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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