Table 1.
Related adverse events occurring in two or more patients during 24 months of olipudase alfa treatment
| 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 |
IAR infusion-associated reaction