{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"119"}],"units":"Participants"}],"description":"FN was defined as an oral temperature \\>38.3 degree Celsius (°C) (101.0 degrees Fahrenheit \\[°F\\]) or two consecutive readings of \\>38.0°C (100.4°F) for 2 hours and ANC \\<1.0×10\\^9/L.","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":"COUNT_OF_PARTICIPANTS","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":"Number of Participants With Febrile Neutropenia (FN) in Cycle 1","type":"SECONDARY","unitOfMeasure":"Participants"}