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Table 6 All-causality treatment-emergent adverse events

From: Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy

 

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)

  1. AE adverse event, CR complete remission, LDAC low-dose cytarabine, N/A not applicable