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

From: Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials

 

Eptinezumab

Placebo

Patients, n (%)

1000 mga

(n = 81)

300 mgb

(n = 823)

100 mgb

(n = 701)

30 mgb

(n = 341)

10 mgc

(n = 130)

All

(N = 2076)

(N = 791)

Any TEAE

46 (56.8)

467 (56.7)

366 (52.2)

184 (54.0)

74 (56.9)

1137 (54.8)

414 (52.3)

Any study-drug–related TEAEd

16 (19.8)

124 (15.1)

92 (13.1)

42 (12.3)

21 (16.2)

295 (14.2)

74 (9.4)

Any serious TEAE

2 (2.5)

17 (2.1)

11 (1.6)

4 (1.2)

1 (0.8)

35 (1.7)

11 (1.4)

Any TEAE leading to study drug discontinuation

0

19 (2.3)

9 (1.3)

12 (3.5)

0

40 (1.9)

8 (1.0)

Any TEAE leading to interruption of study-drug infusion

0

19 (2.3)

11 (1.6)

10 (2.9)

0

40 (1.9)

6 (0.8)

  1. a Single dose study with follow-up for 24 weeks (NCT01772524)
  2. b Single- and multiple-dose studies (NCT02275117, PROMISE-1, PROMISE-2, and PREVAIL) with follow-up ranging from 32 to 56 weeks
  3. c Single-dose study with follow-up for 49 weeks (NCT02275117)
  4. d Relatedness determined by investigator