{"analyses":[{"ciLowerLimit":"0.365","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.812","groupDescription":"GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","paramType":"Odds Ratio (OR)","paramValue":"0.544","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"3.242","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.092","groupDescription":"Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"4.795","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"3.242","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.092","groupDescription":"CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"4.083","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"1.542","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.925","groupDescription":"History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"2.460","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"0.267","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.766","groupDescription":"Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","paramType":"Odds Ratio (OR)","paramValue":"0.452","statisticalMethod":"Regression, Logistic","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"294"}]}]}],"denomUnitsSelected":"Participants","denoms":[{"counts":[{"groupId":"OG000","value":"1078"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"5514"}],"units":"cycles"}],"description":"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.\n\nObjective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006\n\nOnly results with a p-value of \\<0.05 are added as statistical analyses appendices.\n\nCI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score","groups":[{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.","id":"OG000","title":"EP2006"}],"paramType":"NUMBER","populationDescription":"Number of cycles in evaluable sample with any grade 4 CIN data","reportingStatus":"POSTED","timeFrame":"All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days","title":"Modeling Grade 4 CIN Episode: Cycle Level","type":"SECONDARY","typeUnitsAnalyzed":"cycles","unitOfMeasure":"cycles"}