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Table 4 Occurrence of AEs with teriflunomide 14 mga (core and extension period)

From: Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis

  Treatment naive (n = 1018) Previously treated with another DMT (n = 163) Recently treated with another DMT (n = 158) Overall population (N = 1696)b
Patients with any AE, n (%) 918 (90.2) 157 (96.3) 145 (91.8) 1503 (88.6)
Patients with any SAE, n (%) 196 (19.3) 40 (24.5) 34 (21.5) 312 (18.4)
Patients with any AE leading to death, n (%) 7 (0.7) 0 0 10 (0.6)
Patients with any AE leading to permanent treatment discontinuation, n (%) 155 (15.2) 33 (20.2) 31 (19.6) 244 (14.4)
AEs with incidence > 10% in any prior DMT subgroup, n (%)
 Nasopharyngitis 249 (24.5) 47 (28.8) 36 (22.8) 391 (23.1)
 ALT increase 185 (18.2) 25 (15.3) 18 (11.4) 246 (14.5)
 Headache 185 (18.2) 32 (19.6) 40 (25.3) 296 (17.5)
 Diarrhea 178 (17.5) 41 (25.2) 35 (22.2) 284 (16.7)
 Hair thinning (alopecia) 157 (15.4) 28 (17.2) 25 (15.8) 226 (13.3)
 Back pain 148 (14.5) 34 (20.9) 21 (13.3) 231 (13.6)
 Fatigue 136 (13.4) 26 (16.0) 25 (15.8) 203 (12.0)
 Influenza 133 (13.1) 26 (16.0) 17 (10.8) 200 (11.8)
 Nausea 121 (11.9) 26 (16.0) 21 (13.3) 184 (10.8)
 Pain in extremity 121 (11.9) 24 (14.7) 14 (8.9) 181 (10.7)
 Upper respiratory tract infection 121 (11.9) 31 (19.0) 23 (14.6) 202 (11.9)
 Urinary tract infection 113 (11.1) 29 (17.8) 21 (13.3) 197 (11.6)
 Paresthesia 102 (10.0) 24 (14.7) 15 (9.5) 157 (9.3)
 Hypoesthesia 99 (9.7) 22 (13.5) 14 (8.9) 148 (8.7)
 Hypertension 94 (9.2) 18 (11.0) 21 (13.3) 157 (9.3)
 Arthralgia 93 (9.1) 22 (13.5) 14 (8.9) 147 (8.7)
 Bronchitis 78 (7.7) 18 (11.0) 15 (9.5) 126 (7.4)
 Sinusitis 68 (6.7) 24 (14.7) 16 (10.1) 126 (7.4)
 Fall 67 (6.6) 20 (12.3) 17 (10.8) 120 (7.1)
 Abdominal pain, upper 60 (5.9) 10 (6.1) 19 (12.0) 98 (5.8)
 Insomnia 56 (5.5) 20 (12.3) 12 (7.6) 94 (5.5)
 Gastroenteritis 50 (4.9) 18 (11.0) 13 (8.2) 94 (5.5)
  1. aData are reported for AEs occurring after patients started teriflunomide 14 mg; bIncludes an additional cohort of 357 patients from the TOWER and TENERE studies who switched from teriflunomide 7 mg to 14 mg in the extension period; AE adverse event, ALT alanine aminotransferase, DMT disease-modifying therapy, SAE serious adverse event
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