Adverse events that were related to agalsidase β therapy and occurred in at least 10% of patients overalla
| Body System | Adverse Event | n (%) |
|---|---|---|
| Body as a whole, general disorders | Rigors | 34 (59) |
| Temperature-change sensation | 22 (38) | |
| Fever | 21 (36) | |
| Chest pain | 12 (21) | |
| Central and peripheral nervous system disorders | Headache | 17 (29) |
| Tremor | 8 (14) | |
| Gastrointestinal system disorders | Nausea | 16 (28) |
| Vomiting | 12 (21) | |
| Abdominal pain | 10 (17) | |
| Cardiovascular disorders, general | Hypertension | 7 (12) |
| Respiratory system disorders | Dyspnea | 10 (17) |
| Rhinitis | 10 (17) | |
| Skin and appendages disorders | Pruritus | 10 (17) |
| Vascular (extracardiac) disorders | Flushing | 11 (19) |
| Secondary terms | Fabry pain/acroparesthesia | 12 (21) |
| Musculoskeletal system disorders | Myalgia | 8 (14) |
| Psychiatric disorders | Somnolence | 8 (14) |
↵a Percentages are based on the total number of patients; a patient who experienced more than one adverse event was counted once.