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Table 1 Baseline and demographic characteristics

From: Volasertib as a monotherapy or in combination with azacitidine in patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia: summary of three phase I studies

 

Study 1 Part 1 (n = 13)

Study 1 Part 2 (n = 3)

Study 2 (n = 5)

Study 3 (n = 1)

Male/Female, n (%)

11 (85)/2 (15)

2 (67)/1 (33)

3 (60)/2 (40)

1 (100)/0

Mean age, years (SD)

68.6 (7.7)

N/A

73.2 (4.6)

69 (N/A)

ECOG PS, n (%)

 

N/A

  

 0

4 (31)

 

4 (80)

0

 1

7 (54)

 

1 (20)

1 (100)

 2

2 (15)

 

0

0

Disease, n (%)

 

N/A

  

 MDS

12 (92)

 

5 (100)

0

 CMML

1 (8)

 

0

0

 AML

0

 

0

1 (100)

IPSS classification at screening, n (%)

 

N/A

  

 Int-2 (1.5–2.0)

9 (69)

 

2 (40)

0

 High (≥ 2.5)

4 (31)

 

3 (60)

1 (100)

Previous treatments, n (%)

 

N/A

  

 No prior treatment

11 (85)

 

1 (20)

0

 Azacitidine

0

 

4 (80)

1 (100)

 Cytarabine

0

 

1 (20)

0

 Aclarubicin hydrochloride

0

 

1 (20)

0

 Growth factor

1 (8)

 

0

0

 Lenalidomide

1 (8)

 

0

0

 Other

2 (15)

 

0

0

Median BSA, m2 (range)

1.9 (1.7–2.2)

N/A

1.6 (1.4–1.8)

1.7 (N/A)

Median body weight, kg (range)

79.9 (64.2–99.2)

N/A

59.5 (48.0–69.0)

60.5 (N/A)

  1. AML, acute myeloid leukemia; BSA, body surface area; CMML, chronic myelomonocytic leukemia; ECOG PS, Eastern Cooperative Oncology Group performance status; IPSS, international prognostic scoring system; MDS, myelodysplastic syndrome; N/A, data not available; SD, standard deviation