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09/25/18 3:24 PM

#191261 RE: meirluc #191183

Also I wonder why you used the 18, 24, and 30 months intervals. For example, you calculate the survival of patients who survived 18-24 months as if all were alive only 18 months when in reality they are spread between 18 and 24 months. Same with the 24 and 30 months interval. Should it not be the midpoint of the intervals such as 21, 27 and 33 months?



I used the 6 month intervals because the charts were separated in 6 month intervals. So when I counted the censored patients for both meth+ and meth-, they were sectioned in 6 month intervals. And I figured that a patient who was alive at 18 months had a smaller chance of living to 36 months than a patient alive at 24 months. And I had to start at 18 months (which was 6 months after 12 months) because that’s approximately the month where any alive and not LTFU censor patients began on the charts. And to reach the 24 month from 18 months percentage of risk or percentage alive statistic provided by the company (66.7% alive for meth+ and 32.1% alive for meth-), I had to calculate the 6 month risk.

And I also thought that by using the 6 month intervals, I was more fairly allocating the risks based on the numbers provided by the company.

In the met+ group the chance of survival at 12 months is 97.6% and at 24 months it is 67.7%. The difference is 29.9% not 27.8%.



The table shows the meth+ percentage at 12 months is 94.5% - not 97.6%
I wish we had that extra percentage, but unless I’m missing something, I don’t think that’s right.



Regarding the 31 met+ patients between 24-30 months. 89.44% X 31 =28 (27.7) not 25.



OMG, I love it when you find errors like that of mine! You are right. So that would be 3 more patients moving forward to 30 months. So instead of 25 patients added to the 7 meth+ patients alive past 30 months, we have 28 patient + 7 meth+ patients to equal 35 patients.

35 x 89.44% who should live from 30 to 36 months based on the interim blended data = 31.30 or 30 patients who would live to 36 months.

44 had already lived to 36 months
31 methylated should live to 36 months
=75 methylated patients live to 36 months

2 more!

44 already lived to 36 months, 29 methylated should live to 36 months = 73 methylated patients? (29 methylated and 44 with unknown methylation status?



I’m not sure what you’re asking here but we know 44 lived past 36 months. We didn’t know their methylation status, but based on the chart, we can estimate that there were 31 meth+ patients over 36 months, and 13 meth- patients.

44 meth+ censor patients
+ 56 meth + events
= 100 patients prior to 36 months

131 total meth+ patients
-100 patients prior to 36 months
= 31 meth+ patients over 36 months

33 meth- censor patients
116 meth- events
= 149 patients prior to 36 months

162 meth- patients
-149 patients prior to 36 months
= 13 meth- patients over 36 months

31 meth+ PLUS 13 meth- = 44 patients over 36 months

Regarding the met- group, 86.4% live to 12 months and 32.1% to 24 months = 54.3% attrition rate. 54.3%/12 months = 4.5% per month. 4.5% X 6 months = 27%. 73% of these met- patients make it to 24 months?



If 27% is the percentage of patients that we will lose from 18 to 24 months, then 100% - 27% = 73% is the percentage of meth- patients that will live from 18 to 24 months.

But based on your correction, these are the new numbers:

44 already had lived to 36 months
31 methylated should live to 36 months
18 unmethylated should live to 36 months

approx. 93 total patients should live to 36 months or 28% (not 27%) of the trial’s enrollment.


And as a reminder, these figures are based on the 3/17 data numbers. These numbers are likely to be improved if those final 31 patients were all enrolled as treatment patients.