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Table 2 Summary of AE analyses

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

AE categories Treatments
IGIV 10 % IGSC 20 %
Number (%) of patients (n = 77) Number (rate)a of AEs (n = 324) Number (%) of patients (n = 74) Number (rate)a of AEs (n = 4327)
Non-serious AEs (excluding infections) 51 (66.2) 180 (0.556) 57 (77.0) 466 (0.108)
 Mild 43 (55.8) 141 (0.435) 53 (71.6) 360 (0.083)
 Moderate 17 (22.1) 37 (0.114) 31 (41.9) 104 (0.024)
 Severe 2 (2.6) 2 (0.006) 2 (2.7) 2 (<0.001)
Causally related non-serious AEs 28 (36.4) 80 (0.247) 28 (37.8) 157 (0.036)
 Mild 22 (28.6) 59 (0.182) 24 (32.4) 136 (0.031)
 Moderate 9 (11.7) 19 (0.059) 9 (12.2) 21 (0.005)
 Severe 2 (2.6) 2 (0.006) 0 (NA) 0 (NA)
Causally related local non-serious AEs (excluding infections) 2 (2.6) 2 (0.006) 18 (24.3) 67 (0.015)
 Mild 1 (1.3) 1 (0.003) 16 (21.6) 62 (0.014)
 Moderate 1 (1.3) 1 (0.003) 3 (4.1) 5 (0.001)
 Severe 0 (NA) 0 (NA) 0 (NA) 0 (NA)
Causally related systemic non-serious AEs (excluding infections) 27 (35.1) 78 (0.241) 19 (25.7) 90 (0.021)
 Mild 22 (28.6) 58 (0.179) 16 (21.6) 74 (0.017)
 Moderate 8 (10.4) 18 (0.056) 8 (10.8) 16 (0.004)
 Severe 2 (2.6) 2 (0.006) 0 (NA) 0 (NA)
SAEs (including infections) 1 (1.3) 1 (0.003) 2 (2.7) 2 (<0.001)
 Mild 1 (1.3) 1 (0.003) 0 (NA) 0 (NA)
 Moderate 0 (NA) 0 (NA) 1 (1.35) 1 (<0.001)
 Severe 0 (NA) 0 (NA) 1 (1.35) 1 (<0.001)
Causally related SAEs 1 (1.3) 1 (0.003) 0 (NA) 0 (NA)
Causally related AEs leading to discontinuation 1 (1.3) 1 (0.003) 0 (NA) 0 (NA)
AEs leading to death 0 (NA) 0 (NA) 0 (NA) 0 (NA)
  1. n total number of patients or total number of infusions, AE adverse event, NA not applicable; SAE serious AE
  2. aRate per infusion = total number of AEs divided by the total number of infusions