STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN Sample Clauses

STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN. Full details of all statistical aspects and planned statistical analyses will be specified in a separate Statistical Analysis Plan (SAP), which will be finalized prior to the locking of the study database. This section contains an overview of the planned methods of analysis. Statistical methods will focus on summarizing the data collected, using appropriate graphical and tabular presentations. For measurements of continuous endpoints, summary statistics will include n, mean, median, standard deviation, minimum and maximum values. Duration of Response and Survival time will be presented using Xxxxxx-Xxxxx curves with medians calculated if available. 95% confidence intervals will be calculated for the median for each of these endpoints. Endpoints based on binary outcomes, including post-HSCT outcome measures, will be converted to proportions and associated 95% confidence intervals calculated. Data collected in this study may be analyzed on multiple occasions as the study proceeds, in order to facilitate the development program for NI-0501 and to optimize the dissemination of information which may help patient care. The timing and nature of these interim analyses cannot be specified in advance and will depend on the numbers of patients recruited into the study and the nature of the outcomes seen. All data relating to safety will be listed and summarized using descriptive statistics. AEs will be coded and tabulated by body system, and by individual events within each body system. AEs will also be tabulated by severity and relationship to the study medication. For each clinical laboratory test, individual patient values will be listed and summarized and change from baseline values calculated and summarized. Any values outside the standard reference ranges will be flagged. Summaries of out-of-range values and shift tables will be tabulated for each laboratory test. All PD data will be summarized using appropriate graphical and tabular presentations. Exploratory statistical models may be fitted, and correlation analyses undertaken, to investigate the relationships between PD data, other biomarkers and other endpoints recorded in the study. Other exploratory analyses of data collected in this study, including summaries for various subsets of patients, may also be conducted, including comparisons with appropriate historical data extracted from published literature, from external databases, and from other studies, if considered appropriate. No imputations of missing...
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STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN. Full details of all statistical issues and planned statistical analyses will be specified in a separate Statistical Analysis Plan (SAP), which will be finalised prior to the locking of the study database. This section contains an overview of the planned methods of analysis.

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