Monday, May 03, 2021 1:39:04 PM
AVII77,
Low absolute lymphocyte count patients, expected to have poorer outcomes, were allowed into this trial in Germany and yet maturing data which included the German patients suggested an improvement in longer term outcomes was occurring and some of these patients were included in the 100 best survivors category being looked at for long term survivors. If low ALC patients were responding well to treatment while low ALC SOC/placebo patients were eventing early as expected an ethical issue for the Germans would have arisen if a statistical analysis was used to prove this out. Funny that Fraunhofer claimed to only enroll to the point statistically necessary and then never gave enrollment numbers even though all planned for treatment patients were enrolled while 17 SOC/placebo patients were left out even though 31-32 patients were enrolled after the screening halt. Best wishes.
Low absolute lymphocyte count patients, expected to have poorer outcomes, were allowed into this trial in Germany and yet maturing data which included the German patients suggested an improvement in longer term outcomes was occurring and some of these patients were included in the 100 best survivors category being looked at for long term survivors. If low ALC patients were responding well to treatment while low ALC SOC/placebo patients were eventing early as expected an ethical issue for the Germans would have arisen if a statistical analysis was used to prove this out. Funny that Fraunhofer claimed to only enroll to the point statistically necessary and then never gave enrollment numbers even though all planned for treatment patients were enrolled while 17 SOC/placebo patients were left out even though 31-32 patients were enrolled after the screening halt. Best wishes.
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