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
Post-baseline biopsies CRF, Bostwick Yes
Treatment unblinding CRF Yes
Dispensing errors CRF Yes
Hematology and clinical chemistry Quest DONEAdded FH
Unadjusted total PSA and % free PSA Quest Yes
Blood pressure and heart rate CRF DONEAdded
Gynecomastia and DRE evaluations CRF Yes SE
DHT and T ** Quest Yes SE
Deaths (overall and PCa specific)* OCEANS, CRF DONEAdded FH
Study drug exposure CRF DONEAdded SE
Compliance CRF DONEAdded SE
Adjusted total PSA reported to sites I3 DONEAdded 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.
Topic revision: r11 - 16 Aug 2005, SvetlanaEden

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