Table 2 Summary of AEs in Studies 1 (Part 1) and 2 in patients receiving volasertib and azacitidine
n (%) | Study 1 Part 1 (n = 13) | Study 2 (n = 5) |
|---|---|---|
Any AE | 12 (92) | 5 (100) |
DRAE | 12 (92) | 5 (100) |
AE leading to dose reduction of volasertib | 3 (23) | 1 (20) |
AE leading to dose reduction of azacitidine | 0 | 2 (40) |
AE leading to discontinuation of trial medication | 6 (46) | 0 |
SAE | 8 (62) | 2 (40) |
DLT | 2 (15) | 2 (40) |
Worst CTCAE grade | ||
Grade 1 | 0 | 0 |
Grade 2 | 0 | 0 |
Grade 3 | 2 (15) | 0 |
Grade 4 | 10 (77) | 5 (100) |
Grade 5 | 0 | 0 |