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Table 3 Summary of AEs

From: Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study

  AEs of interest Other AEs SAEsa
Patients,
n (%)
(N = 125)
AEs, n Patients,
n (%)
(N = 125)
AEs, n Patients
n (%)
(N = 125)
AEs, n
Any AE 15 (12.0) 20 20 (16.0) 29 5 (4.0) 5
Severity of AEb       
 Mild 10 (8.0) 13 11 (8.8) 14 0 0
 Moderate 5 (4.0) 6 6 (4.8) 12 1 (0.8) 1
 Severe 1 (0.8) 1 3 (2.4) 3 4 (3.2) 4
AEs considered related to Ig20Gly       
 Related 7 (5.6) 8 3 (2.4) 4 0 0
 Possibly related 5 (4.0) 5 4 (3.2) 6 1 (0.8) 1
 Probably related 2 (1.6) 2 2 (1.6) 2 0 0
  1. a SAEs were defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or is an important medical event
  2. b AE severity was defined as follows: mild – usually transient and may require only minimal treatment or therapeutic intervention (the event does not generally interfere with usual activities of daily living); moderate – usually alleviated with specific therapeutic intervention (the event interferes with usual activities of daily living, causing discomfort, but poses no significant or permanent risk of harm to the patient); severe – interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention