TABLE II.
Safety Summary
| Patients, n (%) | |||||
|---|---|---|---|---|---|
|
| |||||
| Total (n = 40) | Velaglucerase alfa dose group
|
||||
| 15 U/kg (n = 14) | 30 U/kg (n = 12) | 45 U/kg (n = 7)a | 60 U/kg (n = 7) | ||
| Experienced ≥1 treatment-emergent AEb | 34 (85) | 11 (79) | 11 (92) | 6 (86) | 6 (86) |
| Experienced ≥1 drug-related AE | 11 (28) | 5 (36) | 3 (25) | 2 (29) | 1 (14) |
| Experienced ≥1 infusion-related AEc | 9 (23) | 5 (36) | 2 (17) | 1 (14) | 1 (14) |
| Experienced ≥1 severe (grade 3) AE | 5 (13) | 0 | 2 (17) | 1 (14) | 2 (29) |
| Possibly/probably treatment-related | 0 | 0 | 0 | 0 | 0 |
| Experienced ≥1 serious AE | 4 (10) | 0 | 1 (8) | 3 (43) | 0 |
| Possibly/probably treatment-related | 1 (3) | 0 | 0 | 1 (14) | 0 |
| Experienced ≥1 life-threatening AE | 0 | 0 | 0 | 0 | 0 |
| Discontinued due to an AE | 1 (3) | 0 | 0 | 1 (14) | 0 |
| Deaths | 0 | 0 | 0 | 0 | 0 |
| Developed anti-velaglucerase alfa antibodies | 0 | 0 | 0 | 0 | 0 |
AE, adverse event.
One patient who received 50 U/kg of imiglucerase was categorized in the 45 U/kg velaglucerase alfa group. This patient was to receive a prescribed dose of 50 U/kg (4000 U/82 kg) of velaglucerase alfa; however, because the patient’s first infusion was discontinued after 30 minutes due to an anaphylactoid reaction she only received 12.7 U/kg but was categorized into the 45 U/kg group for analysis purposes.
A treatment-emergent AE was defined as an AE that occurred on or after the day of the first infusion until 30 days after the patient’s last infusion.
An infusion-related AE was defined as an AE that (1) began either during or within 12 hours after the start of the infusion, and (2) was judged as possibly or probably related to study drug.