Table 1 Baseline patient characteristics

From: A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS

Baseline characteristics

Placebo n = 45

Epoetin-α n = 85

Total N = 130

Age (years), median

75

85

75

 Range (years)

36–87

40–94

36–94

Sex

 Male

25 (55.6%)

46 (54.1%)

71 (54.6%)

 Female

20 (44.4%)

39 (45.9%)

59 (45.4%)

Body mass index (kg/m2)

n = 45

n = 84

N = 129

 Mean (SD)

25.94 (4.486)

27.58 (4.550)

27.01 (4.578)

 Median (range)

25.97 (16.1–36.3)

27.13 (18.2–40.5)

26.67 (16.1–40.5)

Hemoglobin (g/dL)

 Mean (SD)

9 (0.848)

9 (0.939)

 

 Median (range)

9 (6.9–10.5)

9 (6.8–11.0)

 

Transfusions in 8 weeks prior to baseline visit

 Patients with transfusions (%)

22 (48.9%)

44 (51.8%)

 

 No. of transfusion events prior to baseline

36

75

 

 Total RBC units prior to visit

53

114

 

 RBC units required per patient receiving transfusions

2.4

2.6

 

MDS subtype according to WHO classification

n = 44

n = 82

N = 126

 RA

11 (24.4%)

7 (8.2%)

18 (13.8%)

 RARS

2 (4.4%)

9 (10.6%)

11 (8.5%)

 RCMD

21 (46.7%)

36 (42.4%)

57 (43.8%)

 RCMD-RS

5 (11.1%)

12 (14.1%)

17 (13.1%)

 RAEB-1

1 (2.2%)

10 (11.8%)

11 (8.5%)

 RAEB-2

0

1 (1.2%)

1 (0.8%)

 MDS-U

0

1 (1.2%)

1 (0.8%)

 5q-

3 (6.7%)

2 (2.4%)

5 (3.8%)

 AML

0

0

0

 Not available

1 (2.2%)

4 (4.7%)

5 (3.8%)

MDS subtype according to FAB classificationa

n = 44

n = 82

N = 126

 RA

35 (77.8%)

46 (54.1%)

81 (62.3%)

 RARS

7 (15.6%)

21 (24.7%)

28 (21.5%)

 RAEB

1 (2.2%)

11 (12.9%)

12 (9.2%)

 RAEB-t

0

0

0

 CMML

1 (2.2%)

4 (4.7%)

5 (3.8%)

 AML

0

0

0

 Not available

0

0

0

IPSS risk categoryb

n = 45

n = 85

N = 130

 Low

23 (51.1%)

35 (41.2%)

58 (44.6%)

 Intermediate-1 (0.5–1.0)

22 (48.9%)

49 (57.6%)

71 (54.6%)

 Intermediate-2 (1.5–2.0)

0

0

0

 High (≥2.5)

0

0

0

 Missing

0

1 (1.2%)

1 (0.8%)

P value

 

0.355

 

ECOG score

n = 45

n = 85

N = 130

 0—fully active

20 (44.4%)

35(41.2%)

55 (42.3%)

 1—restricted but ambulatory

23 (51.1%)

42 (49.4%)

65 (50.0%)

 2—ambulatory

2 (4.4%)

8 (9.4%)

10 (7.7%)

 3—capable but confined to bed/chair

0

0

0

 4—completely disabled

0

0

0

  1. 5q-   myelodysplastic syndromes associated with isolated del(5q), AML   acute myeloid leukemia, CMML chronic myelomonocytic leukemia, FAB   French-American-British, IPSS   International Prognostic Scoring System, ECOG   Eastern Cooperative Oncology Group, MDS myelodysplastic syndromes, MDS-U   myelodysplastic syndrome, unclassified, RA   refractory anemia, RARS   refractory anemia with ringed sideroblasts, RAEB refractory anemia with excess blasts, RAEB-t refractory anemia with excess blasts in transformation, RBC red blood cells, RCMD   refractory cytopenia with multilineage dysplasia, RCMD-RS   refractory cytopenia with multilineage dysplasia with ringed sideroblasts, SD   standard deviation, WHO World Health Organization
  2. aAccording to FAB, CMML patients were marked as MDS subtype not available in the WHO classification
  3. bOne patient was missing the IPSS category at screening. The pvalue for treatment group differences are based on the Fisher exact test, two-sided
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