Table 1.

Simulating scenarios

S	Congruence	Hypothesis					M
1	yes	H0			+ m	δ	m
2	yes	H1				δ	m
3	no	H0		- δ	(- δ) + m	δ	m
4	no	H1		- δ	- δ	δ	m
5	no	H0		- δ*3/2	(- δ*3/2) + m	δ	m
6	no	H1		- δ*3/2	- δ*3/2	δ	m
7	no	H0		- δ*2	(- δ*2) + m	δ	m
8	no	H1		- δ*2	- δ*2	δ	m

S: Scenario; : estimated proportion of events in the historical controls; : Expected proportion of events in the current controls; : Expected proportion of events in test arm; : clinically significant difference between historical and current control parameters; M: the noninferiority margin