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Property:Specifications on analyses

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A
Kaplan–Meier survival curves were drawn and compared using the log-rank test in an intention-to-treat analysis  +
The specific analysis method is not stated in the study, however, according to the authors, all included patients were evaluated at the end of the study.  +
Separate intention-to-treat (ITT) and all those who completed the study (PP) analysis for primary endpoint, secondary endpoints only PP analysis  +
Separate intention-to-treat (ITT) and all those who completed the study (PP) analysis for primary endpoint, secondary endpoints only PP analysis  +
Only included participants (n=60) reported, NI regarding number of randomized patients  +
Only patients completing 12 wk of treatment were considered evaluable for objective response using WHO criteria; ITT Analysis for endpoints overall survival and progression-free survival  +
B
Main analyses conducted in two ways: 1) among all participants (any supplementation) 2) separately for the first 156 participants (combined intake of beta-carotene and Vitamin E) and for the 384 patients subsequently enrolled (only Vitamin E) Analyses were performed by partitioning the time (after visual check of proportionality assumption of the models): 1) from entry until 3.5 years after randomization 2) beyond 3.5 years after randomization 4 patients (1 in intervention arm, 3 in placebo arm) did not complete their radiation therapy as planned but were included in the analyses  +
Main analyses conducted in two ways: 1) among all participants (any supplementation) 2) separately for the first 156 participants (combined intake of beta-carotene and Vitamin E) and for the 384 patients subsequently enrolled (only Vitamin E) 4 patients (1 in intervention arm, 3 in placebo arm) did not complete their radiation therapy as planned but were included in the analyses  +
Main analyses conducted in two ways: 1) among all participants (any supplementation) 2) separately for the first 156 participants (combined intake of beta-carotene and Vitamin E) and for the 384 patients subsequently enrolled (only Vitamin E) 4 patients (1 in intervention arm, 3 in placebo arm) did not complete their radiation therapy as planned but were included in the analyses  +
Primary analysis for efficacy was on the intention to treat population and toxicity was evaluated in the as-treated population. These two populations were identical.  +
Logistic regression was used to estimate odds ratios for the incidence of nausea; ANOVA used to investigate differences in mean delayed, inter-cycle and anticipatory nausea between treatment arms and compliance to treatment.  +
The specific analysis method is not stated in the study, however, according to the authors, all included patients were evaluated at the end of the study  +
ITT-analysis not specified, but no drop-out occured. The number of patients developing any grade of HFS in both study arms was obtained. The percentage of HFS in both arms was compared. In order to determine whether the diference between groups was signifcant, the number of patients receiving capecitabine, with and without HFS, was obtained, and the P value was determined through chi-square and Fisher exact calculation.  +