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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 years269 (18.5)139 (19.7)158 (21.6)
 ≥ 30 and < 40 years342 (23.6)182 (25.8)194 (26.6)
 ≥ 40 and < 50 years435 (30.0)199 (28.2)192 (26.3)
 ≥ 50 years405 (27.9)185 (26.2)186 (25.5)
Sex
 Male214 (14.8)106 (15.0)121 (16.6)
 Female1237 (85.3)599 (85.0)609 (83.4)
Race
 American Indian or Alaska Native24 (1.7)10 (1.4)16 (2.2)
 Asian89 (6.1)48 (6.8)42 (5.8)
 Black or African American117 (8.1)53 (7.5)59 (8.1)
 Native Hawaiian, Other Pacific Islander2 (0.1)0 (0.0)4 (0.6)
 White1112 (76.6)545 (77.3)555 (76.1)
 Multiple107 (7.4)49 (7.0)53 (7.3)
Ethnicity
 Hispanic or Latino298 (20.5)149 (21.1)170 (23.3)
 Not Hispanic or Latino1077 (74.2)522 (74.0)530 (72.6)
Region
 North America977 (67.3)472 (67.0)496 (68.0)
 Europe262 (18.1)126 (17.9)131 (18.0)
 Other212 (14.6)107 (15.2)103 (14.1)
Comorbid conditions occurring in > 10% of any dose-group
 Seasonal allergy307 (21.2)158 (22.4)122 (16.7)a
 Drug hypersensitivity247 (17.0)123 (17.5)128 (17.5)
 Insomnia165 (11.4)89 (12.6)78 (10.7)
 Anxiety166 (11.4)82 (11.6)81 (11.1)
 Depression181 (12.5)84 (11.9)79 (10.8)
 Back pain151 (10.4)62 (8.8)75 (10.3)
Cardiovascular disease risk groupb
 Yes269 (18.5)123 (17.5)124 (17.0)
 No1182 (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