{"analyses":[{"ciLowerLimit":"-1.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.94","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.685","paramType":"Mean Difference (Final Values)","paramValue":"-0.25","statisticalMethod":"Negative binomial regression"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.565","value":"3.24"},{"groupId":"OG001","spread":"3.589","value":"3.49"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"210"}],"units":"Participants"}],"description":"Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10\\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10\\^9/L.","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":"Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1","type":"SECONDARY","unitOfMeasure":"days"}