{"analyses":[{"ciLowerLimit":"0.108","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.289","estimateComment":"Hazard ratio is expressed as Lu-DOTA-Tyr-Octreotate / Octreotide LAR and estimated from the corresponding Cox model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Derived from a two-sided test between the two groups","paramType":"Hazard Ratio (HR)","paramValue":"0.177","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA: not estimable due to number of censored participants at the time the analysis cut off date was reached.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"5.8","upperLimit":"9.1","value":"8.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Independent Review Committee (IRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).","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":"MEDIAN","populationDescription":"Full Analysis Set (FAS).","reportingStatus":"POSTED","timeFrame":"From date of randomization until date of radiographic 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":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}