Sunday, August 11, 2024 12:09:23 PM
From what I understand partly due to the 41 week covid interuption delay only 33 people started on the PDD OLE trial and 20 finished in so around 60% completion.
If say 70% of the 191 dosed completers continued onto OLE then that would mean 134 from this group. If 60% of 122 placebo completers then 73 from this group.
Would mean 207 at start of OLE so if the same 60% odd OLE completion would be around 124 at end of 96 week trial. Not amazing number number but enough to get some more confirmatory data.
60-70% completion would be roughly the expected completion from this type of trial.
What was the change in wording from the 10k?
If say 70% of the 191 dosed completers continued onto OLE then that would mean 134 from this group. If 60% of 122 placebo completers then 73 from this group.
Would mean 207 at start of OLE so if the same 60% odd OLE completion would be around 124 at end of 96 week trial. Not amazing number number but enough to get some more confirmatory data.
60-70% completion would be roughly the expected completion from this type of trial.
What was the change in wording from the 10k?
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