I lost access to the computer with Statistica software, but we
could get back to a previous post:
Message 3062902
And one could see that 200 patients is more than enough to provide
statistical significant even when one doubles the rate for the phase II BPI group (4% to 10%) and lowers the expected death rate for the
placebo group to 20%.
Now there are 300 plus patients recruited as per last numbers offered by
George the Wowanka. The trial is not just one treatment group, but
two treatment groups and one placebo group.
The groups are:
1. Placebo - control - no BPI
2. BPI, high Glasgow scale group (moderately sick patients)
3. BPI, low Glasgow scale group ( severely sick patients)
This was one of the reason the trial went on for a higher number of
patients, plus the agreement with the FDA to conclude the trial end of
1998 (my recollection of the story).
Now, the trial is very well design for Xoma's chances with the FDA,
if BPI is not good due to being very late on starting the drug then
one have the answer, if earlier is worth it then one will have the answer, if it is worth it in both groups then great. Of course, if it does not work in either see you in another thread.
Regarding the mortality numbers in England and Bpi as a possible cause is just too much to ask for. First: are this blood culture confirmed?
are they all pure shock type patients (ussually about 20% of the total at any time, and this is the group that the BPI trial is aim to)I do not think so, I do think that one have here the meningitis non shock patients included and this just altered everything and to try to calculate is futile. Back to just wait for final report. |
