For the RAMOS data (PatientActivity.csv), the "withdrawal.from.study.visit.date" should correspond to w/d from study for all subjects (which should be the same as w/d from treatment for all subjects except for those diagnosed with prostate cancer). For prostate cancer subjects, there is another variable called "WITHDRAWAL DRUG PCa Visit Date" that should correspond to w/d from treatment for the prostate cancer subjects only (I would expect that very few of these are non-missing at this time). Let me know if you'd like to discuss the other new items - hopefully there should be a clear correspondence of each one to the specifications in Amendment 12 of the protocol. I would only summarize the important RAMOS variables for the IDMC (e.g., I don't think that you need to summarize the occurrence of the 3 month telephone calls between visits). (Matt: Wed, 8 Feb 2006 15:07:47 -0500)

The new variables: a) withdrawal from study visit date and call date b) withdrawal drug PCA visit date and call date c) PCa V3 visit date and call date - PCa V10 visit date and call date (ie, V3 through V10) d) Month 9 visit date and call date - Month 52 visit date and call date (ie month 9, 15, 21, ......52) e) withdr month 6 visit date and call date - withdr month 48 visit date and call date (ie month 6, 12 , 18 .... 48) We have already discussed items a) and b). Item c) denotes the prostate cancer clinic visits after end of treatment (see section 6.8 of the protocol for description). Items d) and e) refer to the telephone calls between clinic visits and follow-up telphone calls, respectively. It does not seem necessary to me to provide summaries of items c), d) or e) for the IDMC. However if you and/or Frank would like to discuss this further please let me know. (Matt: Fri, 17 Feb 2006 14:16:42 -0500)