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Table 4 Time to onset of injection-site reactions 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

 nAllImmediate response (< 60 min)Acute reaction (1 to 6 h)Delayed reaction (6 to 14 h)Reaction > 14 daysTotal on day of injectionTotal after day of injection
On day of injectionAfter day of injection
IS pain, n (%)Placebo1451134 (9.2)130 (97.0)0 (0.0)3 (2.2)1 (0.7)0 (0.0)133 (99.3)1 (0.7)
GMB 120 mg70570 (9.9)62 (88.6)3 (4.3)1 (1.4)3 (4.3)1 (1.4)66 (94.3)4 (5.7)
GMB 240 mg73084 (11.5)71 (84.5)3 (3.6)6 (7.1)3 (3.6)1 (1.2)80 (95.2)4 (4.8)
Unspecified ISR, n (%)Placebo145114 (1.0)13 (92.9)1 (7.1)0 (0.0)0 (0.0)0 (0.0)14 (100.0)0 (0.0)
GMB 120 mg70522 (3.1)8 (36.4)5 (22.7)5 (22.7)4 (18.2)0 (0.0)18 (81.8)4 (18.2)
GMB 240 mg73044 (6.0)13 (29.5)14 (31.8)13 (29.5)4 (9.1)0 (0.0)40 (90.9)4 (9.1)
IS erythema, n (%)Placebo145120 (1.4)18 (90.0)1 (5.0)0 (0.0)1 (5.0)0 (0.0)19 (95.0)1 (5.0)
GMB 120 mg70520 (2.8)7 (35.0)5 (25.0)4 (20.0)4 (20.0)0 (0.0)16 (80.0)4 (20.0)
GMB 240 mg73028 (3.8)7 (25.0)11 (39.3)4 (14.3)6 (21.4)0 (0.0)22 (78.6)6 (21.4)
IS pruritus, n (%)Placebo14512 (0.1)2 (100.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)2 (100.0)0 (0.0)
GMB 120 mg70515 (2.1)3 (20.0)3 (20.0)6 (40.0)3 (20.0)0 (0.0)12 (80.0)3 (20.0)
GMB 240 mg73024 (3.3)2 (8.3)10 (41.7)5 (20.8)7 (29.2)0 (0.0)17 (70.8)7 (29.2)
  1. Abbreviations:GMB galcanezumab, IS injection-site, ISR injection-site reaction, n number of patients with non-missing reaction timings
  2. Note: All values are for 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