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Table 1 Analysis populations and reasons for exclusion from the per-protocol population.

From: Phase II study of two dose schedules of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in anemic patients with advanced non-small cell lung cancer (NSCLC) receiving chemotherapy

 

C.E.R.A. dose group (μg/kg QW)

C.E.R.A. dose group (μg/kg Q3W)

 

0.7

1.4

2.1

2.1

4.2

6.3

Number of patients randomized

36

37

36

37

37

35

Number of patients in ITT/safety population*

36

37

35

34

37

34

Number of patients in PP population

22

23

20

21

27

25

Number of randomized patients excluded from PP population

14

14

16

16

10

10

Reasons for exclusion from PP population**

      

   Blood transfusion during study period

13

12

14

16

7

5

   Acute infection/inflammatory disease (CRP > 50 mg/L)

1

4

1

2

3

3

   Received no study medication

0

0

1

3

0

1

   Blood transfusion during 4-week period before study entry

0

0

0

3

0

0

   Inclusion criteria not met

0

0

0

0

0

1

  1. C.E.R.A.: Continuous Erythropoietin Receptor Activator.
  2. CRP: C-reactive protein.
  3. ITT: intent-to-treat.
  4. PP: per-protocol.
  5. QW: once weekly.
  6. Q3W: once every 3 weeks.
  7. *One patient in the C.E.R.A. 2.1 μg/kg QW group, three patients in the 2.1 μg/kg Q3W group and one patient in the 6.3 μg/kg Q3W group were excluded from the ITT and safety analyses because they did not receive any study drug.
  8. **Patients may have had more than one reason for being excluded from the PP population.