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? |
Inclusion/exclusion violations |
CRF |
Yes |
Baseline variables |
CRF |
Yes |
Non-serious AEs |
CRF |
Yes |
Treatment unblinding |
CRF |
Yes |
Dispensing errors |
CRF |
Yes |
Blood pressure and heart rate |
CRF |
Added |
Gynecomastia and DRE evaluations |
CRF |
Yes SE |
Study drug exposure |
CRF |
Added SE |
Compliance |
CRF |
Added SE |
Post-baseline biopsies |
CRF, Bostwick |
Yes |
Adjusted total PSA reported to sites |
I3 |
Added FH |
Serious AEs |
OCEANS, CRF |
Yes |
Deaths (overall and PCa specific)* |
OCEANS, CRF |
Added FH |
Hematology and clinical chemistry |
Quest |
Added FH |
Unadjusted total PSA and % free PSA |
Quest |
Yes |
DHT and T ** |
Quest |
Yes SE |
Number of subjects at each Visit |
RAMOS, CRF |
Yes |
Withdrawals from run-in |
RAMOS, CRF |
Yes |
Withdrawals from treatment |
RAMOS, CRF |
Yes |
Accrual (registered, randomized) |
RAMOS, CRF |
Yes |
*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.