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Property:Results during intervention

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No significant differences in median duration of PSA progression-free survival; median duration of tumor progression-free survival and median duration of clinical progression-free survival could not be reliably assessed due to the lack of regularly scheduled tumor imaging  +
The incidence of any grade 3 or 4 adverse events was not significantly different; serious adverse events, generally those requiring hospitalization, were observed in 41% of placebo-treated patients and 27% of DN-101-treated patients (p = .023); Among the grade 3 or 4 nonhematologic toxicities, the most common were fatigue (16% placebo; 8% DN-101), infection (13% placebo; 8% DN- 101), and hyperglycemia (12% placebo; 6% DN-101)  +
Within 6 months of enrollment: no significant differences in PSA decline; at any time while on study: PSA decline achieved in 52% of placebo- treated patients and 63% of DN-101-treated patients (p = .07); median time to PSA response was 5.3 months in placebo-treated patients and 2.9 months in DN-101-treated patients (p = .06)  +
Incidence of delayed nausea: no significant differences overall Cycle 1: (intervention vs. placebo: p=0.851 Cycle 2: intervention vs. placebo: p=0.379 Subgroup analysis : in the 2nd cycle lung cancer patients in intervention significantly higher than in placebo (OR 2.67 95%CI 1.03/6.87; p=0.042) Significant delayed nausea: overall no significant differences Cycle 1: intervention vs. placebo: p=0.163 Cycle 2: intervention vs. placebo: p=0.239 Subgroup analysis: men in intervention significantly higher than in placebo (OR 2.74 95% CI 1.28/5.85; p<0.05)  +
Incidence of anticipatory nausea: no significant differences Cycle 1: intervention vs. placebo: p=0.823 Cycle 2:intervention vs. placebo: p=0.629 Significant anticipatory nausea: no significant differences Cycle 1: intervention vs. placebo: p=0.666 Cycle 2: intervention vs. placebo: p=0.536  +
No significant difference between arms. At cycle 1: worsening of the BFI score was smaller with ginger than placebo (treatment difference -0.23, 95% CI: -0.97 to 0.51). At cycle 2: the situation was different: worsening with ginger was slightly higher than with placebo (treatment difference 0.09, 95% CI –0.71 to 0.89). During both cycles, differences in BFI scores were negligible.  +
Incidence of inter-cycle nausea: no significant differences overall Cycle 1: intervention vs. placebo:p=0.367 Cycle 2: intervention vs. placebo: p=0.417 Subgroup analysis: overall and in the first cycle lung cancer patients in intervention higher than in placebo (OR 2.77 95% CI 1.16/6.64; OR 4.27 95% CI 1.60/11.37) Significant inter-cycle nausea: no significant differences overall Cycle 1: intervention vs. placebo: p=0.074 Cycle 2: intervention vs. placebo: p=0.361 Subgroup analysis: Men significantly higher in intervention than in placebo (OR 2.38 95% CI 1.04/5.44; p<0.05)  +
No significant difference in the rate of seroconversion against vaccine antigens according to selected antigens (PS1, PS5, PS6, PS9, PS14, PS18)  +
Significantly higher prevaccinal concentrations of antibodies against polysaccharides PS1, PS5, PS6, PS9, PS14, and PS18 in both arms at both 4 and 16 week after vaccination; concentrations of PS6-specific antibodies in the end of study significantly higher in the placebo arm (MW (95% CI): 2.96 (1.74–5.03), p < 0.01)  +
Change in plasma 25(OH)D concentration from baseline to cycle 8 was not significantly associated with change in body weight, body mass index, muscle area, muscle attenuation, visceral adipose tissue area and subcutaneous adipose tissue area  +
Maximum toxicity intervention vs. control arm: dysphagia 22.7% vs. 35.3%, ageusia 22.7% vs. 47.1%, xerostomia 22.7% vs. 23.5%, and stomatitis 36.4% vs. 23.5%; no significant differences; Significant mean difference between arms only for dysphagia at week 7: mean intervention arm 1.533 vs. control 2.167 (p=0.05)  +
At baseline no significant differences; Significant differences in selenium concentrations (serum and blood) at half of radiotherapy (p<0.0001)  +