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Property:Results after intervention

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Overall no significant arm difference Subgroup analysis: Women and patients with head and neck tumors significantly higher in intervention than in placebo (7.31; 95% CI 14.56/0.06, p=0.048 and 7.43; 95% CI 14.42/0.43, p=0.038, respectively)  +
Time to onset: median in intervention group and placebo group: after 2 chemotherapy cycles Number of subjects with HFS (%): intervention: 10/38 (26%), placebo: 8/39 (21%); p = 0.547, not significant The groups do not differ in terms of HFS incidence Separated by CTCAE grade: Grade 1: intervention group: 4/38 (4%), placebo group: 2/39 (5%) Grade 2/3: intervention group: 6/38 (16%), placebo group: 6/39 (15%)  +
Reduction of capecitabine dose (number): intervention group: 9 (2 patients grade 3 diarrhoea with necessary hospitalization, 1 patient grade 3 stomatitis, 4 patients grade 3 HFS, 2 patients grade 3 neutropenia) placebo group: 8 (3 patients grade 3 diarrhea, 2 patients grade 3 stomatitis, 3 patients grade 3 HFS)  +
''Overall:'' In the subgroup of 105 participants randomization to high-dose vitamin D3 was associated with a lower risk of disease progression or death as compared with low-dose vitamin D3 [HR: 0.67; (95% CI: 0.42, 1.07)]; the magnitude of risk reduction was similar to that observed in the full analysis set of 139 participants as previously reported; Change in body composition over the first 8 cycles of chemotherapy did not mediate the association between randomized arm and progression-free survival  +
No significant differences; overall number of serious adverse events, not significantly different: intervention arm 23x and control arm 22x (p=0.476)  +
At 6 weeks after irradiation no significant differences; Significant differences in selenium concentrations (serum and blood) at the end of radiotherapy (p<0.0001)  +