{"analyses":[{"ciLowerLimit":"-9.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.0","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"1.000","paramType":"Percent Difference","paramValue":"0.3","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"210"}],"units":"Participants"}],"description":"Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"The ITT population included all participants who was randomized.","reportingStatus":"POSTED","timeFrame":"Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)","title":"Number of Participants With Neutropenic Complications in Cycle 1","type":"SECONDARY","unitOfMeasure":"Participants"}