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rafunrafun

10/28/17 7:38 PM

#117048 RE: Whalatane #117044

If the overall population was getting this benefit in, why doesn't it reflect in any recent study?
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HDGabor

10/28/17 7:54 PM

#117049 RE: Whalatane #117044

K-

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.

Best,
G
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HDGabor

10/28/17 11:08 PM

#117056 RE: Whalatane #117044

K-

I forgot, add. to #117049

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?

Best,
G