Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome

Table 3 Parameter values for trial reanalysis based on trial protocols

Design parameter	Unsuccessful trials		Successful trials
	ICON3	RE04	ICON4	RE01
$H R_{I}^{1}$ and $H R_{D}^{1}$	0.75	0.80	0.75	0.71
$H R_{I}^{0}$ and $H R_{D}^{0}$	1.0	1.0	1.0	1.0
Power at stage 1 (ω ₁)	0.95	0.95	0.95	0.95
Power at stage 2 (ω ₂)	0.90	0.90	0.90	0.90
Overall power	0.855	0.855	0.855	0.855
Allocation ratio (control : experimental)	2:1	1:1	1:1	1:1
Median time to event for I outcome (months)	18	5.5	10	2.5
Median time to event for D outcome (months)	36	12	23	10

ISSN: 1745-6215