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Supplementary materialsEffect of Dose Adjustments on the Safety and Efficacy of Afatinib in Chinese Patients with EGFR-Mutated Non-Small Cell Lung Cancer who Participated in the LUX-Lung Clinical Trial ProgramHai-Yan Tu,1 Yi-Long Wu1Table S1 MedDRA Preferred Terms Included in User-Defined Grouped Terms for Treatment-Related Adverse Events Grouped termMedDRA preferred termsRashBlister; dermatitis; dermatitis bullous; dermatitis exfoliative; dermatitis exfoliative generalized; dermatosis; drug eruption; eczema; epidermal necrosis; erythema; exfoliative rash; folliculitis; generalized erythema; mucocutaneous rash; rash; rash erythematous; rash follicular; rash generalized; rash macular; rash maculopapular; rash maculovesicular; rash morbilliform; rash popular; rash papulosquamous; rash pruritic; rash pustular; rash rubelliform; rash scarlatiniform; rash vesicular; skin disorder; skin erosion; skin exfoliation; skin fissures; skin induration; skin irritation; skin lesion; skin necrosis; skin reaction; skin swelling; skin toxicity; skin ulcerAcneAcne; acne conglobate; acne cystic; acne fulminans; acne pustular; dermatitis acneiformStomatitisAphthous stomatitis; mouth ulceration; mucosal erosion; mucosal inflammation; mucosal ulceration; oral mucosa erosion; stomatitisParonychiaNail bed infection; nail infection; paronychiaFatigueAsthenia; autonomic nervous system imbalance; chronic fatigue syndrome; decreased activity; fatigue; lethargy; listless; malaise; sluggishnessConjunctivitisConjunctival hyperemia; conjunctival irritation; conjunctivitisAbbreviations: MedDRA, Medical Dictionary for Regulatory Activities v16.1.Table S2 TRAEs Occurring in ≥10% of Chinese Patients from the LL3, LL6, and LL7 Trials n (%)All Chinese patients (n=299)TRAEaAll grades345Any299 (100.0)111 (37.1)11 (3.7)16 (5.4)Diarrhea272 (91.0)21 (7.0)00Rash224 (74.9)34 (11.4)1 (0.3)0Paronychia130 (43.5)4 (1.3)00Mouth ulceration86 (28.8)4 (1.3)00Alanine aminotransferase increased68 (22.7)5 (1.7)00Stomatitis61 (20.4)10 (3.3)00Cough60 (20.1)000Epistaxis53 (17.7)1 (0.3)00Aspartate aminotransferase increased52 (17.4)1 (0.3)00Decreased appetite47 (15.7)5 (1.7)00Vomiting44 (14.7)5 (1.7)00Back pain44 (14.7)1 (0.3)00Pruritus43 (14.4)000Fatigue40 (13.4)3 (1.0)00Upper respiratory tract infection39 (13.0)2 (0.7)00Headache38 (12.7)2 (0.7)01 (0.3)Nausea38 (12.7)1 (0.3)00Pyrexia 38 (12.7)1 (0.3)00Dry skin36 (12.0)1 (0.3)00Weight decreased34 (11.4)3 (1.0)00Chest pain33 (11.0)1 (0.3)00Hypokalemia30 (10.0)11 (3.7)1 (0.3)0Notes: Data shown are n (%) in >10% of patients and all grade 3, 4, and 5 Medical Dictionary for Regulatory Activities (MedDRA v16.1 for LL3 and LL6 and 19.0 for LL7) preferred terms and grouped termsa graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.Abbreviations: LL, LUX-Lung; TRAE, treatment-related adverse event. Table S3 TRAEs Pre- and Post-Afatinib Dose Reduction from 40 mg/day Afatinib in Chinese Patients from the LL3, LL6, and LL7 Trials Onset prior to first dose reduction from 40 mg afatinib, n=68Onset after first dose reduction from 40 mg afatinib, n=68TRAEGrade 1–2345Grade 1 –2Grade 3Grade 4Grade 5Any13 (19.1)53 (77.9)2 (2.9)047 (69.1)8 (11.8)2 (2.9)3 (4.4)Diarrheaa50 (73.5)11 (16.2)001 (1.5)000Rash/acnea26 (38.2)28 (41.2)1 (1.5)04 (5.9)000Stomatitisa30 (44.1)14 (20.6)005 (7.4)000Nail effects11 (16.2)3 (4.4)0012 (17.6)000Pruritus11 (16.2)0005 (7.4)000Vomiting7 (10.3)2 (2.9)008 (11.8)000Pyrexia7 (10.3)0003 (4.4)000Dry skin6 (8.8)1 (1.5)001 (1.5)000Notes: Data shown are n (%) in >10% of patients and all grade 3, 4, and 5 Medical Dictionary for Regulatory Activities (MedDRA v16.1 for LL3 and LL6 and 19.0 for LL7) preferred terms and grouped termsa graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.Abbreviations: LL, LUX-Lung; TRAE, treatment-related adverse event. Table S4 Frequency of TRAEs Grade ≥3 in Subgroups of Patients According to Dose Reduction from 40 mg/day AfatinibPatient group, n/N (%)Afatinib <40 mgAfatinib ≥40 mgAll patients55/68 (81%)83/231 (36%)EGFR mutation categoryCommon mutations52/63 (83%)73/207 (35%)Del 19 30/36 (83%)38/121 (31%)L858R22/27 (81%)36/95 (38%)Uncommon mutations3/5 (60%)10/24 (42%)Brain metastases at baselineYes6/9 (67%)15/35 (43%)No 47/57 (82%)67/192 (35%)Notes: Shown are TRAEs of grade 3, 4, or 5 (Common Terminology Criteria for Adverse Events v3).Abbreviations: EGFR, epidermal growth factor receptor; TRAE, treatment-related adverse event.Table S5 PFS in All Treated Patients and Subgroups by Dose Reduction from 40 mg/day AfatinibPatient groupAfatinib <40 mgAfatinib ≥40 mgHR (95% CI), p valueNMedian (95% CI)NMedian (95% CI)All patients6811.0 (8.3–14.0)23111.0 (9.6–13.1)1.15 (0.84–1.58), 0.393SexMale218.9 (4.2–19.4)969.7 (6.9–11.1)1.09 (0.63–1.88), 0.756Female4713.7 (8.3–16.6)13511.8 (9.8–16.6)1.11 (0.75–1.64), 0.611Age<65 years4911.0 (8.3–13.8)17011.0 (9.1–13.7)1.11 (0.77–1.60), 0.585≥65 years1916.6 (5.6–27.7)6110.8 (8.1–16.5)1.15 (0.62–2.15), 0.653Weight<50 kg158.9 (5.5–17.5)2116.5 (5.5–19.2)0.86 (0.39–1.90), 0.709≥50 kg5312.3 (8.3–16.6)21010.9 (9.6–11.8)1.21 (0.85–1.72) 0.292Body surface area<1.5 m21913.8 (5.6–19.3)3811.0 (6.8–16.6)1.20 (0.60–2.36), 0.608≥1.5 m24911.0 (8.3–14.0)19110.9 (9.1–13.1)1.14 (0.80–1.64), 0.476Abbreviations: CI, confidence interval; HR, hazard ratio; PFS, progression-free survival.Table S6 Details of approving ethics committees and all participating principal investigators for the LUX-Lung 3 trialArgentinaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)“Comité de ?tica Independiente en Investigación Clínica” Larrea 1381, 3° A – CABA.Dr. Carlos A. Barclay2101 / Lerzo 2102 / Banges 2104 / Silva 2107 / Martin 2108 / Recondo 2109 / Blajman 2110 / Fein 2111 / Perez 2112 / Carraro 2115 / BatajelgProtocolAmendment 1 Global Amendment 2 Global01/JUL/2009 / 10/JAN/201028/JUN/2010 04/AUG/2011“Comité Independiente para la evaluación y el control de la investigación clínica” Estado de Israel 4718-CABA-C1185AASDr. Viviana a RanoneDr. Jorge A. Lescano Dr. Nicasio A. CuneoDr. Jorge A. Lescano2101 / LerzoProtocolAmendment 1 GlobalAmendment 2 Global12/NOV/2009 03/AUG/201027/OCT/2011Comité Revision Institucional del Hospital Británico Perdriel 74 -CABA - (C1280AEB)Lic. Maria Isabel Fadel2104 / SilvaProtocolAmendment 1 Global Amendment 2 Global25/SEP/2009 23/JUL/2010N/A – Site was already closedArgentinaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comité de ?tica Independiente del Hospital Alemán Av. Pueyrredón 1640 CABA (C1118AAT)Departamento de Docencia e Investigación Hospital AlemánAv. Pueyrredón 1640 –Dra. Haydee WimmersDr. Alejandro Ranitzsch2106 / BasProtocolAmendment 1 Global Amendment 2 GlobalProtocolAmendment 1 Global Amendment 2 Global25/FEB/2010 14/JUL/2010N/A – Site was already closed25/NOV/2009 27/JUL/2010N/A – Sites were already closedComité Ejecutivo de Investigación Instituto Médico Especializado Alexander Fleming . Av. Crámer 1180 (C1426ANZ) CABADr. José Mordoh2107 / MartinProtocolAmendment 1 Global Amendment 2 Global07/JAN/2010 09/AUG/2010 27/JAN/2012Comite de Etica en Investigación CEMIC. Av. E Galván 4102 (C1431FWO) –CABADr. Enrique Gadow NAP2108 / RecondoProtocolAmendment 1 Global Amendment 2 Global14/DEC/2009 19/AUG/2010N/A – Sites were already closedArgentinaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comité de Docencia e Investigación de ISIS Centro Especializado . (S3000FFU) Urquiza 3077 - Santa FéDr. Samuel Seireff NAP2109 / BlajmanProtocolAmendment 1 Global Amendment 2 Global27/OCT/2009 22/JUN/2010N/A – Sites were already closed“Comité de Docencia e Investigación” Oro?o 1085 – Rosario – Santa Fé – S2000DKSDr. Daniel Sarcuno2110 / FeinProtocolAmendment 1 Global Amendment 2 Global15/MAR/2010 19/JUL/2010 31/OCT/2011Comité de Bioética – Hospital de Agudos “Dr. L. Lucero” Estomba 968 (8000) Bahia Blanca – Buenos AiresDr. Norman Pasquaré NAP2111 / PerezProtocolAmendment 1 Global Amendment 2 Global08/JUN/2010 22/SEP/2010N/A – Sites were already closed“Comité de Docencia e Investigación” French 2673- CABA – C1425AWCDra. Graciela BarreiroProf. Dra. Clelia Magaril2112 / CarraroProtocolAmendment 1 Global Amendment 2 Global04/MAR/2010 08/JUL/2010 01/NOV/2011ArgentinaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/orAmendment number(s)Date of Final Approval (DD/MMM/YYYY)CECIC – Comité de ?tica de CER Investigaciones Clinicas Vicente López 1441 (B1878DVB) Quilmes – Buenos AiresDr. Damián Del Percio NAP2114 / VarelaProtocolAmendment 1 Global Amendment 2 Global23/APR/2010 11/AUG/2010N/A – Sites were already closedComité Institucional de revisión de Ensayos Clínicos Hospital Militar Central “Cir My Dr. Cosme Argerich” Av. Luis Maria Campos 726 (C1426BOR) CABADr. Gustavo Christian Casado2115 / BatajelgProtocolAmendment 1 Global Amendment 2 Global27/MAY/2010 24/AUG/2010 26/JAN/2012AustraliaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)North Sydney and Central Coast Area Health Service Human Ethics Committee Research Office Level 2, Building 51 Royal North Shore HospitalPacific highway St Leonards, NSW, 2065, AustraliaDr Liz Newton2701 / PavlakisProtocolAmendment 1 Global Amendment 2 Global18/DEC/2009 03/JUN/2010 21/JUL/2011Eastern Health Research Ethics Committee 5 Arnold Street Box Hill, VIC, 3128 AustraliaDr Patricia Molloy2702 / ParenteProtocolAmendment 1 Global Amendment 2 Global17/SEP/2009 09/AUG/2010 08/AUG/2011AustraliaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Human Research Ethics Committee The Prince Charles Hospital Metro North Health Service District Administration Building, Lower Ground Rode Road, Chermside, QLD, 4032, AustraliaMr Philip Masel2703 / HughesProtocolAmendment 1 Global Amendment 2 Global14/OCT/2009 24/JUN/2010 28/JUL/2011Flinders Clinical Research Ethics Committee Human Research and Ethics Department Southern Adelaide Health Service Room 2A 221 Flinders Medical Centre Bedford Park, SA, 5042, AustraliaDr Harry Randhawa2704 / KarapetisProtocolAmendment 1 Global Amendment 2 Global04/MAR/201025/OCT/2010N/A (no active patients)AustraliaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Hunter New England Human Research Ethics Committee Calvary Mater New Castle Edith Street Waratah, NSW, 2298 AustraliaDr Nicole Gerrand2705 / AbellProtocolAmendment 1 Global Amendment 2 Global21/DEC/200904/JUN/2010N/A (no active patients)St Vincent’s Hospital (Melbourne) Human Research Ethics Committee-D St Vincent’s Hospital 41 Victoria Parade Fitzroy, VIC, 3065 AustraliaDr Jacqueline Hastings2706 / McLachlanProtocolAmendment 1 Global Amendment 2 Global22/DEC/2009 28/MAY/2010 28/JUL/2011Mount Hospital Ethics Committee C/- Mount Hospital 150 Mounts Bay Road Perth, WA, 6000 AustraliaProf Ross Baker2707 / van HazelProtocolAmendment 1 Global Amendment 2 Global13/OCT/2009 03/AUG/2010 18/OCT/2011AustraliaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Bellberry Human Research Ethics Committee 229 Greenhill Road Dulwich, SA, 5065 AustraliaYvette L Winter2708 / SlancarProtocolAmendment 1 GlobalAmendment 2 Global09/OCT/2009N/A (site closed prior to Amendment 1 and 2 being effective due to low recruitment activity)N/ABellberry Human Research Ethics Committee 229 Greenhill Road Dulwich, SA, 5065 AustraliaYvette L Winter2709 / ChiaProtocolAmendment 1 Global Amendment 2 Global09/OCT/200913/OCT/2010N/A (no active patients)Sydney South West Area Health ServiceLesley Townsend2711 / BoyerProtocolAmendment 1 Global Amendment 2 Global17/DEC/2009 05/AUG/2010 23/SEP/2011AustriaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Leading ethics committee for Austria: Ethikkommission der Medizinischen Universit?t Wien und des Allgemeinen Krankenhauses AKH, Borschkegasse 8B/E 06, A-1090 WienUniv. Prof. Dr Ernst Singer5102 / PirkerProtocolAmendment 1 Global Amendment 2 Global20/AUG/2009 15/JUN/2010 06/SEP/2011Local ethics committee for Austria: Ethikkommission der Stadt Wien Gesch?ftsführung: Gesundheitsdienst der Stadt Wien (MA 15), TownTown, Thomas-Klestil-Platz 8/2, A-1030 WienDr. Karin Spacek5101 / BurghuberApproval of Leading Ethics Committee takes effect. AustriaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Local ethics committee for Austria: Ethikkommission des A.?. Krankenhaus der Elisabethinen z.Hd. Servicestelle fir klinische Studien und universit?re Angelegenheiten, KH der Elisabethinen, Fadingerstra?e 1, A-4010 LinzUniv. Doz. Dr. Rainer Sch?fl5103 / AignerApproval of Leading Ethics Committee takes effect. Local ethics committee for Austria: Ethikkommission des Landes Ober?sterreich, Wagner-Jauregg-Weg 15, A-4020 LinzUniv. Prof. Prim. Dr. Johannes Fischer5104 / OA Dr. Rainer KOLBApproval of Leading Ethics Committee takes effect. BelgiumIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Leading Ethics Committee:Commissie Medische Ethiek UZ Brussel Laarbeeklaan 101 B – 1090 BRUSSELProfessor P. DEVROEY4101 / De Grève 4102 / Bosquée 4103 / Ninane 4104 / Vuylsteke 4105 / Surmont 4107 / VansteenkisteProtocolAmendment 1 Global Amendment 2 Global22/OCT/ 2009 (for sites 1 to 5) 11/FEB/2010 (for site 7) 26/MAY/2010 (all sites) 28/JUL/2011 (all sites)Comité d’Ethique de la Faculté de Médecine de Liège – ULG Domaine Universitaire du Sart-Tilman B?timent B23 Institut de Pathologie B – 4000 LIEGEProfessor M. LAMY4102 / BosquéeApproval of Leading Ethics Committee takes effect. Comité d’Ethique de l’h?pital Universitaire Saint-Pierre Rue Haute, 322 1000 BruxellesProfessor P. HERMANS4103 / NinaneApproval of Leading Ethics Committee takes effect. BelgiumIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comité d'Ethique Clinique Ste Elisabeth Namur Place Louise Godin 15 B-5000 NamurDoctor I. MATHIEU4104 / VuylstekeApproval of Leading Ethics Committee takes effect. Ethisch Comité Universitair Ziekenhuis De Pintelaan, 185 9000 GENTProfessor Dr. R. RUBENS4105 / SurmontApproval of Leading Ethics Committee takes effect. Commissie Medisch Ethiek van de UZ K.U. Leuven - Toetsingscommissie Campus Gasthuisberg E330 Herestraat 49 B – 3000 LEUVENProfessor Dr. Walter VAN DEN BOGAERT4107 / VansteenkisteApproval of Leading Ethics Committee takes effect. BrazilIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comitê de ?tica em Pesquisa em Seres Humanos da Universidade Federal de S?o Paulo - UNIFESP/EPM / Rua Botucatu, 572 1° Andar Conj. 14 – CEP 04.023-061 – S?o Paulo, SP – BrazilJosé Osmar Medina Pestana (Coordenador do CEP)2201 / TadokoroProtocol Amendment 1 Global Amendment 2 Global04/DEC/2009 26/NOV/2011 17/OCT/2011Comitê de ?tica em Pesquisa em Seres Humanos da Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA / Rua Prof. Annes Dias, 285 – 6° Andar – CEP 90020-090 Porto Alegre, RS – Brazil –Prof. Dr. Cláudio Teloken (Coordenador do CEP)2202 / BarriosProtocolAmendment 1 Global Amendment 2 Global26/MAR/2010 10/JAN/2011 14/DEC/2011 BrazilIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comitê de ?tica em Pesquisa em Seres Humanos do Hospital Life Center / Avenida do Contorno, 4747 - 20° andar, CEP 30110-090 Belo Horizonte, MG – BrazilAndré Márcio Murad (Coordenador do CEP)2204 / MuradProtocolAmendment 1 Global Amendment 2 GlobalN/A10/FEB/2011N/A – Site closedComitê de ?tica em Pesquisa em Seres Humanos da Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA / Rua Prof. Annes Dias, 285 – 6° Andar – CEP 90020-090 Porto Alegre, RS – Brazil –Prof. Dr. Cláudio Teloken(Coordenador do CEP)2205 / ZereuProtocol Amendment 1 Global Amendment 2 Global19/AUG/2010 18/JAN/2011 N/A – Site closedBrazilIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comitê de ?tica em Pesquisa em Seres Humanos do Centro Integrado de Aten??o a Saúde - CIAS/ UNIMED Vitória / Av. Leit?o da Silva, 2311 – Vitória, ES – CEP 29047-575 – BrazilAna Daniela deSadowsky (Coordenador do CEP)2207 / AleixoProtocol Amendment 1 Global Amendment 2 Global10/MAR/2010 22/NOV/2010 N/A – Site closedComitê de ?tica em Pesquisa em Seres Humanos do Hospital de Clínicas da Universidade Federal do Paraná – HCUFPR / Rua Gal. Carneiro, 181 Curitiba, PR – CEP 80060-900 – BrazilRenato Tambara Filho (Coordenador do CEP)2208 / Gunnar SkareProtocol Amendment 1 Global Amendment 2 GlobalN/A 04/DEC/2010 N/A – Site closedBrazilIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comitê de ?tica em Pesquisa em Seres Humanos da Sociedade Brasileira e Japonesa de Beneficência Santa Cruz / Hospital Santa Cruz / Rua Santa Cruz, 539 - CEP 04.122-000 – S?o Paulo, SP – BrazilSigismundo José Gomes Amoroso (Coordenador do CEP)2209 / Marcelo TanakaProtocol Amendment 1 Global Amendment 2 GlobalN/A20/DEC/2010N/A – Site ClosedCanadaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)CHUM Comite d’Ethique de la Recherche Edifice cooper 3981 Boulevard St- Laurent Mezz 2 Montreal, QC H2W 1Y5Marie-Claire Michoud Marie-Josee Bernardi Isabelle Dugas2901 / BlaisProtocol Amendment 1 Global Amendment 2 Global14/JAN/2010 29/JUL/2010 07/SEP/2011CanadaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Alberta Cancer Research Ethics Committee 1500-10123 99 Street Edmonton, AB T5J 3H1Karen Mulder Raul Urtasun Raul Urtasun2902 / ChuProtocol Amendment 1 Global Amendment 2 Global19/JAN/2010 21/JUL/2010 09/SEP/2011McGill Institutional Review Board 3655 Promenade Sir William Osler Montreal, QC H3G 1Y6Serge Gauthier Serge Gauthier Serge Gauthier2903 / HirshProtocolAmendment 1 Global Amendment 2 Global16/FEB/2010 29/JUN/2010 26/SEP/2011Research Ethics Committee Hopital Charles LeMoyne 3120 boul. Taschereau Greenfield Park, QC J4V 2H1Visual Uon Visual Uon Visual Uon2904 / Prady (formally Devaux)Protocol Amendment 1 Global Amendment 2 Global29/JAN/2010 12/JUL/2010 24/OCT/2011CanadaIRB or IECIRB or IEC ChairpersonCentre number(s) /Protocol and/orDate of Final Approval(name/address) Investigator(s)Amendment number(s)(DD/MMM/YYYY)Alberta CancerRaul Urtasun2905 / MorrisProtocol24/JUN/2010Research EthicsRaul Urtasun Committee Amendment 1 Global21/JUL/20101J2 WCM Health Sciences Centre 8440-112 Street Edmonton, AB T6G 2B7 REB address changed to: Alberta CancerRaul Urtasun Amendment 2 Global09/SEP/2011Research Ethics Committee Suite 1500 Sun Life Place 10123-99 Street Edmonton, AB T5J 3H1 ChileIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Address 1.Dr. Stuardo2301 / DiazProtocol24/NOV/2009Servicio de Salud Metropolitano de Amendment 1 Global13/JUL/2010Oriente. Comité de ética Cientifico Amendment 2 Global03/JAN.2012Address 2.Miguel Luis Berr Lama Protocol18/JAN/2010Comité de ?tica- Hospital DIPRECA .Sr. Germán Campos Amendment 1 Global18/NOV/2010Av. Vital ApoquindoOnfray 1200, Las Condes Sr. Germán Campos Onfray Amendment 2 GlobalPending – Not yet receivedComité ?tico CientificoPatricio Valdés Garcia2302 / Ya?ezProtocol17/NOV/2009Servicio de Salud Araucaria Sur. Amendment 1 Global06/OCT/2010Andrés Bello 636. Temuco. Amendment 2 GlobalPending – Not yet receivedChileIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Address 1. Comité de ?tica Científica Servicio de Salud Vi?a del Mar-Quillota Limache 1307-2do Piso-Vi?a del Mar Address 2. Comité de ?tica Clinica Re?aca Anabaena 336. Jardín del Mar. Re?aca.Dr. Tulio MorenoDr. Luis Bavestrello2303 / Gonzalez MellaProtocol Amendment 1 Global Amendment 2 Global Protocol Amendment 1 Global Amendment 2 Global12/NOV/2009 21/OCT/2010 24/NOV/201110/DEC/2009 29/OCT/2010 11/NOV/2011FranceIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)CPP SUD EST IV Centre Léon Bérard - 28, rue La?nnec 69373 LYON Cdx 8Tel 04 78 78 27 61 Fax : 04 78 78 28 58Dr DANIEL ESPINOUSE4201 / Guerin 4202 / Sibilot 4204 / Zalcman 4206 / Falchero 4207 / Bennouna 4210 / Daniel 4211 / Urban 4212 / Bérard 4215 / PaganinProtocol Amendment 1 Global Amendment 2 Global21/JUL/2009 08/JUN/2011 30/AUG/2011GermanyIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Leading Ethics Committee :Ethikkommission der ?rztekammer Hamburg Heinrich Hertz-Strasse 125 22085 HamburgProf. Dr. med. Thomas WeberCentre numbers: 4301 4302 4303 4304 4305 4306 4307 4308 4309 4310 4311 4312Protocol Amendment 1 Germany Amendment 1 Global Amendment 2 Global15/SEP/2009 15/SEP/2009 07/JUL/2010 26/JUL/2011?rztekammer Schleswig-Holstein Ethikkommission Bismarckallee 8-12 23795 Bad SegebergDr. med. Franz-Joseph Bartman4302 / ReckApproval of Leading Ethics Committee takes effect. Ethikkommission der Bayrischen Landes?rztekammer Mühlbaurstrasse 16 81677 MünchenProf. Dr. Joerg Hasford4303 / von PawelApproval of Leading Ethics Committee takes effect. GermanyIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Ethikkommission des Landes Berlin Landesamt fir Gesundheit und Soziales S?chsische Str. 28 10707 BerlinFranz Allert4304 / KeilholzApproval of Leading Ethics Committee takes effect. Ethikkommission der Medizinischen Fakult?t der Universit?t Duisburg-Essen Universit?tsklinikum Essen Robert-Koch-Stra?e 9-11 45147 EssenProf. Dr. med. Werner Havers4305 / SchulerApproval of Leading Ethics Committee takes effect. Ethikkommission der Medizinischen Hochschule Hannover Carl-Neuberg-Stra?e 1 30625 HannoverProf. Dr. Hans-Dieter Tr?ger4306 / DickgreberApproval of Leading Ethics Committee takes effect. GermanyIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Medizinische Ethikkommission II Fakult?t für klinische Medizin Mannheim Maybachstrasse 14 – 16 68169 MannheimProf. Dr. med. Jens P. Striebel4307 / ManegoldApproval of Leading Ethics Committee takes effect. Ethik-Kommission der Medizinischen Fakult?t der Goerg-August- Universit?t G?ttingen Robert-Koch-Strasse 40 3075 G?ttingenProf. Dr. med. Jürgen Brockm?ller4308 / GriesingerApproval of Leading Ethics Committee takes effect. Ethik-Kommission der ?rztekammer Westfahlen-Lippe und der Medizinischen Fakult?t der Westf?lischen Wilhelms-Universit?t Münster Von-Esmarch-Strasse 5248149 MünsterUniv.-Prof. Dr. med. Hans-Werner Bothe4309 / SerkeApproval of Leading Ethics Committee takes effect. GermanyIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Ethikkommission bei der Landes?rztekammer Rheinland-Pfalz Deutschhausplatz 3 55131 MainzProf. Dr. Stephan Letzel4310 / WehlerApproval of Leading Ethics Committee takes effect. Ethikkommission der ?rztekammer Westfalen-Lippe und der Medizinischen Fakult?t der Westf?lischen-Wilhelms-Universit?t Münster Von-Esmarch-Strasse 52 48149 MünsterUniv.-Prof. Dr. med. Hans-Werner Bothe4311 / WiewrodtApproval of Leading Ethics Committee takes effect. Ethikkommission der Medizinischen Fakult?t Heidelberg Amalienstra?e 5 69126 HeidelbergProf. Dr. Med. Thomas Strowitzki4312 / ThomasApproval of Leading Ethics Committee takes effect. Hong KongIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Joint CUHK-NTEC Clinical Research Ethics Committee Flat 3C, Block B, Staff Quarters, Prince of Wales HospitalDr. Chi Kong Li, Prof. Brian Tomlimson3101 / Mok, Tony S. K.Protocol Amendment 1 Global Amendment 2 Global11/AUG/2009 16/JUL/2010 19/JUL/2011HKU/HA HKW IRB Room 901 Administration Block Queen Mary HospitalProf. Yuen Man Fung3102 / Lee, VictorProtocol Amendment 1 Global Amendment 2 Global31/AUG/2010 31/AUG/2010 13/JUL/2011HungaryIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Medical Research Council Ethics Committee for Clinical PharmacologyProf. Dr. Fürst Zsuzsanna5301 / Szima5302 / Papai Szekely 5301 / Szima 5302 / Papai Szekely 5303 / Strausz 5304 / TehenesProtocol Amendment 1 Global Amendment 2 Global16/OCT/2009 02/AUG/2010 07/OCT/2011IrelandIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Research Ethics Committee Adelaide & Meath Hospital, (incorporating the National Children's Hospital), Tallaght, Dublin 24Dr Ray McDermott4401 / O-ByrneProtocol Amendment 1 Global Amendment 2 Global28/SEP/2009 27/MAY/2010 28/JUL/2011ItalyIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comitato Etico delle Aziende Sanitarie della Regione Umbria Via della Rivoluzione, 16 06070 Ellera di Corciano (PG)Prof. Giancarlo Agnelli4501 / Crino' (Coordinating site)ProtocolAmendment 1 Global09/JUL/2009 22/JUL/2010ItalyIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Comitato Etico per la sperimentazione dei medicinali Azienda USL 8 di Arezzo Via Curtatone 54 52100 ArezzoDr. Maura Lodovici4503 / BracardaProtocolAmendment 1 Global22/OCT/2009 23/SEP/2010Comitato Etico A.O. S. Andrea di Roma Via di Grottarossa, 1035 00189 RomaAvv. Gian Domenico Caiazza4504 / MarchettiProtocolAmendment 1 Global09/NOV/2009 11/OCT/2010Comitato Etico Azienda Unità Sanitaria Locale 3 Via S.M. La Grande, 5 95124 CataniaDr. Domenico Barbagallo4505 / GiuffridaProtocolAmendment 1 Global29/OCT/2009 09/NOV/2010JapanIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)The IRB of Shizuoka Cancer Center1007 Shimonagakubo Nagaizumi-cho, Sunto- gun, ShizuokaDr. Tobisu Kenichi3202 / Yamamoto, NobuyukiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global27/OCT/2009 27/OCT/2009 22/JUN/2010 29/JUL/2011The IRB of National Cancer Center Hospital, East Division6-5-1, Kashiwanoha, Kashiwa, ChibaDr. Kinoshita TairaDr. Tamura Tomohide3203 / Goto, KoichiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global28/OCT/2009 28/OCT/2009 23/JUN/2010 27/JUL/2011The IRB of Aichi Cancer Center Hospital1-1, Kanokoden, Chikusa-ku, Nagoya, AichiDr. Hasegawa Yasuhisa Dr. Kodaira Takeshi3204 / Hida, ToyoakiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global24/NOV/2009 24/NOV/2009 20/JUL/2010 23/AUG/2011JapanIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)The IRB of Kinki University Hospital 377-2, Ono-Higashi, Osaka-Sayama, OsakaDr. Kusunoki Susumu Dr. Ikegami Hiroshi3205 / Okamoto, IsamuProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global14/SEP/2009 14/SEP/2009 28/JUN/2010 12/SEP/2011The IRB of Osaka City General Hospital 2-13-22, Miyakojima-hondori, Miyakojima- ku, OsakaDr. Tada Hirohito3206 / Takeda, KojiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global20/NOV/2009 20/NOV/2009 18/JUN/2010 16/SEP/2011The IRB of National Kyushu Cancer Center 3-1-1, Nodame, Minami-ku, Fukuoka, FukuokaDr. Okamura Jun3207 / Sugio, KenjiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global16/NOV/2009 16/NOV/2009 02/JUN/2010 01/SEP/2011JapanIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)The IRB of Okayama University Hospital 2-5-1, Shikata-cho Kita-ku, Okayama, OkayamaDr. Koide NorioDr. Iwatsuki Keiji3209 / Kiura, KatsuyukiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global20/OCT/2009 20/OCT/2009 15/JUN/2010 16/AUG/2011The IRB of Kanazawa University Hospital 13-1, Takara-machi, Kanazawa, IshikawaDr. Matsui OsamuDr. Sugiyama Kazuhisa3211 / Kasahara, KazuoProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global14/OCT/2009 14/OCT/2009 14/JUL/2010 14/SEP/2011The IRB of Kurashiki Central Hospital 1-1-1,Miwa, Kurashiki,OkayamaDr. Goto Tsuyoshi3214 / Yoshioka, HiroshigeProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global19/OCT/2009 19/OCT/2009 21/JUN/2010 20/JUL/2011JapanIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)The IRB of Hokkaido University Hospital North 14, West 5, Kita-ku, Sapporo, HokkaidoDr. Iseki Ken3215 / Oizumi, SatoshiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global20/OCT/2009 20/OCT/2009 15/JUN/2010 30/AUG/2011The IRB of Niigata Cancer Center 2-15-3, Kawagishi-cho, Chuo-ku, Niigata, NiigataDr. Yokoyama Akira3216 / Yokoyama, AkiraProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global09/NOV/2009 09/NOV/2009 14/JUN/2010 12/SEP/2011The IRB of National Hospital Organization Nagoya Medical Center 4-1-1, Sannomaru, Naka-ku, Nagoya, AichiDr. Horibe Keizo3217 / Saka, HideoProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global23/OCT/2009 23/OCT/2009 20/JUL/2010 03/AUG/2011JapanIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)The IRB of Kinki- Chuo Chest Medical Center 1180 Nagasone-cho Kita-ku, Sakai, OsakaDr. Hayashi SeijiDr. Matsumura Akihide3218 / Atagi, ShinjiKawahara, MasaakiProtocol Amendment 1 Local Protocol: Amendment 1 Local Amendment 1 Global Amendment 2: Global16/OCT/2009 16/OCT/2009 09/DEC/2009 09/DEC/2009 09/JUN/2011 14/SEP/2011The Institute of Biomedical Research and Innovation hospital Minatozimaminami- machi Chuo-ku, Kobe, HyogoDr. Okumura Katsuhiko3219 / Katakami, NobuyukiProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global28/OCT/2009 28/OCT/2009 23/JUN/2010 21/DEC/2011The IRB of National Hospital Organization Shikoku Cancer Center 160 Ko Minamiumenomoto-machi, Matsuyama, EhimeDr. Kurita AkiraDr. Iguchi Haruo3220/ Nogami, NaoyukiShinkai, TetsuProtocol Amendment 1 Local Amendment 1 Global Amendment 2: Global13/OCT/2009 13/OCT/2009 21/JUN/2010 27/JUL/2011JapanIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)The IRB of Kanagawa Cardiovascular and Respiratory Center 6-16-1, Tomioka- higashi, Kanazawa-ku, Yokohama, KanagawaDr. Takahashi Hiroshi3221/ Kato, TerufumiProtocol Amendment 1 Local Site Version Amendment 1 Global Amendment 2: Global10/NOV/2009 10/NOV/2009 10/NOV/2009 13/JUL/2010 12/JUL/2011KoreaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)IRB of Asan Medical Center B1, Clinical Research Center 88, OLYMPIC-RO 43-GIL,Sonpa- gu,Seoul,138-736,South KoreaSeong-Wook PARK3301 / Dr. Sang-We KimProtocol Amendment 1 Global Amendment 1 Local Amendment 2: Global13/JUL/2009 28/MAY/2010 13/AUG/2010 29/JUL/2011KoreaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)IRB of Chonnam National University,Hwasun Hospital 2F Clinical trial center,160 Ilsim-ri, Hwasun-eup, Hwasun-gun, Jeollanam-do, 519-809 KoreaIk-Joo CHUNG3302/ Dr. Young-Chul KimProtocol Amendment 1 Global Amendment 1 Local Amendment 2: Global11/SEP/2009 08/JUN/2010 16/SEP/2010 29/JUL/2011IRB of Seoul National University Bundang Hospital Three basement levels, The division of education & research,166 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, KoreaChin Youb CHUNG3303/ Dr. Jong-Seok LeeProtocol Amendment 1 Global Amendment 1 Local Amendment 2: Global04/AUG/2009 16/JUN/2010 26/AUG/2010 02/AUG/2011KoreaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)IRB of Chungbuk National University Hospital 2F, Clinical Center building, 62 Gaeshin-dong, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 361-711, KoreaKyung-Su MIN3304 / Dr. Ki Hyeong LeeProtocol Amendment 1 Global Amendment 1 Local Amendment 2: Global27/AUG/2009 04/JUN/2010 19/AUG/2010 29/JUL/2011IRB of Ulsan University Hospital 6F, The division of education & research, 290-3 Jeonha dong, Dong-gu, Ulsan,682- 714 KoreaCheal In YOO3305 / Dr. Young Joo MinProtocol Amendment 1 Global Amendment 1 Local Amendment 2: Global28/DEC/2009 28/MAY/2010 26/AUG/2010 29/JUL/2011MalaysiaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Research and Ethics committee, Universiti Kebangsaan Malaysia, Jalan Yaacob Latiff, Bandar Tun Razak 56000, Cheras – Kuala Lumpur, MalaysiaProf Dr. Ainoon Othman3401 / Ismail, FuadProtocol Amendment 1 Global Amendment 2 Global06/AUG/2009 01/DEC/2010 08/AUG/2011Medical Research and Ethics committee, Ministry of Health Malaysia, Institute of Health Management, Jalan Rumak Sukit, Bangsar – 69000, Kuala Lumpur, MalaysiaDr. Chang Kian Meng3402 / Muttalif, Haji Abd RazakProtocol Amendment 1 Global Amendment 2 Global02/OCT/2009 04/NOV/2010 04/JUL/2011Medical Ethics Committee, Universiti Malaya Medical Centre, Jalan Universiti, 59100, Kuala LumpurProf Looi Lai Meng3403 / Liam, Chong KinProtocol Amendment 1 Global Amendment 2 Global22/JUL/2009 26/JAN/2011 20/JUL/2011PeruIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)ESSALUD – Comité de ?tica em Investigación –Hospital Nacional Guillermo Almenara Irigoyen Av. Grau 800- Lima 13Dr. Demetrio Molero Castro2501 / SalasProtocol Amendment 1 Global Amendment 2 Global11/MAY/2010 03/AUG/2010 15/NOV/2011Comité Institucional de ?tica en Investigación del Instituto Nacional de Enfermedades. Avenida Angamos Este 2520, Surquillo. Lima 34.Dr. Rolando Calderón Velasco2503 / Dr Mas LopezProtocol Amendment 1 Global Amendment 2 Global03/NOV/2009 03/SEP/2010 16/DEC/2011ESSALUD – Comité de ?tica en Investigación –Red Asistencial ArequipaDr. Antero Peralta Mestas2504 / Alvarez BarredaProtocol Amendment 1 Global Amendment 2 Global06/APR/2010 13/OCT/2010N/A – Site ClosedPeruIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Address 1:Dr. Tejada Zevallos2505 / LozadaProtocol25/NOV/2009Comité de Bioética de la Clínica Anglo Amendment 1 Global23/AUG/2010Americana Amendment 2 Global24/NOV/2011Address 2:Dr. Salomón Zavala Protocol29/OCT/2009Comité de ?tica de laSarrio Asociación Benéfica Amendment 1 Global12/AUG/2010PRISMA Amendment 2 Global24/NOV/2011PhilippinesIRB or IECIRB or IEC ChairpersonCentre number(s) /Protocol and/orDate of Final Approval(name/address) Investigator(s)Amendment number(s)(DD/MMM/YYYY)Institutional Ethics andDr. Marsha Tolentino3501 / Tudtud, DennisProtocol10/JUN/2009Review Board/ Perpetual Succour Amendment 1 Global21/JUL/2010Hospital, Gorordo Avenue, Lahug, Cebu Amendment 2 Global13/JUL/2011City, Philippines 6000 PhilippinesIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)St. Luke’s Institutional Ethics Review Committee/ St. Luke’s Medical Center, No. 279 E. Rodriquez Sr., Blvd., Quezon City, Philippines 1102Dr. Augusto Reyes3502 / Caguioa, PriscillaProtocol Amendment 1 Global Amendment 2 Global09/SEP/2009 21/JUL/2010 13/JUL/2011Institutional Review Board/ Makati Medical Center, #2 Amorsolo Street, Legaspi Village, Makati City, Philippines 1229Dr. Saturnino P.Javier3503 / Parra, JosephProtocol Amendment 1 Global Amendment 2 Global07/DEC/2009 17/MAY/2011 08/AUG/2011RomaniaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)National Ethics CommitteeProf. Dr. Sava Dumitrescu5401 – Dr. Lungulescu Dan5402 – Dr. Cristina CebotaruProtocol Amendment 1 Global Amendment 2 Global12/NOV/2009 30/SEP/2010 28/FEB/2012RussiaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Ethics Committee of St.-Petersburg City Clinical Oncology Dispensary 198255, Veteranov 56, Ave, St.Petersburg, RussiaPavlysh A.D.5501 / Dr. N. KarasevaProtocol Amendment 1 Global Amendment 2 Global15/DEC/2009 26 /JUL/2010 N/AEthics Committee of Scientific Research Institute of Oncology n.a. N.N. Petrov 197758, Leningradskaya str, 68, Pesochny, Saint-Petersburg, RussiaMihnin A.E.5503 / Prof. V. MoiseyenkoProtocol Amendment 1 Global Amendment 2 Global28/DEC/2009 20/JUL/2010 N/AEthics Committee of Saint-Petersburg State Medical University n.a. acad. I.P. Pavlov 197101, Rentgena str.10, Saint-Petersburg, RussiaYagmurov O.D.5504 / Prof. S. OrlovProtocol Amendment 1 Global Amendment 2 Global30/NOV/2009 28/JUN/2010 30/JAN/2012RussiaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Ethics Committee of Russian Oncological research centre n.a. N.N. Blokhin RAMS115478, Kashirskoe shosse, 24, MoscowKomov D.V.5505 / Prof. V. GorbunovaProtocol Amendment 1 Global Amendment 2 Global22/DEC/2009 26/JUL/2010 23/JAN/2012Ethics Committee of RCOD MoHRT Address: 420029, Sibirskiy tract, 29, Kazan, RussiaKarpenko L.G.5506 / Prof. R. KhasanovProtocol Amendment 1 Global Amendment 2 Global01/DEC/2009 07/JUL/2010 23/JAN/2011Ethics Committee of FSBI MRSC 249036, Koroleva str., Obninsk, 4, RussiaAndreev V.G.5507 / Dr. Y. RagulinProtocol Amendment 1 Global Amendment 2 Global29/JUL/2010 29/JUL/2010 20/JAN/2012TaiwanIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Joint Institutional Review Board (JIRB) / No. 5-1, Lane 331, Sec. 2, Shih-Pai Road, TaipeiLow-Tone HoN/AProtocol Amendment 1 Global Amendment 2 Global27/JUL/2009 02/AUG/2010 30/AUG/2011National Taiwan University Hospital Research Ethics Committee / 7, Chung-Shan South Road, Taipei, Taiwan 100, R.O.CHong-Nerng Ho3601 PI / Chih-Hsin YangProtocol Amendment 1 Global Amendment 2 Global30/JUN/2009 22/JUL/2010 18/AUG/2011Taipei Veterans General Hospital Institutional Review Board / 201, Shih-Pai Road, Sec. 2, Taipei, Taiwan 11217, R.hen-Hsen Lee3602 PI / Chun-Ming TsaiProtocol Amendment 1 Global Amendment 2 Global23/SEP/2009 02/NOV/2010 09/SEP/2011TaiwanIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Institutional Review Board of Tri-Service General Hospital, National Defense Medical Center / No.325, Sec. 2, Cheng-Kung Rd., Neihu 11490, Taipei, Taiwan, R.hih-Shung Wong, M.D., Ph.D.3603PI / Ching-Liang HoProtocol Amendment 1 Global Amendment 2 Global10/AUG/2009 15/AUG/2010 08/SEP/2011The Institutional Review Board of Taichung Veterans General Hospital / 160, Sec. 3, Tai-Chung Kang Road, Taichung, Taiwan 40705, R.O.CWayne Huey-Herng HerngJeng-Yuan Hsu, MD3604 / Gee-Chen ChangProtocol Amendment 1 Global Amendment 2 Global14/AUG/2009 27/AUG/2010 15/SEP/2011The Institutional Review Board, China Medical University Hospital / No.2, Yuh-Der Road, Taichung, Taiwan, R.O.CMartin M-T Fuh MD, DM Sci.3605 / Te-Chun HsiaProtocol Amendment 1 Global Amendment 2 Global16/JUL/2009 22/JUL/2010 10/AUG/2011TaiwanIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Human Experiment and Ethics Committee, National Cheng Kung University Hospital / 138, Sheng-Li Rd., Tainan 704, Taiwan R.O.CIh-Jen Su M.D., Ph.D.Chyun-Yu Yang M.D.3606 / Wu-Chou SuProtocol Amendment 1 Global Amendment 2 Global15/SEP/2009 01/SEP/2010 02/SEP/2011Institutional Review Board, Chang-Gung Medical Foundation / 199, Tung-Hwa North Road, Taipei, Taiwan 10507, R.O.CTsang-Tang Hsieh3607 / Meng-Chih Lin 3609 / Ying-Huang TsaiProtocol Amendment 1 Global Amendment 2 Global08/SEP/2009 30/AUG/2010 02/NOV/2011Institutional Review Board 1, Kaohsiung Medical University Chung-Ho Memorial Hospital / No.100, Tzyou 1st Road, Kaohsiung 807, TaiwanMing-Shyan HuangWan-Long Chuang, M.D., Ph.D.3608 / Ming-Shyan HuangProtocol Amendment 1 Global Amendment 2 Global20/AUG/2009 26/OCT/2010 08/NOV/2011ThailandIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Ethics Committee of Faculty of Medicine Prince of songkla UniversityAssoc. Prof. Kitti Limapichat3701 / Lucient Geater, SarayutProtocol Amendment 1 Global Amendment 2 Global26/AUG/2009 18/NOV/2010 26/JUL/2011Research Ethics Committee, Faculty of Medicine, Chiang Mai UniversityProfessor Malai Muttarak, Dean of IEC3702 / Thongprasert, SumitraProtocol Amendment 1 Global Amendment 2 Global19/OCT/ 2009 21/OCT/2009 22/AUG/2011The Khon Kaen University Ethics Committee for Human ResearchAssoc. Prof. Jiraporn Srinakarin,3703 / Phunmanee, AnakapongProtocol Amendment 1 Global Amendment 2 Global02/OCT/2009 29/SEP/2010 06/OCT/2011Ethical Clearance Committee on Human Rights Related to Researches Involving Human Subjects Faculty of Medicine, Ramathibodi Hospital, Mahidol UniversityProf. Boonsong Ongphiphadhanakul3704 / Sirisinha, ThitiyaProtocol Amendment 1 Global Amendment 2 Global21/OCT/2009 20/OCT/2010 20/JUL/2011UkraineIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)IEC:Central Ethics committee of Ministry of health of Ukraine. Ukraine, 03680 Kyiv, 5, Narodnogo Opolcheniya strVasyl KornatskyyN/AProtocol Amendment 1 Global Amendment 2 Global08/OCT/2009 21/OCT/2010 18/AUG/2011IRB: State expert centre of Ministry of health of Ukraine. Ukraine, 03151, Kiev, Ushynskogo str., 40Vasyl BlikharN/AProtocol Amendment 1 Global Amendment 2 Global09/NOV/2009 17/NOV/2010 19/SEP/2011United KingdomIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)NRES Committee London – Hampstead Northwick Park Hospital REC Centre Level 7, Maternity Block Northwick Park Hospital Watford Road Harrow Middx HA1 3UJDr Michael Pegg4801/ Dr Sanjay kumar Popat4802/Dr Mary O’Brien 4803/Dr Gary Middleton 4804/Dr Jeremy Steele 4805/Dr Sunil Upadhyay4806/Dr Matthew Collinson4807/Dr Riyaz Shah 4808/Dr Elizabeth ToyProtocol Amendment 1 Global Amendment 2 Global18/NOV/2009 17/JUN/2010 12/AUG/2011USIRB or IEC (name/address)IRB or IEC ChairpersonCentre number(s) / Investigator(s)Protocol and/or Amendment number(s)Date of Final Approval (DD/MMM/YYYY)Schulman Associates IRB 4445 Lake Forest Drive Suite 300 Cincinnati, Ohio 45242Sharon Nelson, MSN, RN, CNS2603/Robert Asbury 2605/Daniel S. Bradford 2606/Nagarajan Chandrasekaran 2607/Billy Clowney 2609/Mohamad Ghraowi 2616/Marc Saltman 2617/ John P. ThropayProtocol Amendment 1 Global Amendment 2 Global06/JUL/2009 01/JUL/2010 07/JUL/2011Lehigh Valley Health Network IRB Research Participant Protection Office 17th and Chew Streets Allentown, PA 18102Margaret Hoffman-Tepy, MD2608/FriedmanProtocol Amendment 1 Global Amendment 2 Global14/MAY/2009 24/AUG/2010N/A (Site Closed 28/JAN/2011)Mary Greeley Medical Center IRB 1111 Duff Avenue Ames, IA 50010Dario Zaffarano,2615/ProwProtocol Amendment 1 Global Amendment 2 Global21/JUL/2009 26/JUL/2010N/A (Site Closed 3/MAR/2011Table S7 Details of approving ethics committees and all participating principal investigators for the LUX-Lung 6 trialEthics Committee ChairpersonInvestigator(s)Date of approval of final protocol (after 4 amendments)EC of Guangdong General Hospital, No.106 Zhongshan Er Road, Guangzhou, Guangdong Province, 510080, ChinaZhang NianjiaoWu Yilong Zhou Caicun Bai Chunxue Wang Mengzhao Zhang Yuhui Qin Shukui Zhang Yiping Hou Mei Luo Yi Hu Chenping Luo Rongcheng Zhang Helon Zhou Caicun Shi Jianhua He Jianxing Zhu Muyun28/NOV/2013 06/JAN/2014 28/NOV/2013 28/NOV/201328/NOV/2013 30/NOV/2013 08/OCT/2011a 28/NOV/2013 28/NOV/2013 28/NOV/2013 16/JAN/2014 16/JAN/2014 28/NOV/2013 28/NOV/2013 20/JAN/2014 28/NOV/2013EC of Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University, No. 241 Huaihai West Road, Shanghai 200030, ChinaNi YoufangLu Shun06/DEC/2013EC of Shanghai Changhai Hospital, No. 168 Changhai Road, Shanghai, 200433, ChinaXiang YaojunLi Qiang21/NOV/2013EC of 307 Hospital of PLA, No. 8 Dongda Street, Fengtai District, Beijing 100071, ChinaHe YuezhongLiu Xiaoqing10/DEC/2013EC of Jiangsu Cancer Hospital, No. 42 Baiziting Street, Nanjing, 210000, ChinaPan LiangxiFeng Jifeng12/DEC/2013EC of Hebei Medical University Fourth Hospital, No.12 Jiankang Road, Shijiazhuang, Hebei Province, 050011, ChinaLi LianrongLiu Wei18/NOV/2013EC of the First Hospital of China Medical University, No. 155 Nanjingbei Street,Heping District, Shenyang, Liaoning Province, 110001, ChinaYu XiaosongLiu Yunpeng22/NOV/2011aEC of the First Hospital of Jilin University, No. 71 Xinmin Street, Changchun, Jilin Province, 130021, ChinaTan YuquanLi Wei27/DEC/2013EC of Hubei Cancer Hospital, No. 16 South Zhuo Dao Quan Road, Wuhan City, Hubei ProvinceHu RenchongYu Ding30/SEP/2011aEC of The Affiliated Hospital of Medical College Qingdao University, No. 59 Haier Rd, Qingdao, Shandong Province, 266000, ChinaLiang JunLiang Jun26/NOV/2013EC of Fujian Provincial Tumor Hospital, No. 91 Fuma Road Ding, Fuzhou, Fujian Province, 350014, ChinaHuang PingHuang Cheng19/NOV/2013EC of the Affiliated Cancer Hospital of Guangxi Medical University, No. 71 Hedi Road, Nanning City, Guangxi, Province, 210002, ChinaLi YishengZhu Xiaodong18/NOV/2013EC of Beijing Chest Hospital, No. 97 Bei Ma Chang, Tong Zhou District, Beijing, China, 101149Li YanshenZhu Yunzhong21/NOV/2013EC of Shanghai Changzheng Hospital, No. 415 Fengyang Road, Shanghai 200003, ChinaCai JianfeiXiu Qingyu05/NOV/2012aEC of the 3rd Affiliated Hospital of Harbin Medical University, No. 150, Ha Ping Road, Harbin, 150081, ChinaXu XiuyuChen Gongyan05/DEC/2013aDate of approval of third protocol amendment; Abbreviations: EC, ethics committee.Table S8 Details of approving ethics committees and all participating principal investigators for the LUX-Lung 7 trialFranceIRB or IEC (name/address)IRB or IEC ChairpersonCentre number / InvestigatorProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)CPP SUD EST IV Centre Léon Bérard 28 rue Laennec 69373 LYON cedexDr ESPINOUSE3301/PEROL 3302/BENNOUNA 3303/CHOUAID 3305/DUBOS-ARVIS 3306/HUCHOT 3307/ROTARSKI 3308/VERGNENEGRE 3309/MORO-SIBILOTAmendment 1 (dated 29 Sep 2011)08/NOV/2011Amendment 2 (dated 11 Sep 2012)06/NOV/2012Amendment 3 (dated 6 Mar 2013)09/APR/2013Local Amendment to implement PK substudy (dated 26 Sep 2013)03/DEC/2013Amendment 4 (dated 16 Dec 2013)Info 15/JAN/2014Amendment 5 (dated 29 Jul 2015)08/SEP/2015KoreaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number / InvestigatorProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)Samsung Medical Center Institutional Review Board /(06351), 81 Irwon-ro, Gangnam-gu, Seoul, KoreaLee, Suk-Koo8201Park, KeunchilAmendment 1 (dated 29 Sep 2011)23/JAN/2012Amendment 2 (dated 11 Sep 2012)08/NOV/2012Amendment 3 (dated 6 Mar 2013)15/MAY/2013Local Amendment to implement PK substudy (dated 26 Sep 2013)01/DEC/2013Amendment 4 (dated 16 Dec 2013)07/MAR/2014Amendment 5 (dated 29 Jul 2015)04/SEP/2015Seoul National University Hospital Institutional Review Board /101 Daehak-ro, Jongno-gu, Seoul, 03080, KoreaPaick, Jae-Seung8202Kim, Dong-WanAmendment 1 (dated 29 Sep 2011)09/NOV/2011Amendment 2 (dated 11 Sep 2012)11/NOV/2012Amendment 3 (dated 6 Mar 2013)03/MAY/2013 Local Amendment to implement PK substudy (dated 26 Sep 2013)N/AAmendment 4 (dated 16 Dec 2013)18/MAR/2014Amendment 5 (dated 29 Jul 2015)09/SEP/2015Chungbuk National University Hospital Institutional Review Board /776, 1sunhwan-ro, Seowon-gu Cheongju-si, Chungcheongbuk-do, 28644, KoreaShon, Bora8203Lee, Ki HyeongAmendment 1 (dated 29 Sep 2011)09/NOV/2011Amendment 2 (dated 11 Sep 2012)14/NOV/2012Amendment 3 (dated 6 Mar 2013)02/MAY/2013Local Amendment to implement PK substudy (dated 26 Sep 2013)03/DEC/2013Amendment 4 (dated 16 Dec 2013)11/MAR/2014Amendment 5 (dated 29 Jul 2015)22/SEP/2015Gachon University Gil Medical Center Institutional ReviewJong-Hoon Kim8204Cho, EunKyungAmendment 1 (dated 29 Sep 2011)29/DEC/2011Amendment 2 (dated 11 Sep13/NOV/2012Board /21 , Namdong- daero 774 beon-gil, Namdong-gu Incheon, 405-760 Rep, of Korea 2012) Amendment 3 (dated 6 Mar 2013)07/MAY/2013Local Amendment to implement PK substudy (dated 26 Sep 2013)N/AAmendment 4 (dated 16 Dec 2013)18/MAR/2014Amendment 5 (dated 29 Jul 2015)08/SEP/2015Asan Medical Center Institutional Review Board /88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, KoreaJong Woo Chung8205Kim, Sang-WeAmendment 1 (dated 29 Sep 2011)14/NOV/2011Amendment 2 (dated 11 Sep 2012)09/NOV/2012Amendment 3 (dated 6 Mar 2013)26/APR/2013Local Amendment to implement PK substudy (dated 26 Sep 2013)28/NOV/2013Amendment 4 (dated 16 Dec 2013)13/MAR/2014Amendment 5 (dated 29 Jul 2015)24/SEP/2015Severance Hospital, Institutional Review Board /50 -1, Yonsei-ro, Seodaemun-gu, Seoul, 03722, KoreaSeung Min Kim8206Cho, Byoung ChulAmendment 1 (dated 29 Sep 2011)N/AAmendment 2 (dated 11 Sep 2012)10/AUG/2012Amendment 3 (dated 6 Mar 2013)10/MAY2013Local Amendment to implement PK substudy (dated 26 Sep 2013)N/AAmendment 4 (dated 16 Dec 2013)08/MAR/2014Amendment 5 (dated 29 Jul 2015)16/SEP/2015CanadaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number / InvestigatorProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)McGill Faculty of Medicine 3655 Promenade Sir William Osler # 633 Montreal, QC H3G 1Y6Harvey Sigman, MD Chair – Committee B1001/Vera HirshAmendment 1 (dated 29 Sep 2011)20/FEB/2012Amendment 2 (dated 11 Sep 2012)26/NOV/2012Amendment 3 (dated 6 Mar 2013)27/MAY/2013Amendment 4 (dated 16 Dec 2013)24/FEB/2014Amendment 5 (dated 29 Jul 2015)26/OCT/2015UBC- BC Cancer Agency Fairmont Medical Bldg. Suite 902 750 West Broadway Vancouver, BC V5Z 1H8Ken Swenerton, MD1002/Janessa LaskinAmendment 1 (dated 29 Sep 2011)02/MAR/2012Amendment 2 (dated 11 Sep 2012)30/NOV/2012Amendment 3 (dated 6 Mar 2013)19/AUG/2013Amendment 4 (dated 1603/APR/2014 Dec 2013) Amendment 5 (dated 29 Jul 2015)23/SEP/2015Ottawa Health Science Network Research Ethics Board 725 Parkdale Avenue Ottawa, ON K1Y 4E9Raphael Saginur, MD1003/Scott LaurieAmendment 1 (dated 29 Sep 2011)19/APR/2012Amendment 2 (dated 11 Sep 2012)25/JAN/2013Amendment 3 (dated 6 Mar 2013)30/MAY/2013Amendment 4 (dated 16 Dec 2013)05/MAR/2014Amendment 5 (dated 29 Jul 2015)23/OCT/2015UBC- BC Cancer Agency Fairmont Medical Bldg. Suite 902 750 West Broadway Vancouver, BC V5Z 1H8Ken Swenerton, MD1004/Christopher LeeAmendment 1 (dated 29 Sep 2011)02/MAR/2012Amendment 2 (dated 11 Sep 2012)30/NOV/2012Amendment 3 (dated 6 Mar 2013)19/AUG/2013 Amendment 4 (dated 16 Dec 2013)03/APR/2014Amendment 5 (dated 29 Jul 2015)23/SEP/2015Health Research Ethics Board of Alberta (HREBA) Cancer Committee 1500-10104-103 Avenue NWEdmonton, AB T5J 4A7Raul Urtasun, MD (Associate Chair)1005/Sandeep SanghaAmendment 1 (dated 29 Sep 2011)06/MAR/2012Amendment 2 (dated 11 Sep 2012)19/NOV/2012Amendment 3 (dated 6 Mar 2013)10/MAY/2013Amendment 4 (dated 16 Dec 2013)24/FEB/2014Amendment 5 (dated 29 Jul 2015)25/SEP/2015Local Amendment to implement PK substudy (dated 26 Sep 2013)10/DEC/2013Lakeridge Health 1 Hospital Court Oshawa, ON L1G 2B9John Montgomery, LLB (Bachelor of Law)1006/Rafael WierzbickiAmendment 1 (dated 29 Sep 2011)05/DEC/2011Amendment 2 (dated 11 Sep 2012)03/DEC/2012 Amendment 3 (dated 6 Mar 2013)06/MAY/2013Amendment 4 (dated 16 Dec 2013)03/MAR/2014Amendment 5 (dated 29 Jul 2015)05/OCT/2015Local Amendment to implement PK substudy (dated 26 Sep 2013) McGill Faculty of Medicine 3655 Promenade Sir William Osler # 633 Montreal, QC H3G 1Y6Harvey Sigman, MD Chair – Committee B1007/Vera HirshAmendment 1 (dated 29 Sep 2011)20/FEB/2012Amendment 2 (dated 11 Sep 2012)26/NOV/2012Amendment 3 (dated 6 Mar 2013)27/MAY/2013Amendment 4 (dated 16 Dec 2013)24/FEB/2014Amendment 5 (dated 29 Jul 2015)26/OCT/2015ChinaIRB or IEC (name/address)IRB or IEC ChairpersonCentre number / InvestigatorProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)EC of Sun Yat-SenPeng, Wangqing8601/Zhang, LiAmendment 1 (dated 29 Sep 2011)13/JUN/2012Amendment 2 (dated 11 Sep 2012)10/DEC/2012Amendment 3 (dated 6 Mar 2013)20/JUN/2013Amendment 4 (dated 16 Dec 2013)15/APR/2014Amendment 5 (dated 29 Jul 2015)04/NOV/2015Local Amendment to implement PK substudy (dated 26 Sep 2013)09/OCT/2014EC of Shanghai Chest HospitalZheng, Ning8602/Lu,ShunAmendment 1 (dated 29 Sep 2011)06/JUN/2012Amendment 2 (dated 11 Sep 2012)27/NOV/2012Amendment 3 (dated 6 Mar 2013)09/JUL/2013Amendment 4 (dated 1623/APR/2014 Dec 2013) Amendment 5 (dated 29 Jul 2015)10/NOV/2015Local Amendment to implement PK substudy (dated 26 Sep 2013)11/MAR/2014EC of The First Hospital of China Medical UniversityXiaosong YU Jian KANG8603/Yupeng LIUAmendment 1 (dated 29 Sep 2011)12/JUN/2012Amendment 2 (dated 11 Sep 2012)29/JAN/2013Amendment 3 (dated 6 Mar 2013)22/OCT/2013Amendment 4 (dated 16 Dec 2013)23/JUL/2014Amendment 5 (dated 29 Jul 2015)30/SEP/2015EC of Zhongshan Hospital Fudan UniversityWang, Yuqi8604/Bai, ChunxueAmendment 1 (dated 29 Sep 2011)20/JUN/2012Amendment 2 (dated 11 Sep 2012)31/DEC/2012Amendment 3 (dated 6 Mar 2013)24/JUN/2013Amendment 4 (dated 1617/APR/2014 Dec 2013) Amendment 5 (dated 29 Jul 2015)Not obtained yetEC of Shanghai Chest HospitalZheng, Ning8605/ Han, BaohuiAmendment 1 (dated 29 Sep 2011)06/JUN/2012Amendment 2 (dated 11 Sep 2012)27/NOV/2012Amendment 3 (dated 6 Mar 2013)09/JUL/2013Amendment 4 (dated 16 Dec 2013)23/APR/2014Amendment 5 (dated 29 Jul 2015)Not obtained yetEC of Beijing Cancer HospitalJie LI8606/Tongtong ANAmendment 1 (dated 29 Sep 2011)15/MAY/2012Amendment 2 (dated 11 Sep 2012)15/JAN/2013Amendment 3 (dated 6 Mar 2013)18/JUN/2013Amendment 4 (dated 16 Dec 2013)17/JUN/2014Amendment 5 (dated 29 Jul 2015)26/DEC/2015EC of The Affiliated Cancer Hospital, Guangxi Medical UniversityLin, Yuan8607/Song, XiangqunAmendment 1 (dated 29 Sep 2011)25/JUN/2012Amendment 2 (dated 11 Sep 2012)07/MAR/2013Amendment 3 (dated 6 Mar 2013)10/OCT/2013Amendment 4 (dated 16 Dec 2013)14/MAR/2014Amendment 5 (dated 29 Jul 2015)24/SEP/2015EC of Cancer Hospital of Chinese Academy of Medical SciencesDatong CHU8608/Yuankai SHIAmendment 1 (dated 29 Sep 2011)6/JUN/2012Amendment 2 (dated 11 Sep 2012)25/MAR/2013Amendment 3 (dated 6 Mar 2013)6/JUN/2013Amendment 4 (dated 16 Dec 2013)5/MAY/2014Amendment 5 (dated 29 Jul 2015)30/SEP/2015Local Amendment to implement PK substudy (dated 26 Sep 2013)21/AUG/2014GermanyIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)Leading ethics committee for Germany: Ethik-Kommission der Medizinischen Fakult?t der Universit?t Duisburg-Essen Robert-Koch-Stra?e 9-11 45147 EssenProf. Dr. med. Werner Havers4901 Dr. Martin Schuler 4902 Dr. Juergen Alt 4905 Dr. Martin FaehlingProtocol (dated 30 Aug 2011)N/A as update necessary. First CTP Version to IRB was CTP Version 2.0.Amendment 1 (dated 29 Sep 2011)11/JAN/2012Amendment 2 (dated 11 Sep 2012)06/NOV/2012Amendment 3 (dated 6 Mar 2013)23/APR/2013Amendment 4 (dated 16 Dec 2013)N/A as CTP was not necessary to submit to IRB.Amendment 5 (dated 29 Jul 2015)N/A as CTP was not necessary to submit to IRB.Loc. AM 111/JAN/2012Loc. AM 206/NOV/2012 Loc. AM 323/APR/2013Loc. AM 428/NOV/2013Ethik-Kommission der Medizinischen Fakult?t der Universit?t Duisburg-Essen Robert-Koch-Stra?e 9-11s 45147 EssenProf. Dr. med. Werner Havers4901 Dr. Martin SchulerApproval of leading ethic committee takes effect.Ethikkommission bei der Landes?rztekammer Rheinland-Pfalz Deutschhausplatz 3 55116 MainzProf. Dr. med. Dipl. Ing. Stephan Letzel4902 Dr. Jürgen AltApproval of leading ethic committee takes effect.Ethikkommission bei der Landes?rztekammer Baden- Württemberg Jahnstra?e 40 70597 StuttgartProf. Dr. med. Gerlinde Egerer4905 Dr. Martin FaehlingApproval of leading ethic committee takes effect.SpainIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)Comité ?tico Investigación Clínica Hospital 12 de Octubre/ Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)Maria Ugalde Díez3401 / Dr. Paz Ares 3402/ Dr. Ponce 3403 / Dr. López Brea 3404 / Dr. Cobo 3405 / Dr. EstebanAmendment 1 (dated 29 Sep 2011)13/DEC/2011Comité ?tico Investigación Clínica Hospital 12 de Octubre/Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)Maria Ugalde Díez3401 / Dr. Paz Ares 3402/ Dr. Ponce 3403 / Dr. López Brea 3404 / Dr. Cobo 3405 / Dr. EstebanAmendment 2 (dated 11 Sep 2012)06/NOV/2012Comité ?tico Investigación Clínica Hospital 12 de Octubre/Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)Maria Ugalde Díez3401 / Dr. Paz Ares 3402/ Dr. Ponce 3403 / Dr. López Brea 3404 / Dr. Cobo 3405 / Dr. EstebanAmendment 3 (dated 6 Mar 2013)28/MAY/2013Comité ?tico Investigación Clínica Hospital 12 de Octubre/Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)Maria Ugalde Díez3401 / Dr. Paz AresLocal Amendment to implement PK substudy (dated 26 Sep 2013)29/NOV/2013Comité ?tico Investigación Clínica Hospital 12 de Octubre/Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)Maria Ugalde Díez3404 / Dr. CoboLocal Amendment to implement PK substudy (dated 26 Sep 2013)28/JAN/2014Comité ?tico Investigación Clínica Hospital 12 de Octubre/Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)Maria Ugalde Díez3401 / Dr.Paz Ares 3402/ Dr. Ponce 3403 / Dr. López Brea 3404 / Dr. Cobo 3405 / Dr. EstebanAmendment 4 (dated 16 Dec 2013)25/FEB/2014Comité ?tico Investigación Clínica Hospital 12 de OctubreMaria Ugalde Díez3401 / Dr. Corral 3402/ Dr. Ponce3403 / Dr. López BreaAmendment 5 (dated 29 Jul 2015)12/JAN/2016/ 3404 / Dr. Cobo Av de Córdoba s/n 28041 3405 / Dr. Esteban Madrid (Reference Ethical Committee) Hong KongIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorProtocol and/or Amendment numberDate of Final Approval (DD/MMM/YYYY)Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee / Flat 3C, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, HKBenny C. Y. Zee8521 / Mok, Shu Kam TonyAmendment 1 (dated 29 Sep 2011)06/JUN/2012Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee / Flat 3C, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, HKBenny C. Y. Zee8521 / Mok, Shu Kam TonyAmendment 2 (dated 11 Sep 2012)06/FEB/2013Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee / Flat 3C, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, HKBenny C. Y. Zee8521 / Mok, Shu Kam TonyAmendment 3 (dated 6 Mar 2013)09/JUN/2013Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee / 8/F, Lui Che Woo Clinical SciencesBuilding, Prince of Wales Hospital, Shatin, HKBenny C. Y. Zee8521 / Mok, Shu Kam TonyAmendment 4 (dated 16 Dec 2013)21/MAR/2014Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee / 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HKBenny C. Y. Zee8521 / Mok, Shu Kam TonyAmendment 5 (dated 29 Jul 2015)02/OCT/2015Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB) / Room 901, Administration Block, Queen Mary Hospital, Hong KongTang, Sydney8522 / Lee, Ho Fun VictorAmendment 1 (dated 29 Sep 2011)06/JUN/2012Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB) / Room 901, Administration Block, Queen Mary Hospital, Hong KongTang, Sydney8522 / Lee, Ho Fun VictorAmendment 2 (dated 11 Sep 2012)17/DEC/2012Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB) / Room 901, Administration Block, Queen Mary Hospital, Hong KongTang, Sydney8522 / Lee, Ho Fun VictorAmendment 3 (dated 6 Mar 2013)07/JUN/2013Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB) / Room 901, Administration Block, Queen Mary Hospital, Hong KongTang, Sydney8522 / Lee, Ho Fun VictorAmendment 4 (dated 16 Dec 2013)20/MAR/2013Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB) / Room 901, Administration Block, Queen Mary Hospital, Hong KongTang, Sydney8522 / Lee, Ho Fun VictorAmendment 5 (dated 29 Jul 2015)12/OCT/2015SingaporeIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)Domain Specific Review Board (DSRB) Nexus @One-North (South Tower), No. 3 Fusionopolis Link, #03-08, Singapore 138543A/Prof Chng Wee Joo6502Protocol (dated 30 Aug 2011) Amendment 1 (dated 29 Sep 2011)27/JAN/2012Amendment 2 (dated 11 Sep 2012)17/DEC/2012Amendment 3 (dated 6 Mar 2013)19/APR/2013Amendment 4 (dated 16 Dec 2013)27/JAN/2014Amendment 5 (dated 29 Jul 2015)12/NOV/2015SingHealth CIRB Secretariat Office of Research Singapore Health Services Pte Ltd 168 Jalan Bukit Merah #06-08 Tower 3 Connection One Singapore 150168A/Prof Lim Soon Thye6501Protocol (dated 30 Aug 2011) Amendment 1 (dated 29 Sep 2011)10/NOV/2011Amendment 2 (dated 11 Sep 2012)27/DEC/2012Amendment 3 (dated 6 Mar 2013)16/APR/2013 Amendment 4 (dated 16 Dec 2013)23/NOV/2013Amendment 5 (dated 29 Jul 2015)15/SEP/2015TaiwanIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)Research Ethics Committee A National Taiwan HospitalHong-Nerng Ho Fu-Chang Tsai8861 8861 8861 8861 8861Amendment 1 (dated 29 Sep 2011)15/FEB/2012Amendment 2 (dated 11 Sep 2012)14/NOV/2012Amendment 3 (dated 6 Mar 2013)21/JUN/2013Amendment 4 (dated 16 Dec 2013)17/MAR/2014Amendment 5 (dated 29 Jul 2015)23/OCT/2015Institutional Review Board Taipei Veterans General HospitalTung-Ping Su Shung-Tai Ho Fa-Yauh Lee8862Amendment 1 (dated 29 Sep 2011)13/FEB/2012Amendment 2 (dated 11 Sep 2012)01/DEC/2012Amendment 3 (dated 6 Mar 2013)07/JUN/2013Amendment 4 (dated 16 Dec 2013)07/APR/2014Amendment 5 (dated 29 Jul 2015)22/OCT/2015Institutional Review Board B Chang Gung Medical FoundationTsang-Tang Hsieh8863Amendment 1 (dated 29 Sep 2011)09/APR/2012Amendment 2 (dated 11 Sep 2012)19/DEC/2012Amendment 3 (dated 6 Mar 2013)15/JUL/2013Amendment 4 (dated 16 Dec 2013)28/MAY/2014Amendment 5 (dated 29 Jul 2015)12/NOV/2015Institutional Review Board of Taichung Veterans General HospitalJeng-Yuan Hsu8864Amendment 1 (dated 29 Sep 2011)08/MAR/2012Amendment 2 (dated 11 Sep 2012)08/NOV/2012Amendment 3 (dated 6 Mar 2013)06/MAY/2013Amendment 4 (dated 16 Dec 2013)19/MAR/2014Amendment 5 (dated 29 Jul 2015)15/OCT/2015Institutional Review Board National Cheng Kung University HospitalChyun-Yu YangThy-Sheng Lin, Vice Chairman8866Amendment 1 (dated 29 Sep 2011)06/JAN/2012Amendment 2 (dated 1106/NOV/2012 (The chairman was backup of president, NCKUH, so not involved in the meeting) Sep 2012) Amendment 3 (dated 6 Mar 2013)01/JUL/2013Amendment 4 (dated 16 Dec 2013)24/MAR/2014Amendment 5 (dated 29 Jul 2015)19/OCT/2015AustraliaIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)Sydney Local Health District Research Development Office Royal Prince Alfred Hospital Camperdown NSW 2050Lesley Townsend Executive Officer Ethics Review Committee (RPAH Zone)6101 - Michael Boyer, FRACP, MBBS, PhDAmendment 1 (dated 29 Sep 2011)09/MAR/2012Amendment 2 (dated 11 Sep 2012)19/DEC/2012Amendment 3 (dated 6 Mar 2013)19/JUL/2013Amendment 4 (dated 16 Dec 2013)12/MAR/2014Sydney Local Health District Research Development Office Royal Prince Alfred Hospital Camperdown NSW 2050Sharon Falleiro Executive OfficerEthics Review Committee(RPAH Zone)6101 - Michael Boyer, FRACP, MBBS, PhDAmendment 5 (dated 29 Jul 2015)25/SEP/2015Bellberry HREC 229 Greenhill Road Dulwich SA 5065Michael James Chair6103 - Paul Mainwaring, FRACP, MD, MBBSAmendment 1 (dated 29 Sep 2011)22/NOV/2011Austin Health HREC Austin HospitalJill Davis Research Ethics Unit Manager6102 - Brett Hughes, FRACP, MBBS6104 - Phillip Parente,Amendment 1 (dated 29 Sep 2011)01/MAR/2012145 Studley Road PO Box 5555 Heidelberg VIC Australia 3084 FRACP, MBBS6105 - Shane White, FRACP, MD, MBBS6107 - Chee Lee, FRACP, PhD, MBBS Sianna Panagiotopoulos Manager, Office for Research6102 - Brett Hughes, FRACP, MBBS6104 - Phillip Parente, FRACP, MBBS6105 - Shane White, FRACP, MD, MBBS6107 - Chee Lee, FRACP, PhD, MBBSAmendment 2 (dated 11 Sep 2012)26/NOV/2012Amendment 3 (dated 6 Mar 2013)04/APR/2013Amendment 4 (dated 16 Dec 2013)31/MAR/2014Amendment 5 (dated 29 Jul 2016)16/SEP/2016Sir Charles Gairdner Group HREC Level 2 A Block, Hospital Ave, Nedlands, WA 6009Jenny Westgarth- Taylor Delegate of the Chair6106 - Michael Millward, FRACP, MBBSAmendment 1 (dated 29 Sep 2011)23/FEB/2012Amendment 2 (dated 11 Sep 2012)28/FEB/2013Amendment 3 (dated 6 Mar 2013)30/APR/2013Amendment 4 (dated 16 Dec 2013)13/MAR/2014Sean Howarth Delegate of the Chair6106 - Michael Millward, FRACP, MBBSAmendment 5 (dated 29 Jul 2015)01/SEP/2015Great BritainIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)East of Scotland Research Ethics Service Tayside Medical Sciences Centre (TASC) Residency Black C, Level 3 Ninewells Hospital & Medical School, George Pirie Way Dundee DD1 9SYFiona Bain4401 – Dr. Marianne Nicolson4402 – Dr. Jason Lester4404 – Prof. Allan Price4405 – Dr. Gary Middleton Dr. Muthuveni Ezhil4406 – Dr. Qamar GhafoorAmendment 1 (dated 29 Sep 2011)20/MAR/2012Substantial Amendment 120/AUG/2012Amendment 2 (dated 11 Sep 2012)17/OCT/2012Substantial Amendment 305/DEC/2012Amendment 3 (dated 6 Mar 2013)30/APR/2013Substantial Amendment 504/OCT/2013Substantial Amendment 616/DEC/2013Amendment 4 (dated 16 Dec 2013)07/APR/2013Substantial Amendment 817/OCT/2014Amendment 5 (dated 29 Jul 2015)10/NOV/2015IrelandIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorsProtocol and/or Amendment numbersDate of Final Approval (DD/MMM/YYYY)Clinical Research Ethics Committee of the Cork Teaching Hospitals Lancaster Hall 6 Little Hanover Street CorkDr. Michael O’Reilly3531 – Dr. Sinéad Cuffe3531 – Dr. Ken O’Byrne3532 – Dr.Oscar BreathnachAmendment 1 (dated 29 Sep 2011)07/DEC/2011Non Substantial Amendment 122/AUG/2012Amendment 2 (dated 11 Sep 2012)03/OCT/2012Substantial Amendment 310/JAN/2013Amendment 3 (dated 6 Mar 2013)23/APR/2013Substantial Amendment 524/APR/2013Substantial Amendment 630/SEP/13Substantial Amendment 711/DEC/2013Amendment 4 (dated 16 Dec 2013)07/APR/2014Substantial Amendment 824/SEP/2014Amendment 5 (dated 29 Jul 2015)28/OCT/2015NorwayIRB or IEC (name/address)IRB or IEC ChairpersonCentre numbers / InvestigatorProtocol and/or Amendment numberDate of Final Approval (DD/MMM/YYYY)REK S?r-?st C Gullhaug torg 4 A, Nydalen, 0484 OsloArvid Heiberg4701 - Odd Terje Brustugun4702 - Sveinung S?rhaugAmendment 1 (dated 29 Sep 2011)06/FEB/20124701 - Odd Terje Brustugun4702 - Sveinung S?rhaugAmendment 2 (dated 11 Sep 2012)09/NOV/20124701 - Odd Terje Brustugun4702 - Sveinung S?rhaugAmendment 3 (dated 6 Mar 2013)09/APR/2013REK S?r-?st C Gullhaug torg 4 A, Nydalen, 0484 OsloBritt-Ingjerd Nesheim4701 - Odd Terje BrustugunAmendment 4 (dated 16 Dec 2013)Non substantial – not requiredAmendment 5 (dated 29 Jul 2015)Non substantial – not requiredIB v.12, 02JAN2012Not required by ECIB v.13, 11JUL2012Not required by ECSwedenIRB or IEC (name/address)IRB or IEC ChairpersonCentre number / InvestigatorProtocol and/or Amendment numberDate of Final Approval (DD/MMM/YYYY)Regionala etikpr?vningsn?mnden i Lund Box 133 221 00 LUNDJan Rosenquist4601 Ronny ?hman 4602 Anders Vikstr?m 4603 Bengt Bergman 4604 Magnus L?fdahlAmendment 1 (dated 29 Sep 2011)29/DEC/2011Regionala etikpr?vningsn?mnden i Lund Box 133 221 00 LUNDGunilla Hedesten Nordin4601 Ronny ?hman 4602 Anders Vikstr?m 4603 Bengt Bergman 4604 Magnus L?fdahlAmendment 2 (dated 11 Sep 2012)22/NOV/2012Regionala etikpr?vningsn?mnden i Lund Box 133 221 00 LUNDJan Rosenquist4601 Ronny ?hman 4602 Anders Vikstr?m 4603 Bengt Bergman 4604 Karl K?lbeckAmendment 3 (dated 6 Mar 2013)20/MAR/2013Regionala etikpr?vningsn?mnden i Lund Box 133221 00 LUNDRolf Ljung4601 Ronny ?hman 4602 Anders Vikstr?m 4603 Bengt Bergman 4604 Karl K?lbeckAmendment 5 (dated 29 Jul 2015)24/SEP/2015 ................
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