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Table 2 Summary of adverse events 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

  Sirukumab 50 mg q4w (N = 61) Sirukumab 100 mg q2w (N = 61) All (N = 122)
AEs 56 (91.8) 58 (95.1) 114 (93.4)
Serious AEs 4 (6.6) 5 (8.2) 9 (7.4)
AEs in ≥ 10% patients
Infections and infestations 39 (63.9) 38 (62.3) 77 (63.1)
 Nasopharyngitis 27 (44.3) 27 (44.3) 54 (44.3)
 Pharyngitis 6 (9.8) 7 (11.5) 13 (10.7)
General disorders and administration site conditions 26 (42.6) 27 (44.3) 53 (43.4)
 Injection-site erythema 19 (31.1) 20 (32.8) 39 (32.0)
 Injection-site swelling 10 (16.4) 12 (19.7) 22 (18.0)
 Injection-site pruritus 7 (11.5) 13 (21.3) 20 (16.4)
Investigations 28 (45.9) 21 (34.4) 49 (40.2)
 Alanine aminotransferase increased 10 (16.4) 10 (16.4) 20 (16.4)
 Aspartate aminotransferase increased 9 (14.8) 11 (18.0) 20 (16.4)
 White blood cell count decreased 7 (11.5) 7 (11.5) 14 (11.5)
 Platelet count decreased 9 (14.8) 3 (4.9) 12 (9.8)
 Neutrophil count decreased 7 (11.5) 4 (6.6) 11 (9.0)
Skin and subcutaneous tissue disorders 15 (24.6) 25 (41.0) 40 (32.8)
 Eczema 7 (11.5) 7 (11.5) 14 (11.5)
Vascular disorders 5 (8.2) 7 (11.5) 12 (9.8)
 Hypertension 5 (8.2) 7 (11.5) 12 (9.8)
Serious AEs
Infections and infestations 1 (1.6) 2 (3.3) 3 (2.5)
 Acute sinusitis 0 1 (1.6) 1 (0.8)
 Hepatitis E 0 1 (1.6) 1 (0.8)
 Osteomyelitis 1 (1.6) 0 1 (0.8)
Gastrointestinal disorders 1 (1.6) 1 (1.6) 2 (1.6)
 Gastroesophageal reflux disease 0 1 (1.6) 1 (0.8)
 Large intestine polyp 1 (1.6) 0 1 (0.8)
Injury, poisoning and procedural complications
 Comminuted fracture 1 (1.6) 0 1 (0.8)
Musculoskeletal and connective tissue disorders
 Intervertebral disc protrusion 0 1 (1.6) 1 (0.8)
Neoplasms benign, malignant and unspecified
 Borderline serous tumor of ovary 0 1 (1.6) 1 (0.8)
Psychiatric disorders
 Schizophrenia 1 (1.6) 0 1 (0.8)
Reproductive system and breast disorders
 Endometriosis 0 1 (1.6) 1 (0.8)
  1. Data presented as n (%)
  2. AE adverse event, q2w once in 2 weeks, q4w once in 4 weeks