1. DONE Add argument prmsd so mixedvarReport could show mean and standard deviation (SE?)
  2. DONE CRF completeness report(SE)
  3. DONE Automatically sense date of last I3 data and include in first part of reports(SE) - report.s will stop if new visits are added
  4. DONE Dataset withdrawn. Distinguish between withdrawn from the study and withdrawn from treatment, report them separately (dataset 'summary').The primary interest should be in reasons for discontinuing study drug, and would suggest reporting reasons for stopping study drug separately from reasons for w/d from study. The only subjects who stop study drug but continue in the study should be prostate cancer subjects. (Matt's e-mail from Wed, 5 Oct 2005 10:09:35 ). (SE)
  5. DONE Make sure there are no duplicates in SAE (SE)
  6. DONE The PRDRUG data (CRF page 3) represent NSAIDS/selenium/vitamin E that were taken within 12 months prior to visit 1 but stopped prior to visit 1; the DRUG data represents con meds taken sometime beyond visit 1. Since Table 5 reports medications taken prior to the study then it would seem that PRDRUG should be included. I would suggest that the reporting be based on the preferred terms as per the drug coding via the DRUGCODE.CSV file. Regarding the other 5ARIs, the only one I know of is finasteride (Proscar, Propecia). For the next go-round on this we need clinical input on this issue. (Matt's e-mail from Wed, 5 Oct 2005 10:09:35 )(SE)
  7. DONE Check if there is a new variable "route" in concomitant medications (ketoconazole: oral-prohibited, topical-allowed)(SE)
  8. DONE Testosterone values corresponding to the triangles in the figure of DHT against compliance should be shown (SE)
  9. DONE For serious cerebrovascular SAEs a listing of time on drug should be included in the next report (SE)
  10. DONE Change labels in the pathology data (labels: "suspicious" and "ASAP" should be the same)(SE)
  11. DONE Denominator errors in SDC biobsy reports need to be corrected (openMinutes.pdf).(SE)
  12. DONE Separate out cases with HGPIN also having a diagnosis of PCa from subjects with HGPIN without also having a diagnosis of PCa (openMinutes.pdf).(SE)
  13. DONE Include "Severe nervous system disorders" frequensy table (SE)
  14. DONE One additional summary that would be very useful would be that of CRF page 46 (2 year scheduled biopsy page) and CRF page 74 (4 year scheduled biopsy) - i.e., sumamries of n/% of scheduled biopsies that were/were not conducted and summaries of reasons not conducted. Is this already being planned? If not can you please add it? (Matt:Tue, 28 Mar 2006 08:35:04)(BIOPSY data)(SE)
  15. DONEChange the code for PSA data (I3... file) (SE)
  16. DONEsummaries of cross-tabulations of the occurrence of prostate cancer, HGPIN and ASAP (two 2-way tables, one table for PCa=yes and one table for PCa=no).
  17. DONEsummary of occurrence of prostate cancer by relevant baseline variables (age, race, family history, total PSA, % free PSA, prostate volume, BMI). For the continuous variables Id suggest using tertiles to define the subgroups.
  18. DONEsummary of clinical chemistry and hematology data

Plan for IDMC outputs for May 2006

Date Event
DONE 04 November 2005 Intermediate data transfer to SDC
DONE 07 February 2006 Intermediate data transfer to SDC
DONE 07 April 2006 Final data transfer to SDC
DONE 24 April 2006 SDC sends outputs to IDMC members
DONE 1 May 2006 IDMC meeting; Washington, DC

Outputs to be produced by SDC for May 2006 IDMC meeting:

Outputs to be produced will be based on those generated for the previous meeting (12 October 2005). In addition, several action items were noted in our correspondence on 17 October 2005. In this correspondence some modifications to existing analyses were noted; in addition the following new analyses were identified:
  1. summaries of cross-tabulations of the occurrence of prostate cancer, HGPIN and ASAP (two 2-way tables, one table for PCa=yes and one table for PCa=no).
  2. reporting of concomitant medications using preferred terms based on drug codes
  3. separate summaries of reasons for stopping study drug and reasons for w/d from study

The following additional summaries are also requested:
  1. summary of reasons for unscheduled (for-cause) biopsies
  2. summary of occurrence of prostate cancer by relevant baseline variables (age, race, family history, total PSA, % free PSA, prostate volume, BMI). For the continuous variables Id suggest using tertiles to define the subgroups.
  3. summary of clinical chemistry and hematology data
It is recognized that further discussion may be necessary to identify the most appropriate approach for some of these new summaries.
Topic revision: r1 - 14 Sep 2006, SvetlanaEden
 

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