Mi D,
If you're right about the trial not being stopped until they had 248 events, and events mean deaths, then were 80+ alive when it ended. The trial as originally designed I believe would have considered progression as events and that should have occurred substantially earlier, but if it didn't they probably reclassified the earlier progressions that were really pseudoprogression. Again, if this is the case it just shows how bad the regulators can be. Should a trial go on for decades because sufficient people hadn't died. I think they could easily have said until 248 people either evented, or past 3 or 4 or 5 years since treatment was initiated. 3 years should have been sufficient, but the regulators could easily insist on 4 or 5, regardless the trial would have been over for years.
While you're right about the clinicians being blinded, once all patients crossed over they weren't blinded to much, each patient either got the vaccine up front, or on crossing over. This gave Drs. Liau and others the knowledge that people on the vaccine were living longer, whether they spoke to specifics or not.
Gary
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