{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.1"},{"groupId":"OG001","value":"2.8"},{"groupId":"OG002","value":"7.3"}]}],"title":"CIN grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.0"},{"groupId":"OG001","value":"1.2"},{"groupId":"OG002","value":"2.1"}]}],"title":"FN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.8"},{"groupId":"OG001","value":"5.4"},{"groupId":"OG002","value":"9.1"}]}],"title":"Composite^"}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"851"},{"groupId":"OG002","value":"473"}],"units":"Participants"}],"description":"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.\n\nTable presents incidences of outcomes on a cycle level by day of study drug initiation. \\^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance\n\nCIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010). \\*Day of EP2006 initiation- Day 0 (during chemotherapy); \\*\\*Day of EP2006 initiation- Days 1-3 (per guidelines)","groups":[{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)","id":"OG000","title":"EP2006: Day 0 (During Chemotherapy)"},{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)","id":"OG001","title":"EP2006: Days 1-3 (Per Guidelines)"},{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later","id":"OG002","title":"EP2006: Day 4 or Later"}],"paramType":"NUMBER","populationDescription":"Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.","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":"Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level","type":"PRIMARY","unitOfMeasure":"percentage of participants"}