Skip to main content

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
Back to article page

Arthritis Research & Therapy

ISSN: 1478-6362

Contact us