showed a trendP =0.057
However, analysis of the published data by Fisher's Exact test ( Benner, 1999 ; Pazdur et al , 1999 ) showed a trend for increased incidence of grade 3 or 4 diarrhoea with UFT plus LV ( P =0.057), based on a safety population of 406 patients for UFT plus LV and 396 for the Mayo Clinic regimen ( Cunningham and James, 2001 ).