Table 2.

The “Placebo”/“Standard” hazard ratios of 10 MA studies as presented in FDA Guidance Example 4; the “New”/“Standard” HR is also shown for the corresponding noninferiority(NI) Study 2 (Food and Drug Administration, 2010)

Study	Hazard ratio	Log hazard ratio	SE (log hazard ratio)
MA 1	1.35	0.301	0.232
MA 2	1.26	0.235	0.188
MA 3	0.78	–0.253	0.171
MA 4	1.15	0.143	0.153
MA 5	1.39	0.329	0.185
MA 6	1.35	0.300	0.184
MA 7	1.38	0.324	0.166
MA 8	1.34	0.294	0.126
MA 9	1.03	0.0296	0.165
MA 10	1.95	0.670	0.172
NI 0	0.92	–0.0844	0.0867