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. 2019 Jun 5;39(8):957–966. doi: 10.1177/0333102419855080

Table 5.

Summary of TEAEs that occurred in 2% or more of patients in any lasmiditan dose group and more frequently with lasmiditan than placebo (p < 0.05).

Placebo (n = 1262) Lasmiditan 50 mg (n = 654) Lasmiditan 100 mg (n = 1265) Lasmiditan 200 mg (n = 1258) Lasmiditan pooled doses (n = 3177)
Dizziness 37 (2.9) 56 (8.6)a 194 (15.3)a,b 216 (17.2)a,b 466 (14.7)a
OR vs. placebo 3.7 6.0 6.9 5.7
Paresthesia 19 (1.5) 16 (2.4)a 73 (5.8)a,b 91 (7.2)a,b 180 (5.7)a
OR vs. placebo 2.7 4.0 5.1 4.1
Somnolence 27 (2.1) 35 (5.4)a 65 (5.1)a 75 (6.0)a 175 (5.5)a
OR vs. placebo 2.7 2.5 2.9 2.7
Fatigue 8 (0.6) 18 (2.8)a 52 (4.1)a 50 (4.0)a 120 (3.8)a
OR vs. placebo 3.0 6.7 6.5 6.0
Nausea 20 (1.6) 18 (2.8) 52 (4.1)a 50 (4.0)a 107 (3.4)a
OR vs. placebo 2.3 (ns) 2.0 2.5 2.3
Muscular weakness 0 7 (1.1)a 16 (1.3)a 19 (1.5)a 42 (1.3)a
OR vs. placebo na na na na
Hypoesthesia 3 (0.2) 2 (0.3) 17 (1.3)a,b 20 (1.6)a 39 (1.2)a
OR vs. placebo 1.0 (ns) 5.7 6.8 5.3

Number of patients (%) reported. OR: odds ratio point estimate; vs: versus; na: not applicable.

a

Significant difference vs. placebo (p < 0.05).

b

Significant difference vs. lasmiditan 50 mg (p < 0.05).

No significant differences between lasmiditan 100 mg vs. 200 mg.