REDUCE Study | Report Components

Previous reports

To Do for the December 2007 Report (see also 08/24/2006 Meeting Notes)

  1. (June 2007): page 126, Table 41: Since these data are from the CRF, the denominator here should be all subjects who have data from CRF page 46 (for 2 year biopsies) and page 74 (for 4 year biopsies). That is, summarize the BYPFD variable (Yes/No for scheduled biopsy conducted), and then for BYPFD=No summarize reason not conducted as a percent of the overall number of BYPFD values for year 2 scheduled biopsies and then separately for year 4 scheduled biopsies. This would allow comparison of the CRF # of scheduled visits vs. the Central Pathology # of scheduled visits. (Matt: Mon, 17 Apr 2006 15:54:09)
  2. (June 2007): Update the rangeCheck function changed by Terri.
  3. (June 2007): Add the makeNA function created by Terri.
  4. (June 2007): Make survReport produce output for f(y)=1-y (cumul incidence) and for both closed and open reports.
  5. (June 2007): After having done the item 14,15 put them into the rreport "to do list" and check it as done.
  6. (June 2007): Replace all mySurvReport() with survReport() in report.s
  7. (June 2007): In function listTable() set default appendix=TRUE and make corresponding changes in report.s
  8. Open report:(May 2006) Dot charts should have category frequencies added in the right margin.
  9. Open report:(May 2006) Add a summary of $\alpha$ blockers in the same tables.
  10. Open report:(May 2006) For Table 47, work with GSK to get a tabulation of ``other.''
  11. Open report:(May 2006) For the survival curves for dropouts, add new curves that censor on scheduled biopsies that are positive for cancer. This will allow the committee to see how much of the dropout at two years is due to positive biopsies, which are legitimate reasons for termination.
  12. Closed report: Add lab summaries for total cholesterol, LDL cholesterol, and triglycerides.
  13. (October 2006): Regarding SAEs, no differences were apparent between A and B for the common class of cardiac events. The committee asked how prostate cancer shows up in the SAE table.
  14. (October 2006): Serious cerebrovascular-related nervous system disorders needs to be tabulated.

Minutes (December 2007):

  1. under construction...

Matt's tables priority list:

  1. under construction...

Matt's tables due to June-2008 Meeting

  1. E1: Summary of Subjects Biopsied by Procedure Type (CRF Data)
  2. E2: Summary of Subjects for Whom Scheduled Biopsies Were Not Conducted (CRF Data)
  3. E3: Summary of Subjects Biopsied by Procedure Type (Central Pathology Data)
  4. E8: Summary of Life Table Estimates for Biopsy-Detectable Prostate Cancer (Crude Rate Approach)
  5. E10: Summary of Life Table Estimates for Biopsy-Detectable Prostate Cancer (Modified Crude Rate Approach)
  6. E30: Summary of time to Death or Biopsy-Detectable Prostate Cancer (Crude Rate Approach)
  7. E31: Summary of Effect of Baseline Covariates on Biopsy-Detectable Prostate Cancer
  8. E34: Summary of Subjects with Prostate Cancer by Prostate Volume at Biopsy
  9. E35: Summary of Time to Biopsy Detectable Prostate Cancer
  10. E104: Summary of Overall Survival

Plan for IDMC outputs for December 2007

Date Event
11 February 2008 Intermediate data transfer to SDC
11 April 2008 Intermediate data transfer to SDC
28 May 2008 Final data transfer to SDC
02 July 2008 SDC sends outputs to IDMC members
09 July 2008 IDMC meeting; place: ?

Dataset Documentation Files

  1. Latest SAS data specs are in file SAS_Specs.txt dated June 2005
  2. Notes about Reported PSA data from I3 Research

Steps for Creating Analysis Files

File Definitions

Meanings of Variable SESS (Based on CRF Pages)

Organization of the Data

Assumptions about the Data

Analysis Plan Notes

R Functions for Competing Risk and Stratified Analysis

Topic revision: r157 - 19 Dec 2014, JoAnnAlvarez

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