Table 3.

Adverse events that were related to agalsidase β therapy and occurred in at least 10% of patients overalla

Body SystemAdverse Eventn (%)
Body as a whole, general disordersRigors34 (59)
Temperature-change sensation22 (38)
Fever21 (36)
Chest pain12 (21)
Central and peripheral nervous system disordersHeadache17 (29)
Tremor8 (14)
Gastrointestinal system disordersNausea16 (28)
Vomiting12 (21)
Abdominal pain10 (17)
Cardiovascular disorders, generalHypertension7 (12)
Respiratory system disordersDyspnea10 (17)
Rhinitis10 (17)
Skin and appendages disordersPruritus10 (17)
Vascular (extracardiac) disordersFlushing11 (19)
Secondary termsFabry pain/acroparesthesia12 (21)
Musculoskeletal system disordersMyalgia8 (14)
Psychiatric disordersSomnolence8 (14)
  • a Percentages are based on the total number of patients; a patient who experienced more than one adverse event was counted once.