Table N° 4. Safety profile.
| Adverse Events | SoC group (n = 51) | Ruxolitinib group (n = 51) | ||
|---|---|---|---|---|
| Baseline | Follow-up | Baseline | Follow-up | |
| N (%) | N (%) | N (%) | N (%) | |
| Anemia | 2 (4%) | 8 (16%) | 7 (13%) | 2 (4%) |
| (hemoglobin < 12 g/dl) | ||||
| Polycythemia | 1 (2%) | 0 | 1 (2%) | 0 |
| (hemoglobin >18 g/dl) | ||||
| Leukocytosis | 6 (12%) | 8 (16%) | 12 (24%) | 5 (10%) |
| (>11.5 x103 cells/µl) | ||||
| Leucopenia | 7 (14%) | 1 (2%) | 4 (8%) | 2 (4%) |
| (< 4.5 x 103 cells/µl) | ||||
| Thrombocytopenia | 10 (20%) | 0 | 4 (8%) | 0 |
| (< 140 x 103 cells/µl) | ||||
| Thrombocytosis | 2 (4%) | 8 (16%) | 2 (4%) | 21 (42%) |
| (> 450 x 103 cells/µl) | ||||
| AST (< 34 IU/ml) and/or ALT(< 55 IU/ml) | 19 (38%) |
24 (48%) * |
20 |
29 (58%) * |
| Creatinine clearance reduction | 1 (2%) | 7 (14%) | 0 | 4 (8%) |
| Lymphopenia | 19 (38%) | 5 (10%) | 24 (48%) | 5 (10%) |
| (<1.5 x 103 cells/µl) | ||||
| Bradycardia | 0 | 11 (22%) | 0 | 11 (22%) |
| (< 55/min) | ||||
| QT prolongation | 0 | 0 | 0 |
1 (2%) † |
| (> 450 ms) | ||||
| Superinfection | 0 | 7 (14%) | 0 |
10 (20%) ** |
| Facial cellulites | 0 | 0 | 0 | 1 (2%) |
| Acute pancreatitis | 0 | 0 | 0 | 1 (2%) |
| Definitely interruption due to AEs | NA | NA | NA | 4 (8%) |
Safety data were available for 102 patients
(*) Grade 3 AE (4 patients in the ruxolitinib group, 1 patient in the SoC group)
(†) Grade 3 AE (1 patient)
(**) Febrile curve pattern #5 and #6 were described in 9 cases