Skip to main content

Table 2 List of SAEs by MedDRA system organ class

From: Short-term safety results from compassionate use of risdiplam in patients with spinal muscular atrophy in Germany

Serious adverse events, n (%)* SMA1 SMA2 Total
Total number 2 (6.7) 8 (8.0) 10 (7.7)
Gastrointestinal disorders 5 (5.0) 5 (3.8)
General disorders and administration site conditions 1 (1.0) 1 (0.8)
Infections and infestations 2 (6.7) 2 (2.0) 4 (3.0)
  1. Of 111 patients who received at least one dose of risdiplam (31 patients with SMA1 and 80 patients with SMA2), 3 patients (1 patient with SMA1 and 2 patients with SMA2) experienced at least 1 SAE
  2. *Percentages are based on total number of AEs (30 in SMA1 and 100 in SMA2). MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; SMA1, spinal muscular atrophy type 1; SMA2, spinal muscular atrophy type 2