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Table 1 Baseline demographics and comorbid conditions in EVOLVE-1, EVOLVE-2 and REGAIN studies

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

 

Placebo (N = 1451)

GMB 120 mg (N = 705)

GMB 240 mg (N = 730)

Demographics

 Age, mean years, (SD)

41.8 (11.6)

40.8 (11.5)

40.4 (11.9)

 Gender (female), n (%)

1237 (85.3)

599 (85.0)

609 (83.4)

 Race, n (%)

  White

1112 (76.6)

545 (77.3)

a555 (76.1)

  Black or African American

117 (8.1)

53 (7.5)

a59 (8.1)

  Asian

89 (6.1)

48 (6.8)

a42 (5.8)

  American Indian or native Alaska

24 (1.7)

10 (1.4)

a16 (2.2)

  Native Hawaiian or other pacific islander

2 (0.1)

0

a4 (0.6)

  Multiple

107 (7.4)

49 (7.0)

a53 (7.3)

 Region, n (%)

  North America

977 (67.3)

472 (67.0)

496 (68.0)

  Europe

262 (18.1)

126 (17.9)

131 (18.0)

  Other

212 (14.6)

107 (15.2)

103 (14.1)

 Years since migraine diagnosis, mean (SD)

21.1 (12.7)

20.7 (12.5)

19.6 (12.3)

Comorbid conditions that occurred in > 10% of all participants, n (%)

 Seasonal allergy

307 (21.2)

158 (22.4)

122 (16.7)

 Drug hypersensitivity

247 (17.0)

123 (17.5)

128 (17.5)

 Insomnia

165 (11.4)

89 (12.6)

78 (10.7)

 Anxiety

166 (11.4)

82 (11.6)

81 (11.1)

 Depression

181 (12.5)

84 (11.9)

79 (10.8)

 Back pain

151 (10.4)

62 (8.8)

75 (10.3)

  1. Abbreviations:GMB galcanezumab, ISR injection-site reaction, N number of participants in the intent-to-treat population, n number of participants within each specific category, SD standard deviation
  2. aN = 729
  3. Note: All values are for injection-site reactions 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