Table 4 Mean ANC values for planned sampling days in cycle 1 (FAS-As Randomized and FAS-As Treated)
Characteristics | Proposed biosimilar pegfilgrastim (APO-Peg) N = 294 | US-licensed pegfilgrastim reference product (US-Neulasta®) N = 148 | EU-approved pegfilgrastim reference product (EU-Neulasta®) N = 147 | Total N = 589 |
|---|---|---|---|---|
FAS-As Randomized | ||||
Day on which the peak ANC value was reached | ||||
N | 294 | 148 | 147 | 589 |
Mean (SD) | 3.4 (2.3) | 3.1 (0.6) | 3.1 (1.4) | 3.2 (1.8) |
Median | 3.0 | 3.0 | 3.0 | 3.0 |
Minimum–maximum | 1–24 | 3–9 | 1–18 | 1–24 |
95% CIs of mean | 3.1–3.6 | 3.0–3.2 | 2.9–3.4 | 3.1–3.4 |
Peak ANC value (× 109/L) | ||||
N | 294 | 148 | 147 | 589 |
Mean (SD) | 28.4 (9.5) | 29.9 (10.2) | 28.7 (9.3) | 28.9 (9.6) |
Median | 27.7 | 29.4 | 27.9 | 28.0 |
Minimum–maximum | 3.9–60.5 | 11.3–88.0 | 5.8–55.9 | 3.9–88.0 |
95% CIs of mean | 27.3–29.5 | 28.3–31.6 | 27.2–30.2 | 28.1–29.7 |
Day on which the depth of ANC nadir was reached | ||||
N | 294 | 148 | 147 | 589 |
Mean (SD) | 7.1 (1.8) | 7.1 (0.6) | 7.3 (2.1) | 7.1 (1.7) |
Median | 7.0 | 7.0 | 7.0 | 7.0 |
Minimum–maximum | 1–21 | 6–11 | 6–21 | 1–21 |
95% CIs of mean | 6.9–7.3 | 7.0–7.2 | 7.0–7.7 | 7.0–7.3 |
Depth of ANC nadir (× 109/L) | ||||
N | 294 | 148 | 147 | 589 |
Mean (SD) | 0.6 (1.1) | 0.4 (0.6) | 0.4 (0.7) | 0.5 (0.9) |
Median | 0.2 | 0.2 | 0.1 | 0.2 |
Minimum–maximum | 0.0–9.8 | 0.0–3.4 | 0.0–6.0 | 0.0–9.8 |
95% CIs of mean | 0.4–0.7 | 0.3–0.5 | 0.3–0.5 | 0.4–0.6 |
Day on which recovery of ANC was reached | ||||
N | 267 | 136 | 137 | 540 |
Mean (SD) | 9.4 (2.0) | 9.5 (2.1) | 9.2 (1.0) | 9.4 (1.8) |
Median | 9.0 | 9.0 | 9.0 | 9.0 |
Minimum–maximum | 6–25 | 8–22 | 8–13 | 6–25 |
95% CIs of mean | 9.2–9.7 | 9.1–9.8 | 9.0–9.4 | 9.2–9.5 |
Characteristics | Proposed biosimilar pegfilgrastim (APO-Peg) N = 298 | US-licensed pegfilgrastim reference product (US-Neulasta®) N = 147 | EU-approved pegfilgrastim reference product (EU-Neulasta®) N = 147 | Total N = 589 |
|---|---|---|---|---|
FAS-As Treated | ||||
Day on which the peak ANC value was reached | ||||
N | 298 | 147 | 144 | 589 |
Mean (SD) | 3.4 (2.3) | 3.1 (0.5) | 3.1 (1.4) | 3.2 (1.8) |
Median | 3.0 | 3.0 | 3.0 | 3.0 |
Minimum–maximum | 1–24 | 3–9 | 1–18 | 1–24 |
95% CIs of mean | 3.1–3.6 | 3.0–3.2 | 2.9–3.4 | 3.1–3.4 |
Peak ANC value (× 109/L) | ||||
N | 298 | 147 | 144 | 589 |
Mean (SD) | 28.5 (9.6) | 29.7 (10.2) | 28.8 (9.2) | 28.9 (9.6) |
Median | 27.7 | 28.6 | 28.3 | 28.0 |
Minimum–maximum | 3.9–60.5 | 11.3–88.0 | 5.8–55.9 | 3.9–88.0 |
95% CIs of mean | 27.4–29.6 | 28.1–31.4 | 27.3–30.4 | 28.1–29.7 |
Day on which the depth of ANC nadir was reached | ||||
N | 298 | 147 | 144 | 589 |
Mean (SD) | 7.1 (2.0) | 7.1 (0.6) | 7.2 (1.8) | 7.1 (1.7) |
Median | 7.0 | 7.0 | 7.0 | 7.0 |
Minimum–maximum | 1–21 | 6–11 | 6–21 | 1–21 |
95% CIs of mean | 6.9–7.4 | 7.0–7.2 | 6.9–7.5 | 7.0–7.3 |
Depth of ANC nadir (× 109/L) | ||||
N | 298 | 147 | 144 | 589 |
Mean (SD) | 0.6 (1.1) | 0.4 (0.6) | 0.4 (0.7) | 0.5 (0.9) |
Median | 0.2 | 0.2 | 0.1 | 0.2 |
Minimum–maximum | 0.0–9.8 | 0.0–3.4 | 0.0–6.0 | 0.0–9.8 |
95% CIs of mean | 0.4–0.7 | 0.3–0.5 | 0.3–0.5 | 0.4–0.6 |
Day on which recovery of ANC was reached | ||||
N | 270 | 135 | 135 | 540 |
Mean (SD) | 9.4 (2) | 9.4 (2.1) | 9.2 (1.0) | 9.4 (1.8) |
Median | 9.0 | 9.0 | 9.0 | 9.0 |
Minimum–maximum | 6–25 | 8–22 | 8–13 | 6–25 |
95% CIs of mean | 9.2–9.7 | 9.1–9.8 | 9.0–9.4 | 9.2–9.5 |