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Table 2 Baseline patient demographics and disease characteristics of the integrated double-blind studies

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

  

Galcanezumab

Placebo

N = 1451

n (%)

120 mg

N = 705

n (%)

240 mg

N = 730

n (%)

Age

 < 30 years

269 (18.5)

139 (19.7)

158 (21.6)

 ≥ 30 and < 40 years

342 (23.6)

182 (25.8)

194 (26.6)

 ≥ 40 and < 50 years

435 (30.0)

199 (28.2)

192 (26.3)

 ≥ 50 years

405 (27.9)

185 (26.2)

186 (25.5)

Sex

 Male

214 (14.8)

106 (15.0)

121 (16.6)

 Female

1237 (85.3)

599 (85.0)

609 (83.4)

Race

 American Indian or Alaska Native

24 (1.7)

10 (1.4)

16 (2.2)

 Asian

89 (6.1)

48 (6.8)

42 (5.8)

 Black or African American

117 (8.1)

53 (7.5)

59 (8.1)

 Native Hawaiian, Other Pacific Islander

2 (0.1)

0 (0.0)

4 (0.6)

 White

1112 (76.6)

545 (77.3)

555 (76.1)

 Multiple

107 (7.4)

49 (7.0)

53 (7.3)

Ethnicity

 Hispanic or Latino

298 (20.5)

149 (21.1)

170 (23.3)

 Not Hispanic or Latino

1077 (74.2)

522 (74.0)

530 (72.6)

Region

 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)

Comorbid conditions occurring in > 10% of any dose-group

 Seasonal allergy

307 (21.2)

158 (22.4)

122 (16.7)a

 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)

Cardiovascular disease risk groupb

 Yes

269 (18.5)

123 (17.5)

124 (17.0)

 No

1182 (81.5)

582 (82.6)

606 (83.0)

  1. Abbreviations: MedDRA Medical Dictionary for Regulatory Activities, N Number of patients in the analysis population with non-missing demographic measures, n Number of patients within each specific category
  2. aIndicates a statistically significant difference (P < 0.05) compared with placebo
  3. bThe following were standardized MedDRA® (certified terminology, and the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) queries used to identify patients in the “yes” subgroup if patients affirmed one or more of the following as pre-existing or in their medical history: Ischaemic heart disease (including myocardial infarction, and other ischaemic heart disease), Hypertension, Cardiac failure, Cardiomyopathy, Ischaemic central nervous system vascular conditions, Dyslipidaemia and Hyperglycaemia/new onset diabetes mellitus