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 |