2.8. Outcome measures
pneumonitis, bone pain, CIN, fever
ADVERSE EVENTS, PNEUMONITIS, CHEMOTHERAPY INDUCED NEUTROPENIA, CIN
Outcome measures are listed in Table Detailed descriptions of the endpoints.AEs = adverse events, CIN = chemotherapy induced neutropenia, Gr = grade.Duration of Gr4 CIN (cycle 1): duration (in days) of ANC < 500/μL in the first chemotherapy cycle.Incidence of Gr 3 to 4 CIN (cycle 1): subjects with ANC < 1000/μL in the first chemotherapy cycle.Severity of CIN (cycle 1): minimum ANC level in the first chemotherapy cycle.Time to ANC recovery (cycle 1): time (in days) from day 1 of chemotherapy to ANC > 1000/μL after the nadir in the first chemotherapy cycle.FN incidence (cycle 1–4): development of FN until 28 days after the end of cycle 4. FN is defined as an oral temperature rise to 38.3°C or higher or a fever of 38.0°C or higher that lasts for 1 hour or more with an ANC <500/mmIncidence of CIN-related dose delay (cycle 1–4).Relative dose intensity (RDI) (cycle 1–4): RDI is calculated by dividing the total dose of chemotherapy (mg/mPegteograstim-related AEs (cycle 1–4): the occurrence of bone pain and pneumonitis during cycles 1 to 4.