{"analyses":[{"ciLowerLimit":"-0.292","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.129","groupIds":["OG000","OG001"],"nonInferiorityComment":"The study used non inferiority margin of 0.62 days for the above comparison. 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","paramValue":"-0.074","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":"0.688","value":"0.31"},{"groupId":"OG001","spread":"0.949","value":"0.39"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"119"}],"units":"Participants"}],"description":"DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \\[ANC\\] \\<0.5×10\\^9 per liter \\[L\\]) from the first occurrence of ANC below the threshold.","dispersionType":"Standard Deviation","groups":[{"description":"At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \\[3.6 mg granulocyte colony-stimulating factor {G-CSF}\\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\\^2 and cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.","id":"OG000","title":"(Arm 1): SPI-2012 and TC"},{"description":"At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\\^2 and cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.","id":"OG001","title":"(Arm 2): Pegfilgrastim and TC"}],"paramType":"MEAN","populationDescription":"ITT population included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)","title":"Duration of Severe Neutropenia (DSN) in Cycle 1","type":"PRIMARY","unitOfMeasure":"Days"}