Table 6.
Achieved CR | Did not achieve CR | |||
---|---|---|---|---|
N (%) | Glasdegib + LDAC | LDAC alone | Glasdegib + LDAC | LDAC alone |
During the first 90 days | n= 15 | n= 1 | n= 60 | n= 35 |
AEs | 15 (100) | 1 (100) | 59 (98.3) | 35 (100) |
Serious AEs | 10 (66.7) | 0 | 39 (65.0) | 26 (74.3) |
Grade 3 or 4 AEs | 14 (93.3) | 0 | 49 (81.7) | 33 (94.3) |
Grade 5 AEs | 0 | 0 | 12 (20.0) | 13 (37.1) |
Discontinued due to AEs | 1 (6.7) | 0 | 16 (26.7) | 12 (34.3) |
Glasdegib dose reduced due to AEs | 2 (13.3) | N/A | 6 (10.0) | N/A |
Backbone chemotherapy dose reduced due to AEs | 2 (13.3) | 0 | 3 (5.0) | 0 |
Glasdegib temporary discontinuation due to AEs | 8 (53.3) | N/A | 30 (50.0) | N/A |
Backbone chemotherapy temporary discontinuation due to AEs | 4 (26.7) | 0 | 16 (26.7) | 9 (25.7) |
After 90 days | n= 14 | n= 1 | n= 29 | n= 13 |
AEs | 13 (92.9) | 1 (100) | 23 (79.3) | 9 (69.2) |
Serious AEs | 6 (42.9) | 0 | 16 (55.2) | 7 (53.8) |
Grade 3 or 4 AEs | 10 (71.4) | 1 (100) | 20 (69.0) | 7 (53.8) |
Grade 5 AEs | 1 (7.1) | 0 | 9 (31.0) | 3 (23.1) |
Discontinued due to AEs | 3 (21.4) | 0 | 8 (27.6) | 5 (38.5) |
Glasdegib dose reduced due to AEs | 4 (28.6) | N/A | 1 (3.4) | N/A |
Backbone chemotherapy dose reduced due to AEs | 4 (28.6) | 0 | 3 (10.3) | 0 |
Glasdegib temporary discontinuation due to AEs | 9 (64.3) | N/A | 8 (27.6) | N/A |
Backbone chemotherapy temporary discontinuation due to AEs | 9 (64.3) | 1 (100) | 6 (20.7) | 3 (23.1) |
AE adverse event, CR complete remission, LDAC low-dose cytarabine, N/A not applicable