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

Table 3 Overview of adverse events

	Integrated double-blind studies									All 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/TPY	EAIR (95% CI)	%	n/TPY	EAIR (95% CI)	%	n/TPY	EAIR (95% CI)	%	n/TPY	EAIR (95% CI)	%	n/TPY	EAIR (95% CI)
Deaths		0			0			0			0			0
SAEs^a	1.0	14/530.37	2.64 (1.44,4.43)	1.7	12/264.47	4.54 (2.34,7.93)	1.5	11/266.95	4.12 (2.06,7.37)	2.8	26/521.05	4.99 (3.26,7.31)	3.0	40/876.06	4.57 (3.26,6.22)
DCAEs	1.7	24/530.08	4.53 (2.90,6.74)	1.8	13/266.26	4.88 (2.60,8.35)	3.0	22/266.50	8.26 (5.17,12.50)	4.0	37/524.43	7.06 (4.97,9.72)	3.9	52/882.74	5.89 (4.40,7.72)
TEAEs^a	57	827/295.25	280.10 (261.34,299.86)	62.6	441/145.16	303.80 (276.10,333.52)	64.7	472/133.62	353.25 (322.10,386.61)	68.8	664/228.62	290.44 (268.77,313.40)	74.4	897/308.13	291.11 (272.37,310.80)

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
^a In ≥1 patient

ISSN: 1471-2377