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Table 2 Summary of adverse events by SCP statusa

From: A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial

Number (percentage), incidence ratio (95% CI)b, unless otherwise indicated +SCP (n = 314) −SCP (n = 422) All patients (n = 736)
Total time at risk (100 PY) 2.44 3.49 5.92
Any TEAEs 259 (82.5), 351.3 (309.8, 396.8) 300 (71.1), 201.9 (179.7, 226.1) 559 (76.0), 251.4 (231.0, 273.2)
TEAEs (≥5% in any SOCc)
 Gastrointestinal disorders 65 (20.7), 31.3 (24.2, 39.9) 73 (17.3), 24.0 (18.8, 30.2) 138 (18.8), 26.9 (22.6, 31.8)
 General disorders and administration site conditions 48 (15.3), 22.5 (16.6, 29.8) 53 (12.6), 17.1 (12.8, 22.3) 101 (13.7), 19.3 (15.7, 23.4)
 Infections and infestations 166 (52.9), 108.6 (92.7, 126.4) 144 (34.1), 56.0 (47.2, 65.9) 310 (42.1), 75.6 (67.4, 84.5)
 Injury, poisoning, and procedural complications 41 (13.1), 18.6 (13.4, 25.3) 34 (8.1), 10.2 (7.1, 14.3) 75 (10.2),13.6 (10.7, 17.0)
 Investigations 39 (12.4), 17.6 (12.5, 24.1) 50 (11.8), 15.8 (11.7, 20.8) 89 (12.1), 16.5 (13.3, 20.4)
 Metabolism and nutrition disorders 21 (6.7), 9.1 (5.6, 13.9) 22 (5.2), 6.6 (4.1, 9.9) 43 (5.8), 7.6 (5.5, 10.2)
 Musculoskeletal and connective tissue disorders 100 (31.8), 52.5 (42.7, 63.9) 80 (19.0), 26.0 (20.6, 32.4) 180 (24.5), 36.2 (31.1, 41.8)
 Nervous system disorders 59 (18.8), 28.5 (21.7, 36.8) 34 (8.1), 10.3 (7.1, 14.3) 93 (12.6), 17.3 (14.0, 21.2)
 Psychiatric disorders 29 (9.2), 12.8 (8.5, 18.3) 10 (2.4), 2.9 (1.4, 5.4) 39 (5.3), 6.9 (4.9, 9.4)
 Respiratory, thoracic, and mediastinal disorders 48 (15.3), 22.4 (16.5, 29.7) 48 (11.4), 14.9 (11.0, 19.8) 96 (13.0), 17.9 (14.5, 21.9)
 Skin and subcutaneous tissue disorders 44 (14.0), 20.1 (14.6, 27.0) 50 (11.8), 15.5 (11.5, 20.5) 94 (12.8), 17.4 (14.0, 21.3)
 Vascular disorders 26 (8.3), 11.4 (7.5, 16.8) 17 (4.0), 5.0 (2.9, 8.0) 43 (5.8), 7.6 (5.5, 10.2)
Serious TEAEs 34 (10.8), 14.8 (10.3, 20.7) 37 (8.8), 10.9 (7.7, 15.0) 71 (9.6), 12.5 (9.8, 15.8)
Serious infections and infestations 12 (3.8), 5.0 (2.6, 8.7) 6 (1.4), 1.7 (0.6, 3.8) 18 (2.4), 3.1 (1.8, 4.8)
Discontinuation due to TEAEsd 34 (10.8), NA 44 (10.4), NA 78 (10.6), NA
Drug-related TEAEs 80 (25.5), NA 93 (22.0), NA 173 (23.5), NA
Severe TEAEs 38 (12.1), NA 38 (9.0), NA 76 (10.3), NA
Deaths (TEAEs leading to death) 1 (0.3), NA 1 (0.2), NA 2 (0.3), NA
  1. Safety set. Medical Dictionary for Regulatory Activities (MedDRA) v15.1
  2. SCP somatization comorbidity phenotype, TEAEs treatment-emergent adverse events, PY patient-years, NA data not available
  3. aCombining the RAPID3 and CDAI arms.
  4. bn: number of subjects reporting at least one TEAE in that category, incidence rates reported per 100 patient-years
  5. cSystem organ class
  6. dThere was one patient in this group reporting a TEAE of pneumonia, who did not discontinue the study drug permanently