In February, Pfizer announced that the phase-III trial was stopped early since the drug met the primary endpoint in time to progression.
These results were promising, but recent large randomized phase III trials including 525 patients demonstrated no beneficial effects on either the secondary or primary endpoints, including reduction in time to amputation or death [ 14].
Instead, they're sweating about whether the primaries will be held in time to populate their state conventions in early June.
The SWAMP trial was powered for the primary end point of 'difference in time to progression on serial CT scan between patients demonstrating a metabolic response to chemotherapy on interval PET-CT vs those demonstrating no metabolic response'.
GPPAQ scores from participants' computerised primary care records (n = 56) were compared to PACE-Lift trial recorded GPPAQ scores, using trial data closest in time to the primary care record.
In a 1-year trial of donepezil 10 mg/day, there was significant benefit versus placebo in the primary endpoint, time to clinically evident decline in function (Wolfson et al. 2002; Birks & Harvey 2003; Warner et al. 2004).
Screened variables were the 10 most common presenting complaints, age-group, referral status, triage priority, presentation on a shift experiencing many visits (see definition below), presentation on night shift and during weekends, sex, leaving without being seen (LWBS), entering ED via primary triage, time to physician and in-hospital occupancy.
The primary outcome was time to in-hospital death.
Secondly, locomotion must be primary in time: for this is the only motion possible for things.
There was no significant difference between the groups in the primary outcome of time to recovery, or in the number of children with diarrhoea at three, five or seven days, although point estimates tended to favour the group receiving metronidazole combined with nalidixic acid.
