Table 3.

Summary of adverse events related to injection-site reaction (≥2%) in pooled EVOLVE-1, EVOLVE-2 and REGAIN (placebo-controlled analysis set)

	IS pain			Unspecified ISR			IS erythema			IS pruritus
	Placebo (N = 1451)	GMB 120 mg (N = 705)	GMB 240 mg (N = 730)	Placebo (N = 1451)	GMB 120 mg (N = 705)	GMB 240 mg (N = 730)	Placebo (N = 1451)	GMB 120 mg (N = 705)	GMB 240 mg (N = 730)	Placebo (N = 1451)	GMB 120 mg (N = 705)	GMB 240 mg (N = 730)
Participants with ≥2% TEAE, n (%)	138 (9.5)	71 (10.1)	85 (11.6)	14 (1.0)	22 (3.1)	45 (6.2)	20 (1.4)	20 (2.8)	29 (4.0)	2 (0.1)	15 (2.1)	24 (3.3)
Maximum severity of ISRs n (%)
Mild	79 (5.4)	41 (5.8)	50 (6.9)	8 (0.6)	8 (1.1)	23 (3.2)	11 (0.8)	13 (1.8)	21 (2.9)	2 (0.14)	10 (1.4)	12 (1.6)
Moderate	41 (2.8)	21 (3.0)	29 (4.0)	6 (0.4)	14 (2.0)	20 (2.7)	9 (0.6)	5 (0.7)	5 (0.7)	0	2 (0.3)	6 (0.8)
Severe	18 (1.2)	9 (1.3)	6 (0.8)	0	0	2 (0.3)	0	2 (0.3)	3 (0.4)	0	3 (0.4)	6 (0.8)
SAE of ISR, n (%)	0	0	0	0	0	0	0	0	0	0		0
aDiscontinued due to ISR, n (%)	0	0	1 (0.1)	0	1 (0.1)	3 (0.4)	0	1 (0.1)	0	0	0	0
Median duration of ISR event, days (SD)	1.6 (8.4)	1.2 (1.0)	1.5 (2.7)	1.2 (0.8)	5.3 (9.3)	3.7 (3.9)	3.8 (16.0)	6.5 (9.4)	4.6 (5.6)	1.0 (0.00)	6.1 (7.5)	6.2 (7.2)

Abbreviations:AE adverse events, GMB galcanezumab, IS injection-site, ISR injection-site reaction, N number of participants in the safety population, n number of participants within each specific category, SAE serious adverse event, SD standard deviation, TEAE treatment-emergent adverse event

^aone galcanezumab 240 mg participant discontinued due to injection-site swelling

Note: All values include AEs related to ISR during the double-blind treatment phase from study start up to 6 months for EVOLVE-1, and EVOLVE-2 and up to 3 months for REGAIN