Skip to main content

Advertisement

Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

Table 3 Summary of safety events related to blood parameters and hematology: shift from CTCAE grade 0 at baseline through week 52 (safety analysis set)

From: Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients

Parameter Total (N) Grade 0 at baseline Grade 0 Grade 1 Grade 2 Grade 3 Grade 4
Neutrophils decreased
 Sirukumab 50 mg q4w 61 61 (100.0) 33 (54.1) 17 (27.9) 8 (13.1) 3 (4.9) 0
 Sirukumab 100 mg q2w 61 61 (100.0) 34 (55.7) 14 (23.0) 11 (18.0) 2 (3.3) 0
Platelets decreased
 Sirukumab 50 mg q4w 61 61 (100.0) 44 (72.1) 17 (27.9) 0 0 0
 Sirukumab 100 mg q2w 61 61 (100.0) 54 (88.5) 6 (9.8) 0 0 1 (1.6)a
Leukocytes decreased
 Sirukumab 50 mg q4w 61 61 (100.0) 34 (55.7) 21 (34.4) 6 (9.8) 0 0
 Sirukumab 100 mg q2w 61 61 (100.0) 42 (68.9) 11 (18.0) 6 (9.8) 2 (3.3) 0
Lymphocytes decreased
 Sirukumab 50 mg q4w 61 58 (95.1) 51 (83.6) 3 (4.9) 4 (6.6) 0 0
 Sirukumab 100 mg q2w 61 58 (95.1) 50 (82.0) 1 (1.6) 7 (11.5) 0 0
Alanine aminotransferase increased
 Sirukumab 50 mg q4w 61 58 (95.1) 30 (49.2) 26 (42.6) 2(3.3) 0 0
 Sirukumab 100 mg q2w 61 56 (91.8) 31 (50.8) 24 (39.3) 1 (1.6) 0 0
Aspartate aminotransferase increased
 Sirukumab 50 mg q4w 61 59 (96.7) 33 (54.1) 25 (41.0) 1 (1.6) 0 0
 Sirukumab 100 mg q2w 61 55 (90.2) 32 (52.5) 23 (37.7) 0 0 0
Bilirubin increased
 Sirukumab 50 mg q4w 61 61 (100.0) 48 (78.7) 10 (16.4) 3 (4.9) 0 0
 Sirukumab 100 mg q2w 61 61 (100.0) 47 (77.0) 10 (16.4) 4 (6.6) 0 0
Cholesterol increased
 Sirukumab 50 mg q4w 59 59 (100.0) 51 (83.6) 5 (8.2) 3 (4.9) 0 0
 Sirukumab 100 mg q2w 60 60 (100.0) 54 (88.5) 5 (8.2) 1 (1.6) 0 0
Triglycerides increased
 Sirukumab 50 mg q4w 59 55 (93.2) 34 (55.7) 20 (32.8) 0 1 (1.6) 0
 Sirukumab 100 mg q2w 60 54 (90.0) 33 (54.1) 20 (32.8) 0 1 (1.6) 0
  1. Data presented as n (%) unless stated otherwise
  2. CTCAE Common Terminology Criteria For Adverse Events, q4w once in 4 weeks, q2w once in 2 weeks
  3. aErroneously reported