Target Rate (Ru):        Anticipate Response Rate (Prior):

  Threshold Probability at Stage I and Stage II (lambda1, lambda2):     

 

The design only provides the results with (1) 10<=N<=90; (2) 5<=N1<=N-5;

Otherwise, it reports the following:

a (N<10); b (N>=10, but N1<5); c (N>90).

where N = the overall sample size for phase II trials;   N1 = the sample size for stage I.


STAGE I:                     

X1: the minimum response by the end of stage I.

N1: the number of patients required for stage I.

Xc: the minimum optimal response by the end of stage I.

 

STAGE II:                    

N2: the number of patients suggested for stage II, given the observed response at the end of stage I is within (X1, Xc].

Nn: the number of patients suggested for stage II, given the observed response at the end of stage I is very good, within (Xc, N1].

 

OVERALL:               

XL: the minmum response by the end of phase II.

N(N1+N2): the overall patients required for phase II, given the observed response at the end of stage I is within (X1, Xc].

NN(N1+Nn): the overall patients required for phasae II, given the observed response at the end of stage I is within (Xc, N1].