The last 79 patients..were they "abdominally septic only"?Below in black from Spectral..green from your truly..
The composite mortality rate of randomized patients in the trial since the protocol change has increased significantly and is now, on average, approximately 50 percent, which trend prompted the Data Safety Monitoring Board (“DSMB“) to recommend that the Company consider another interim analysis in order to recalculate the appropriate sample size for this specific patient population. By comparison, the composite mortality rate at the time of the planned interim analysis, conducted in January 2014, was approximately 30 percent.
This was written at patient 371, or 101 patients into the last 180. In order to satisfy the reported 45% we finished with at patient 180, we would have needed to produce a CM of 39% on the final 79 patients or 30 additional deaths to accompany the 50 deaths on the first 101 patients. If the placebo remained at 47.5%, our PMX group died at 30.5% and our absolute benefit is 17%.
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