Property:Specifications on analyses
This is a property of type Text.
D
Data analyses were performed in three patient populations:
Full analysis set (FAS) population: n=61; 8 drop-outs; FAS population represents the
intent-to-treat population with data available for > 2 weeks of treatment
Per protocol (PP) population: n=55 (29 enzyme-arm, 26 placebo-arm); FAS population exclusive of patients with major protocol deviations (termination of radiotherapy before week 5 or significant treatment interruptions > 1 week)
Dresden (DD) population: n=46 (23 enzyme-arm, 23 placebo-arm) from Dresden from the PP population were analyzed separately +
E
Ehrenpreis et al. (2005): A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Retinol Palmitate (Vitamin A) for Symptomatic Chronic Radiation Proctopathy +
- 2 patients did not take any doses of medicine and were therfore excluded from the analysis
- Used tests: Fisher’s exact test and Mann-Whitney U test +
Emami et al. (2014): Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of green tea in preventing acute gastrointestinal complications due to radiotherapy +
Two-sample t-tests: comparison of continuous variables
Pearson’s Chi-square tests: comparison of categorical variables
Mann–Whitney U-test: comparison of the grade of diarrhea and vomiting between two groups
Nonparametric analysis (Friedman): comparison of the score of diarrhea and vomiting during 4 weeks +
Ertekin et al. (2004): Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study +
NI +
F
Fahimi et al. (2011): Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens +
McNemar and the Wilcoxon Signed Rank tests were used +
Fallahi et al. (2013): Does vitamin E protect salivary glands from I-131 radiation damage in patients with thyroid cancer? +
ITT not explicitly stated, but no drop-out occured. +
Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
n = 2 no intervention received
Wilcoxon rank-sum test was conducted for percent improvement in average pain NRS score (from baseline to end of treatment in study 1, and from eligibility
pre-treatment baseline to end of treatment in study 2).
Analysis of covariance (ANCOVA) was applied on the primary and the key secondary efficacy endpoints, including percent improvement, average pain/worst pain/sleep disruption scores, with corresponding baseline value as a covariate and treatment group as a factor. The time-course of these four efficacy endpoints from week 1 through week 5 was also analysed using Mixed-Effect Model Repeat Measurement (MMRM) on the ITT analysis set in both studies.
For both study 1 and study 2, the primary endpoint and the key secondary endpoints were tested with their Type I error controlled by use of a hierarchical gate-keeping procedure.
In each study, p-values from Wilcoxon rank-sum tests on percent improvement and ANCOVA on average pain/worst pain/sleep disruption scores were used for the hierarchical gate-keeping procedure in the sequence of the primary endpoint and the key secondary endpoints. No adjustments for covariates were made for the analyses of the other secondary endpoints in both studies with analysis of variance (ANOVA), including PGIC, SGIC or PSQ, and daily total, maintenance, and breakthrough opioid dose. Subgroup analyses for region (United States and rest of world (ROW)) were performed for the primary and the key secondary endpoints. +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
Procedure
Part A: all received Sativex® for 10 days, then 4 days therapy at adjusted dose; patients who showed an improvement of at least 15% for pain (NRS) entered Part B: randomized in A or B with intervention for 5 weeks, follow-up 2 weeks later
Discussed is part B of the study. +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
NA +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
A total of 244 patients were included in the ITT analysis, which was based on 769 observations and four time points over 12 weeks;
A total of 150 patients completed all 12 weeks of vitamin D (n=67) or placebo (n=83) and constitute the PP population +
Freedland et al. (2020): A Randomized Controlled Trial of a 6-month low carbohydrate intervention on disease progression in men with recurrent prostate cancer: Carbohydrate and Prostate Study 2 (CAPS2) +
Results are calculated and analyzed as the mean of log-transformed PSADT, but back transformed for presentation and interpretation. An amendment to the study protocol was added to conduct a two-step interim analysis to test for efficacy and/or futility after 44 of the targeted 60 patients had completed the study. First, efficacy was assessed by comparing the mean PSADT between arms using a two-sided, two-sample t-test at alpha level of 0.01. Next, given a non-significant efficacy test, treatment futility was assessed by calculating the conditional power of the t-test given the interim data with conditional power <0.2 determining futility. +
G
Ghoreishi et al. (2007): Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation +
ITT not specified, but no drop-out reported. +
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial +
Evaluated ITT n=292, PP n=259;
Sensitivity analysis n=216 +
Gorgu et al. (2013): The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patents with head and neck cancer +
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 +
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial +
Only participants who have received both interventions have been included in the efficacy analyses. Data on safety were sourced from the safety population (all participants who received ≥1 dose of study drug). The primary analysis was a comparison of the proportion of participants with complete response between the two treatment arms during two overall phases of treatment (0-120 h) of cycles A and B, using McNemar’s test to account for the within-patient correlation. Continuous outcomes were analysed with a linear model, and accounted for the correlation within a participant. All tests used a two-sided significance level of 10%. Secondary analyses have not been adjusted for multiple comparisons. +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
Primary endpoints: all patients were analysed (ITT),
secondary endpoints: just 93 patients were analysed (PP) +
H
Hajimohammadebrahim-Ketabforoush et al. (2019): Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical Trial +
NI +
Halyard et al. (2007): Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4) +
NI +
Heggie et al. (2002): A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue +
17 drop-outs during study, additional 5 subjects were excluded from the pain analyses because they reported grade 2 or more pain on day 1 from surgery. +