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Table 2 Patient characteristics and doses given in each subject, cohort, and cycle

From: Model-based adaptive phase I trial design of post-transplant decitabine maintenance in myelodysplastic syndrome

Cohort

Subject number

Sex/age

WHO diagnosis

Donor

GVHD gradea

Cycle (mg/m2/day for 5 days)

Acute

Chronic

1

2

3

4

1

1

F/19

RAEB-2

MSD

0

0

5b,c

1.5

1.5

1.5

2

M/36

AML

MSD

0

0

5b

6

5.5

6

3

M/60

RAEB-2

MUD

1

0

5

–

–

–

4

M/48

AML

MSD

0

0

5b,c

1.5

2.5

3

2

5

M/64

RAEB-2

PMUD

1

0

4b

4

5.5

7

6

F/43

RAEB-2

MSD

0

0

4b

7

8

12

7

M/64

AML

MSD

0

0

4b

6

5.5

5.5

3

8

F/51

RAEB-2

MUD

1

0

5b

7.5b,c

7.5c

7

9

F/59

RAEB-1

MUD

2

0

5b,c

3.5

4

4.5

10

F/36

RAEB-2

MUD

1

0

5b

6b

8.5

9

4

11

M/64

RAEB-2

MSD

2

0

5.5b

2b

–

–

12

M/60

RAEB-2

MSD

0

Mild

5.5b,c

4.5b

7

8

13

M/41

RAEB-2

MSD

0

0

5.5b,c

3

5

8

5

14

M/49

AML

MUD

2

0

5b

1.5

2.5

3

15

F/50

AML

MSD

2

0

5b,c

4

6

9

16

F/49

RAEB-2

MSD

2

0

5b

7.5

8

11c

  1. GVHD graft-versus-host disease, RAEB refractory anemia with excess blast, MSD matched sibling donor, PMUD partially matched unrelated donor, MUD matched unrelated donor
  2. aAssessed at the time of decitabine initiation
  3. bIndividual dose titration (IDT) by the PK-PD model was not applied
  4. cThe cycles where grade 4 toxicities occurred