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Table 7 Percentage of patients in integrated double-blind studies who experienced a hypersensitivity eventa,b

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 (%)
Hypersensitivity SMQ40 (2.8)36 (5.1)c33 (4.5)
 Rash17 (1.2)8 (1.3)10 (1.4)
 Injection site rash2 (0.1)6 (0.9)c4 (0.6)
 Dermatitis contact4 (0.3)3 (0.4)4 (0.6)
 Rhinitis allergic3 (0.2)3 (0.4)4 (0.6)
 Hypersensitivity0 (0.0)3 (0.4)c2 (0.3)c
 Injection site hypersensitivity0 (0.0)1 (0.1)3 (0.4)c
 Dermatitis allergic0 (0.0)3 (0.4)c0 (0.0)
 Eczema3 (0.2)1 (0.1)2 (0.3)
 Rash pruritic0 (0.0)2 (0.3)c1 (0.1)
 Urticaria5 (0.3)2 (0.3)1 (0.1)
 Injection site urticaria1 (0.1)1 (0.1)1 (0.1)
 Rash generalized1 (0.1)1 (0.1)1 (0.1)
 Rash papulosquamous0 (0.0)1 (0.1)1(0.1)
 Dermatitis atopic1 (0.1)0 (0.0)1(0.1)
 Eye allergy0 (0.0)1 (0.1)0 (0.0)
 Pruritus allergic0 (0.0)1 (0.1)0 (0.0)
 Rash erythematous1 (0.1)0 (0.0)1 (0.1)
 Rash maculo-papular1 (0.1)1 (0.1)0 (0.0)
 Bronchospasm1 (0.1)0 (0.0)0 (0.0)
 Conjunctivitis allergic1 (0.1)0 (0.0)0 (0.0)
 Drug hypersensitivity1 (0.1)0 (0.0)0 (0.0)
  1. Abbreviations: MedDRA Medical Dictionary for Regulatory Activities, N Number of patients in the analysis population, n Number of patients within each specific category; SMQ, standardized MedDRA query
  2. aThese are likely events per medical review
  3. bCategorized by narrow standardized MedDRA®b (v.19.1) query search terms. MedDRA®, the certified Medical Dictionary for Regulatory Activities terminology, is the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
  4. cIndicates a statistically significant difference (P < 0.05) compared with placebo