{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17.7"},{"groupId":"OG001","value":"17.5"},{"groupId":"OG002","value":"9.2"}]}],"title":"CIN grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26.9"},{"groupId":"OG001","value":"24.7"},{"groupId":"OG002","value":"18.9"}]}],"title":"Composite^"}],"denoms":[{"counts":[{"groupId":"OG000","value":"390"},{"groupId":"OG001","value":"308"},{"groupId":"OG002","value":"725"}],"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 by day (mean GIS over all visits). \\^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).","groups":[{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5","id":"OG000","title":"EP2006: Mean GIS 0-0.5"},{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99","id":"OG001","title":"EP2006: Mean GIS 0.51-0.99"},{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1","id":"OG002","title":"EP2006: Mean GIS 1"}],"paramType":"NUMBER","populationDescription":"Evaluable sample by mean GIS","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 Mean GIS: Patient Level","type":"PRIMARY","unitOfMeasure":"percentage of participants"}