{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.47","value":"99.1"},{"groupId":"OG001","spread":"8.45","value":"98.1"}]}],"title":"Docetaxel"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.86","value":"99.3"},{"groupId":"OG001","spread":"4.33","value":"99.0"}]}],"title":"Cyclophosphamide"}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and 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":"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":"Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population.","reportingStatus":"POSTED","timeFrame":"Cycles 1 to 4 (each cycle was 21 days)","title":"Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4","type":"SECONDARY","unitOfMeasure":"percentage of planned dose"}