Statistical Methods. A chi-squared test and a multi-variate logistic regression was employed for the study of dichotomous variables. The level of significance of the test was set at 95% (α=0,05). The calculations were performed using STATA® software package. Updating the galenic formulations handbook
Statistical Methods. Analysis Populations: Randomized: This population will be comprised of all subjects who were initially randomized. This population will be used for summaries of subject disposition and baseline subject characteristics. Intent-to-treat (ITT)/Safety: This population will be comprised of all subjects who were initially randomized and received at least one dose of study drug. This will be the primary population for all summaries of subject disposition and baseline characteristics, efficacy analyses, and safety analyses for purposes of regulatory submissions. Comparisons in the primary endpoint of change from the baseline BMI between treatment groups will be assessed using a mixed effects model with repeated measures (MMRM) with factors of treatment, visit, treatment by visit interaction, baseline BMI value, age stratification, and gender stratification. Appropriate contrast will be applied for treatment comparisons at Week 56. The 3 comparisons of interest are 1) top-dose vs. placebo; 2) mid-dose vs. placebo; and 3) top-dose vs. mid-dose. Sensitivity analyses will be conducted to examine the impact of missing data on the robustness of statistical conclusions. In previous studies in adults, PHEN/TPM 7.5 mg/46 mg dose resulted in a placebo-subtracted BMI reduction of 2.4 units with a standard deviation of 2.9. Assuming a similar effect size, with enrollment of 200 subjects (100 randomized to the top-dose, 50 randomized to the mid-dose, and 50 randomized to the placebo), the present study will have greater than 90% power to detect a significant difference in BMI reduction between the top-dose and the placebo, and approximately 80% power to detect a significant difference between the mid-dose group and the placebo. The above power calculation assumes very conservative differences between the active doses and placebo and a worst case 30% dropout rate.
Statistical Methods. Efficacy: In order to compare the primary efficacy parameter, duration of diarrhea between the treatment groups a Xxxxxx Xxxxx analysis will be performed. The log-rank test will be used to test whether the difference of the duration of diarrhea between two treatment groups is statistically significant, i.e. p-value <0.
Examples of Statistical Methods in a sentence
Technical Manual: Statistical Methods and Algorithms Used in SUDAAN Release 7.0, Research Triangle Park, NC: Research Triangle Institute.
Statistical Methods for Assessing Agreement Between Two Methods of Clinical Measurement.
Statistical Methods for Assessing Agreement between Two Methods of Clinical Measurement.
Statistical Methods and Algorithms Used in SUDAAN Release 7.0, Research Triangle Park, NC: Research Triangle Institute.
MATH 1100 (800:023) Mathematics in Decision Making, 3 hoursMATH 1420 (800:060) Calculus I, 4 hoursSTAT 1774 (800:064) Introductory Statistics for Life Sciences, 3 hours STAT 1772 (800:072) Introduction to Statistical Methods, 3 hoursCS 1025 (810:025) Modern Tools for Exploring Data, 3 hours*Elementary Education students may meet the category 1C requirement by completing MATH 1204 (800:031).
Statistical Methods Used to Test for Agreement of Medical Instruments Measuring Continuous Variables in Method Comparison Studies: A Systematic Review.
Technical Manual: Statistical Methods and Algorithms Used in SUDAAN Release 7.0. Research Triangle Park, NC: Research Triangle Institute.
The Statistical Methods Requirement Proficiency in statistical methods may be demonstrated by completing both Psychology 506 and 507 with a grade not lower than B-.
Statistical Methods in Psychology Journals: Guidelines and Explanations.
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More Definitions of Statistical Methods
Statistical Methods. Means (M) and standard deviations (SD).- T-Test- One Way ANOVA (Analysis)
Statistical Methods. Means and standard deviations were used to identify the levels of customers’ perceived service quality towards FFRs. Whereas, Pearson correlation coefficient and linear regression were used to investigate both the correlation and relationship between customers’ perceived service quality and customer satisfaction as well as between customer satisfaction and purchase intentions.Lastly, multiple linear regression was used to identify the most important factors or SERVPERF dimensions that contribute to customer satisfaction.
Statistical Methods. Sample size: Phase 2: With 30 patients, the Phase 2 portion of the study will have over 80% power to detect a change from baseline in eGFR relative to zero. The power calculation, which was based on a 2-sided t-test, assumes the following: • Two-sided Type I error rate of 0.05 • 5% of the patients will not complete at least 12 weeks of study treatment • A change from baseline in eGFR of approximately 4.3 mL/min/1.73 m2 • Standard deviation of change from baseline in eGFR of 8 mL/min/1.73 m2 Phase 3: Primary endpoint With 150 patients enrolled (75 in each group), the study will have approximately 80% power to detect a difference between the two treatment groups in change from baseline in eGFR of 3.1 mL/min/1.73 m2 at Week 48. The power calculation, which was based on mixed-model repeated measures (MMRM) analysis, assumes the following: • 9 repeated measurements (Weeks 1, 2, 4, 6, 8, 12, 24, 36, and 48) having compound symmetry covariance structure • The correlation between observations on the same subject is 0.7 • Two-sided Type I error rate of 0.05 • Standard deviation of change from baseline in eGFR of 8 mL/min/1.73 m2 • Analyses at Week 48 are based on the intent-to-treat (ITT) population • Missing data for the Week 48 analysis will be imputed using Jump to Reference (J2R) multiple imputation (Ratitch, 2013) based on available data collected from patients discontinuing from study treatment but continuing in the study. Key secondary endpoint With 150 patients enrolled and at least 140 patients having available Week 52 data after completing 48 weeks of treatment, the study will have a minimum detectable difference between the two treatment groups in change from baseline in eGFR of approximately 2.2 mL/min/1.73 m2 at Week 52. The power calculation was based on the same analysis method and assumptions as the primary endpoint, with the following exceptions: • With the addition of Week 52, the model has 10 repeated measurements (Weeks 1, 2, 4, 6, 8, 12, 24, 36, 48, and 52) • Analyses at Week 52 are based on available Week 52 data from the subset of patients who complete the 48-week treatment course. Since the Phase 2 and Phase 3 cohorts are independent sets of patients, the Phase 2 analysis will not impact the type I error rate for the Phase 3 analysis. The analysis of efficacy will use an unstructured covariance structure, which is expected to have approximately the same power as the analysis with compound symmetry used for study planning. The method for main...
Statistical Methods. The number of pediatric subjects for the dose escalation part of the study will be determined based in part on the number of dose escalations required to determine the protocol-defined MTD and/or RP2D.
Statistical Methods. The primary endpoint for this clinical trial is the percent of patients with radiographic disease progression according to RECIST 1.1 at 6 months. Without maintenance therapy, 92% of patients are expected to progress by 6 months. Therefore, we assume 1/12 (0.083) pembrolizumab + placebo arm show no progression versus 7/12 pembrolizumab + paricalcitol. This gives 90% statistical power with one side alpha = (0.05). TABLE OF CONTENTS
Statistical Methods. Efficacy: In order to compare the primary efficacy parameter, duration of diarrhea between the treatment groups a Xxxxxx Xxxxx analysis will be performed. The primary efficacy parameter, duration of diarrhea, will be analyzed using descriptive statistics. In addition, a Xxxxxx-Xxxxx plot will be generated for which summary statistics will be presented as well. Secondary efficacy parameters will be analyzed similarly. All parameters will be summarized using descriptive statistics. Safety: The safety sample will be used for the analysis of the safety and tolerability data. Treatment emergent AEs are summarized. Severity and drug-event relationship of treatment emergent AEs are summarized separately. Vitals signs, including changes from baseline will be Name of Sponsor: Xxxxxx Taiwan Name of Finished Product: Hidrasec Infants Granules for Oral Suspension 10 mg Hidrasec Children Granules for Oral Suspension 30 mg Name of Active Ingredient(s): Racecadotril summarized. A frequency table will be presented for markedly abnormal values. Sample size In total, 40 subjects will be allocated to receive Racecadotril treatment, 20 subjects in each age group (< 24 months of age and ≥ 24 months of age). Results of a recently finalized study in Russian children showed that all children under Racecadotril treatment recovered within 3 days of drug treatment. A sample size of 40 subjects is sufficient to estimate a two-sided 95% confidence interval with the precision of 3.1 percentage points for a recovery of at least 99% of the subjects after 3 days of Racecadotril treatment. In order to account for drop-outs, maximum 48 subjects will be recruited. Recruitment will be stopped once 40 subjects have completed the study. 1.1 Independent Ethics Committee or Institutional Review Board 14