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Table 2 Summary of safety data up to 288 weeks of observation in 486 patients

From: Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study

Variable Number (%)
All AEs 476 (97.9)
Serious AEs 139 (28.6)
Discontinuations due to AEs 118 (24.3)
Discontinuations due to serious AEs 75 (15.4)
Dose reduction or temporary discontinuation due to AEs 261 (53.7)
Infections and infestations  
 Nasopharyngitis 293 (60.3)
 Herpes zoster 94 (19.3)
 Bronchitis 51 (10.5)
 Upper respiratory tract infection 48 (9.9)
 Influenza 48 (9.9)
 Cystitis 46 (9.5)
 Pharyngitis 46 (9.5)
 Gastroenteritis 46 (9.5)
 Tinea pedis 34 (7.0)
 Oral herpes 33 (6.8)
Injury, poisoning or procedural complications  
 Fall 71 (14.6)
 Contusion 49 (10.1)
Metabolism and nutrition disorders  
 Hyperlipidaemia 56 (11.5)
Vascular disorders  
 Hypertension 55 (11.3)
Gastrointestinal disorders  
 Dental caries 54 (11.1)
 Constipation 43 (8.8)
 Diarrhoea 33 (6.8)
 Stomatitis 32 (6.6)
 Gastritis 26 (5.3)
Nervous system disorders  
 Headache 48 (9.9)
Musculoskeletal and connective tissue disorders  
 Back pain 46 (9.5)
Investigations  
 Lymphocyte count decreased 38 (7.8)
 White blood cell count decreased 27 (5.6)
 Alanine aminotransferase increased 27 (5.6)
Respiratory, thoracic and mediastinal disorders  
 Upper respiratory tract inflammation 34 (7.0)
 Cough 33 (6.8)
Skin and subcutaneous tissue disorders  
 Eczema 27 (5.6)
Blood and lymphatic system disorders  
 Anaemia 26 (5.3)
  1. Treatment-emergent adverse events (AEs) affecting ≥5 % of patients in the total population (all causalities) according to Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and MedDRA (v16.1) preferred term. Data are number (%)