"sc","ptid","randomdt","maxevaldt","stopdrugdt","stopreason","wdrawdt","tplntdate","deathdt","following","followstat","cancerdt","losttofup","wdreason" 1,1001,2/9/1994,12/18/2003,11/13/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1002,6/22/1994,11/19/2003,11/14/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1003,4/10/1995,1/21/2004,11/11/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1004,2/7/1994,1/5/2004,1/27/2003,"per DSMB",,,,"Yes","3 Month",,, 1,1005,2/2/1994,12/15/2003,4/22/1999,"voluntary",4/22/1999,,,"Yes","3 Month",,,"voluntary; Pt. felt medication was not helpful and did not wish to continue taking it" 1,1006,1/26/1994,12/17/2003,11/15/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1007,3/28/1994,12/8/2003,11/19/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1008,5/16/1994,2/4/2004,8/5/1997,"persistently 80,000 plateletes",,,,"Yes","3 Month",,, 1,1009,2/9/1994,1/5/2004,1/8/1997,"Neuropathy",,,,"Yes","3 Month",,, 1,1012,6/22/1994,8/19/1998,7/29/1998,"Poor appetite, Disabling fatigue, Patient died 08/19/1998",7/29/1998,,8/19/1998,"No","No",,,"Poor appetite; Pt suffering from disabling fatigue and multiple complications of her liver disease. Unable to keep" 1,1013,2/9/1994,12/8/2003,11/15/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1014,8/1/1994,11/19/2003,5/26/1997,"Ovarian cancer",5/26/1997,,,"Yes","3 Month",5/5/1997,,"Ovarian cancer" 1,1015,4/18/1994,12/15/2003,11/18/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1016,8/15/1994,2/28/2000,3/28/2000,"Liver transplant 03/28/2000",3/28/2000,3/28/2000,,"No","12 Month",,,"Liver transplant" 1,1018,8/22/1994,12/15/1999,6/22/1999,"plt less than 80,000 2.5 mg. per week; patient died 02/12/2000 Sepsis",2/12/2000,,2/12/2000,"No","No",,,"Death" 1,1020,10/5/1994,12/16/2003,12/21/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1022,3/16/1994,11/12/2003,11/14/2002,"per DSMB",6/22/2003,,,"Yes","3 Month",6/22/2003,,"Colon Cancer" 1,1024,5/4/1994,1/7/2004,11/6/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1026,7/13/1994,12/17/2003,11/13/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1027,11/21/1994,11/10/2003,11/11/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1028,10/5/1994,1/12/2004,7/14/1997,"Low Platelets; 06/27/2000 Breast cancer",6/27/2000,,,"Yes","3 Month",6/27/2000,,"development of breast cancer." 1,1029,10/17/1994,1/5/2004,12/10/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1030,6/8/1994,4/7/1999,7/17/1996,"rapidrise in bilirubin., liver transplant 05/05/1999",5/5/1999,5/5/1999,,"No","12 Month",,,"Liver Transplant" 1,1037,9/28/1994,12/1/2003,11/15/2002,"per DSMB",1/20/2003,,,"Yes","3 Month",1/20/2003,,"Lymphoma" 1,1038,11/9/1994,2/2/2004,11/20/2002,"per DSMB",,,,"Yes","3 Month",,, 1,1039,12/12/1994,12/1/2003,11/20/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1040,12/5/1994,12/1/2003,11/18/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1043,6/26/1995,12/3/2001,3/5/2002,"withdrew-time commitment",3/5/2002,,,"No","No",,3/5/2002,"Extensive time commitment is burdensome" 1,1044,7/10/1995,2/19/2003,11/14/2002,"Per DSMB",3/21/2003,,3/21/2003,"No","No",,,"Pt. died of Cardiopulmonary arrest." 1,1045,6/21/1995,12/17/2003,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1049,4/12/1995,10/22/2003,10/9/1996,"Pt developed pulmonary disease that was eventually shown to be granulomatous in nature",9/19/2001,,,"Yes","3 Month",,,"Pt developed pulmonary disease that was eventually shown to be granulomatous in nature; has been ca" 1,1055,10/25/1995,11/12/2003,11/13/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1057,3/25/1996,12/8/2003,11/11/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1058,8/14/1996,1/12/2004,11/13/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1060,5/5/1997,1/12/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1062,6/2/1997,11/17/2003,11/25/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1063,7/2/1997,1/14/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1064,5/28/1997,11/5/2003,1/29/1999,"Renal cell ca",1/29/1999,,,"Yes","3 Month",11/9/1998,,"renal cell ca" 1,1065,6/25/1997,6/18/2003,7/3/2002,"per transplant physician.",7/3/2002,,,"No","12 Month",,,"Transplant physician recommended that actigall and mtx be stopped. the pt obviously needed a transpl" 1,1066,8/2/1994,1/7/2004,11/11/2002,"Per DSMB",,,,"Yes","3 Month",,, 1,1067,3/18/1994,2/4/2004,11/11/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2001,4/26/1994,10/2/2003,11/22/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2002,4/26/1994,11/7/2003,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2003,4/26/1994,9/24/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2005,4/26/1994,9/25/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2006,1/3/1995,9/13/1999,3/5/1997,"variceal bleed",10/26/1999,10/26/1999,,"No","12 Month",,,"Patient transplanted." 2,2007,4/26/1994,4/4/2002,11/24/2002,"Per DSMB",11/24/2002,,,"No","12 Month",,,"patient compliance" 2,2017,1/3/1995,10/13/2003,11/22/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2018,1/3/1995,11/24/2003,11/16/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2021,1/3/1995,12/31/2003,11/24/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2022,1/3/1995,10/14/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2023,1/6/1995,6/19/2000,12/19/2000,"Relocated, Time commitment, Travel costs",2/20/2001,,,"No","12 Month",,,"Pt relocated; Extensive time commitment is burdensome; Travel costs are prohibitive" 2,2024,1/3/1995,12/10/2003,11/23/2002,"Per DSMB",1/15/2004,1/15/2004,,"No","12 Month",,,"pt had liver transplant" 2,2038,4/30/1996,11/1/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2056,11/1/1995,9/9/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 2,2058,2/23/1998,6/23/1999,9/20/1999,"Relocated, Travel costs",9/20/1999,,,"No","No",,6/23/1999,"Pt relocated; Travel costs are prohibitive" 3,3001,6/6/1994,3/6/2000,3/13/2000,"Activated for transplant;Death 05/25/2000 - Sepsis",3/13/2000,,5/25/2000,"No","No",,,"Activated for transplant" 3,3003,6/6/1994,10/21/2003,1/5/1998,"Cancer of Vulvar in Situ",1/5/1998,,,"Yes","3 Month",3/24/1997,,"Cancer of Vulvar" 3,3005,6/6/1994,10/7/2003,11/4/2002,"Per DSMB",,,,"Yes","3 Month",,, 3,3006,9/19/1994,12/22/2003,11/11/2002,"Per DSMB",,,,"Yes","3 Month",,, 3,3018,3/20/1995,1/14/2004,12/23/1996,"bone pain",,,,"Yes","3 Month",,, 3,3021,5/10/1995,12/9/2003,2/27/2002,"Subject dx. with cancer, lg. cell lymphoma of bone",2/27/2002,,,"Yes","3 Month",2/22/2002,,"Dx. with lg. cell lymphoma of bone" 3,3022,3/20/1995,12/15/2003,11/4/2002,"Per DSMB",1/20/2003,,,"Yes","3 Month",1/20/2003,,"Pre cancerous lesion of pancreatic head" 3,3023,3/27/1995,10/21/2003,11/4/2002,"Per DSMB",,,,"Yes","3 Month",,, 3,3049,8/16/1996,12/8/2003,11/4/2002,"Per DSMB",,,,"Yes","3 Month",,, 3,3051,9/2/1997,3/31/2000,3/31/2000,"Time committment too overwhelming",3/31/2000,,,"No","No",,3/31/2000,"Pt. has hx. of severe depression and anxiety and found being in the study too stressfull" 4,4001,6/2/1994,2/19/2002,3/23/2001,"hepatocellular carcinoma; Patient transplanted 04/18/2002",3/23/2001,4/18/2002,,"No","12 Month",4/9/2001,,"Hepatocellular Carcinoma" 4,4003,4/28/1994,12/3/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4005,7/28/1994,8/17/2000,8/17/2000,"SOB;Patient died 03/05/2001 - Cardiac decompensation",3/5/2001,,3/5/2001,"No","No",,,"Death" 4,4007,2/18/1994,10/15/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4008,1/27/1994,1/8/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4009,6/30/1994,1/8/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4010,5/15/1994,9/10/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4014,5/19/1994,8/25/1994,7/7/1994,"Relocated,No longer wanted to participate",7/21/1994,,,"No","12 Month",,,"PT RELOCATED TO WINTER HOME FOR 6 MONTHS. DOES NOT WANT TO PARTICIPATE IN STUDY." 4,4018,4/28/1994,12/4/2003,7/5/2001,"decreased creatinine clearance",,,,"Yes","3 Month",,, 4,4019,10/20/1994,11/13/2003,11/13/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4020,3/10/1994,8/14/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4021,5/2/1996,8/28/2003,12/12/2001,"ovarian cancer",12/19/2001,,,"Yes","3 Month",12/19/2001,,"Ovarian Cancer" 4,4022,8/25/1994,1/21/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4023,9/8/1994,11/3/2003,3/11/1999,"workup for lytic lesion of skull",,,,"Yes","3 Month",,, 4,4025,9/22/1994,7/24/2003,3/19/1996,"Pregnancy",3/19/1996,,,"Yes","3 Month",,,"Pregnancy 3/19/96, Re-entered 2/23/00" 4,4026,4/27/1995,1/22/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4027,11/4/1994,1/22/2004,11/10/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4030,5/9/1996,1/22/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4032,9/29/1994,12/4/2003,11/12/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4033,3/16/1995,5/5/2003,11/14/2002,"Per DSMB",6/16/2003,6/16/2003,,"No","12 Month",,,"Pt transplanted" 4,4034,3/2/1995,10/22/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4035,10/27/1994,12/11/2003,11/8/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4042,7/27/1995,11/24/1997,8/29/1996,"Breast Cancer;Death 11/24/1997 - Hepatic failure",8/29/1996,,11/24/1997,"No","No",8/19/1996,,"Cancer of the R. breast, partial mastectomy on 8/30/96" 4,4045,4/13/1995,9/20/2001,6/28/2001,"wbc 2.1, gran 1.05, PI d/c drug; Death 11/26/2001 - Sepsis",11/26/2001,,11/26/2001,"No","No",,,"Pt death due to sepsis" 4,4047,7/20/1995,9/25/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4048,6/29/1995,12/11/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4054,8/17/1995,8/2/2002,12/3/1998,"abnormal pft's",8/2/2002,,,"No","12 Month",,,"Extensive time commitment is burdensome; Travel costs are prohibitive" 4,4057,9/7/1995,12/18/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4060,11/9/1995,12/4/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4061,10/12/1995,10/30/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4062,11/30/1995,11/13/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4067,4/11/1996,8/7/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4068,3/19/1996,9/25/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4069,3/7/1996,2/25/1997,6/27/1996,"thrombocytopenia;Patient transplanted 03/27/1997",3/27/1997,3/27/1997,,"No","12 Month",,,"Liver transplant" 4,4070,3/28/1996,10/16/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4072,7/24/1996,1/24/2002,4/25/2002,"Time commitment",4/25/2002,,,"No","12 Month",,,"Extensive time commitment is burdensome; travel time is 3 1/2 hours" 4,4078,12/5/1996,8/31/1999,4/30/1998,"does not feel well, Patient transplanted 09/03/1999",9/3/1999,9/3/1999,,"No","12 Month",,,"Pt had cadaveric liver transplant 9/3/99" 4,4079,10/17/1996,1/22/2004,10/24/2002,"nausea and vomiting",10/23/2003,,,"Yes","3 Month",3/18/1999,,"Hepatocellular Carcinoma" 4,4080,12/5/1996,10/24/2002,11/14/2002,"Per DSMB",11/14/2002,,,"No","12 Month",,,"Extensive time commitment is burdensome; Travel costs are prohibitive; study drug was d/c per DSMB" 4,4081,12/5/1996,12/4/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4082,12/5/1996,1/22/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4083,1/16/1997,12/11/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4084,2/6/1997,1/22/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4085,1/9/1997,11/13/2003,11/8/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4087,3/13/1997,9/25/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4090,6/19/1997,12/11/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4091,5/15/1997,11/20/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4092,6/19/1997,12/11/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4093,7/3/1997,1/7/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4094,8/7/1997,1/8/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4095,7/24/1997,11/6/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4096,8/14/1997,6/29/2000,6/1/1998,"rectal bleeding; Patient transplanted 09/27/2000",9/27/2000,9/27/2000,,"No","12 Month",,,"Pt transplanted (living donor)" 4,4097,4/24/1997,1/7/2002,10/15/1998,"uticaria, diarrhea; Patient died 03/15/2002 Hepatic failure",3/15/2002,,3/15/2002,"No","No",,,"Pt expired 3/15/02" 4,4100,10/30/1997,1/8/2004,1/1/1998,"Time commitment",1/7/1998,,,"Yes","3 Month",,,"Extensive time commitment is burdensome; Diarrhea; Pt also has u/c Pt states improvement in diarrhea after d/c both study drug and actigall." 4,4101,11/6/1997,10/30/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 4,4106,11/6/1997,10/16/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5001,7/25/1994,5/2/1995,4/11/1995,"anxiety,depression",4/11/1995,,,"No","No",,10/5/2001,"anxiety, depression" 5,5002,7/25/1994,7/10/1995,4/1/1995,"thrombocytopenia; Patient transplanted 10/08/1997",4/1/1995,10/8/1997,,"No","No",,9/10/2001,"Thrombocytopenia; splenectomy" 5,5003,8/12/1994,11/12/2003,11/1/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5004,8/17/1994,12/11/2003,11/1/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5005,9/2/1994,1/17/2002,4/9/2002,"Patient died - multisystem failure due to hepatic failure - metabolic acidosis",4/9/2002,,4/9/2002,"No","No",,,"Patient died - multisystem failure due to hepatic failure - metabolic acidosis" 5,5006,10/5/1994,11/18/2003,9/30/2002,"Renal dysfunction",,,,"Yes","3 Month",,, 5,5007,9/16/1994,10/1/2003,11/1/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5008,8/23/1994,1/7/2004,11/4/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5009,10/21/1994,1/7/2004,11/30/2000,"Platelets were 58,000",,,,"Yes","3 Month",,, 5,5011,11/25/1994,12/1/1999,10/30/1999,"sepsis/hospitalization ; Patient transplanted 02/28/2000",2/28/2000,2/28/2000,,"No","12 Month",,,"stopped study drug due to infection. Transplanted 2/28/00" 5,5012,1/18/1995,10/23/2003,6/20/2001,"SOB",,,,"Yes","3 Month",,, 5,5013,2/1/1995,11/20/2003,11/5/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5014,5/16/1995,10/20/2003,5/21/1996,"malignant melanoma r arm",6/3/1996,,,"Yes","3 Month",4/24/1996,,"malignant melanoma of the r arm" 5,5017,6/3/1995,12/10/2003,8/24/1998,"kidney disease",,,,"Yes","3 Month",,, 5,5022,8/21/1995,11/3/2003,11/7/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5023,10/26/1995,8/7/2003,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5024,11/14/1995,4/17/2002,10/14/2001,"ascites; Patient transplanted 04/25/2002",4/25/2002,4/25/2002,,"No","12 Month",,,"Transplanted 4/25/02" 5,5025,8/7/1996,1/22/2004,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5026,8/19/1996,12/4/2003,11/4/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5027,2/19/1997,2/3/2000,8/11/1999,"H Pylori gastritis;patient discontinued/abd pain",2/3/2000,,,"No","No",,4/12/2001,"Pt did not specify why" 5,5029,1/15/1997,1/21/2004,11/8/2002,"Per DSMB",,,,"Yes","3 Month",,, 5,5032,10/7/1997,1/15/2004,11/5/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6001,3/18/1994,10/14/1998,12/9/1998,"Time commitment",1/13/1999,,,"No","12 Month",,,"Extensive time commitment is burdensome; Pt has difficulty commuting to new study site." 6,6002,3/16/1994,11/12/2003,11/6/2002,"Per DSMB; Colon cancer 02/11/2003",2/11/2003,,,"Yes","3 Month",2/11/2003,,"Colon Cancer" 6,6004,4/8/1994,12/17/2003,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6005,3/25/1994,11/3/1998,11/2/1998,"Time commitment",11/3/1998,,,"No","12 Month",,,"Extensive time commitment is burdensome" 6,6006,4/22/1994,1/14/2004,11/11/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6007,4/29/1994,10/8/2003,11/7/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6008,2/1/1995,1/21/2004,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6009,4/29/1994,10/8/2003,11/5/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6010,7/1/1994,8/11/2000,7/24/2000,"Travel costs prohibitive",3/21/2001,,,"No","12 Month",,,"Travel costs are prohibitive" 6,6011,5/6/1994,7/15/1999,12/9/1997,"rash(found to be SQ lupus);Transplanted 07/16/1999;Death 08/13/1999 - Sepsis",7/16/1999,7/16/1999,8/13/1999,"No","No",,,"Living donor liver transplant 7/16/99" 6,6012,5/13/1994,10/7/2003,3/19/2001,"dyspnea",,,,"Yes","3 Month",,, 6,6013,5/27/1994,11/19/2003,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6014,6/1/1994,8/31/1994,8/15/1994,"encephalopathy",8/15/1994,,,"No","12 Month",,,"encephalopathy(08/25/94 EEG consistent with),not allowed to drive & no one to drive him (6hr drive)" 6,6015,6/10/1994,10/15/2003,11/11/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6016,6/17/1994,11/3/1998,1/6/1999,"Pt does not want to continue care at new site and insurance will not cover care at new site.",1/12/1999,,,"No","12 Month",,,"Pt does not want to continue care at new site and insurance will not cover care at new site." 6,6017,6/24/1994,4/9/2003,2/20/2002,"pt discontinued on her own",4/9/2003,,,"No","12 Month",,,"Extensive time commitment is burdensome" 6,6018,7/22/1994,8/2/2000,1/24/2000,"Platelets",12/2/2000,12/2/2000,,"No","12 Month",,,"Orthotopic Liver Transplant" 6,6019,10/7/1994,11/4/2003,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6021,2/5/1996,3/5/2003,11/4/2002,"Per DSMB",8/16/2003,,8/16/2003,"No","No",,,"death due to complications of liver disease and sepsis" 6,6022,3/10/1997,11/19/2003,11/4/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6023,10/22/1997,12/9/2003,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 6,6024,12/15/1997,1/21/2004,11/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7001,10/7/1994,10/31/2003,11/9/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7002,10/21/1994,1/16/2004,4/26/1996,"Breast cancer",2/10/1996,,,"Yes","3 Month",2/10/1996,,"breast ca, mastectomy 2/10/96" 7,7003,11/4/1994,12/12/2003,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7004,5/27/1994,12/12/2003,12/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7005,4/15/1994,10/17/2003,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7006,5/27/1994,12/12/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7007,5/23/1994,10/31/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7008,6/3/1994,11/30/2001,12/23/2001,"Patient died 12/26/2001 - Sepsis",12/26/2001,,12/26/2001,"No","No",,,"patient died of sepsis." 7,7009,1/6/1995,1/2/1998,1/2/1998,"Patient transplanted 01/02/1998",1/2/1998,1/2/1998,,"No","12 Month",,,"pt transplanted on 01/02/98" 7,7011,12/2/1994,5/17/1996,6/10/1996,"Relocated",6/10/1996,,,"No","No",,6/10/1996,"Pt relocated" 7,7012,10/28/1994,1/20/2004,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7013,11/18/1994,1/20/2004,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7014,12/16/1994,12/12/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7015,12/16/1994,12/12/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7023,12/22/1995,9/7/2001,12/7/2001,"Time commitment;Travel costs",12/6/2001,,,"No","12 Month",,,"Extensive time commitment is burdensome; Travel costs are prohibitive" 7,7029,2/24/1995,12/12/2003,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7033,5/12/1995,10/17/2003,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7035,6/23/1995,1/16/2004,12/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7036,7/21/1995,1/20/2004,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7039,8/11/1995,12/12/2003,4/19/1996,"severe diarrhea",,,,"Yes","3 Month",,, 7,7040,2/2/1996,10/31/2003,12/6/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7042,11/22/1996,1/20/2004,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7043,9/6/1996,10/31/2003,11/15/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7044,9/6/1996,1/20/2004,8/15/1997,"SOB",,,,"Yes","3 Month",,, 7,7045,1/31/1997,3/14/1997,3/14/1997,"Time commitment",3/14/1997,,,"No","No",,3/14/1997,"Extensive time commitment is burdensome; ""I will not be coming up there every two weeks, sorry, can't deal with it" 7,7047,10/17/1997,1/20/2004,11/29/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7048,8/1/1997,1/20/2004,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7501,11/9/1994,5/17/1996,3/30/1996,"general side effects, respiratory acidosis, hyponatremia",5/17/1996,,,"No","No",,11/14/1996,"pt discontinued due to serious adverse event of central nervous system toxicity." 7,7503,5/17/1994,10/22/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7504,1/16/1995,9/25/1996,11/25/1996,"Wanted to be unblinded because wants to take actual Methotrexate for Sjogrens. Never Returned.",9/25/1996,,,"No","12 Month",,,"Wanted to be unblinded because wants to take actual Methotrexate for Sjogrens. Never Returned." 7,7505,1/10/1995,10/22/2003,11/27/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7506,2/23/1995,5/28/2003,11/27/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7508,3/16/1995,9/11/2003,3/28/1997,"significant fatty change on biopsy",,,,"Yes","3 Month",,, 7,7509,3/7/1995,10/22/2003,11/20/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7510,4/24/1995,7/16/2003,11/1/1996,"cranial nerve symptoms",7/16/2003,,,"No","12 Month",,,"Extensive time commitment is burdensome; Travel costs are prohibitive" 7,7511,6/7/1995,8/13/2003,12/2/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7512,8/15/1995,11/8/1995,11/8/1995,"Severe nausea or vomiting; Rash, urticaria",11/16/1995,,,"No","No",,11/16/1995,"Severe nausea or vomiting; Rash, urticaria" 7,7514,9/20/1995,9/10/2003,11/22/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7515,5/18/1995,4/11/2003,4/10/1996,"personal choice; withdrew from study then re-entered the study",4/10/1996,,,"Yes","3 Month",,,"personal choice; re-entered study" 7,7516,6/13/1996,11/24/2003,11/28/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7517,7/22/1996,11/5/2003,11/27/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7518,10/24/1996,7/12/1999,6/10/1998,"Prostate Cancer; Patient died 09/12/1999 - ischemic cardiomyopathy",6/10/1998,,9/12/1999,"No","No",4/17/1998,,"Diagnosed with severe Prostate Cancer" 7,7519,1/30/1997,10/1/2003,4/22/1999,"development of Duodenal Villous adenoma",,,,"Yes","3 Month",,, 7,7522,10/10/1996,11/5/2003,11/27/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7523,7/25/1997,11/12/2003,11/25/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7529,3/17/1998,10/22/2003,11/18/2002,"Per DSMB",,,,"Yes","3 Month",,, 7,7703,7/23/1997,1/14/2004,3/24/1999,"MTX for Psoriasis",3/24/1999,,,"Yes","3 Month",2/14/2003,,"pt went on open label MTX for psoriasis" 8,8001,6/28/1994,10/8/2003,12/22/1998,"anemia/gastric ulcers",12/22/1998,,,"Yes","3 Month",,,"gastric ulcers and anemia" 8,8002,7/19/1994,3/19/2002,1/14/2002,"Pt is in rehab at this time, was on ventilator, has severe polymyositis",3/19/2002,,,"No","12 Month",,,"Pt is in rehab at this time, was on ventilator, has severe polymyositis" 8,8003,7/26/1994,12/8/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 8,8004,7/12/1994,11/10/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 8,8006,9/27/1994,1/19/1996,9/15/1995,"""it's too much of a hassle, and too time consuming; Patient died 01/19/1996 Heart failure",9/14/1995,,1/19/1996,"No","No",,,"Extensive time commitment is burdensome; Travel costs are prohibitive; Rash, urticaria; ""it's too much of a hassle, and too time consuming" 8,8007,2/21/1995,8/15/1996,12/26/1995,"Per Dr. Boyers decision; Patient transplanted 08/15/1996",8/15/1996,8/15/1996,,"No","12 Month",,,"Patient was transplanted" 8,8008,10/18/1994,11/10/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 8,8009,1/3/1995,3/29/1999,3/26/1996,"Vol. Discontinuation;Transplanted 04/07/1999; Death 02/10/2001",4/7/1999,4/7/1999,2/10/2001,"No","No",,,"patient ws transplanted , liver transplant 4/7/99" 8,8010,9/12/1995,11/10/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 8,8017,9/12/1995,9/13/1999,2/18/1997,"Breast Cancer; Transplanted 11/01/1999",1/9/1997,11/1/1999,,"No","12 Month",1/9/1997,,"Breast Cancer - lumpectomy" 8,8020,10/10/1995,12/8/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 8,8021,12/19/1995,11/10/2003,11/19/2002,"Per DSMB",,,,"Yes","3 Month",,, 8,8022,1/23/1996,2/5/2001,5/15/2001,"6 hour drive to this site too much for her",5/15/2001,,,"No","12 Month",,,"Extensive time commitment is burdensome; 6 hour drive to this site too much for her" 8,8025,7/23/1996,4/22/2002,4/22/2002,"Relocated; Lost to follow-up",4/22/2002,,,"No","No",,4/22/2002,"Pt relocated; and lost to follow up" 8,8026,8/27/1996,11/24/2003,3/23/1999,"Platelets",,,,"Yes","3 Month",,, 8,8027,10/7/1996,6/2/1997,10/19/1997,"Poor patient compliance",11/17/1997,,,"No","No",,12/15/1999,"Poor patient compliance" 8,8033,5/30/1994,1/11/1999,1/20/1999,"pt. committed suicide",1/20/1999,,1/20/1999,"No","No",,,"pt. committed suicide" 8,8035,11/4/1997,8/28/2000,11/27/2000,"Lives in Alabama, family moved away,Cannot get a ride",11/27/2000,,,"No","12 Month",,,"Lives in Alabama, family moved away,Cannot get a ride" 9,9002,3/30/1995,8/5/2003,9/6/2001,"Chronic Lymphocytic Leukemia",9/6/2001,,,"Yes","3 Month",1/9/2001,,"chronic lymphocytic leukemia" 9,9004,1/4/1996,1/16/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9005,7/20/1995,1/9/2004,11/7/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9007,6/22/1995,9/26/1997,12/6/1996,"development of ascites, encephalopathy;Transplanted 09/28/1997",9/28/1997,9/28/1997,,"No","12 Month",,,"Patient received O.L.T. 9/28/97" 9,9008,4/10/1997,7/21/2003,11/17/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9010,5/11/1995,6/12/2003,9/17/2001,"Breast Cancer",9/17/2001,,,"Yes","3 Month",9/7/2001,,"breast cancer" 9,9013,6/8/1995,1/12/2004,11/17/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9014,4/13/1995,5/13/2003,2/27/2003,"Per DSMB",,,,"Yes","3 Month",,, 9,9015,7/20/1995,1/6/2004,11/17/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9016,10/26/1995,1/14/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9017,3/28/1996,1/19/2004,11/17/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9018,4/25/1996,2/3/2004,11/17/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9019,8/1/1996,4/25/2003,11/27/2002,"Per DSMB",4/23/2003,,,"No","No",,4/25/2003,"Patient non-compliant" 9,9021,9/12/1996,10/15/2003,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9022,9/12/1996,1/2/2004,11/14/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9023,11/7/1996,9/23/2003,11/17/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9025,7/3/1997,1/20/2004,11/7/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9026,5/22/1997,1/6/2004,11/17/2002,"Per DSMB; Breast cancer 11/27/2002",11/27/2002,,,"Yes","3 Month",11/27/2002,,"Breast Cancer" 9,9027,4/10/1997,1/5/2004,11/7/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9028,5/22/1997,1/9/2004,11/7/2002,"Per DSMB",,,,"Yes","3 Month",,, 9,9030,9/11/1997,2/16/1999,12/17/1998,"decompensating liver function ; Transplanted 02/16/1999",2/16/1999,2/16/1999,,"No","12 Month",,,"OLT on 2/16/99" 9,9035,3/2/1994,12/8/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10001,5/22/1997,1/28/2004,11/22/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10002,11/7/1996,12/10/2003,11/22/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10003,5/22/1997,1/28/2004,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10004,5/22/1997,1/28/2004,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10006,7/3/1997,11/19/2003,11/13/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10007,7/3/1997,12/3/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10008,7/3/1997,12/10/2003,12/12/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10010,10/30/1997,12/17/2003,11/21/2002,"Per DSMB",,,,"Yes","3 Month",,, 10,10013,2/12/1998,1/17/2004,12/2/2002,"Per DSMB",,,,"Yes","3 Month",,, 11,11007,3/28/1996,11/20/2003,12/1/2002,"Per DSMB",,,,"Yes","3 Month",,, 11,11019,3/16/1994,11/20/2003,10/17/2001,"Breast cancer",10/17/2001,,,"Yes","3 Month",10/19/2001,,"Right breast adenocarcinoma" 11,11020,7/20/1997,11/20/2003,11/24/2002,"Per DSMB",,,,"Yes","3 Month",,,