Table 2.
Efficacy parameters (FAS)
| LA-EP2006 (N=314) | Reference (N=310) | |
|---|---|---|
| Primary efficacy parameter | ||
| DSN in cycle 1, mean±SD (median) | 1.05±1.055 | 1.01±0.958 |
| (1.0) | (1.0) | |
| Secondary efficacy parameter | ||
| Depth of ANC nadir (×109/l) in cycle 1, mean±SD | 0.800±1.2436 | 0.687±0.9586 |
| Time to ANC recovery in cycle 1, mean±SD (median) | 1.84±1.01 | 1.88±1.04 |
| (2.0) | (2.0) | |
| Patients with ≥1 episode of FN/NS, n (%)a | ||
| Cycle 1 | 18 (5.7) | 26 (8.4) |
| All cycles | 25 (8.0) | 32 (10.3) |
| Patients with ≥1 episode of fever, n (%)a | ||
| Cycle 1 | 22 (7.0) | 31 (10.0) |
| All cycles | 58 (18.5) | 61 (19.7) |
| Patients with ≥1 infection, n (%)a | ||
| Cycle 1 | 17 (5.4) | 18 (5.8) |
| All cycles | 49 (15.6) | 56 (18.1) |
| Mortality due to infection, n (%) | 0 | 2 (0.6) |
All patients with FN/NS also experienced ≥1 fever episode.
a
Patients with >1 episode are counted only once.
ANC, absolute neutrophil count; ANC nadir, lowest ANC (109/l) in cycle 1; DSN, duration of severe neutropenia; FAS, full analysis set; FN/NS, febrile neutropenia/neutropenic sepsis; N, number of patients in a treatment group or analysis set; n, number of patients with at least one episode; SD, standard deviation; time to ANC recovery, time in days from ANC nadir until ANC had increased to ≥2 × 109/l.