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. 2021 Jun 30;33(3):405–416. doi: 10.21147/j.issn.1000-9604.2021.03.11

Table 4. Mean changes in peripheral CD19+ and CD20+ B lymphocyte following HLX01 and reference rituximab administration (phase 1b study).

Time point Statistics CD19+ B cell (count/µL) CD20+ B cell (count/µL)
HLX01 (N=43) Reference rituximab (N=43) HLX01 (N=43) Reference rituximab (N=43)
Reference rituximab was sourced from China (MabThera®; rituximab-CN); 375 mg/m2 of HLX01 or reference rituximab was administered.
Baseline n (miss) 43 (0) 42 (1) 43 (0) 42 (1)
Mean 114.7 132.8 112.0 132.7
Median 55.0 94.6 54.0 96.5
Min, Max 0.1, 591.1 0.1, 632.7 0, 522.9 0, 629.1
5 min after infusion n (miss) 43 (0) 42 (1) 43 (0) 42 (1)
Mean 1.8 0.9 0.1 0.1
Median 0.3 0.7 0.0 0.1
Min, Max 0, 32.3 0, 4.1 0, 0.7 0, 0.6
24 h after infusion n (miss) 43 (0) 42 (1) 43 (0) 42 (1)
Mean 1.5 1.4 0.1 0.1
Median 0.6 1.0 0.0 0.0
Min, Max 0, 17.5 0, 6.4 0, 0.3 0, 0.7
14 d after infusion n (miss) 42 (1) 42 (1) 42 (1) 42 (1)
Mean 0.6 0.6 0.1 0.1
Median 0.4 0.3 0.0 0.1
Min, Max 0, 4.6 0, 5.5 0, 0.7 0, 0.8
56 d after infusion n (miss) 42 (1) 42 (1) 42 (1) 42 (1)
Mean 2.0 0.5 1.7 0.3
Median 0.4 0.3 0.2 0.2
Min, Max 0, 58.4 0, 2.9 0, 59.0 0, 1.1
91 d after infusion n (miss) 42 (1) 42 (1) 42 (1) 42 (1)
Mean 4.2 1.2 4.1 1.0
Median 0.3 0.3 0.3 0.2
Min, Max 0, 142.4 0, 34.1 0, 142.4 0, 34.1