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Table 3 Causally related non-serious AEs during the IGSC 20 % treatment

From: Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America

Adverse eventa % of patientsc N = 74 Rate per infusiond N = 4327
Causally relatedb systemic AEs 25.7 0.021
 Headache 10.8 0.011
 Fatigue 6.8 0.002
 Nausea 6.8 0.002
 Diarrhea 2.7 <0.001
 Myalgia 4.1 0.001
 Dizziness 2.7 0.001
 Migraine 2.7 <0.001
 Somnolence 2.7 <0.001
 Abdominal pain lower 1.4 <0.001
 Anti-GAD antibody positive 1.4 <0.001
 Pain 1.4 <0.001
 Pruritus 1.4 <0.001
Causally relatedb local AEs 24.3 0.016
 Infusion site erythema (including Injection site erythema) 10.8 0.005
 Infusion site pain (including Infusion site discomfort and Injection site pain) 16.2 0.008
 Infusion site pruritus (including Injection site pruritus) 4.1 <0.001
 Infusion site urticaria 2.7 <0.001
 Burning sensation 1.4 <0.001
 Infusion site edema 1.4 <0.001
 Urticaria 1.4 <0.001
  1. aAEs excluding infections
  2. bRelated AE as assessed by the investigator. Missing relationships were treated as related
  3. c% of patients = (total number of affected patients divided by the total number of patients under treatment) × 100
  4. dRate per infusion = total number of AEs divided by the total number of infusions under treatment
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