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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 TEAE199 (99·5)204 (99·0)
Patients with ≥1 SAE68 (34·0)67 (32·5)
Patients with ≥1 AE leading to treatment discontinuation14 (7)9 (4·4)
Patients deaths due to AE5 (2·5)3 (1·5)
Adverse events with an incidence ≥10%
 Hematological
  Decreased white blood cell count171 (85·5)177 (85·9)
  Decreased neutrophil count158 (79·0)168 (81·6)
  Anemia77 (38·5)72 (35·0)
  Decreased platelet count34 (17·0)19 (9·2)
  Decreased lymphocyte count24 (12·0)34 (16·5)
  Decreased hemoglobin concentration23 (11·5)20 (9·7)
 Non-hematological
  Nausea46 (23·0)49 (23·8)
  Increased alanine aminotransferase49 (24·5)38 (18·4)
  Fever47 (23·5)34 (16·5)
  Decreased appetite32 (16·0)42 (20·4)
  Increased lactate dehydrogenase30 (15·0)40 (19·4)
  Debilitation38 (19·0)31 (15·0)
  Alopecia35 (17·5)34 (16·5)
  Increased aspartate aminotransferase34 (17·0)30 (14·6)
  Cough31 (15·5)26 (12·6)
  Vomiting22 (11·0)30 (14·6)
  Upper respiratory tract infection19 (9·5)29 (14·1)
  Hypokalemia28 (14·0)17 (8·3)
  Constipation27 (13·5)25 (12·1)
  Non-infectious pneumonia19 (9·5)24 (11·7)
  Pulmonary infection19 (9·5)24 (11·7)
  Diarrhea16 (8·0)22 (10·7)
  Chills20 (10·0)14 (6·8)
 Adverse events by CTCAE Grade
  Grade 18 (4·0)6 (2·9)
  Grade 235 (17·5)35 (17·0)
  Grade 354 (27·0)75 (36·4)
  Grade 498 (49·0)85 (41·3)
  Grade 54 (2·0)3 (1·5)
 Grade 4 adverse events with an incidence ≥2·5%
  Decreased neutrophil count85 (42·5)75 (36·4)
  Decreased white blood cell count44 (22·0)42 (20·4)
  Febrile neutropenia5 (2·5)6 (2·9)
  Bone marrow failure5 (2·5)5 (2·4)
  1. Data are n (%). Percentage values may not total 100% because of rounding