Mortality
In the ITT population (n=75), mortality was numerically lower for
nebulised UFH on top of standard of care (6 out of 38 patients; 15.8%)
versus standard of care (10 out of 37 patients; 27.0%), but this
difference was not statistically significant (odds ratio 0.51,
p=0.2349), with similar results observed for the per protocol population
(odds ratio 0.31, p=0.1482) (Table 4). However, there were statistical
differences between treatments in favour of nebulised UFH in the mITT
population (odds ratio 0.2,
p=0.0353), and the post-hoc analysis of PP6 population (odds ratio 0.1,
p=0.0184), Table 4.
All deaths occurred in patients who scored 4 or 5 on the WHO ordinal
scale on the day of hospital admission.
Table 3 -Mortality comparison between the two groups)