Analysis of Primary Endpoint Sample Clauses

Analysis of Primary Endpoint. Disease progression at 6 months All patients that receive trial treatment will be included in the analysis to determine the percentage of patients progressing by RECIST 1.1 criteria at 6 months when maintained on a combination regimen of paricalcitol plus pembrolizumab versus pembrolizumab alone. The 6-month time-point will be defined as 6 months (180 days) from the initial treatment (cycle 1/day 1). Statistical analysis will compare the proportion progression free at 6 months using a one-sided test of binomial proportions (equivalent to a Xxxxxxx’x xxx-squared test). If the assumptions of the Xxxxxxx'x xxx-squared test are not met, we will analyze the data using Xxxxxxx'x exact unconditional test of equality, as implemented in StatXact.20
Sample 1
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Analysis of Primary Endpoint. The primary calculated endpoints for this trial are based on the percent weight loss at week 28, and the percentage of subjects with at least 5% weight loss at week 28. The percent weight loss at week 28 will be calculated as ***. The primary subject population is the Intent to Treat (ITT) population that consists of all subjects who are randomized, receive at least 1 dose of trial treatment, and have at least 1 post-dosing trial assessment. For subjects who discontinue treatment prior to trial completion, every attempt will be made to have them return to the clinic at week 28 for final assessments, regardless of when they discontinued trial treatment. For subjects who ***. The primary objective of the statistical test is to confirm that at least one of the proposed phentermine/topiramate combinations evaluated in this trial is an effective combination therapy for weight reduction. To demonstrate that a combination therapy is effective, it is necessary to show that a *** versus each *** comprising the ***, and *** versus ***, are all significant at the *** using ***. If any one of the *** does not reach the *** level for either of the co-primary endpoints, then the efficacy of that combination cannot be confirmed. A step-down multiple testing procedure will be used to control the overall type I error for this trial. The hypothesis that the *** is an effective combination therapy will be tested first. Once the efficacy of this *** is confirmed, then the efficacy of the *** will be tested using the same criteria. Comparisons between treatments for the endpoint of percent weight loss will be assessed using a *** model with factors of ***. Comparisons between treatment of the percentage of subjects with at least 5% weight loss at week 28 will be evaluated by ***. Once the efficacy of both the *** has been confirmed, the difference in mean weight reduction between the *** therapies will be estimated. *** percent confidence intervals for the difference in mean percent body weight reduction between the two combination therapies will be derived.
Sample 1
Analysis of Primary Endpoint. ‌ The primary endpoint is the difference between treatment groups in the proportion of subjects with a 5% or greater relative change from baseline to Day 28 of FEV1 measured in liters, calculated as: To test the null hypothesis that there is no difference between the treatment groups, a two-sample test of proportions will be performed adjusted for baseline FEV1 strata. The difference between treatment groups will be provided with associated 95% CI. Additional analyses of the relative change in FEV1 through Day 56 will include the development of a mixed-effect model for repeated measures (MMRM). Adjusted means and 95% CIs will be presented for each visit. Treatment comparisons of the average response at each visit will be generated within the MMRM model based on the linear contrast of the average using the estimated least square means (LSMeans) at Days 14, 28, and 56. Missing data methods will be described in the SAP.
Sample 1
Analysis of Primary Endpoint. Based on evidence from prior studies, it is hypothesized that six months of oral GSH will be associated with an improved weight-for-age z-score as compared to six months of oral placebo. Therefore the null hypothesis is that there is no difference between treatment groups in the 6 month change in weight-for-age z-score. The primary endpoint is the difference between the GSH and placebo groups in the change in weight-for-age z-score from Visit 2 to Visit 4 (Week 24). The difference between treatment groups will be estimated using a linear mixed effects model which will incorporate Visit 3 (Week 12) weight-for-age z-score measurements. The model will adjust for randomization strata and assume, if estimable, an unstructured covariance structure. Least squares means at each visit and the estimated treatment effect and corresponding 95% confidence intervals and p-values will be reported from the model. The p-value will be evaluated against a two-sided 0.05 level of significance. Weight-for-age z-scores will be calculated using CDC reference equations [32]. Graphical displays will be used to show both unadjusted and adjusted mean changes in weight- for-age z-score between visits for the two treatment groups. Sensitivity analyses of the primary endpoint will include: ▪ Performing the primary efficacy analysis on the per-protocol population. ▪ Performing the primary efficacy analysis on the sub population of subjects determined to be pancreatic insufficient (defined as documented fecal elastase < 200 µg/g). ▪ Missing data methods. Missing data sensitivity analyses of the primary endpoint will include the least favorable treatment arm imputation method, which imputes missing values with the mean change from the treatment arm with the worst change in the observed case analysis. Further details regarding missing data methods will be provided in the SAP. Additional sensitivity analyses of the primary endpoint may be performed to adjust for potential baseline confounders.
Sample 1

Related to Analysis of Primary Endpoint

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall: (a) supervise all aspects of the operations of the Funds; (b) obtain and evaluate pertinent information about significant developments and economic, statistical and financial data, domestic, foreign or otherwise, whether affecting the economy generally or the Funds, and whether concerning the individual issuers whose securities are included in the assets of the Funds or the activities in which such issuers engage, or with respect to securities which the Advisor considers desirable for inclusion in the Funds' assets; (c) determine which issuers and securities shall be represented in the Funds' investment portfolios and regularly report thereon to the Board of Trustees; (d) formulate and implement continuing programs for the purchases and sales of the securities of such issuers and regularly report thereon to the Board of Trustees; and (e) take, on behalf of the Trust and the Funds, all actions which appear to the Trust and the Funds necessary to carry into effect such purchase and sale programs and supervisory functions as aforesaid, including but not limited to the placing of orders for the purchase and sale of securities for the Funds.

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  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

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  • Disturbance Analysis Data Exchange The Parties will cooperate with one another and the NYISO in the analysis of disturbances to either the Large Generating Facility or the New York State Transmission System by gathering and providing access to any information relating to any disturbance, including information from disturbance recording equipment, protective relay targets, breaker operations and sequence of events records, and any disturbance information required by Good Utility Practice.

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  • Independent Analysis Each Party hereby confirms that its decision to execute this Agreement has been based upon its independent assessment of documents and information available to it, as it has deemed appropriate.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • Investment Analysis and Commentary The Subadviser will provide quarterly performance analysis and market commentary (the “Investment Report”) during the term of this Agreement. The Investment Reports are due within 10 days after the end of each quarter. In addition, interim Investment Reports shall be issued at such times as may be mutually agreed upon by the Adviser and Subadviser; provided however, that any such interim Investment Report will be due within 10 days of the end of the month in which such agreement is reached between the Adviser and Subadviser. The subject of each Investment Report shall be mutually agreed upon. The Adviser is freely able to publicly distribute the Investment Report.

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