: Public Class
Created: 9/3/2008 12:15:42 PM
Modified: 8/26/2017 2:52:37 AM
Project:
Advanced:
DEFINITION:<br/>Information needed for computing the sample size, including any detail not provided <br/>in the study protocol.<br/><br/>EXAMPLE(S):<br/>"Approximately 100 patients will be randomized to each of the 3 treatment groups. <br/>Previous experience with the oral formulation of xanomeline suggests that this <br/>sample size has 90% power to detect a 3.0 mean treatment difference in ADAS-Cog <br/>(p#lt;.05, two-sided), based on a standard deviation of 6.5. Furthermore, this sample <br/>size has 80% power to detect a 0.36 mean treatment difference in CIBIC+ (p#lt;.05, <br/>two-sided), based on a standard deviation of 0.9."<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>InterventionalStudyProtocolVersion.interventionGroupQuantity, <br/>Arm.targetAccrualNumberRange, and StudyProtocolVersion.targetAccrualNumberRange are <br/>all related to parts of the SampleSizeConsideration that are not yet fully modeled <br/>here.<br/>
Attribute
Public ED
  text
Details:
Map:Statistics v1.0=SampleSizeConsideration.text
Notes: DEFINITION:<br/>A textual or media-based representation of the sample size consideration, including <br/>details needed to replicate sample size calculations.<br/><br/>EXAMPLE(S):<br/>"Approximately 100 patients will be randomized to each of the 3 treatment groups. <br/>Previous experience with the oral formulation of xanomeline suggests that this <br/>sample size has 90% power to detect a 3.0 mean treatment difference in ADAS-Cog <br/>(p#lt;.05, two-sided), based on a standard deviation of 6.5. Furthermore, this sample <br/>size has 80% power to detect a 0.36 mean treatment difference in CIBIC+ (p#lt;.05, <br/>two-sided), based on a standard deviation of 0.9."<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Details included could be: difference to be detected, variability, assumptions.<br/>
Element Source Role Target Role
StatisticalAnalysisPlanVersion
Class   		Name: includedSampleSizeConsideration
  		Name: includingStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each SampleSizeConsideration always is included in one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might include one or more SampleSizeConsideration.<br/><br/>DEFINITION:<br/>Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:Statistics v1.0 SampleSizeConsideration
Details:
 
Object Type Connection Direction Notes
StatisticalAnalysisPlanVersion Class Weak To DESCRIPTION: Each SampleSizeConsideration always is included in one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might include one or more SampleSizeConsideration. DEFINITION: Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan. EXAMPLE(S): OTHER NAME(S): NOTE(S):