Statistical Analysis Plan Sample Clauses

Statistical Analysis Plan. This trial uses a Simon two-step design. In step 1, we will evaluate the overall response rate to possibly stop for futility according to the plans described in the sample size determination. In addition, after step 1 we will also evaluate the dose of AE37. If 4 or more of the first 13 patients (> 25%) have Grade 3 or higher toxicity we will de-escalate the dose from 1000 to 500 micrograms daily. Following step 2, we will declare the combination therapy suitable for further study if at least 8 of 29 total patients have objective response. 95% confidence intervals will be reported along with the objective response rate. All patients with a baseline tumor measurement and receiving any protocol treatment will be included in efficacy analysis. All secondary aims will be analyzed after the end of the study, that is after step 1 if the study closes early or after step 2 otherwise. Xxxxxx-Xxxxx estimates of PFS and OS will be provided. Tabulations of maximum Grade observed for each patient for each observed toxicity will be provided along with a summary of maximum Grade observed for each patient for any toxicity.
Sample 1Sample 2
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Statistical Analysis Plan. The statistical analysis plan for Aim 2 is similar to that for Aim 1. Specifically, we will code the primary outcome for Aim 2, the occurrence of carbohydrate intolerance and GDM at 24-28 weeks of gestation as 1 in presence of carbohydrate intolerance and GDM and 0 otherwise. Model selection and checking will be the same as that proposed for Aim 1. For the secondary outcome, fasting blood glucose and HbA1C values, we plan to compare them between the standard care group and the intervention group using two-sample Wilcoxon test. Linear model will be fitted to account for effects of other relevant covariates on this outcome. Normality assumption will be checked. In case this assumption is violated, standard transformation techniques will be applied. Model selection will use classic stepwise, backward, or forward strategy. Power. Aim 2 will compare the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation and shortly after delivery between the lifestyle intervention group and standard care groups. The results of this exploratory/pilot study aim will serve as the basis for power calculations to support a larger trial designed to investigate the effects of the intervention in prevention of CHO intolerance and GDM in Hispanic women.
Sample 1
Statistical Analysis Plan. The outcomes of interest for this aim include maternal outcome (such as hemoglobin HbA1C levels, occurrence of C-section) and fetal outcome (such as occurrence of rate of macrosomia, shoulder dystocia). For a continuous outcome, we will follow the same plan proposed for analyzing the secondary outcome in Aim 2. For a categorical outcome that has more than two levels (i.e. non-binary), we will use Chi-square (or Xxxxxx’x exact) tests and Xxxxxxx-Xxxxxx-Haenszel tests which adjust for BMI categories for group comparisons. Poisson regression or negative binomial regression will be conducted to model the effects of intervention and potential predictors on the categorical endpoint. Model selection and checking will follow the standard procedure for these models. Power. Aim 3 will explore the impact of the lifestyle intervention in preventing maternal and fetal complications between women in the lifestyle intervention group and women receiving standard care. We anticipate that Aim 3 will be underpowered to assess many of the mentioned clinical outcomes, but the results of this exploratory aim will serve as the basis for sample size calculations to support a larger, future trial designed to investigate the effects of the intervention in prevention of maternal/fetal complications and costs associated with such complications.
Sample 1
Statistical Analysis Plan. The Parties shall cooperate in good faith in preparing any statistical analysis plans (including, but not limited to, determining the primary statistical endpoints) with respect to the Product, including, but not limited to, with respect to any studies set forth in the Initial Joint Development Plan and Budget; provided that in the event of any disputes with respect thereto, Lundbeck shall have the final determination with respect to any such statistical analysis plan with respect to the Product in the Territory and Myriad shall have the final determination with respect to any such statistical analysis plan with respect to the Product outside the Territory.
Sample 1
Statistical Analysis Plan. A final statistical analysis plan will be developed and approved by both Opthea and the study biostatistician prior to database lock. The primary efficacy analysis will occur when target enrollment or randomization is complete and each participant either completes the week 12 follow-up visit or withdraws from the study. The final analysis for all other endpoints will occur after all participants complete the week 24 follow-up visit. The following is a summary of the planned analyses; full details are captured in the statistical analysis plan. Continuous variables will be summarized using descriptive statistics (N, mean, standard deviation, median, minimum and maximum), while categorical variables will be summarized as counts and percentages of participants in each category. Results will be presented by study arm as appropriate. The primary efficacy analysis will be presented using the PP analysis set. Secondary efficacy analyses will be presented using the PP and ITT populations. For efficacy analyses, no missing values will be imputed as the primary efficacy analysis is on the PP population. Safety analyses will be presented using the safety and ITT populations. All baseline and demographic summaries will be based on the ITT dataset.
Sample 1

Related to Statistical Analysis Plan

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.

  • Statistical Data The statistical, industry-related and market-related data included in the Registration Statement, the Sale Preliminary Prospectus, and/or the Prospectus are based on or derived from sources that the Company reasonably and in good faith believes are reliable and accurate, and such data materially agree with the sources from which they are derived.

  • Statistical, Demographic or Market-Related Data All statistical, demographic or market-related data included in the Registration Statement, the Disclosure Package or the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate and all such data included in the Registration Statement, the Disclosure Package or the Prospectus accurately reflects the materials upon which it is based or from which it was derived.

  • Statistical and Marketing-Related Data All statistical or market-related data included or incorporated by reference in the Registration Statement, the Time of Sale Disclosure Package or the Final Prospectus, or included in the Marketing Materials, are based on or derived from sources that the Company reasonably believes to be reliable and accurate, and the Company has obtained the written consent to the use of such data from such sources, to the extent required.

  • Statistical and Market Data Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related data included in the Registration Statement, the Pricing Disclosure Package and the Prospectus is not based on or derived from sources that are reliable and accurate in all material respects.

  • Statistical Information Any third-party statistical and market-related data included in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate in all material respects.

  • Statistical and Market-Related Data Any statistical and market-related data included in the Registration Statement, the General Disclosure Package or the Prospectus are based on or derived from sources that the Company believes, after reasonable inquiry, to be reliable and accurate and, to the extent required, the Company has obtained the written consent to the use of such data from such sources.

  • Statistics 1. Each Party shall provide to the other Party statistics that are required by domestic laws and regulations, and, upon request, other available statistical information as may be reasonably required for the purpose of reviewing the operation of the air services.

  • Statistical or Market-Related Data Any statistical, industry-related and market-related data included or incorporated by reference in the Time of Sale Disclosure Package, are based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate, and such data agree with the sources from which they are derived.

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

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