{"analyses":[{"ciLowerLimit":"1.152","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.281","groupDescription":"Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.006","paramType":"Odds Ratio (OR)","paramValue":"1.621","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"1.209","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.979","groupDescription":"History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","paramType":"Odds Ratio (OR)","paramValue":"1.898","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"1.200","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.984","groupDescription":"History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.016","paramType":"Odds Ratio (OR)","paramValue":"2.680","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"0.291","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.660","groupDescription":"Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"0.438","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"1.295","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.256","groupDescription":"Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","paramType":"Odds Ratio (OR)","paramValue":"2.053","statisticalMethod":"Regression, Logistic","testedNonInferiority":false},{"ciLowerLimit":"0.332","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.939","groupDescription":"GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.028","paramType":"Odds Ratio (OR)","paramValue":"0.558","statisticalMethod":"Regression, Logistic","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"323"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1291"}],"units":"Participants"}],"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 shown in the statistical appendices.\n\nCI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score. H/o repeated infections refers at enrollment; H/o: History of","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":"Patients in evaluable sample with composite outcome 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 Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level","type":"SECONDARY","unitOfMeasure":"participants"}