Jump to content

Property:Specifications on analyses

From CAMIH

This is a property of type Text.

Showing 20 pages using this property.
H
Comparisons of baseline clinical and demographic variables between green tea arm, black tea arm and water arm was conducted using the ANOVA or Kruskal–Wallis tests for continuous variables and Fisher’s exact test or chisquare tests for categorical variables. If a statistically significant overall group effect was found, follow-up analysis was performed using pairwise t-tests or the Mann Whitney U tests to investigate which pairs of groups were significantly different.  +
All nine subjects were analysed. This is a Phase I study about safety, pharmapharmacokinetics, pharmacodynamics and not an efficacy study. PK: Statistical analyses for pharmacokinetic data included linear regression with 1/concentration weighting and descriptive statistics. PD: Means were compared via one way, one sided ANOVA followed by Tukey’s post hoc test.  +
I
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.  +
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  +
J
No information provided on intent-to-treat analyses, but according to the tables all randomized patients appear to have been included in the analyses.  +
For the two coprimary efficacy variables (NRS pain score and use of break-through medication), the Hochberg method was used to test the global hypothesis for a treatment effect on pain. The daily pain NRS score was the mean of the three daily assessments. The change in mean NRS pain score from baseline (all days in run-in period) to the end of treatment (last three days on treatment) was analyzed using analysis of covariance (ANCOVA), with baseline pain as a covariate and grouped study center and treatment as factors. The proportions of responders (patients with ≥30% improvement from baseline to end of study NRS pain score) were compared between treatments. Use of breakthrough medication (number of days of use during last three days on treatment) was analyzed using logistic regression with a cumulative logit model. In addition, the change from baseline in mean number of doses of escape medication was analyzed using ANCOVA.  +
K
All patients were analysed in the intention-to-treat evaluation, 71 patients in the per-protocol I evaluation and 83 patients in the per-protocol II evaluation Per-protocol I: Patients who discontinued before Visit 4 were excluded if the discontinuation was not efficacy-related Per-protocol II: Patients who discontinued before Visit 3 were excluded  +
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.  +