{"analyses":[{"ciLowerLimit":"-0.266","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.031","groupIds":["OG000","OG001"],"nonInferiorityComment":"The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \\<0.62 days.","nonInferiorityType":"NON_INFERIORITY","pValue":"<0.0001","paramType":"Mean Difference (Final Values)","paramValue":"-0.148","statisticalComment":"The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.","statisticalMethod":"t-statistics"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.503","value":"0.20"},{"groupId":"OG001","spread":"0.683","value":"0.35"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"210"}],"units":"Participants"}],"description":"DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \\[ANC\\] \\<0.5×10\\^9/L), after the administration of study drug in Cycle 1.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care.","id":"OG000","title":"Arm 1: SPI-2012 and TC"},{"description":"Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care.","id":"OG001","title":"Arm 2: Pegfilgrastim and TC"}],"paramType":"MEAN","populationDescription":"The ITT population included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)","title":"Duration of Severe Neutropenia (DSN) in Cycle 1","type":"PRIMARY","unitOfMeasure":"days"}