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Table 6 Treatment-emergent adverse events occurred at similar rates in patients using and not using migraine preventive treatments

From: Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials

TEAE

Lasmiditan dose (mg)

Using preventives

Not using preventives

n/N (%)

n/N (%)

Dizziness

PBO

6/231 (2.6)

31/1031 (3.0)

All LTN

81/544 (14.9)

385/2633 (14.6)

Paresthesia

PBO

2/231 (0.9)

17/1031 (1.6)

All LTN

44/544 (8.1)

136/2633 (5.2)

Somnolence

PBO

5/231 (2.2)

22/1031 (2.1)

All LTN

22/544 (4.0)

153/2633 (5.8)

Fatigue

PBO

2/231 (0.9)

6/1031 (0.6)

All LTN

16/544 (2.9)

104/2633 (3.9)

Nausea

PBO

3/231 (1.3)

17/1031 (1.6)

All LTN

21/544 (3.9)

86/2633 (3.3)

Muscular Weakness

PBO

0/231 (0.0)

0/1031 (0.0)

All LTN

3/544 (0.6)

39/2633 (1.5)

Hypoesthesia

PBO

1/231 (0.4)

2/1031 (0.2)

All LTN

3/544 (0.6)

36/2633 (1.4)

  1. N number of patients in the subgroup of safety population, n number of patients with TEAE, TEAE treatment-emergent adverse event, All LTN, pooled population receiving lasmiditan (LTN) 50 mg, 100 mg, or 200 mg LTN
  2. Treatment-by-subgroup interaction did not indicate any statistically significant interaction for any TEAE (all interaction p-values > 0.1)