{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.70","value":"96.9"},{"groupId":"OG001","spread":"7.89","value":"98.4"}]}],"title":"Docetaxel"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.27","value":"98.4"},{"groupId":"OG001","spread":"6.40","value":"98.8"}]}],"title":"Cyclophosphamide"}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"118"}],"units":"Participants"}],"description":"RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.","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":"Safety analysis (SAF) population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).","reportingStatus":"POSTED","timeFrame":"Cycles 1, 2, 3 and 4 (each cycle = 21 days)","title":"Relative Dose Intensity (RDI) of TC Chemotherapy","type":"SECONDARY","unitOfMeasure":"Percentage of planned dose"}