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Property:Results during intervention

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A
After chemotherapy (8 days): significantly better cardiac ejection fraction in sodium selenite arm (mean(SD)= 63(6%)) vs. control arm (69(6%)); p <0.05  +
After chemotherapy (8 days): significant less infections in sodium selenite arm (20%) compared to control arm (67%); p<0.05  +
No difference between treatment arms in the rate of PSA response, no difference in the median time to PSA response  +
No complete responses were observed, partial objective response rate was not significantly different, neither was stable disease rate  +
Mean value After the 1st cycle Intervention arm (paste): 1.2, intervention arm (tablets): 1.3, placebo arm: 1; p = ns After 2nd cycle Intervention arm (paste): 2, intervention arm (tablets): 1.9, placebo arm: 2.2; p = ns After 3rd cycle Intervention arm (paste): 2.43, intervention arm (tablets): 3.8, placebo arm: 4.4; p = 0.05  +
Number in % with grade 3-4 After 1st cycle intervention arm (paste): 7.6, intervention arm (tablets): 8.3, placebo arm: 7.6; p = ns After 2nd cycle intervention arm (paste): 11.5, intervention arm (tablets): 12.5, placebo arm: 15.3; p = ns After 3rd cycle intervention arm (paste): 21.7, intervention arm (tablets): 33.3, placebo arm: 31.8; p = 0.01  +
B
DFS for '''any supplementation''' up to 3.5 years after randomization: HR = 1.65 (95% CI: 1.21, 2.25), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm) DFS for '''beta-carotene + Vit. E''' up to 3.5 years after randomization: HR = 1.27 (95% CI: 0.73, 2.21), i.e. no significant difference between intervention and placebo arm DFS for '''only Vit. E''' up to 3.5 years after randomization: HR = 1.86 (95% CI: 1.27, 2.72), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm)  +
SPT for '''any supplementation''' up to 3.5 years after randomization: HR = 2.42 (95% CI: 1.45, 4.04), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm) SPT for '''beta-carotene + Vit. E''' up to 3.5 years after randomization: HR = 1.51 (95% CI: 0.58, 3.98), i.e. no significant difference between intervention and placebo arm SPT for '''only Vit. E''' up to 3.5 years after randomization: HR = 2.88 (95% CI: 1.56, 5.31), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm) No influence of smoking status  +
Side effects for '''any supplementation''' during radiotherapy (T1): ''All sides'': OR = 0.72 (95% CI: 0.52, 1.02), i.e. no significant difference between intervention and placebo arm ''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences Side effects for '''beta-carotene + Vit. E''' during radiotherapy (T1): ''All sides'': OR = 0.38 (95% CI: 0.20, 0.74), i.e. significant difference between intervention and placebo arm (lower risk for intervention arm) ''Larynx only'': OR = 0.38 (95% CI: 0.21, 0.71), i.e. significant difference between intervention and placebo arm (lower risk for intervention arm) ''Skin, mucosa, pharynx and esophagus'': no significant differences Side effects for '''only Vit. E''' during radiotherapy (T1): ''All sides'': OR = 0.92 (95% CI: 0.62, 1.38), i.e. no significant difference between intervention and placebo arm ''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences  +
After adjustment for baseline characteristics of hemoglobin and Eastern Cooperative Oncology Group performance status, overall survival showed a promising improvement in intervention arm over the placebo arm with a HR of 0.67 (95% CI, 0.45 to 0.97; p = .04)  +