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

Table 3. TEAEs following single administration of HLX01 or reference rituximaba (phase 1b study) .

TEAEb n (%)
HLX01 (N=43) Reference rituximab (N=43)
TEAE, treatment-emergent adverse event; ADR, adverse drug reaction; SAE, serious adverse event; WBC, white blood cell; a, The reference rituximab was sourced from China (MabThera®; rituximab-CN); b, Excluding infusion-related reactions; c, This includes events of chills, pyrexia and upper respiratory infection that started during the single dose phase; d, Where possible causal relationship to drug, device or administration.
Patients with ≥1 TEAEc 24 (55.8) 29 (67.4)
 Patients with ADRd 14 (32.6) 21 (48.8)
 Patients with significant TEAE 12 (27.9) 16 (37.2)
 Patients with SAE 0 0
 Patient death due to TEAE 0 0
 Patient discontinuation due to TEAE 0 1 (2.3)
Grade Grade 1 Grade 2 Grade 3 Grade 1 Grade 2 Grade 3
 Patients with ≥1 TEAE 14 (32.6) 10 (23.3) 0 15 (34.9) 12 (28.0) 2 (4.7)
TEAEs ≥2 events by preferred term
 Urinary tract infection 2 (4.7) 0 0 1 (2.3) 0 0
 Upper respiratory tract infection 0 2 (4.7) 0 1 (2.3) 3 (7.0) 0
 WBC decreased 1 (2.3) 4 (9.3) 0 1 (2.3) 1 (2.3) 1 (2.3)
 Neutrophil count decreased 1 (2.3) 4 (9.3) 0 1 (2.3) 2 (4.7) 0
 Blood immunoglobulin M decreased 0 0 0 2 (4.7) 0 0
 Blood glucose increased 0 0 0 2 (4.7) 0 0
 Arthralgia 1 (2.3) 2 (4.7) 0 0 0 0
 Pruritus 3 (7.0) 0 0 3 (7.0) 0 0
 Headache 0 0 0 2 (4.7) 0 0
 Cough 2 (4.7) 0 0 0 2 (4.7) 0
 Nausea 3 (7.0) 0 0 0 0 0
 Rash 1 (2.3) 0 0 4 (9.3) 3 (7.0) 0
 Dry mouth 1 (2.3) 0 0 2 (4.7) 0 0