Table 5 Summary of key safety findings for the first 24 weeks and for the entire study duration (safety analysis set)

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

 

First 24 weeks

Entire studya

 

Placebo

Epoetin-α

Placebo

Epoetin-α

Numbers

45

85

24

85

At least 1 treatment-emergent AE

40 (88.9%)

66 (77.6%)

41 (91.1%)

73 (85.9%)

At least 1 treatment-emergent serious AE

8 (17.8%)

22 (25.9%)

10 (22.2%)

35 (41.2%)

At least 1 treatment-emergent Grade 3 or 4 AE

12 (26.7%)

22 (25.9%)

15 (33.3%)

32 (37.6%)

At least 1 treatment-emergent AE leading to study discontinuation

6 (13.3%)

9 (10.6%)

6 (13.3%)

15 (17.6%)

Deaths

1 (2.2%)

4 (4.7%)

1 (2.2%)

7 (8.2%)

At least 1 thrombotic vascular event

0

4 (4.7%)

0

4 (4.7%)

Disease progression (including progression to AML)

4 (8.9%)

11 (12.9%)

4 (8.9%)

14 (16.5%)

Progression to AML

2 (4.4%)

3 (3.5%)

2 (4.4%)

3 (3.5%)

  1. AML   acute myeloid leukemia
  2. aIncludes all data from baseline through Week 52 (i.e., end-of-study visit after end of treatment extension phase [Week 48]) for patients who entered the treatment extension phase. For patients who did not enter the treatment extension phase, an end of study visit that included safety evaluations was performed at Week 28 (i.e., 4 weeks after last dose at Week 24); all data after Week 24 through Week 28 for these patients are included in the entire study period data set
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