Table 2 Overview of treatment-emergent adverse events

From: Bemcentinib as monotherapy and in combination with low-dose cytarabine in acute myeloid leukemia patients unfit for intensive chemotherapy: a phase 1b/2a trial

 

Dose escalation cohort

LDAC cohort

 

Bemcentinib

Bemcentinib

Bemcentinib

Bemcentinib

Bemcentinib

 

Bemcentinib + LDAC

 

400/100 mg

600/200 mg

900/300 mg

200/100 mg

400/200 mg

Overall

400/200 mg + 20 mg

 

(N = 6)

(N = 14)

(N = 5)

(N = 4)

(N = 7)

(N = 36)

(N = 36)

 

n (%)

E

n (%)

E

n (%)

E

n (%)

E

n (%)

E

n (%)

E

n(%)

E

Treatment-emergent adverse events [1]

TEAEs

5 (83)

95

14 (100)

196

5 (100)

65

4 (100)

53

7 (100)

168

35 (97)

577

36 (100)

693

SAEs

4 (67)

12

11 (79)

21

4 (80)

8

4 (100)

7

7 (100)

23

30 (83)

70

28 (78)

77

Related AEs

4 (67)

34

7 (50)

20

5 (100)

31

2 (50)

5

7 (100)

44

25 (69)

134

30 (83)

243

Related SAEs

1 (17)

1

2 (14)

2

0 (0)

0

1 (25)

1

4 (57)

5

8 (22)

9

14 (39)

26

Patients with any TEAE leading to

Discontinuation

2 (33)

2

1 (7)

2

0 (0)

0

0 (0)

0

1 (14)

1

4 (11)

5

4 (11)

4

Death

2 (33)

2

2 (14)

2

0 (0)

0

0 (0)

0

3 (43)

3

7 (19)

7

4 (11)

4

TEAEs by CTCAE Grade [3]

Grade 1: Mild

5 (83)

35

13 (93)

64

5 (100)

21

4 (100)

25

7 (100)

74

34 (94)

219

33 (92)

243

Grade 2: Moderate

4 (67)

20

12 (86)

52

5 (100)

16

4 (100)

11

7 (100)

42

32 (89)

141

32 (89)

181

Grade 3: Severe

5 (83)

17

14 (100)

55

5 (100)

13

4 (100)

10

6 (86)

23

34 (94)

118

33 (92)

121

Grade 4: Life-Threatening

4 (67)

4

2 (14)

2

1 (20)

1

3 (75)

3

4 (57)

10

14 (39)

20

22 (61)

42

Grade 5: Death

2 (33)

2

2 (14)

2

0 (0)

0

0 (0)

0

3 (43)

3

7 (19)

7

4 (11)

4

TEAE by relationship to bemcentinib [2,3]

Definitely Related

0 (0)

0

2 (14)

7

1 (20)

1

2 (50)

2

1 (14)

3

6 (17)

13

5 (14)

12

Probably Related

1 (17)

4

2 (14)

4

2 (40)

17

1 (25)

1

3 (43)

11

9 (25)

37

9(25)

28

Possibly Related

4 (67)

21

4 (29)

8

5 (100)

11

2 (50)

2

5 (71)

18

20 (56)

60

23 (64)

89

Unlikely Related

5 (83)

22

4 (29)

4

4 (80)

10

0 (0)

0

4 (57)

24

17 (47)

60

23 (64)

162

Unrelated

5 (83)

36

14 (100)

171

3 (60)

21

4 (100)

47

6 (86)

102

32 (89)

377

35 (97)

354

Not Applicable

0 (0)

0

2 (14)

2

2 (40)

2

0 (0)

0

1 (14)

1

5 (14)

5

4 (11)

4

TEAE by relationship to cytarabine [2,3]

Definitely Related

            

4 (11)

15

Probably Related

            

15 (42)

46

Possibly Related

            

24 (67)

117

Unlikely Related

            

21 (58)

152

Unrelated

            

34 (94)

282

Not Applicable

            

7 (19)

21

  1. Table presents number and percentage of subjects (n(%)) and number of events (E). Percentages are based on the number of subjects in the safety population in each group. AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, E number of events, N, n number of patients (total, affected), SAE serious adverse event, TEAE treatment-emergent adverse event. Headings and subheadings in bold,
  2. [1] Only treatment-emergent adverse events are included in summary statistics. TEAE period was between the first dose of bemcentinib and 28 days after the last dose. If a subject had multiple occurrences of an AE, the subject was counted only once.
  3. [2] Related refers to those events that were possibly, probably, or definitely related to bemcentinib.
  4. [3] If a subject experienced the same adverse event at more than one severity, or with more than one relationship to study drug, the most severe event and the strongest relationship was chosen.
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