Table 1.

Trial A Fisher’s Exact Test Method – Death @ 30 Days for Intervention Arm B. Cumulative Enrollment and Events

	Control (Expected)			Intervention Arm B (Observed)
Period	Events	Patients	Event Rate (%)	Events	Patients	Event Rate (%)	p
1	0	0	0.0	0	5	0.0	*
2	0	17	0.0	0	16	0.0	*
3	0	48	0.0	1	52	1.9	1.000
4	0	135	0.0	4	131	3.1	0.122
5	1	268	0.4	6	279	2.2	0.124
6	4	463	0.9	12	486	2.5	0.078
7	5	764	0.7	21	794	2.6	0.003
8	8	1,089	0.7	30	1,118	2.7	<0.001
9	11	1,412	0.8	36	1,459	2.5	<0.001
10	16	1,805	0.9	50	1,882	2.7	<0.001
11	21	2,173	1.0	59	2,277	2.6	<0.001
12	33	2,701	1.2	66	2,824	2.3	0.003
13	46	3,360	1.4	81	3,470	2.3	0.005
14	46	3,421	1.3	81	3,537	2.3	0.005