Table 3.
AESI, VOCs occurring within 24 hours of infusion (the same day or the day after infusion), and deaths in SOLACE-adults
| Safety topic | Crizanlizumab, 5.0 mg/kg, N = 45 |
Crizanlizumab, 7.5 mg/kg, N = 12 |
||
|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | |
| No. of patients with AESI, n (%) | ||||
| Infections (all) | 26 (57.8) | 8 (17.8) | 5 (41.7) | 1 (8.3) |
| Potential signs and symptoms of IRRs (standard search)∗ | 16 (35.6) | 0 | 3 (25.0) | 0 |
| IRR (severe reactions search)∗ | 1 (2.2) | 0 | 1 (8.3) | 1 (8.3) |
| Pain events∗ | 10 (22.2) | 1 (2.2) | 1 (8.3) | 0 |
| CARPA (complement-mediated search)∗ | 0 | 0 | 0 | 0 |
| Effect on hemostasis, hemorrhage | 8 (17.8) | 2 (4.4) | 1 (8.3) | 0 |
| Antidrug antibodies | 0 | 0 | 0 | 0 |
| VOCs | ||||
| Patients with a VOC on the same d or the d after infusion, n (%) | 19 (42.2) | 4 (33.3) | ||
| Total number of VOCs on the same d or the d after infusion, n | 32 | 6 | ||
| Proportion of infusions associated with a VOC on the same d or the d after infusion, % | 3.0 | 2.6 | ||
| Deaths, n (%) | ||||
| On-treatment deaths | 1 (2.2) | 1 (8.3) | ||
| Deaths deemed related to treatment | 0 | 0 | ||
| Deaths deemed unrelated to treatment | 1 (2.2) | 1 (8.3) | ||
AEs were evaluated based on MedDRA version 23.1.
CARPA, complement activation–related pseudoallergy.
∗
As the different searches are not mutually exclusive (ie, some events are captured in multiple searches), the total number of patients in the combined search is less than the sum of the individual search categories.