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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