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Property:Results after intervention

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Overall incidence of grade 2 diarrhea: intervention arm 20.5% vs. control arm 44.5% (p = 0.04)  +
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One month after completion of radiotherapy: taste perception threshold was increased in the placebo arm for al four tastes (p = 0.001), in the intervention arm, there was only slight increase in threshold for perception of the salty taste (p = 0.046)  +
''Overall:'' No significant differences; Supporting analysis: multivariable HR for progression-free survival or death was 0.64 (95% CI, 0-0.90; p=.02) Subgroupanalysis: High-dose vitamin D<sub>3</sub> on progression-free survival appeared to be greater among patients with a lower body mass index (p=.04 for interaction), more metastatic sites (p=.02 for interaction), and KRAS wild-type tumors (p=.04 for interaction) Post-Hoc-Analysis: Comparison between the both arms: ECOG performance status was statistically significant (p=.03); No effects for adjustment by enrollment sites or tumor location  +
PSA values showed a greater decrease for those on polyphenon E than those on placebo but this did not reach statistical significance (p=0.26). Reduction of PSA in Polyphenon E arm = 14 (58.3), in Placbo arm = 8 (36.4), but no significant group difference (p=0.15).  +