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Table 3 Overview of adverse events

From: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

 Integrated double-blind studiesAll galcanezumab exposures
Placebo
N = 1451
GMB 120 mg
N = 705
GMB 240 mg
N = 730
GMB 120 mg
N = 926
GMB 240 mg
N = 1350
%n/TPYEAIR (95% CI)%n/TPYEAIR (95% CI)%n/TPYEAIR (95% CI)%n/TPYEAIR (95% CI)%n/TPYEAIR (95% CI)
Deaths 0  0  0  0  0 
SAEsa1.014/530.372.64 (1.44,4.43)1.712/264.474.54 (2.34,7.93)1.511/266.954.12 (2.06,7.37)2.826/521.054.99 (3.26,7.31)3.040/876.064.57 (3.26,6.22)
DCAEs1.724/530.084.53 (2.90,6.74)1.813/266.264.88 (2.60,8.35)3.022/266.508.26 (5.17,12.50)4.037/524.437.06 (4.97,9.72)3.952/882.745.89 (4.40,7.72)
TEAEsa57827/295.25280.10 (261.34,299.86)62.6441/145.16303.80 (276.10,333.52)64.7472/133.62353.25 (322.10,386.61)68.8664/228.62290.44 (268.77,313.40)74.4897/308.13291.11 (272.37,310.80)
  1. Abbreviations: CI Confidence interval, DCAEs Adverse events leading to discontinuation, EAIR Time-at-risk incidence rate, GMB Galcanezumab, N Number of patients in the analysis population, n Number of patients in specific category, SAEs Serious adverse events, TEAEs Treatment-emergent adverse events, TPY Total patient-year-at-risk
  2. a In ≥1 patient