Table 2 Safety profiles in the safety analysis dataset
From: A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma
H-CHOP (n = 200) | R-CHOP (n = 206) | |
|---|---|---|
Patients with ≥1 TEAE | 199 (99·5) | 204 (99·0) |
Patients with ≥1 SAE | 68 (34·0) | 67 (32·5) |
Patients with ≥1 AE leading to treatment discontinuation | 14 (7) | 9 (4·4) |
Patients deaths due to AE | 5 (2·5) | 3 (1·5) |
Adverse events with an incidence ≥10% | ||
Hematological | ||
Decreased white blood cell count | 171 (85·5) | 177 (85·9) |
Decreased neutrophil count | 158 (79·0) | 168 (81·6) |
Anemia | 77 (38·5) | 72 (35·0) |
Decreased platelet count | 34 (17·0) | 19 (9·2) |
Decreased lymphocyte count | 24 (12·0) | 34 (16·5) |
Decreased hemoglobin concentration | 23 (11·5) | 20 (9·7) |
Non-hematological | ||
Nausea | 46 (23·0) | 49 (23·8) |
Increased alanine aminotransferase | 49 (24·5) | 38 (18·4) |
Fever | 47 (23·5) | 34 (16·5) |
Decreased appetite | 32 (16·0) | 42 (20·4) |
Increased lactate dehydrogenase | 30 (15·0) | 40 (19·4) |
Debilitation | 38 (19·0) | 31 (15·0) |
Alopecia | 35 (17·5) | 34 (16·5) |
Increased aspartate aminotransferase | 34 (17·0) | 30 (14·6) |
Cough | 31 (15·5) | 26 (12·6) |
Vomiting | 22 (11·0) | 30 (14·6) |
Upper respiratory tract infection | 19 (9·5) | 29 (14·1) |
Hypokalemia | 28 (14·0) | 17 (8·3) |
Constipation | 27 (13·5) | 25 (12·1) |
Non-infectious pneumonia | 19 (9·5) | 24 (11·7) |
Pulmonary infection | 19 (9·5) | 24 (11·7) |
Diarrhea | 16 (8·0) | 22 (10·7) |
Chills | 20 (10·0) | 14 (6·8) |
Adverse events by CTCAE Grade | ||
Grade 1 | 8 (4·0) | 6 (2·9) |
Grade 2 | 35 (17·5) | 35 (17·0) |
Grade 3 | 54 (27·0) | 75 (36·4) |
Grade 4 | 98 (49·0) | 85 (41·3) |
Grade 5 | 4 (2·0) | 3 (1·5) |
Grade 4 adverse events with an incidence ≥2·5% | ||
Decreased neutrophil count | 85 (42·5) | 75 (36·4) |
Decreased white blood cell count | 44 (22·0) | 42 (20·4) |
Febrile neutropenia | 5 (2·5) | 6 (2·9) |
Bone marrow failure | 5 (2·5) | 5 (2·4) |