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Table 4 Comparison of the DESR and Fleming for Early Stopping and Rejection of H nul

From: A comparison of a new multinomial stopping rule with stopping rules of fleming and gehan in single arm phase II cancer clinical trials

 

Stage I (n = 15 unless indicated)a

Stage II*

Stage I Stop?

Drug Activity

Trial

Res

Prog

Resp

Prog

Flem

DESR epd0.4/0.6

DESR epd0.3/0.5

Flem

DESR epd0.4/0.6

DESR epd0.3/0.5

1

0

6

  

Y

N

Y

N

P

N

2

0

1

  

Y

N

N

N

P

P

3

0

10

  

Y

Y

Y

N

N

N

4

0

7

  

Y

N

Y

N

P

N

5

0

9

  

Y

Y

Y

N

N

N

6

0

14

  

Y

Y

Y

N

N

N

7

0/14

7/14

  

Y

N

Y

N

P

N

8

0

6

  

Y

N

Y

N

P

N

9

0

3

  

Y

N

N

N

P

P

10

0

12

  

Y

Y

Y

N

N

N

11

1

9

  

N

Y

Y

?

N

N

12

7

6

13/30

13/30

N

N

N

Y

Y

Y

13

1

6

1/25

12/25

N

N

Y

N

Y

N

14

1

6

3/30

13/30

N

N

Y

N

Y

N

15

2

4

2/30

8/30

N

N

N

N

Y

Y

16

1

6

4/29

12/29

N

N

Y

Y

Y

N

  1. aActual trial results.
  2. DESR epd 0.4/0.6 = Dual Endpoint Stopping Rule epd alt = 0.4, epd nul = 0.6
  3. DESR epd 0.3/0.5 = Dual Endpoint Stopping Rule epd alt = 0.3, epd nul = 0.5
  4. Flem = result according to rules of Fleming
  5. Prog = Progression
  6. Res = Response
  7. Y, N, P = Yes, No, Possible