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Table 3 Summary of adverse events (full analysis set)

From: Long-term survival with sebelipase alfa enzyme replacement therapy in infants with rapidly progressive lysosomal acid lipase deficiency: final results from 2 open-label studies

Event

VITAL (N = 9),

n (%)

CL08 (N = 10),

n (%)

Any TEAE

9 (100)

10 (100)

Mild or moderate TEAEs

0 (0)

3 (30)

Any treatment-related or possibly related TEAE

6 (67)

8 (80)

Any SAE

9 (100)

10 (100)

Any treatment-related or possibly related SAE

1 (11)

5 (50)

Any IAR

5 (56)

8 (80)

Mild or moderate IARs

5 (56)

6 (60)

Dose modification due to a TEAEa

7 (78)

7 (70)

Discontinuation due to a TEAE

0 (0)

0 (0)

Death

4 (44)

2 (20)

  1. IAR infusion-associated reaction, SAE serious adverse event, TEAE treatment-emergent adverse event
  2. aIncludes dose increases, dose decreases, drug interruptions, and study drug withdrawal