Tuesday, January 05, 2021 2:33:47 PM
"The excessive censoring occurred to a higher percentage in the Optune arm, but Stupp’s SOC arm was pumped with excessive censoring as well."
Then there's no issue so long as the censoring reasons are the same for both arms and the numbers are similar which they more or less seem to be. Also it doesn't matter so much that it's unblinded so long as those reasons for censoring are defined a priori.
"Hell, they even censored if they did not have the exact date of death in an unblinded trial, yet they don’t document the number of censors there"
i presume those numbers belong to the lost to follow up category as they have to be in one of those categories and it's clearly not the others. So documented numbers at the time of approval for optune arm are =<1, =<1, =<3, =<12 and SOC arm are =<1, =<2, =<3, =<4 at 6, 12, 18 and 24 months respectively. You're not going to move the KM curves very much fiddling with those numbers.
"Are you going to put that in your letter of complaint?"
i wasn't planning on writing one.
Then there's no issue so long as the censoring reasons are the same for both arms and the numbers are similar which they more or less seem to be. Also it doesn't matter so much that it's unblinded so long as those reasons for censoring are defined a priori.
"Hell, they even censored if they did not have the exact date of death in an unblinded trial, yet they don’t document the number of censors there"
i presume those numbers belong to the lost to follow up category as they have to be in one of those categories and it's clearly not the others. So documented numbers at the time of approval for optune arm are =<1, =<1, =<3, =<12 and SOC arm are =<1, =<2, =<3, =<4 at 6, 12, 18 and 24 months respectively. You're not going to move the KM curves very much fiddling with those numbers.
"Are you going to put that in your letter of complaint?"
i wasn't planning on writing one.
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