Table 3. Overall safety.
|
24-Week double-blind period |
48-Week open-label DAR |
|||
|---|---|---|---|---|
| Placebo (n=48) | DAR (n=98) | Prior placebo (n=38) | Prior DAR (n=87) | |
| AEs leading to IP discontinuation | 2 (4.2) | 3 (3.1) | 3 (7.9) | 3 (3.4) |
| Grade⩾3 | 13 (27.1) | 15 (15.3) | 9 (23.7) | 27 (31.0) |
| Grade⩾4 | 6 (12.5) | 5 (5.1) | 4 (10.5) | 9 (10.3) |
| Fatal AEs (none treatment-related) | 2 (4.2) | 1 (1.0) | 1 (2.6) | 1 (1.1) |
| Serious AEs | 8 (16.7) | 11 (11.2) | 7 (18.4) | 22 (25.3) |
| Treatment-related serious AEs | - | 1 (1.0) | 1 (2.6) | 1 (1.1) |
| Thrombovascular events | - | 1 (1.0) | 3 (7.9) | 3 (3.4) |
| Progression to AML | 1 (2.2) | 2 (2.1) | - | 2 (2.3) |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; DAR, darbepoetin alfa; IP, investigational product.
Data are n (%). One patient randomized to placebo received a dose of DAR and so is included in that group. One patient enrolled into the 48-week open-label portion but did not receive any DAR; thus, total N=125 (not 126).