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Property:Results after intervention

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A
Mean value After 4th cycle Intervention arm (paste): 2.9, intervention arm (tablets): 4.33, placebo arm: 4.86; p = 0.001  +
Number in % with grade 3-4 After 4th cycle intervention arm (paste): 26.3, intervention arm (tablets): 43.7, placebo arm: 42.8; p = 0.01  +
B
DFS for '''any supplementation''' beyond 3.5 years after randomization: HR = 0.85 (95% CI: 0.48, 1.50), i.e. no significant difference between intervention and placebo arm DFS for '''beta-carotene + Vit. E''' beyond 3.5 years after randomization: HR = 1.11 (95% CI: 0.47, 2.61), i.e. no significant difference between intervention and placebo arm DFS for '''only Vit. E''' beyond 3.5 years after randomization: HR = 0.71 (95% CI: 0.33, 1.53), i.e. no significant difference between intervention and placebo arm  +
SPT for '''any supplementation''' beyond 3.5 years after randomization: HR = 0.57 (95% CI: 0.31, 1.07), i.e. no significant difference between intervention and placebo arm SPT for '''beta-carotene + Vit. E''' beyond 3.5 years after randomization: HR = 1.11 (95% CI: 0.47, 2.61), i.e. no significant difference between intervention and placebo arm SPT for '''only Vit. E''' beyond 3.5 years after randomization: HR = 0.41 (95% CI: 0.16, 1.03), i.e. no significant difference between intervention and placebo arm No influence of smoking status  +
Local recurrence for '''any supplementation''' HR = 1.37 (95% CI: 0.93, 2.02),i.e. no significant difference between intervention and placebo arm Local recurrence for '''beta-carotene + Vit. E''' HR = 1.56 (95% CI: 0.79, 3.07), i.e. no significant difference between intervention and placebo arm Local recurrence for '''only Vit. E''' HR = 1.29 (95% CI: 0.89, 2.08), i.e. no significant difference between intervention and placebo arm  +
Side effects for '''any supplementation''' directly post-radiotherapy (T2): ''All sides'': OR = 0.77 (95% CI: 0.54, 1.09), 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''' directly post-radiotherapy (T2): ''Total'': OR = 0.33 (95% CI: 0.17, 0.65), i.e. significant difference between intervention and placebo arm (lower risk for intervention arm) ''Larynx only'': OR = 0.42 (95% CI: 0.23, 0.77), 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''' directly post-radiotherapy (T2): ''Total'': OR = 1.06 (95% CI: 0.70, 1.60), i.e. no significant difference between intervention and placebo arm ''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences Side effects for '''any supplementation''' 1 month post-radiotherapy (T3): ''All sides'': OR = 1.11 (95% CI: 0.79, 1.55), 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''' 1 month post-radiotherapy (T3): ''Total'': OR = 0.98 (95% CI: 0.52, 1.87), i.e. no significant difference between intervention and placebo arm ''Larynx only'': OR = 0.61 (95% CI: 0.32, 1.17), i.e. no significant difference between intervention and placebo arm ''Skin, mucosa, pharynx and esophagus'': no significant differences Side effects for '''only Vit. E''' 1 month post-radiotherapy (T3): ''Total'': OR = 1.17 (95% CI: 0.78, 1.74), i.e. no significant difference between intervention and placebo arm ''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences  +
Mean difference (95% CI) between intervention and placebo arm for '''any supplementation''' 1 month post-radiotherapy (T3): - EORTC QLQ-C30 sleep disturbance: 4.05 (0.37, 8.48); p = 0.07 (p = 0.02 for '''beta-carotene + Vit. E''' ) - EORTC QLQ-C30 diarrhea: -2.74 (-4.54, -0.93); p = 0.003) - EORTC QLQ-C30 remaining scales: no significant differences - HNQR: no significant differences No reported results regarding '''only Vit. E'''  +
'''Overall''' Number of any cause deaths for ''any supplementation'': - intervention arm n=102 vs. placebo arm n=77 - HR = 1.38 (95% CI: 1.03, 1.85), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm) Number of any cause deaths for ''beta-carotene + Vit. E'': - intervention arm n=37 vs. placebo arm n=30 - HR = 1.31 (95% CI: 0.81, 2.11), i.e. no significant difference between intervention and placebo arm Number of any cause deaths for ''only Vit. E'': - intervention arm n=65 vs. placebo arm n=47 - HR = 1.43 (95% CI: 0.98, 2.07), i.e. no significant difference between intervention and placebo arm No significant differences in other causes of cancer  +
Decrease Baseline to 4 weeks in % Frequency of hot flashes per day: Intervention arm: 25%, Placebo arm: 22%; p = 0.90 ns. Correlation with baseline value: r = 0.12; p = 0.21 ns. Daily hot flash score (frequency with average severity): Intervention arm: 28%, Placebo arm: 20%; p = 0.68 ns. Correlation with baseline value: r = 0.13; p = 0.18 ns. -------------- Crossover: Decrease 4 weeks to 8 weeks in % Frequency of hot flashes per day: Intervention arm: 0.04%, Placebo arm: 17%; p = 0.32 ns. Daily hot flash score: Intervention arm: 0.03%, Placebo arm: 25%; p = 0.24 ns. Within-subject analysis: Significant differences in frequency and hot flash score between placebo and Vit. E (both p ≤ 0.05), approximately 1 less hot flash Frequency differences between placebo and Vitamin E per week: Intervention arm (Vitamin E first then Placebo): Week 1 vs. 5: p = 0.01; Week 2-4 vs. Week 6-9: p < 0.05, sign. Placebo arm (Placebo first then Vitamin E): Week 1 vs. 5: p = 0.001; Week 2 vs. 6: p = 0.0004; Week 3 vs. 7: 0.003; Week 4 vs. 8: p = 0.07, sign. Similar results for hot flash score Question about patient preference in both arms: Vit. E: 32%, Placebo: 29%, No preference: 38%.  +