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Re: Protector post# 202201

Sunday, 01/11/2015 2:54:27 PM

Sunday, January 11, 2015 2:54:27 PM

Post# of 345890
Hi CP;

You wrote.

So bottom line, your WORST CASE assumption 4 months/120 days per patient per centre with a limit of 3 patients per centre gives currently 238 patients enrolled. And 322 for your second worst simulation of 3 months/90 days.



There may be a slight misunderstanding of what I wrote in my “Implied results” paragraph.

I wrote:

Implied results:
1 - Enrollment will be complete in the time frame of July to December 2015 based on the 3 assumptions above and August 2016 based on historical data.

I then addressed the more important issue of the first look-in with the following two statements:

2 - If the first look-in is based on ~150 events it will occur around August-November 2015
3 - If the first look-in is based on ~200 events it will occur around September – December 2015

But to address your question regarding current enrollment projections, the spreadsheet projects for the end of January enrollment numbers of:
For the 1 patient every 4 months I am projecting 206 vs your 238
For the 1 patient every 3 months I am projecting 293 vs your 322

It appears that we are within roughly 10% of each other.

Side note: I chose not to use formulas and macros to produce these calculations. Mine resembles a fix slide rule…

How many remember those…???
And how many want too…??? I got the answer to that one: ZERO


Regards
golfho
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