Table 4.
Most common (≥5% of patients in any group) grade 3/4 adverse events reported in MDS-003 (overall) and MDS-004 (drug-related)
| Overall AEs in the MDS-003 study [17], n (%) | Drug-related AEs in the MDS-004 study [18]a, n (%) |
|||
|---|---|---|---|---|
| 10 mgb (N = 148) | LEN 10 mgc (N = 69) | LEN 5 mgd (N = 69) | Placebod (N = 67) | |
| Neutropenia | 81 (55) | 52 (75) | 51 (74) | 10 (15) |
| Thrombocytopenia | 65 (44) | 28 (41) | 23 (33) | 1 (1) |
| Leukopenia | 9 (6) | 6 (9) | 9 (13) | 0 (0) |
| Anemia | 10 (7) | 2 (3) | 4 (6) | 6 (9) |
| Deep vein thrombosis | 4 (3) | 4 (6) | 1 (1) | 1 (1) |
| Rash | 9 (6) | NA | NA | NA |
Only overall AEs have been reported for MDS-003 and only drug-related AEs have been reported for MDS-004.
aSafety population, double-blind phase.
bThe first 46 patients were treated on days 1–21 of 28-day cycles, and following a protocol amendment, 102 patients received continuous daily dosing [17].
cDays 1–21 of 28-day cycles.
dContinuous daily dosing.
AE, adverse event; LEN, lenalidomide; NA, not available.