Table 5.

Agreement between clinical site PI and Medical Safety Monitors

Serious					Unexpected					Related to Study Drug
PI	MSM1	MSM2	N	%	PI	MSM1 MSM2		N	%	PI	MSM1 MSM2		N	%
Yes	Yes	Yes	384	92.5	Yes	Yes	Yes	190	45.8	Yes	Yes	Yes	23	5.5
Yes	Yes	No	10	2.4	Yes	Yes	No	105	25.3	Yes	Yes	No	1	0.2
Yes	Yes	---	4	1.0	Yes	Yes	---	3	0.7	Yes	Yes	---	2	0.5
Yes	No	Yes	11	2.7	Yes	No	Yes	5	1.2	Yes	No	Yes	5	1.2
Yes	---	Yes	1	0.2	Yes	No	No	12	2.9	Yes	No	No	2	0.5
Yes	---	---	2	0.5	Yes	---	Yes	1	0.2	No	No	No	344	82.9
No	Yes	Yes	1	0.2	No	No	No	32	7.7	No	Yes	Yes	1	0.2
No	Yes	No	1	0.2	No	No	Yes	11	2.7	No	Yes	No	2	0.5
					No	Yes	No	27	6.5	No	No	Yes	29	7.0
					No	Yes	Yes	25	6.0	No	No	---	2	0.5
					No	Yes	---	1	0.2	No	---	No	2	0.5
					No	---	No	1	0.2	No	---	---	2	0.5
					No			2	0.5