Wednesday, February 03, 2021 10:14:41 AM
And one of the cool mathematical aspects of the trial
is the required number of evaluable patients. = 784
which divided by 7 is exactly 112.
The two comparative arms need a minimum of 336 to reach statistical significance.
Original design: total enrollment was pegged at 880 to allow for dropouts.
Adhering to that enrollment (880), the total enrollees in each of the two comparative arms was scheduled to be: 377
Laidlaw report 2013.
The trial design was 298 events in the two comparative arms.
The actual enrollment was an additional 40 total in the two comparative arms...and NO CHANGE to the concluding event number of 298.
With 40 additional enrollees the 298th event should have been reached sooner than original trial design.
Yet it still went on two years past historic OS rates.
is the required number of evaluable patients. = 784
which divided by 7 is exactly 112.
The two comparative arms need a minimum of 336 to reach statistical significance.
Original design: total enrollment was pegged at 880 to allow for dropouts.
Adhering to that enrollment (880), the total enrollees in each of the two comparative arms was scheduled to be: 377
These trial arms will have about 377 patients each. The third arm of the trial will have about 125 patients.
Laidlaw report 2013.
The trial design was 298 events in the two comparative arms.
The actual enrollment was an additional 40 total in the two comparative arms...and NO CHANGE to the concluding event number of 298.
With 40 additional enrollees the 298th event should have been reached sooner than original trial design.
Yet it still went on two years past historic OS rates.
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