{"analyses":[{"ciLowerLimit":"-0.032","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.116","groupDescription":"DSN in Cycle 2","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% 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":"0.042","statisticalMethod":"t-statistics"},{"ciLowerLimit":"-0.032","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.085","groupDescription":"DSN in Cycle 3","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% 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":"0.026","statisticalMethod":"t-statistics"},{"ciLowerLimit":"-0.036","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.089","groupDescription":"DSN in Cycle 4","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% 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":"0.027","statisticalMethod":"t-statistics"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.383","value":"0.13"},{"groupId":"OG001","spread":"0.374","value":"0.09"}]}],"title":"Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.326","value":"0.11"},{"groupId":"OG001","spread":"0.273","value":"0.08"}]}],"title":"Cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.362","value":"0.11"},{"groupId":"OG001","spread":"0.281","value":"0.09"}]}],"title":"Cycle 4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"210"}],"units":"Participants"}],"description":"DSN was defined as the number of days of severe neutropenia (ANC \\<0.5×10\\^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4.","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":"Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)","title":"Duration of Severe Neutropenia in Cycle 2, 3 and 4","type":"SECONDARY","unitOfMeasure":"days"}