{"analyses":[{"ciLowerLimit":"0.93","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.56","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.155","paramType":"Median Difference (Final Values)","paramValue":"1.2","statisticalComment":"P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.","statisticalMethod":"Asymptotic normality assumption"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.086","value":"2.56"},{"groupId":"OG001","spread":"3.317","value":"2.53"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"Depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or Pegfilgrastim) 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. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)","title":"Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1","type":"SECONDARY","unitOfMeasure":"10^9 ANC/L"}