{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"116"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"48"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"4"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"118"}],"units":"Participants"}],"description":"An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.","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.","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.","id":"OG001","title":"(Arm 2): Pegfilgrastim and TC"},{"description":"In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.","id":"OG002","title":"(Arm 1): SPI-2012 and TC: Follow-up Period"},{"description":"In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment","id":"OG003","title":"Arm 2: Pegfilgrastim and TC: Follow-up Period"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Data was summarized and reported for Treatment and Follow-up period separately for both groups.","reportingStatus":"POSTED","timeFrame":"Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death","type":"SECONDARY","unitOfMeasure":"Participants"}