expected the final event for R-IT to be in 2017 ...correct . Thats they way it was designed .
Now they acknowledge it will probably be Q1 in 2018 What changed ?
e.g. speed of the enrolment ... top of that the 2017 was the expectation / projection only
but not good enough to justify a stop at Interm 2 .
It was discussed several times, so I do not repeat: stopping rule / boundary at any interim was not equel with the RRR of PE ...
My view is that R-IT type patients are getting more aggressive care / monitoring ...especially those in Kaiser plans
That should be a "huge" number ...
- Total enrollment: 8,175 patients - US sites: 175 (43% of total) -> 3,489 patients - Kaiser Permanente had 11.7 million health plan members (3.63% of US population) ... -> 127 patients, 1.55% of R-IT population ... 50-50% in placebo and V arm
... but let's see it differently (
- US sites: 175 (43% of total) -> 3,489 patients - To join Kaiser Permanente, you must live or work in one of our regional service areas located in: Northern California, Southern California, Colorado, Georgia, Hawaii, Mid- Atlantic States (District of Columbia, Maryland and Virginia) and Northwest (Oregon and Washington) ... (Kaiser Permanente Service Areas) ... 23% of US sites -> 798 patients - Kaiser Permanente had 11.7 million health plan members (14% of eligible population) ... -> 113 patients, 1.38% of R-IT population ...50-50% in placebo and V arm ...
... and we know (at least) 1 (covered by Kaiser) isn't in the R-IT study.
45+ are app. 41% of of US population 127 -> -> 52 patients, 0.64% of R-IT population ... 50-50% in placebo and V arm 113 -> -> 46 patients, 0.57% of R-IT population ... 50-50% in placebo and V arm
Safe to say: "especially those in Kaiser plans" are more likely app. 50 patients (0.61% of R-IT population) 50-50% in placebo and V arm
How do you think (guess ...) what is the affect of these patients on R-IT result?