Summaries of Follow-up Data to Include in Reports, October 2004 and Later
Matt Somerville, GSK 30Aug04
Following are data summaries to be provided in a blinded (i.e., combined across treatment groups) manner for the Open Session Report, and to be provided by treatment group for the Closed Session Report:
Summary Type |
Data Source |
Previously reported by SDC? |
Number of subjects at each Visit |
RAMOS, CRF |
Yes |
Inclusion/exclusion violations |
CRF |
Yes |
Withdrawals from run-in |
RAMOS, CRF |
Yes |
Withdrawals from treatment |
RAMOS, CRF |
Yes |
Accrual (registered, randomized) |
RAMOS, CRF |
Yes |
Baseline variables |
CRF |
Yes |
Non-serious AEs |
CRF |
Yes |
Serious AEs |
OCEANS, CRF |
Yes |
Biopsies post-baseline |
CRF, Bostwick |
Yes |
Treatment unblinding |
CRF |
Yes |
Dispensing errors |
CRF |
Yes |
Hematology and clinical chemistry |
Quest |
Added FH |
Unadjusted total PSA and % free PSA |
Quest |
Yes |
Blood pressure and heart rate |
CRF |
Added |
Gynecomastia and DRE evaluations |
CRF |
Yes SE |
DHT and T ** |
Quest |
Yes SE |
Biopsy-detectable prostate cancer post-baseline |
Bostwick |
Added SE/FH |
Deaths (overall and PCa specific)* |
OCEANS, CRF |
Added FH |
Study drug exposure |
CRF |
Added SE |
Compliance |
CRF |
Added SE |
Adjusted total PSA reported to sites |
I3 |
Added FH |
*obtained from OCEANS SAE data, CRF SAE data, CRF Survival page
**For purposes of the IDMC meeting open session and closed session reports I would recommend that the DHT and T data be summarized by assessment (visit). At this point it does not seem to me that a statistical analysis comparing treatment groups is necessary for the closed report unless the IDMC has expressed interest in this. The formal statistical analysis described in the protocol was intended for the year 2 interim analysis (for which the final assessment is the 24 month visit) and the year 4 formal analysis (for which the final assessment is the 48 month visit) - Matt, Wed, 29 Sep 2004 11:31:41.