":"POSTED","timeFrame":"From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}