SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 1 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ BLR/ 48/M/WH Yes Yes Yes WITHDRAWAL OF CONSENT 2001/ 004 BLR/ 61/M/WH Yes Yes 2004/ 001 BLR/ 51/F/WH Yes Yes 2004/ 003 GEO/ 72/M/OT Yes Yes Yes PROGRESSIVE DISEASE 2101/ 001 GEO/ 56/M/WH Yes Yes Yes ADVERSE EVENT 2101/ 004 GEO/ 58/M/WH Yes Yes Yes ADVERSE EVENT 2101/ 005 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 2 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ GEO/ 54/M/WH Yes Yes 2101/ 007 GEO/ 63/M/WH Yes Yes Yes ADVERSE EVENT 2102/ 002 GEO/ 53/M/WH Yes Yes 2102/ 003 GEO/ 53/M/WH Yes Yes 2102/ 006 GEO/ 59/M/WH Yes Yes Yes PROGRESSIVE DISEASE 2106/ 002 GEO/ 59/M/WH Yes Yes Yes DEATH 2106/ 003 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 3 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ GEO/ 52/M/WH Yes Yes Yes PROGRESSIVE DISEASE 2106/ 004 GEO/ 74/M/WH Yes Yes Yes WITHDRAWAL OF CONSENT 2106/ 005 GEO/ 46/M/WH Yes Yes Yes PROGRESSIVE DISEASE 2108/ 001 GEO/ 79/M/WH Yes Yes Yes ADVERSE EVENT 2108/ 012 HUN/ 69/M/WH Yes Yes 0502/ 003 HUN/ 69/F/WH Yes Yes 0502/ 004 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 4 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ HUN/ 63/M/WH Yes Yes 0502/ 005 HUN/ 69/F/WH Yes Yes 0502/ 006 HUN/ 62/F/WH Yes Yes 0502/ 009 HUN/ 50/F/WH Yes Yes 0502/ 011 HUN/ 62/F/WH Yes Yes 0507/ 003 HUN/ 61/F/WH Yes Yes 0507/ 004 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 5 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ KOR/ 73/M/AS Yes Yes Yes WITHDRAWAL OF CONSENT 0103/ 001 KOR/ 74/M/AS Yes Yes 0103/ 002 KOR/ 48/F/AS Yes Yes 0105/ 001 KOR/ 72/M/AS Yes Yes Yes ADVERSE EVENT 0109/ 002 KOR/ 73/M/AS Yes Yes 0110/ 001 POL/ 60/F/WH Yes Yes Yes Yes 1001/ 001 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 6 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ POL/ 64/M/WH Yes Yes 1001/ 005 ROU/ 60/M/WH Yes Yes 1103/ 001 RUS/ 59/M/WH Yes Yes 1601/ 001 RUS/ 55/M/WH Yes Yes 1601/ 003 RUS/ 77/F/WH Yes Yes 1601/ 008 RUS/ 70/M/WH Yes Yes 1601/ 009 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 7 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 72/M/WH Yes Yes 1601/ 010 RUS/ 62/M/WH Yes Yes 1601/ 015 RUS/ 69/M/WH Yes Yes 1604/ 001 RUS/ 60/M/WH Yes Yes 1604/ 002 RUS/ 63/F/WH Yes Yes 1605/ 001 RUS/ 78/M/WH Yes Yes 1605/ 003 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 8 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 63/F/WH Yes Yes 1607/ 001 RUS/ 53/M/WH Yes Yes 1612/ 001 RUS/ 58/M/WH Yes Yes 1612/ 003 RUS/ 66/M/WH Yes Yes Yes ADVERSE EVENT 1612/ 004 RUS/ 60/M/WH Yes Yes 1612/ 006 RUS/ 51/M/WH Yes Yes 1613/ 001 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 9 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 66/M/WH Yes Yes 1613/ 004 RUS/ 63/F/WH Yes Yes 1615/ 001 RUS/ 51/M/WH Yes Yes 1617/ 002 RUS/ 46/M/WH Yes Yes 1617/ 003 RUS/ 70/M/WH Yes Yes 1617/ 005 RUS/ 52/M/WH Yes Yes 1617/ 010 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 10 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 56/F/WH Yes Yes 1617/ 011 RUS/ 66/M/WH Yes Yes 1617/ 012 RUS/ 53/M/WH Yes Yes 1617/ 013 RUS/ 60/M/WH Yes Yes 1617/ 014 RUS/ 67/F/WH Yes Yes 1617/ 016 RUS/ 55/F/WH Yes Yes 1617/ 017 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 11 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 56/F/WH Yes Yes 1617/ 021 RUS/ 72/F/WH Yes Yes 1620/ 001 RUS/ 56/M/WH Yes Yes 1620/ 003 RUS/ 66/M/OT Yes Yes 1620/ 008 RUS/ 54/M/WH Yes Yes 1620/ 010 RUS/ 69/M/WH Yes Yes 1621/ 002 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 12 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ SRB/ 62/M/WH Yes Yes Yes DEATH 2301/ 001 SRB/ 59/M/WH Yes Yes 2303/ 002 SRB/ 39/M/WH Yes Yes 2303/ 003 SRB/ 40/M/WH Yes Yes 2303/ 004 SRB/ 65/M/WH Yes Yes 2303/ 006 SRB/ 62/F/WH Yes Yes 2303/ 010 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 13 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ SRB/ 54/F/WH Yes Yes 2303/ 012 SRB/ 56/M/WH Yes Yes 2303/ 013 SRB/ 55/F/WH Yes Yes 2303/ 014 TWN/ 58/M/AS Yes Yes 2502/ 001 TWN/ 49/F/AS Yes Yes 2502/ 003 UKR/ 61/M/WH Yes Yes 1201/ 001 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 14 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 63/M/WH Yes Yes Yes WITHDRAWAL OF CONSENT 1201/ 002 UKR/ 61/F/WH Yes Yes 1202/ 001 UKR/ 66/F/WH Yes Yes 1202/ 002 UKR/ 58/F/WH Yes Yes 1202/ 003 UKR/ 61/M/WH Yes Yes 1202/ 005 UKR/ 67/M/WH Yes Yes 1202/ 006 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 15 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 55/M/WH Yes Yes 1203/ 001 UKR/ 60/F/WH Yes Yes 1203/ 003 UKR/ 58/M/WH Yes Yes 1204/ 001 UKR/ 63/F/WH Yes Yes 1204/ 003 UKR/ 64/M/WH Yes Yes Yes ADVERSE EVENT 1204/ 004 UKR/ 43/F/WH Yes Yes 1204/ 005 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 16 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 75/M/WH Yes Yes Yes DEATH 1204/ 009 UKR/ 54/M/WH Yes Yes 1204/ 011 UKR/ 77/F/WH Yes Yes 1204/ 015 UKR/ 64/F/WH Yes Yes 1206/ 005 UKR/ 51/F/WH Yes Yes 1207/ 001 UKR/ 76/M/WH Yes Yes Yes DEATH 1207/ 003 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 17 of 34) Subject Disposition Randomised Set Treatment: Group A ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 69/M/WH Yes Yes 1209/ 002 UKR/ 56/F/WH Yes Yes 1209/ 005 UKR/ 66/F/WH Yes Yes 1209/ 006 UKR/ 49/M/WH Yes Yes 1209/ 011 UKR/ 76/M/WH Yes Yes 1209/ 013 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 18 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ BLR/ 75/F/WH Yes Yes 2001/ 002 BLR/ 59/M/WH Yes Yes 2001/ 003 BLR/ 65/F/WH Yes Yes 2001/ 005 BLR/ 62/M/WH Yes Yes 2005/ 001 BLR/ 63/F/WH Yes Yes 2005/ 002 BLR/ 64/M/WH Yes Yes 2005/ 003 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 19 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ BLR/ 70/M/WH Yes Yes 2006/ 001 BLR/ 63/M/WH Yes Yes 2006/ 002 DEU/ 73/F/WH Yes Yes 2202/ 001 ESP/ 67/F/WH Yes Yes 2402/ 001 GEO/ 57/M/OT Yes Yes 2101/ 002 GEO/ 70/M/WH Yes Yes Yes ADVERSE EVENT 2102/ 004 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 20 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ GEO/ 61/M/WH Yes Yes 2102/ 005 GEO/ 65/M/WH Yes Yes Yes ADVERSE EVENT 2104/ 001 GEO/ 76/F/WH Yes Yes Yes Yes 2106/ 001 GEO/ 67/M/WH Yes Yes 2106/ 007 GEO/ 44/M/WH Yes Yes 2106/ 008 GEO/ 65/M/WH Yes Yes Yes DEATH 2106/ 009 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 21 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ GEO/ 53/M/WH Yes Yes 2106/ 011 GEO/ 38/F/WH Yes Yes 2108/ 003 GEO/ 56/F/WH Yes Yes 2108/ 008 GEO/ 49/M/WH Yes Yes 2108/ 009 GEO/ 61/M/WH Yes Yes 2108/ 010 GEO/ 52/M/WH Yes Yes 2108/ 011 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 22 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ HUN/ 61/F/WH Yes Yes Yes PROGRESSIVE DISEASE 0502/ 001 HUN/ 68/M/WH Yes Yes 0502/ 013 HUN/ 54/M/WH Yes Yes 0504/ 001 HUN/ 45/M/WH Yes Yes 0504/ 003 HUN/ 55/F/WH Yes Yes 0507/ 002 KOR/ 51/M/AS Yes Yes 0105/ 002 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 23 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ KOR/ 75/M/AS Yes Yes 0106/ 001 KOR/ 69/M/AS Yes Yes 0109/ 001 KOR/ 70/M/AS Yes Yes Yes ADVERSE EVENT 0109/ 003 POL/ 54/F/WH Yes Yes 1001/ 002 POL/ 65/F/WH Yes Yes 1001/ 003 POL/ 61/M/WH Yes Yes 1001/ 004 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 24 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ ROU/ 62/M/WH Yes Yes 1102/ 001 ROU/ 43/M/WH Yes Yes 1102/ 002 RUS/ 63/F/WH Yes Yes 1601/ 002 RUS/ 60/M/WH Yes Yes 1601/ 004 RUS/ 63/F/WH Yes Yes 1601/ 005 RUS/ 57/M/WH Yes Yes 1601/ 006 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 25 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 56/M/WH Yes Yes 1601/ 007 RUS/ 62/M/WH Yes Yes 1601/ 011 RUS/ 56/M/WH Yes Yes 1601/ 012 RUS/ 68/F/WH Yes Yes 1601/ 013 RUS/ 42/F/WH Yes Yes 1604/ 004 RUS/ 66/F/WH Yes Yes 1606/ 001 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 26 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 65/M/WH Yes Yes 1607/ 002 RUS/ 65/F/WH Yes Yes 1609/ 001 RUS/ 67/F/WH Yes Yes 1612/ 002 RUS/ 61/M/WH Yes Yes 1612/ 005 RUS/ 62/F/WH Yes Yes 1613/ 002 RUS/ 70/F/WH Yes Yes 1613/ 003 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 27 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 50/F/WH Yes Yes 1615/ 003 RUS/ 55/M/WH Yes Yes 1617/ 001 RUS/ 56/M/WH Yes Yes 1617/ 004 RUS/ 41/F/WH Yes Yes 1617/ 006 RUS/ 69/F/WH Yes Yes 1617/ 007 RUS/ 60/F/WH Yes Yes 1617/ 008 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 28 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 70/M/WH Yes Yes 1617/ 015 RUS/ 38/M/WH Yes Yes 1617/ 018 RUS/ 42/M/WH Yes Yes 1617/ 020 RUS/ 54/F/WH Yes Yes 1617/ 022 RUS/ 64/M/WH Yes Yes 1620/ 002 RUS/ 61/M/AS Yes Yes 1620/ 004 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 29 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ RUS/ 39/M/WH Yes Yes 1620/ 006 RUS/ 57/M/WH Yes Yes 1620/ 009 RUS/ 55/M/WH Yes Yes 1621/ 001 SRB/ 56/M/WH Yes Yes Yes DEATH 2302/ 001 SRB/ 62/M/WH Yes Yes 2302/ 002 SRB/ 53/M/WH Yes Yes 2302/ 003 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 30 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ SRB/ 53/M/WH Yes Yes 2303/ 001 SRB/ 69/M/WH Yes Yes 2303/ 007 SRB/ 65/M/WH Yes Yes 2303/ 008 SRB/ 66/M/WH Yes Yes 2303/ 009 SRB/ 63/M/WH Yes Yes 2305/ 001 TWN/ 47/F/AS Yes Yes 2502/ 002 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 31 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 53/M/WH Yes Yes 1201/ 003 UKR/ 64/F/WH Yes Yes 1202/ 004 UKR/ 57/M/WH Yes Yes Yes WITHDRAWAL OF CONSENT 1203/ 002 UKR/ 63/F/WH Yes Yes 1204/ 002 UKR/ 79/M/WH Yes Yes 1204/ 006 UKR/ 62/M/WH Yes Yes 1204/ 007 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 32 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 62/M/WH Yes Yes 1204/ 010 UKR/ 65/M/WH Yes Yes 1204/ 013 UKR/ 65/F/WH Yes Yes 1206/ 001 UKR/ 44/M/WH Yes Yes 1206/ 002 UKR/ 68/F/WH Yes Yes Yes PROGRESSIVE DISEASE 1206/ 003 UKR/ 67/F/WH Yes Yes Yes PROGRESSIVE DISEASE 1206/ 004 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 33 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 64/M/WH Yes Yes Yes OTHER 1207/ 002 UKR/ 58/M/WH Yes Yes 1207/ 004 UKR/ 56/M/WH Yes Yes 1207/ 005 UKR/ 68/M/WH Yes Yes 1207/ 006 UKR/ 75/F/WH Yes Yes 1209/ 003 UKR/ 61/M/WH Yes Yes 1209/ 004 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41 SB8-G31-NSCLC DSMB1 Listing 16.2.1-1 (Page 34 of 34) Subject Disposition Randomised Set Treatment: Group B ________________________________________________________________________________________________________________________ Country/ Age/ Completed Discontinued Ongoing Discontinued Centre/ Sex/ induction induction maintenance maintenance Reason for discontinued Subject Race Randomised Treated period period period period (specify if other) ________________________________________________________________________________________________________________________ UKR/ 59/M/WH Yes Yes 1209/ 007 UKR/ 62/M/WH Yes Yes 1209/ 008 UKR/ 64/M/WH Yes Yes 1209/ 012 ________________________________________________________________________________________________________________________ /projects/samsu226810/stats/dmc/prog/listings/l_dis.sas Final 19JAN2017 6:41