The BOLD part is EXACTLY what I addressed in the post, i used the wording "external factors" in-staid of "external variables" and positioned the patients assignment to groups, not spreading the ECOG levels, as an external factor which in the pancreatic was heavily in favor of the control arm.
You explained stat sig well but something needs to be added. The p < 0.05 is really arbitrarily set number, it is 5% or second standard deviation. What that means is that if a drug is approved with p=0.04999 the chance is still about 5% that the drugs really doesn't work and the result of that particular phase 3 was a statistical fluke. We could have set the standard for approval to be first standard deviation, or the third one, or any number in between. So saying that p=0.04999 is stat sig and p=0.05001 is not and sticking strictly to that as a condition for a drug approval is almost ridiculous.