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Message: Patient Enrollment Modeling

Yep. I'm penciling in 2400 patient hours for mid June based on his numbers. Is anyone else accounting for patients remaining? Taking patient hours and multiplying it to event rate gives us 172.8 MACE events in Mid June. If we assume the dropout rate is the same as the MACE rate, as it has been in previous trials, this would mean in mid June there were approximately 2050 patients still in the trial.

And then three months later, in Mid September (Sept 12th to be precise), the company provides us with “we now stand almost bang on 200” Mace Events. Thus between Mid June and Mid September, MACE events transpired at about 9.7 per month. Granted MACE rates should rise as we go into winter, and it will be interesting to see how quickly that happens. But if we use the September 200 MACE data points with the extrapolated total patient hours we find that the event rate dropped below 7% in September. The shaded boxes are numbers provided either by Turndup or the company. The rest of the numbers have been extrapolated to give rough estimates. Here are my rought numbers. Hoping to get comments and criticism. Thanks.

Date Patients Remaining Patient Hours MACE events Event Rate Events / Month
06/15/2018 2054.4 2400 172.8 0.072 12.3264
07/15/2018 2036 2571.2 182.5333333 0.07099149554 9.733333333
08/15/2018 2018 2740.866667 192.2666667 0.07014812833 9.733333333
09/15/2018 2000 2909.033333 202 0.06943887431 9.733333333
10/15/2018 1975 3075.7 214.5 0.06974022174 12.5
11/15/2018 1950 3240.283333 227 0.07005560213 12.5
12/15/2018 1925 3402.783333 239.5 0.07038355856 12.5
01/15/2019 1900 3563.2 252 0.07072294567 12.5
02/15/2019 1875 3721.533333 264.5 0.07107285527 12.5
03/15/2019 1850 3877.783333 277 0.07143256242 12.5

 

 

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