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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