Koman I know two ways PIII was adjusted for immune system damage.
First, more patients were added to the trial which naturally resulted in a delay in the trial of nearly a year.
This was the capacity to expand the trial that Linda Powers kept bragging about before pulling the trigger. Absent the immune system issue (which we were not fully aware of) adding patients to a blinded trial never made sense since it would just result in a delay. By definition, with a blinded trial you should never know you need to add patients...or so it seemed. But then this research came out about immune system damage, research that was not available when the PIII was designed and started.
The information arm has not been adjusted with additional patients to account for the compromised immune systems unlike the main PIII.
Second, in reporting the PIII trial results, FDA would allow NWBO to report on which of the patients had compromised immune systems and that this would somehow be taken into account. This is only fair since SOC is not necessary for DCVax but is only used first because the regulations require it.
Thus post-approval you wouldn't be using DCVax on patients with immune systems badly damaged by chemo and radiation since they would not have received those older forms of treatment in the first place. Some "legacy patients" who were treated using the old SOC would present of course, and you would try your best but are you going to blame the DCVax for failing due to the SOC it is striving to replace?
The Information Arm, to my knowledge did not separately track patients who had the issue with immune response highlighted in the study that forced the revision of the main PIII trial.
Had I been there in Germany, I would have loved to ask Dr. Bosch about that issue though. Q&A was way too short to cover all the issues, just as it always is.
