Statistical Methods definition

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.
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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...
Sample 1
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. Results Updating the galenic formulations handbook
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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.

  • MATH 1342 Elementary Statistical Methods Collection, analysis, presentation and interpretation of data and probability.

  • Statistical Methods and Algorithms Used in SUDAAN Release 7.0, Research Triangle Park, NC: Research Triangle Institute.

  • Technical Manual: Statistical Methods and Algorithms Used in SUDAAN Release 7.0. Research Triangle Park, NC: Research Triangle Institute.

  • Statistical Methods development grants were made to the University of Geneva (MH090941 & MH101814), the University of Chicago (MH090951,MH090937, MH101825, & MH101820), the University of North Carolina - Chapel Hill (MH090936), North Carolina State University (MH101819),Harvard University (MH090948), Stanford University (MH101782), Washington University (MH101810), and to the University of Pennsylvania (MH101822).

  • Data Analysis Statistical tests Linear regression Statistical Methods in Pattern Recognition Learning materials and literature X.X. Xxxx, X.

  • Coordinator Xx Xxxxx XXXXXXXXX Email : Xxxxx.Xxxxxxxxx@xxx-xxx.xx ECTS: 6 Language: English MAT-7098: Application of Statistical Methods Organisation Class work: 54h Home work: 66h Total workload: 120h Lectures: 18h Tutorial: 18h Labs: 18h Assessment continuous exam written exam Objectives Master major statistical theory and application.

  • NASA is establishing a partnership with EPRI focused on the possibility of integrating NASA data and models into EPRI’s load forecasting decision support systems.76 73 Xxxxx, X., Electricity Load and Price Forecasting Using Statistical Methods and Models, Second Moment, xxxx://xxx.xxxxxxxxxxxx.xxx/articles/electricity.php.

  • MTH143 (NE- ELECTIVE) Introduction to Statistics (Nurse Education Directed Elective) STAT 3001 Statistical Methods and Applications 5 North Shore Community College Articulation Agreement 0 Xxxxxxxxx Xxxx Xxxxxxx, XX 00000 (000) 000-0000 Table 3.

  • Statistical Methods for Assessing Agree- ment between Two Methods of Clinical Measurement.


More Definitions of Statistical Methods

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.
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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 <0.05. 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 by unique treatment. Severity and drug-event relationship of treatment emergent AEs are summarized separately. Vitals signs, including changes from baseline will be summarized. A frequency table will be presented for markedly abnormal values. Sample size The sample size of this study is based on the results obtained with a randomized, double blind, study with Racecadotril in the treatment of hospitalized children aged 3-60 months suffering from acute watery diarrhea (Bio-Projet Study nr. 45, Xxxxxxx Xxxxx et al. 1998). A total of 135 subjects were analyzed in this study. Data of the study showed following recovery rates over time: Duration of treatment Percentage of recovered patients Placebo Racecadotril Sample size per group required for a power of 80% using log-rank test (+10% drop out rate) after 1 day (24 hours) 18.3% 46.6% 41 (46) After 2 days (50 hours) 35.8% 70.1% 36 (40) After 3 days (72 hours) 59.4% 84.2% 55 (62) Name of Sponsor: Xxxxxx Laboratories GmbH Name of Finished Product: Hidrasec Infants: Granules for Oral Suspension 10 mg Hidrasec Children: Granules for Oral Suspension 30 mg Hidrasec: 100 mg capsules Name of Active Ingredient(s): Racecadotril After 4 days (96 hours) 76.3% 90.1% 119 (132) After 5 days (120 hours) 80.6% 94.7% 90 (100) The mean duration of diarrhea was 64 (±4.6) hours in the placebo group (median 64 hours) and 40 (±4.1) hours in the Racecadotril group (median 28 hours). Therefore an appropriate approach to investigate a difference between recovery rates of the two treatment groups would be after a treatment duration of at least 3 days (i.e. 72 hours).When the sample size in each group is 55 (with a total number of recoveries of at least 26), the two-sided log-rank test for equality of survival curves will have 80% power to detect the difference between 84.2% rate of recovery in the Racecadotril group and the 59.4% rate of recovery in the placebo group after...
Sample 1
Statistical Methods. Means (M) and standard deviations (SD).- T-Test- One Way ANOVA (Analysis)
Sample 1Sample 2
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.
Sample 1
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). Statistical analysis will compare the proportion progression free at 6 months using a one-sided test comparing binomial proportions (equivalent to a Xxxxxxx’x xxx-square test). The incidence of toxicities will be tabulated. Overall survival will be estimated for each arm using a Xxxxxx- Xxxxx estimate. Statistical comparison of overall survival will be performed using a log-rank test with estimation of the hazards ratio using a Xxx proportional hazards model. TABLE OF CONTENTS
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Related to Statistical Methods

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  • Nationally Recognized Statistical Rating Organization means a nationally recognized statistical rating organization within the meaning of Rule 436 under the Securities Act.

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  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

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