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Table 3 Summary of treatment-emergent adverse events for the pooled safety population

From: Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials

 

Randomized, Placebo-Controlled Trials

Long-term Safety Trials

Atogepant

 

Atogepant

60 mg once daily

(n = 1228)

Standard Care

(n = 196)

10 mg once daily

(n = 314)

30 mg once daily

(n = 411)

60 mg once daily (n = 417)

Placebo

(n = 408)

Any TEAE, n (%)

178 (56.7)

234 (56.9)

231 (55.4)

218 (53.4)

792 (64.5)

154 (78.6)

Any study drug–related TEAE, n (%)

68 (21.7)

73 (17.8)

87 (20.9)

50 (12.3)

158 (12.9)

71 (36.2)

Any serious TEAE, n (%)

3 (1.0)

2 (0.5)

2 (0.5)

4 (1.0)

47 (3.8)a

7 (3.6)

Any TEAE leading to discontinuation, n (%)

13 (4.1)

14 (3.4)

12 (2.9)

11 (2.7)

53 (4.3)

5 (2.6)

  1. The participants in the standard care arm could have been non-naive to their preventive treatment, could have selected their treatment based on their prior experience, and could switch preventive as needed; therefore, direct comparisons of adverse event rates between standard care and atogepant treatment arms cannot be made
  2. TEAE treatment-emergent adverse event
  3. aNone due to atogepant 
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The Journal of Headache and Pain

ISSN: 1129-2377

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