To: aknahow who wrote (8194 ) 1/6/1999 12:27:00 AM From: Cacaito Read Replies (1) | Respond to of 17367
Caveat: numbers are base on educated guess, sometimes wild guess, and sometimes hype guess. Caveat Emptor. Total meningococcal disease in England 2800, Mortality is 10% or 280 deaths. This is a mix of 80% meningitis = 2260 and 20% menigococcemia/true shock type = 540 (this is the group that qualifies for xom's trial of bpi. Mortality in meningitis (non shock type) 5% to 10%. If one takes 7% of 2260 then = 158 deaths in that group. There are 75% of xoma's trial patients from UK, So far enrollment is 303, then : 75% x 303 = 228 patients from the UK. This 228 trial recruits belong to the 540 truly shock patients (20% of total meningo of UK) this 540 will bear the majority of deaths. But they are divided roughly in 3 groups: 1. non recruits: 540 - 228 = 312 x 25% mortality = 78 deaths. Historical mortality could vary from 30% to 50% ( 20% in Lancet phase II comparison. 2. recruits non bpi, control 228 x 50%(ramdomized eventually will be half and half, not exactly but roughly) = 114 x 25% mort = 29 deaths 3. recruits on bpi, 228 x 50% = 114 x 10% mortality (and this is more than double the 4% seen in the phase II study of bpi, so it is allowing a generous degree of failure to bpi due to more objectivity from a blind study) then = 14 deaths Total deaths in the "shock type patients" both non trial and trial in bpi an trial not in bpi = 78 + 29 + 14 = 121 Meningitis type 158 + shock type 121 = overall total of 279, and this is very similar to the 10% of 2800 for the UK. One could add or take out one or two patients, one could even add that there is an adult trial in the UK (non blinded)independent of Xoma by one of xoma's UK collaborators that was going to treat 10 adults, this could save lives by BPI and contribute further to the overall low 10%. I assume that the ones in this small trial will be the shock type patients. One probability is improved general care of the trial control group, it usually happens in many studies due to the high level of quality in the overall study, and the attention to detail and resource$, even if you are in a placebo control group you will have a slight better chance than the general population. As Mark Twain said: lies , dammed lies and Statistics. Xoma results should be after the 90 days follow up end of march? Tharos you are in the right track, the least morbidity in survivors, less amputations and less disability could lead to approval even if mortality is not statistically proven. But even for 25% vs 10%, and even for 20% vs 10% they do have the numbers. George, we discussed in the past the existence of two Bpi arms of the study, but if they also planned for an overall number they could use the two arms as one leg: total bpi vs control and go ahead with limping but with FDA approval, if previously plan with FDA .