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Table 2—

Overall incidence of treatment-emergent adverse events potentially related to manifestations of insulin allergy

Event classificationHumulin R (N = 2,265)Insulin lispro (N = 2,247)Total (N = 1,512)
Patients with ≥1 treatment-emergent adverse events 165 (7.3) 178 (7.9) 343 (7.6) 
Patients with no treatment-emergent adverse events 2,100 (92.7) 2,069 (92.1) 4,169 (92.4) 
Rash 63 (2.8) 64 (2.9) 127 (2.8) 
Allergic reaction 52 (2.3) 60 (2.7) 112 (2.5) 
Pruritus 15 (0.7) 26 (1.2) 41 (0.9) 
Vasodilatation 10 (0.4) 12 (0.5) 22 (0.5) 
Urticaria 4 (0.2) 10 (0.4) 14 (0.3) 
Application site reaction 9 (0.4) 4 (0.2) 13 (0.3) 
Hypotension 5 (0.2) 5 (0.2) 10 (0.2) 
Face edema 5 (0.2) 4 (0.2) 9 (0.2) 
Maculopapular rash 3 (0.1) 6 (0.3) 9 (0.2) 
Injection site reaction 1 (0.0) 4 (0.2) 5 (0.1) 
Generalized edema 3 (0.1) 1 (0.0) 4 (0.1) 
Reaction unevaluable 1 (0.0) 3 (0.1) 4 (0.1) 
Injection site pain 1 (0.0) 2 (0.1) 3 (0.1) 
Injection site atrophy 2 (0.1) 2 (0.0) 
Shock 1 (0.0) 1 (0.0) 2 (0.0) 
Injection site inflammation 1 (0.0) 1 (0.0) 
Injection site mass 1 (0.0) 1 (0.0) 
Petechial rash 1 (0.0) 1 (0.0) 
Event classificationHumulin R (N = 2,265)Insulin lispro (N = 2,247)Total (N = 1,512)
Patients with ≥1 treatment-emergent adverse events 165 (7.3) 178 (7.9) 343 (7.6) 
Patients with no treatment-emergent adverse events 2,100 (92.7) 2,069 (92.1) 4,169 (92.4) 
Rash 63 (2.8) 64 (2.9) 127 (2.8) 
Allergic reaction 52 (2.3) 60 (2.7) 112 (2.5) 
Pruritus 15 (0.7) 26 (1.2) 41 (0.9) 
Vasodilatation 10 (0.4) 12 (0.5) 22 (0.5) 
Urticaria 4 (0.2) 10 (0.4) 14 (0.3) 
Application site reaction 9 (0.4) 4 (0.2) 13 (0.3) 
Hypotension 5 (0.2) 5 (0.2) 10 (0.2) 
Face edema 5 (0.2) 4 (0.2) 9 (0.2) 
Maculopapular rash 3 (0.1) 6 (0.3) 9 (0.2) 
Injection site reaction 1 (0.0) 4 (0.2) 5 (0.1) 
Generalized edema 3 (0.1) 1 (0.0) 4 (0.1) 
Reaction unevaluable 1 (0.0) 3 (0.1) 4 (0.1) 
Injection site pain 1 (0.0) 2 (0.1) 3 (0.1) 
Injection site atrophy 2 (0.1) 2 (0.0) 
Shock 1 (0.0) 1 (0.0) 2 (0.0) 
Injection site inflammation 1 (0.0) 1 (0.0) 
Injection site mass 1 (0.0) 1 (0.0) 
Petechial rash 1 (0.0) 1 (0.0) 

Data are n (%). N = total number of patients; n = number of patients (Studies A–H) who reported at least one event in the category.

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