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Table 1 Related adverse events occurring in two or more patients during 24 months of olipudase alfa treatment

From: Long-term safety and clinical outcomes of olipudase alfa enzyme replacement therapy in pediatric patients with acid sphingomyelinase deficiency: two-year results

Related adverse event

Patients n (%) N=20

Events

Events categorized as IARs

Severity by event

Pyrexia

8 (40.0)

25

23/25

All mild

Vomiting

7 (35.0)

17

16/17

16 mild, 1 moderate

Urticaria

6 (30.0)

28

28/28

23 mild, 5 moderate

Headache

5 (25.0)

10

7/10

9 mild, 1 moderate

C-reactive protein increased

4 (20.0)

4

4/4

3 mild, 1 moderate

Nausea

4 (20.0)

4

4/4

2 mild, 2 moderate

Rash

3 (15.0)

6

4/6

5 mild, 1 moderate

Serum ferritin increased

3 (15.0)

3

3/3

2 mild, 1 moderate

Abdominal pain

2 (10.0)

6

5/6

All mild

Blood bilirubin increased

2 (10.0)

2

1/2

All mild

Erythema

2 (10.0)

3

3/3

All mild

Macule

2 (10.0)

3

0/3

All mild

  1. IAR infusion-associated reaction