{"analyses":[{"ciLowerLimit":"0.01","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.17","groupDescription":"Null hypothesis: response probability \\< 5%; alternative hypothesis: response probability \\> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Response probability","paramValue":"0.05","statisticalMethod":"two-stage binomial","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"}]}],"title":"No Response"}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"units":"Participants"}],"description":"Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.","groups":[{"description":"Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.","id":"OG000","title":"Treatment (E7389 IV)"}],"paramType":"NUMBER","populationDescription":"Only eligible patients were included in the analysis","reportingStatus":"POSTED","timeFrame":"Every 6 weeks until progression of disease up to a maximum of 3 years after registration","title":"Response Probability (Confirmed Complete and Partial Responses)","type":"PRIMARY","unitOfMeasure":"participants"}