Table 3.
Adverse events reported in ≥5% of patients in any infusion group (safety population)
| Adverse event, n (%)a | Days 1–7 | Day 8 | |
|---|---|---|---|
| 30-min infusion (n = 43) | 15-min infusion (n = 55) | 2- to 5-min infusion (n = 12)b | |
| Dizziness | 4 (9.3) | 8 (14.5) | 2 (16.7) |
| Cellulitis | 2 (4.7) | 4 (7.3) | 0 |
| Somnolence | 2 (4.7) | 3 (5.5) | 0 |
| Ecchymosis | 1 (2.3) | 3 (5.5) | 0 |
| Headache | 1 (2.3) | 3 (5.5) | 0 |
| Infusion-site reaction | 1 (2.3) | 3 (5.5) | 0 |
| Rash | 0 | 4 (7.3) | 0 |
| Anemia | 1 (2.3) | 0 | 1 (8.3) |
| Muscle spasms | 0 | 0 | 1 (8.3) |
a
Patients with ≥1 occurrences of the same event were counted only once.
b
Twelve patients in the 15-min infusion group also received four, 2- to 5-min infusions on day 8. AEs experienced on day 8 were counted separately.