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Table 3 Summary of adverse events related to injection-site reaction (≥2%) in pooled EVOLVE-1, EVOLVE-2 and REGAIN (placebo-controlled analysis set)

From: Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase 3 studies in participants with migraine

 IS painUnspecified ISRIS erythemaIS 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 (%)
 Mild79 (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)
 Moderate41 (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)02 (0.3)6 (0.8)
 Severe18 (1.2)9 (1.3)6 (0.8)002 (0.3)02 (0.3)3 (0.4)03 (0.4)6 (0.8)
SAE of ISR, n (%)0000000000 0
aDiscontinued due to ISR, n (%)001 (0.1)01 (0.1)3 (0.4)01 (0.1)0000
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)
  1. 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
  2. aone galcanezumab 240 mg participant discontinued due to injection-site swelling
  3. 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