{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.8"},{"groupId":"OG001","value":"11.8"},{"groupId":"OG002","value":"15.9"}]}],"title":"CIN grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.9"},{"groupId":"OG001","value":"3.5"},{"groupId":"OG002","value":"8.9"}]}],"title":"FN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16.9"},{"groupId":"OG001","value":"20.9"},{"groupId":"OG002","value":"25.2"}]}],"title":"Composite^"}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"650"},{"groupId":"OG002","value":"640"}],"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 different outcomes and composite outcome by chemotherapy risk group. \\^Composite endpoint includes any of 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 with low risk(\\<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.","id":"OG000","title":"EP2006: Low (<10%) Risk"},{"description":"Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.","id":"OG001","title":"EP2006: Medium (10-20%) Risk"},{"description":"Cancer patients treated with chemotherapy with high risk(\\>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.","id":"OG002","title":"EP2006: High (>20%) Risk"}],"paramType":"NUMBER","populationDescription":"Evaluable sample by chemotherapy risk","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 Chemotherapy Risk: Patient Level","type":"PRIMARY","unitOfMeasure":"percentage of participants"}