To Do for the Oct 2005 Report

  1. DONEAsk Matt how to process unscheduled biopsy records dates (for one subject) that differ by few days (SE)
  2. DONETo write a function: like mixedvarReport, but for one variable and for many visits (see aeReport ?). Such function could be useful to summarize: compliance, DHT, TOTST, Gynecomastia, ... - SE wrote a function that takes a dataframe containing value and visits and reports value by visit using mixedvarReport().
  3. DONE Add to closed (stratified by treatment) report a scatterplot of DHT against compliance.
  4. DONE In all subject listings that include treatment assignment (only for closed report) sort rows so that all like-treated subjects are together
  5. DONE Make sure that sexual function and prostatitis in follow-up are reported
  6. DONE Send SAE summaries to all IDMC committee members at three month intervals, for between meetings
  7. DONE Drug exposure (SE)
  8. DONE Merge dataset BIOPSY to unschedBiop dataset (SE)
  9. DONE Start reporting scheduled biopsies (SE)
  10. DONE Finish imputation for CPSI (SE)
  11. DONE Reformat and impute MOS Score according to Matt's e-mail from Tue, 2 Aug 2005 13:10:55 -0400 (SE)
  12. DONE Add prostate volume report (SE)
  13. DONE Make two separate reports for biopsy data: one based on Central Lab data, the other one based on the local labs data and Central Lab data (SE)
  14. DONE Ask Matt what medications EXACTLY are permitted/prohibited (p. 45 of the protocol)
  15. DONE Report on concomitant med usage, especially NSAIDS and prostate cancer prevention meds - baseline (only salenium, vitamin E?) + one year CRF
  16. DONE Update section 7 (Actual and Reported PSA) in open report (FH)

Plan for IDMC outputs for October 2005

Date Event
05 April 2005 intermediate data transfer to SDC (DONE)
07 July 2005 intermediate data transfer to SDC (DONE)
07 September 2005 final data transfer to SDC (DONE)
05 October 2005 SDC sends outputs to IDMC members (DONE)
12 October 2005 IDMC meeting (DONE)

Outputs to be produced by SDC for October 2005 IDMC meeting:

Outputs to be produced will be based on those generated for the previous meeting (04 March 2005). Following are some additional considerations:
  1. Since interim and final reporting will be based on the CRF and lab data and not the RAMOS data, and since we expect to have baseline CRF data in-house on all subjects by September 2005, reporting to the IDMC from this point on should primarily be based on the ITT population as determined by the CRF data alone (see protocol section 11.5). Reporting of RAMOS data should continue to be done for the registration and randomization summaries and summaries of pertinent subject activities such as visits and withdrawals. The distinction between the RAMOS data and the other data should be clearly mainained in the open and closed session report text and accompanying tables and figures.
  2. Additional analyses of compliance based on DHT (guidance for this report will be provided soon)
  3. additional analyses of AEs of interest (especially cardiovascular) by smoking history/status
  4. The mortality monitoring plan was modified to start in October 2005
Topic revision: r2 - 13 Oct 2005, SvetlanaEden

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