Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®

Incidence of Febrile Neutropenia (FN)

FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) \< 0.5 × 10\^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account.

Time frame: across all cycles (18 weeks)

Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles

Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once.

Time frame: across al cycles (18 weeks)

Depth of ANC Nadir in Cycle 1

The depth of ANC nadir was defined as the patient's lowest ANC (10\^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given.

Time frame: Cycle 1 (3 weeks)

Number of Patients With ANC Nadir Per Day in Cycle 1

Numbers of patients with ANC nadir based per day during Cycle 1 are given.

Time frame: Cycle 1 (3 weeks)

Time to ANC Recovery in Days in Cycle 1

Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10\^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10\^9 cells/L are given.