B8:
Major protocol violations (open report)
B14:
Summary of Family History of Prostate Cancer
E4:
Summary of Subjects With Prostate Cancer by Procedure Type (Central Pathology Data)
E5:
Summary of Subjects Diagnosed as Suspicious by Procedure Type
E7:
Summary of Biopsy-Detectable Prostate Cancer (Crude Rate Approach)
E9:
Summary of Biopsy-Detectable Prostate Cancer (Modified Crude Rate Approach)
E41:
Summary of Biopsy-Detectable Prostate Cancer (Crude Rate Approach) Based on Central and Local Pathology Laboratory Results
E42:
Summary of Biopsy-Detectable Prostate Cancer (Modified Crude Rate Approach) Based on Central and Local Pathology Laboratory Results
E43:
Summary of Number of Cores Sampled
E44:
Summary of Number of Cancer Positive Cores
E45:
Summary of Percentage of Core Involved
E46:
Summary of Volume of Cancer
E47:
Summary of Number of Subjects by Overall Gleason Score for All Biopsies (Central Lab)
E50:
Summary of Number of Subjects by Overall Gleason Score for All Biopsies (Central+Local Lab)
Date | Event |
---|---|
20 June 2007 | Intermediate data transfer to SDC |
10 September 2007 | Intermediate data transfer to SDC |
05 November 2007 | Final data transfer to SDC |
26 November 2007 | SDC sends outputs to IDMC members |
3 December 2007 | IDMC meeting; place: Atlanta |