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Property:Results after intervention

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- Intervention group 20% vs. placebo group 10% - According to authors no significant differences (no p-value given)  +
- None in intervention group - Two in placebo group (1 case of tongue cancer and 1 of floor of mouth cancer) - No p-values reported  +
Mean (μg/ml) after three years - intervention group: 0.78 - placebo group: 0.5 - no p-values reported  +
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Selenium level at baseline (n=1,022), year 2 (n=375), and year 4 (n=194): at baseline selenium level mostly in normal range, after 2 and 4 years significantly increased selenium concentration in the intervention arm  +
Intervention arm: 76.8% (SE, 1.6%) vs. placebo arm: 79.9% (SE, 2.1%); p=0.154 Note: Distribution significantly different for smoking status (p=0.027): active smokers or those who had quit within one year showed a 3-year OS of 85.5% (SE, 1.7%) and 5-year OS of 74.9% (SE, 2.4%), whereas participants who had never smoked showed a 3-year OS of 90% (SE, 2.8%) and a 5-year OS of 83.6% (SE, 3.6%); no difference for DFS; p=0.245  +
Collected in 865 patients in intervention arm and 477 in placebo arm: * Grade 1-2 toxicity in intervention arm: 31% and placebo arm: 26% of subjects * Grade ≥ 3 toxicity occurred in less than 2% of subjects in intervention arm and 3% in placebo arm * n=1 patient in placebo arm had constitutional lethal toxicity * no arm comparison performed  +
Interim analysis October 2009: N=83 secondary lung tumors; Rate intervention arm: 1.91 per 100 persons per year vs. 1.36 in placebo arm; p=ns June 2011: N=252 secondary tumors in 224 patients, of which 98 (out of 97 patients) were lung cancer (38.9%); Lung cancer and other cancers (SPT) in intervention arm: 1.62 and 3.54 per 100 persons per year vs. placebo arm: 1.30 and 3.39 per 100 persons per year; p=0.294 5-year DFS: October 2009: Intervention arm: 72% vs. placebo arm: 78%, no significance values given June 2011: Intervention arm: 74.4% vs. placebo arm: 79.6%; p=0.69 Note: 5-year DFS rates with subdivision into low, average and high selenium concentration intervention vs. placebo: 75.5% (SE, 10.3%) vs. 72.9% (SE, 12.7%), 75.6% (SE, 2.27%) vs. 78.2% (SE, 3.3%), and 72.9% (SE, 4.5%) vs. 80.9% (SE, 5.2%)  +
Mean tension of the ill arm after 45 days: Enzyme-arm = 0.4; Placebo-arm = 0.5 Both arms show a similar decrease of tension in the ill arm, but but the decrease was a little bit greater in the enzyme-arm (p=NI).  +
Mean volume of the upper ill arm at day 45: Enzyme-arm = 4mm; Placebo-arm = 3.4mm Both arms show similiar developement of skin thickness after 45 days. Similar development in the lower arm, hand and third finger. There is a slight advantage for the enzyme-arm for upper ill arm and lower arm; (p=NI).  +
Mean Volometer of the ill arm at day 45: Enzyme-arm = 2275.1; Placebo-arm = 2225.7 Both arms show a decrease of volume until day 45, but there was no significant difference between the arms (p = NI).  +
Complete histological tumor clearance was observed in 1 of 21 (5%) and 2 of 21 (10%) patients in the sinecatechins and placebo group, respectively no significant difference in histological tumor clearance between the sinecatechins and placebo groups (p > .99).  +
Decrease in tumor size was slightly greater after sinecatechins application, but the difference was nonsignificant (p = 0.15).  +
Significant effect only for subgroup: overall survival was higher in intervention arm compared to comparison arm for patients undergoing neoadjuvant treatment (p=0.04) after 3 months n = 25 (intervention) + 19 (comparison)  +