Table 2.
Baseline characteristics
Period 1 | Period 2 | |||
---|---|---|---|---|
Sandoz proposed biosimilar pegfilgrastim (N = 92) | Reference pegfilgrastim (N = 92) | Sandoz proposed biosimilar pegfilgrastim (N = 84) | Reference pegfilgrastim (N = 86) | |
Body weight (kg), mean (SD) | 75.86 (9.77) | 73.98 (8.85) | 74.11 (8.83) | 75.88 (10.06) |
WBC (109 l–1), mean (SD) | 6.77 (1.33) | 6.99 (1.42) | 6.69 (1.52) | 6.24 (1.46) |
Haemoglobin (mmol l–1), mean (SD) | 9.10 (0.76) | 9.09 (0.85) | 9.01 (0.90) | 9.03 (0.82) |
Platelets (109 l–1), mean (SD) | 246.30 (53.96) | 251.50 (54.08) | 245.10 (48.89) | 235.80 (51.14) |
ANC (109 l–1), mean (SD) | 2.90 (0.93) | 2.97 (0.91) | 2.70 (0.89) | 2.49 (0.83) |
N, number of subjects in treatment group; SD, standard deviation; WBC, white blood cells; ANC, absolute neutrophil count