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Table 2 Overall safety and TEAEs of interest (n = 466)*

From: An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis

Variable Number of patients, n (%)
Overall summary of TEAEs
 Any adverse event 297 (63.7)
 Any grade ≥ 3 adverse event 42 (9.0)
 Any adverse event with the outcome of death 0 (0.0)
 Any serious adverse event 46 (9.9)
 Treatment-related serious adverse event 3 (0.6)
 Any adverse event leading to discontinuation of IP 17 (3.6)
 Any adverse event leading to discontinuation from study 8 (1.7)
Most frequent TEAEs by preferred term
 Nasopharyngitis 43 (9.2)
 Upper respiratory tract infection 40 (8.6)
 Bronchitis 30 (6.4)
 Rheumatoid arthritis 29 (6.2)
 Hypertension 22 (4.7)
 Pharyngitis 19 (4.1)
Serious TEAEs
 Musculoskeletal and connective tissue disorders 12 (2.6)
 Infections and infestations 6 (1.3)
 Cardiac disorders 5 (1.1)
 Eye disorders 4 (0.9)
 Gastrointestinal disorders 4 (0.9)
 Neoplasms benign, malignant, and unspecified (including cysts and polyps) 4 (0.9)
 Reproductive system and breast disorders 3 (0.6)
 Vascular disorders 3 (0.6)
 Injury, poisoning, and procedural complications 2 (0.4)
 Nervous system disorders 2 (0.4)
 Surgical and medical procedures 2 (0.4)
 General disorders and administration site conditions 1 (0.2)
 Hepatobiliary disorders 1 (0.2)
 Pregnancy, puerperium, and perinatal conditions 1 (0.2)
 Psychiatric disorders 1 (0.2)
 Respiratory, thoracic, and mediastinal disorders 1 (0.2)
TEAEs of interest
 Infections 190 (40.8)
 Malignancies 8 (1.7)
 Hypersensitivity 20 (4.3)
 Demyelinating diseases 0 (0.0)
 Hematological reactions 5 (1.1)
 Heart failure 0 (0.0)
 Lupus-like syndrome 0 (0.0)
 Liver enzyme elevations 25 (5.4)
 Injection site reactions 0 (0.0)
  1. For each category, patients were included only once even if they had multiple events in that category. AEs were coded using MedDRA V.17.1
  2. AE adverse event, IP investigational product, TEAE treatment-emergent adverse event
  3. *One subject did not receive any IP and was not included in these analyses