Web viewBlister; dermatitis; dermatitis bullous; dermatitis exfoliative; dermatitis exfoliative generalized; dermatosis; drug eruption; eczema; epidermal necrosis; erythema

Supplementary materials

Effect 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 Program

Hai-Yan Tu,1 Yi-Long Wu1

Table S1 MedDRA Preferred Terms Included in User-Defined Grouped Terms for Treatment-Related Adverse Events

Grouped term

MedDRA preferred terms

Rash

Blister; 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 ulcer

Acne

Acne; acne conglobate; acne cystic; acne fulminans; acne pustular; dermatitis acneiform

Stomatitis

Aphthous stomatitis; mouth ulceration; mucosal erosion; mucosal inflammation; mucosal ulceration; oral mucosa erosion; stomatitis

Paronychia

Nail bed infection; nail infection; paronychia

Fatigue

Asthenia; autonomic nervous system imbalance; chronic fatigue syndrome; decreased activity; fatigue; lethargy; listless; malaise; sluggishness

Conjunctivitis

Conjunctival hyperemia; conjunctival irritation; conjunctivitis

Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities v16.1.

LL 367 dose adjustment in Chinese patients: Lung Cancer: Targets and Therapy

21

Table S2 TRAEs Occurring in ≥10% of Chinese Patients from the LL3, LL6, and LL7 Trials

n (%)

All Chinese patients (n=299)

TRAEa

All grades

3

4

5

Any

299 (100.0)

111 (37.1)

11 (3.7)

16 (5.4)

Diarrhea

272 (91.0)

21 (7.0)

0

0

Rash

224 (74.9)

34 (11.4)

1 (0.3)

0

Paronychia

130 (43.5)

4 (1.3)

0

0

Mouth ulceration

86 (28.8)

4 (1.3)

0

0

Alanine aminotransferase increased

68 (22.7)

5 (1.7)

0

0

Stomatitis

61 (20.4)

10 (3.3)

0

0

Cough

60 (20.1)

0

0

0

Epistaxis

53 (17.7)

1 (0.3)

0

0

Aspartate aminotransferase increased

52 (17.4)

1 (0.3)

0

0

Decreased appetite

47 (15.7)

5 (1.7)

0

0

Vomiting

44 (14.7)

5 (1.7)

0

0

Back pain

44 (14.7)

1 (0.3)

0

0

Pruritus

43 (14.4)

0

0

0

Fatigue

40 (13.4)

3 (1.0)

0

0

Upper respiratory tract infection

39 (13.0)

2 (0.7)

0

0

Headache

38 (12.7)

2 (0.7)

0

1 (0.3)

Nausea

38 (12.7)

1 (0.3)

0

0

Pyrexia

38 (12.7)

1 (0.3)

0

0

Dry skin

36 (12.0)

1 (0.3)

0

0

Weight decreased

34 (11.4)

3 (1.0)

0

0

Chest pain

33 (11.0)

1 (0.3)

0

0

Hypokalemia

30 (10.0)

11 (3.7)

1 (0.3)

0

Notes: 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.Comment by Justine Waterson: This indicator has not been used in the above table. Please add to the above table, or remove from the table footnotes.Comment by Steven Kirkham: We have now added the indicator to the table above

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=68

Onset after first dose reduction from 40 mg afatinib,

n=68

TRAE

Grade 1–2

3

4

5

Grade 1 –2

Grade 3

Grade 4

Grade 5

Any

13 (19.1)

53 (77.9)

2 (2.9)

0

47 (69.1)

8 (11.8)

2 (2.9)

3 (4.4)

Diarrheaa

50 (73.5)

11 (16.2)

0

0

1 (1.5)

0

0

0

Rash/acnea

26 (38.2)

28 (41.2)

1 (1.5)

0

4 (5.9)

0

0

0

Stomatitisa

30 (44.1)

14 (20.6)

0

0

5 (7.4)

0

0

0

Nail effects

11 (16.2)

3 (4.4)

0

0

12 (17.6)

0

0

0

Pruritus

11 (16.2)

0

0

0

5 (7.4)

0

0

0

Vomiting

7 (10.3)

2 (2.9)

0

0

8 (11.8)

0

0

0

Pyrexia

7 (10.3)

0

0

0

3 (4.4)

0

0

0

Dry skin

6 (8.8)

1 (1.5)

0

0

1 (1.5)

0

0

0

Notes: 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 Afatinib

Patient group, n/N (%)

Afatinib <40 mg

Afatinib ≥40 mg

All patients

55/68 (81%)

83/231 (36%)

EGFR mutation category

Common mutations

52/63 (83%)

73/207 (35%)

Del 19

30/36 (83%)

38/121 (31%)

L858R

22/27 (81%)

36/95 (38%)

Uncommon mutations

3/5 (60%)

10/24 (42%)

Brain metastases at baseline

Yes

6/9 (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 Afatinib

Patient group

Afatinib <40 mg

Afatinib ≥40 mg

HR (95% CI), p value

N

Median (95% CI)

N

Median (95% CI)

All patients

68

11.0 (8.3–14.0)

231

11.0 (9.6–13.1)

1.15 (0.84–1.58), 0.393

Sex

Male

21

8.9 (4.2–19.4)

96

9.7 (6.9–11.1)

1.09 (0.63–1.88), 0.756

Female

47

13.7 (8.3–16.6)

135

11.8 (9.8–16.6)

1.11 (0.75–1.64), 0.611

Age

<65 years

49

11.0 (8.3–13.8)

170

11.0 (9.1–13.7)

1.11 (0.77–1.60), 0.585

≥65 years

19

16.6 (5.6–27.7)

61

10.8 (8.1–16.5)

1.15 (0.62–2.15), 0.653

Weight

<50 kg

15

8.9 (5.5–17.5)

21

16.5 (5.5–19.2)

0.86 (0.39–1.90), 0.709

≥50 kg

53

12.3 (8.3–16.6)

210

10.9 (9.6–11.8)

1.21 (0.85–1.72) 0.292

Body surface area

<1.5 m2

19

13.8 (5.6–19.3)

38

11.0 (6.8–16.6)

1.20 (0.60–2.36), 0.608

≥1.5 m2

49

11.0 (8.3–14.0)

191

10.9 (9.1–13.1)

1.14 (0.80–1.64), 0.476

Abbreviations: 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 trial

Argentina

IRB or IEC (name/address)

IRB or IEC Chairperson

Centre number(s) / Investigator(s)

Protocol and/or Amendment number(s)

Date of Final Approval (DD/MMM/YYYY)

“Comité de Ética Independiente en Investigación Clínica” Larrea 1381, 3° A – CABA.

Dr. Carlos A. Barclay

2101 / Lerzo 2102 / Banges 2104 / Silva 2107 / Martin 2108 / Recondo 2109 / Blajman 2110 / Fein 2111 / Perez 2112 / Carraro 2115 / Batajelg

Protocol

Amendment 1 Global Amendment 2 Global

01/JUL/2009 / 10/JAN/2010

28/JUN/2010 04/AUG/2011

“Comité Independiente para la evaluación y el control de la investigación clínica” Estado de Israel 4718-CABA-C1185AAS

Dr. Viviana a Ranone

Dr. Jorge A. Lescano Dr. Nicasio A. Cuneo

Dr. Jorge A. Lescano

2101 / Lerzo

Protocol

Amendment 1 Global

Amendment 2 Global

12/NOV/2009 03/AUG/2010

27/OCT/2011

Comité Revision Institucional del Hospital Británico Perdriel 74 -CABA - (C1280AEB)

Lic. Maria Isabel Fadel

2104 / Silva

Protocol


25/SEP/2009 23/JUL/2010

N/A – Site was already closed

Argentina






Comité de Ética Independiente del Hospital Alemán Av. Pueyrredón 1640 CABA (C1118AAT)

Departamento de Docencia e Investigación Hospital Alemán

Av. Pueyrredón 1640 –

Dra. Haydee Wimmers

Dr. Alejandro Ranitzsch

2106 / Bas

Protocol


Protocol


25/FEB/2010 14/JUL/2010

N/A – Site was already closed

25/NOV/2009 27/JUL/2010

N/A – Sites were already closed

Comité Ejecutivo de Investigación Instituto Médico Especializado Alexander Fleming . Av. Crámer 1180 (C1426ANZ) CABA

Dr. José Mordoh

2107 / Martin

Protocol


07/JAN/2010 09/AUG/2010 27/JAN/2012

Comite de Etica en Investigación CEMIC. Av. E Galván 4102 (C1431FWO) –CABA

Dr. Enrique Gadow NAP

2108 / Recondo

Protocol


14/DEC/2009 19/AUG/2010


Argentina






Comité de Docencia e Investigación de ISIS Centro Especializado . (S3000FFU) Urquiza 3077 - Santa Fé

Dr. Samuel Seireff NAP

2109 / Blajman

Protocol


27/OCT/2009 22/JUN/2010


“Comité de Docencia e Investigación” Oroño 1085 – Rosario – Santa Fé – S2000DKS

Dr. Daniel Sarcuno

2110 / Fein

Protocol


15/MAR/2010 19/JUL/2010 31/OCT/2011

Comité de Bioética – Hospital de Agudos “Dr. L. Lucero” Estomba 968 (8000) Bahia Blanca – Buenos Aires

Dr. Norman Pasquaré NAP

2111 / Perez

Protocol


08/JUN/2010 22/SEP/2010


“Comité de Docencia e Investigación” French 2673- CABA – C1425AWC

Dra. Graciela Barreiro

Prof. Dra. Clelia Magaril

2112 / Carraro

Protocol


04/MAR/2010 08/JUL/2010 01/NOV/2011

Argentina




Protocol and/or

Amendment number(s)


CECIC – Comité de Ética de CER Investigaciones Clinicas Vicente López 1441 (B1878DVB) Quilmes – Buenos Aires

Dr. Damián Del Percio NAP

2114 / Varela

Protocol


23/APR/2010 11/AUG/2010


Comité Institucional de revisión de Ensayos Clínicos Hospital Militar Central “Cir My Dr. Cosme Argerich” Av. Luis Maria Campos 726 (C1426BOR) CABA

Dr. Gustavo Christian Casado

2115 / Batajelg

Protocol


27/MAY/2010 24/AUG/2010 26/JAN/2012

Australia






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, Australia

Dr Liz Newton

2701 / Pavlakis

Protocol


18/DEC/2009 03/JUN/2010 21/JUL/2011

Eastern Health Research Ethics Committee 5 Arnold Street Box Hill, VIC, 3128 Australia

Dr Patricia Molloy

2702 / Parente

Protocol


17/SEP/2009 09/AUG/2010 08/AUG/2011

Australia






Human Research Ethics Committee The Prince Charles Hospital Metro North Health Service District Administration Building, Lower Ground Rode Road, Chermside, QLD, 4032, Australia

Mr Philip Masel

2703 / Hughes

Protocol


14/OCT/2009 24/JUN/2010 28/JUL/2011

Flinders Clinical Research Ethics Committee Human Research and Ethics Department Southern Adelaide Health Service Room 2A 221 Flinders Medical Centre Bedford Park, SA, 5042, Australia

Dr Harry Randhawa

2704 / Karapetis

Protocol


04/MAR/2010

25/OCT/2010

N/A (no active patients)

Australia






Hunter New England Human Research Ethics Committee Calvary Mater New Castle Edith Street Waratah, NSW, 2298 Australia

Dr Nicole Gerrand

2705 / Abell

Protocol


21/DEC/2009

04/JUN/2010


St Vincent’s Hospital (Melbourne) Human Research Ethics Committee-D St Vincent’s Hospital 41 Victoria Parade Fitzroy, VIC, 3065 Australia

Dr Jacqueline Hastings

2706 / McLachlan

Protocol


22/DEC/2009 28/MAY/2010 28/JUL/2011

Mount Hospital Ethics Committee C/- Mount Hospital 150 Mounts Bay Road Perth, WA, 6000 Australia

Prof Ross Baker

2707 / van Hazel

Protocol


13/OCT/2009 03/AUG/2010 18/OCT/2011

Australia






Bellberry Human Research Ethics Committee 229 Greenhill Road Dulwich, SA, 5065 Australia

Yvette L Winter

2708 / Slancar

Protocol

Amendment 1 Global

Amendment 2 Global

09/OCT/2009

N/A (site closed prior to Amendment 1 and 2 being effective due to low recruitment activity)

N/A

Bellberry Human Research Ethics Committee 229 Greenhill Road Dulwich, SA, 5065 Australia

Yvette L Winter

2709 / Chia

Protocol


09/OCT/2009

13/OCT/2010


Sydney South West Area Health Service

Lesley Townsend

2711 / Boyer

Protocol


17/DEC/2009 05/AUG/2010 23/SEP/2011

Austria






Leading ethics committee for Austria: Ethikkommission der Medizinischen Universität Wien und des Allgemeinen Krankenhauses AKH, Borschkegasse 8B/E 06, A-1090 Wien

Univ. Prof. Dr Ernst Singer

5102 / Pirker

Protocol


20/AUG/2009 15/JUN/2010 06/SEP/2011

Local ethics committee for Austria: Ethikkommission der Stadt Wien Geschäftsführung: Gesundheitsdienst der Stadt Wien (MA 15), TownTown, Thomas-Klestil-Platz 8/2, A-1030 Wien

Dr. Karin Spacek

5101 / Burghuber

Approval of Leading Ethics Committee takes effect.

Austria






Local ethics committee for Austria: Ethikkommission des A.ö. Krankenhaus der Elisabethinen z.Hd. Servicestelle fir klinische Studien und universitäre Angelegenheiten, KH der Elisabethinen, Fadingerstraße 1, A-4010 Linz

Univ. Doz. Dr. Rainer Schöfl

5103 / Aigner


Local ethics committee for Austria: Ethikkommission des Landes Oberösterreich, Wagner-Jauregg-Weg 15, A-4020 Linz

Univ. Prof. Prim. Dr. Johannes Fischer

5104 / OA Dr. Rainer KOLB


Belgium






Leading Ethics Committee:Commissie Medische Ethiek UZ Brussel Laarbeeklaan 101 B – 1090 BRUSSEL

Professor P. DEVROEY

4101 / De Grève 4102 / Bosquée 4103 / Ninane 4104 / Vuylsteke 4105 / Surmont 4107 / Vansteenkiste

Protocol


22/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 Bâtiment B23 Institut de Pathologie B – 4000 LIEGE

Professor M. LAMY

4102 / Bosquée


Comité d’Ethique de l’hôpital Universitaire Saint-Pierre Rue Haute, 322 1000 Bruxelles

Professor P. HERMANS

4103 / Ninane


Belgium






Comité d'Ethique Clinique Ste Elisabeth Namur Place Louise Godin 15 B-5000 Namur

Doctor I. MATHIEU

4104 / Vuylsteke


Ethisch Comité Universitair Ziekenhuis De Pintelaan, 185 9000 GENT

Professor Dr. R. RUBENS

4105 / Surmont


Commissie Medisch Ethiek van de UZ K.U. Leuven - Toetsingscommissie Campus Gasthuisberg E330 Herestraat 49 B – 3000 LEUVEN

Professor Dr. Walter VAN DEN BOGAERT

4107 / Vansteenkiste


Brazil






Comitê de Ética em Pesquisa em Seres Humanos da Universidade Federal de São Paulo - UNIFESP/EPM / Rua Botucatu, 572 1° Andar Conj. 14 – CEP 04.023-061 – São Paulo, SP – Brazil

José Osmar Medina Pestana (Coordenador do CEP)

2201 / Tadokoro

Protocol

Amendment 1 Global

Amendment 2 Global

04/DEC/2009 26/NOV/2011 17/OCT/2011

Comitê de Ética 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 / Barrios

Protocol

Amendment 1 Global

Amendment 2 Global

26/MAR/2010 10/JAN/2011 14/DEC/2011

Brazil






Comitê de Ética em Pesquisa em Seres Humanos do Hospital Life Center / Avenida do Contorno, 4747 - 20° andar, CEP 30110-090 Belo Horizonte, MG – Brazil

André Márcio Murad (Coordenador do CEP)

2204 / Murad

Protocol


N/A

10/FEB/2011

N/A – Site closed

Comitê de Ética 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 / Zereu

Protocol

Amendment 1 Global

Amendment 2 Global

19/AUG/2010 18/JAN/2011 N/A – Site closed

Brazil






Comitê de Ética em Pesquisa em Seres Humanos do Centro Integrado de Atenção a Saúde - CIAS/ UNIMED Vitória / Av. Leitão da Silva, 2311 – Vitória, ES – CEP 29047-575 – Brazil

Ana Daniela de

Sadowsky (Coordenador do CEP)

2207 / Aleixo

Protocol

Amendment 1 Global

Amendment 2 Global

10/MAR/2010 22/NOV/2010 N/A – Site closed

Comitê de Ética em Pesquisa em Seres Humanos do Hospital de Clínicas da Universidade Federal do Paraná – HCUFPR / Rua Gal. Carneiro, 181 Curitiba, PR – CEP 80060-900 – Brazil

Renato Tambara Filho (Coordenador do CEP)

2208 / Gunnar Skare

Protocol

Amendment 1 Global

Amendment 2 Global

N/A

04/DEC/2010

N/A – Site closed

Brazil






Comitê de Ética 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 – São Paulo, SP – Brazil

Sigismundo José Gomes Amoroso (Coordenador do CEP)

2209 / Marcelo Tanaka

Protocol

Amendment 1 Global

Amendment 2 Global

N/A

20/DEC/2010

N/A – Site Closed

Canada






CHUM Comite d’Ethique de la Recherche Edifice cooper 3981 Boulevard St- Laurent Mezz 2 Montreal, QC H2W 1Y5

Marie-Claire Michoud Marie-Josee Bernardi Isabelle Dugas

2901 / Blais

Protocol

Amendment 1 Global

Amendment 2 Global

14/JAN/2010 29/JUL/2010 07/SEP/2011

Canada






Alberta Cancer Research Ethics Committee 1500-10123 99 Street Edmonton, AB T5J 3H1

Karen Mulder Raul Urtasun Raul Urtasun

2902 / Chu

Protocol

Amendment 1 Global

Amendment 2 Global

19/JAN/2010 21/JUL/2010 09/SEP/2011

McGill Institutional Review Board 3655 Promenade Sir William Osler Montreal, QC H3G 1Y6

Serge Gauthier Serge Gauthier Serge Gauthier

2903 / Hirsh

Protocol


16/FEB/2010 29/JUN/2010 26/SEP/2011

Research Ethics Committee Hopital Charles LeMoyne 3120 boul. Taschereau Greenfield Park, QC J4V 2H1

Visual Uon Visual Uon Visual Uon

2904 / Prady (formally Devaux)

Protocol

Amendment 1 Global

Amendment 2 Global

29/JAN/2010 12/JUL/2010 24/OCT/2011

Canada

IRB or IEC


Centre number(s) /

Protocol and/or

Date of Final Approval

(name/address)

Investigator(s)

Amendment number(s)

(DD/MMM/YYYY)

Alberta Cancer

Raul Urtasun

2905 / Morris

Protocol

24/JUN/2010

Research Ethics

Raul Urtasun

Committee

Amendment 1 Global

21/JUL/2010

1J2 WCM Health

Sciences Centre

8440-112 Street

Edmonton, AB

T6G 2B7

REB address changed to:

Alberta Cancer

Raul Urtasun

Amendment 2 Global

09/SEP/2011

Research Ethics

Committee

Suite 1500

Sun Life Place

10123-99 Street

Edmonton, AB

T5J 3H1

Chile






Address 1.

Dr. Stuardo

2301 / Diaz

Protocol

24/NOV/2009

Servicio de Salud

Metropolitano de

Amendment 1 Global

13/JUL/2010

Oriente. Comité de ética Cientifico

Amendment 2 Global

03/JAN.2012

Address 2.

Miguel Luis Berr Lama

Protocol

18/JAN/2010

Comité de Ética-

Hospital DIPRECA .

Sr. Germán Campos

Amendment 1 Global

18/NOV/2010

Av. Vital Apoquindo

Onfray

1200, Las Condes

Sr. Germán Campos Onfray

Amendment 2 Global

Pending – Not yet received

Comité Ético Cientifico

Patricio Valdés Garcia

2302 / Yañez

Protocol

17/NOV/2009

Servicio de Salud

Araucaria Sur.

Amendment 1 Global

06/OCT/2010

Andrés Bello 636.

Temuco.

Amendment 2 Global

Pending – Not yet received

Chile






Address 1. Comité de Ética Científica Servicio de Salud Viña del Mar-Quillota Limache 1307-2do Piso-Viña del Mar

Address 2. Comité de Ética Clinica Reñaca Anabaena 336. Jardín del Mar. Reñaca.

Dr. Tulio Moreno

Dr. Luis Bavestrello

2303 / Gonzalez Mella

Protocol

Amendment 1 Global

Amendment 2 Global

Protocol

Amendment 1 Global

Amendment 2 Global

12/NOV/2009 21/OCT/2010 24/NOV/2011

10/DEC/2009 29/OCT/2010 11/NOV/2011

France






CPP SUD EST IV Centre Léon Bérard - 28, rue Laënnec 69373 LYON Cdx 8

Tel 04 78 78 27 61 Fax : 04 78 78 28 58

Dr DANIEL ESPINOUSE

4201 / Guerin 4202 / Sibilot 4204 / Zalcman 4206 / Falchero 4207 / Bennouna 4210 / Daniel 4211 / Urban 4212 / Bérard 4215 / Paganin

Protocol

Amendment 1 Global

Amendment 2 Global

21/JUL/2009 08/JUN/2011 30/AUG/2011

Germany






Leading Ethics Committee :

Ethikkommission der Ärztekammer Hamburg Heinrich Hertz-Strasse 125 22085 Hamburg

Prof. Dr. med. Thomas Weber

Centre numbers: 4301 4302 4303 4304 4305 4306 4307 4308 4309 4310 4311 4312

Protocol

Amendment 1 Germany

Amendment 1 Global

Amendment 2 Global

15/SEP/2009 15/SEP/2009 07/JUL/2010 26/JUL/2011

Ärztekammer Schleswig-Holstein Ethikkommission Bismarckallee 8-12 23795 Bad Segeberg

Dr. med. Franz-Joseph Bartman

4302 / Reck


Ethikkommission der Bayrischen Landesärztekammer Mühlbaurstrasse 16 81677 München

Prof. Dr. Joerg Hasford

4303 / von Pawel


Germany






Ethikkommission des Landes Berlin Landesamt fir Gesundheit und Soziales Sächsische Str. 28 10707 Berlin

Franz Allert

4304 / Keilholz


Ethikkommission der Medizinischen Fakultät der Universität Duisburg-Essen Universitätsklinikum Essen Robert-Koch-Straße 9-11 45147 Essen

Prof. Dr. med. Werner Havers

4305 / Schuler


Ethikkommission der Medizinischen Hochschule Hannover Carl-Neuberg-Straße 1 30625 Hannover

Prof. Dr. Hans-Dieter Tröger

4306 / Dickgreber


Germany






Medizinische Ethikkommission II Fakultät für klinische Medizin Mannheim Maybachstrasse 14 – 16 68169 Mannheim

Prof. Dr. med. Jens P. Striebel

4307 / Manegold


Ethik-Kommission der Medizinischen Fakultät der Goerg-August- Universität Göttingen Robert-Koch-Strasse 40 3075 Göttingen

Prof. Dr. med. Jürgen Brockmöller

4308 / Griesinger


Ethik-Kommission der Ärztekammer Westfahlen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster Von-Esmarch-Strasse 52

48149 Münster

Univ.-Prof. Dr. med. Hans-Werner Bothe

4309 / Serke


Germany






Ethikkommission bei der Landesärztekammer Rheinland-Pfalz Deutschhausplatz 3 55131 Mainz

Prof. Dr. Stephan Letzel

4310 / Wehler


Ethikkommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen-Wilhelms-Universität Münster Von-Esmarch-Strasse 52 48149 Münster

Univ.-Prof. Dr. med. Hans-Werner Bothe

4311 / Wiewrodt


Ethikkommission der Medizinischen Fakultät Heidelberg Amalienstraße 5 69126 Heidelberg

Prof. Dr. Med. Thomas Strowitzki

4312 / Thomas


Hong Kong






Joint CUHK-NTEC Clinical Research Ethics Committee Flat 3C, Block B, Staff Quarters, Prince of Wales Hospital

Dr. Chi Kong Li, Prof. Brian Tomlimson

3101 / Mok, Tony S. K.

Protocol

Amendment 1 Global

Amendment 2 Global

11/AUG/2009 16/JUL/2010 19/JUL/2011

HKU/HA HKW IRB Room 901 Administration Block Queen Mary Hospital

Prof. Yuen Man Fung

3102 / Lee, Victor

Protocol

Amendment 1 Global

Amendment 2 Global

31/AUG/2010 31/AUG/2010 13/JUL/2011

Hungary






Medical Research Council Ethics Committee for Clinical Pharmacology

Prof. Dr. Fürst Zsuzsanna

5301 / Szima5302 / Papai Szekely 5301 / Szima 5302 / Papai Szekely 5303 / Strausz 5304 / Tehenes

Protocol

Amendment 1 Global

Amendment 2 Global

16/OCT/2009

02/AUG/2010

07/OCT/2011

Ireland






Research Ethics Committee Adelaide & Meath Hospital, (incorporating the National Children's Hospital), Tallaght, Dublin 24

Dr Ray McDermott

4401 / O-Byrne

Protocol

Amendment 1 Global

Amendment 2 Global

28/SEP/2009 27/MAY/2010 28/JUL/2011

Italy






Comitato Etico delle Aziende Sanitarie della Regione Umbria Via della Rivoluzione, 16 06070 Ellera di Corciano (PG)

Prof. Giancarlo Agnelli

4501 / Crino' (Coordinating site)

Protocol

Amendment 1 Global

09/JUL/2009 22/JUL/2010

Italy






Comitato Etico per la sperimentazione dei medicinali Azienda USL 8 di Arezzo Via Curtatone 54 52100 Arezzo

Dr. Maura Lodovici

4503 / Bracarda

Protocol

Amendment 1 Global

22/OCT/2009 23/SEP/2010

Comitato Etico A.O. S. Andrea di Roma Via di Grottarossa, 1035 00189 Roma

Avv. Gian Domenico Caiazza

4504 / Marchetti

Protocol

Amendment 1 Global

09/NOV/2009 11/OCT/2010

Comitato Etico Azienda Unità Sanitaria Locale 3 Via S.M. La Grande, 5 95124 Catania

Dr. Domenico Barbagallo

4505 / Giuffrida

Protocol

Amendment 1 Global

29/OCT/2009 09/NOV/2010

Japan



Centre numbers / Investigators



The IRB of Shizuoka Cancer Center

1007 Shimonagakubo Nagaizumi-cho, Sunto- gun, Shizuoka

Dr. Tobisu Kenichi

3202 / Yamamoto, Nobuyuki

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

27/OCT/2009 27/OCT/2009 22/JUN/2010 29/JUL/2011

The IRB of National Cancer Center Hospital, East Division

6-5-1, Kashiwanoha, Kashiwa, Chiba

Dr. Kinoshita Taira

Dr. Tamura Tomohide

3203 / Goto, Koichi

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

28/OCT/2009 28/OCT/2009 23/JUN/2010 27/JUL/2011

The IRB of Aichi Cancer Center Hospital

1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi

Dr. Hasegawa Yasuhisa Dr. Kodaira Takeshi

3204 / Hida, Toyoaki

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

24/NOV/2009 24/NOV/2009 20/JUL/2010 23/AUG/2011

Japan






The IRB of Kinki University Hospital 377-2, Ono-Higashi, Osaka-Sayama, Osaka

Dr. Kusunoki Susumu Dr. Ikegami Hiroshi

3205 / Okamoto, Isamu

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

14/SEP/2009 14/SEP/2009 28/JUN/2010 12/SEP/2011

The IRB of Osaka City General Hospital 2-13-22, Miyakojima-hondori, Miyakojima- ku, Osaka

Dr. Tada Hirohito

3206 / Takeda, Koji

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

20/NOV/2009 20/NOV/2009 18/JUN/2010 16/SEP/2011

The IRB of National Kyushu Cancer Center 3-1-1, Nodame, Minami-ku, Fukuoka, Fukuoka

Dr. Okamura Jun

3207 / Sugio, Kenji

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

16/NOV/2009 16/NOV/2009 02/JUN/2010 01/SEP/2011

Japan






The IRB of Okayama University Hospital 2-5-1, Shikata-cho Kita-ku, Okayama, Okayama

Dr. Koide Norio

Dr. Iwatsuki Keiji

3209 / Kiura, Katsuyuki

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

20/OCT/2009 20/OCT/2009 15/JUN/2010 16/AUG/2011

The IRB of Kanazawa University Hospital 13-1, Takara-machi, Kanazawa, Ishikawa

Dr. Matsui Osamu

Dr. Sugiyama Kazuhisa

3211 / Kasahara, Kazuo

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

14/OCT/2009 14/OCT/2009 14/JUL/2010 14/SEP/2011

The IRB of Kurashiki Central Hospital 1-1-1,Miwa, Kurashiki,Okayama

Dr. Goto Tsuyoshi

3214 / Yoshioka, Hiroshige

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

19/OCT/2009 19/OCT/2009 21/JUN/2010 20/JUL/2011

Japan






The IRB of Hokkaido University Hospital North 14, West 5, Kita-ku, Sapporo, Hokkaido

Dr. Iseki Ken

3215 / Oizumi, Satoshi

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

20/OCT/2009 20/OCT/2009 15/JUN/2010 30/AUG/2011

The IRB of Niigata Cancer Center 2-15-3, Kawagishi-cho, Chuo-ku, Niigata, Niigata

Dr. Yokoyama Akira

3216 / Yokoyama, Akira

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

09/NOV/2009 09/NOV/2009 14/JUN/2010 12/SEP/2011

The IRB of National Hospital Organization Nagoya Medical Center 4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi

Dr. Horibe Keizo

3217 / Saka, Hideo

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

23/OCT/2009 23/OCT/2009 20/JUL/2010 03/AUG/2011

Japan






The IRB of Kinki- Chuo Chest Medical Center 1180 Nagasone-cho Kita-ku, Sakai, Osaka

Dr. Hayashi Seiji

Dr. Matsumura Akihide

3218 / Atagi, Shinji

Kawahara, Masaaki

Protocol

Amendment 1 Local

Protocol:

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

16/OCT/2009 16/OCT/2009 09/DEC/2009 09/DEC/2009 09/JUN/2011 14/SEP/2011

The Institute of Biomedical Research and Innovation hospital Minatozimaminami- machi Chuo-ku, Kobe, Hyogo

Dr. Okumura Katsuhiko

3219 / Katakami, Nobuyuki

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

28/OCT/2009 28/OCT/2009 23/JUN/2010 21/DEC/2011

The IRB of National Hospital Organization Shikoku Cancer Center 160 Ko Minamiumenomoto-machi, Matsuyama, Ehime

Dr. Kurita Akira

Dr. Iguchi Haruo

3220/ Nogami, Naoyuki

Shinkai, Tetsu

Protocol

Amendment 1 Local

Amendment 1 Global

Amendment 2: Global

13/OCT/2009 13/OCT/2009 21/JUN/2010 27/JUL/2011

Japan






The IRB of Kanagawa Cardiovascular and Respiratory Center 6-16-1, Tomioka- higashi, Kanazawa-ku, Yokohama, Kanagawa

Dr. Takahashi Hiroshi

3221/ Kato, Terufumi

Protocol

Amendment 1 Local

Site Version

Amendment 1 Global

Amendment 2: Global

10/NOV/2009 10/NOV/2009 10/NOV/2009 13/JUL/2010 12/JUL/2011

Korea






IRB of Asan Medical Center B1, Clinical Research Center 88, OLYMPIC-RO 43-GIL,Sonpa- gu,Seoul,138-736,South Korea

Seong-Wook PARK

3301 / Dr. Sang-We Kim

Protocol

Amendment 1 Global

Amendment 1 Local

Amendment 2: Global

13/JUL/2009 28/MAY/2010 13/AUG/2010 29/JUL/2011

Korea






IRB of Chonnam National University,Hwasun Hospital 2F Clinical trial center,160 Ilsim-ri, Hwasun-eup, Hwasun-gun, Jeollanam-do, 519-809 Korea

Ik-Joo CHUNG

3302/ Dr. Young-Chul Kim

Protocol

Amendment 1 Global

Amendment 1 Local

Amendment 2: Global

11/SEP/2009 08/JUN/2010 16/SEP/2010 29/JUL/2011

IRB 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, Korea

Chin Youb CHUNG

3303/ Dr. Jong-Seok Lee

Protocol

Amendment 1 Global

Amendment 1 Local

Amendment 2: Global

04/AUG/2009 16/JUN/2010 26/AUG/2010 02/AUG/2011

Korea






IRB of Chungbuk National University Hospital 2F, Clinical Center building, 62 Gaeshin-dong, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 361-711, Korea

Kyung-Su MIN

3304 / Dr. Ki Hyeong Lee

Protocol

Amendment 1 Global

Amendment 1 Local

Amendment 2: Global

27/AUG/2009 04/JUN/2010 19/AUG/2010 29/JUL/2011

IRB of Ulsan University Hospital 6F, The division of education & research, 290-3 Jeonha dong, Dong-gu, Ulsan,682- 714 Korea

Cheal In YOO

3305 / Dr. Young Joo Min

Protocol

Amendment 1 Global

Amendment 1 Local

Amendment 2: Global

28/DEC/2009 28/MAY/2010 26/AUG/2010 29/JUL/2011

Malaysia






Research and Ethics committee, Universiti Kebangsaan Malaysia, Jalan Yaacob Latiff, Bandar Tun Razak 56000, Cheras – Kuala Lumpur, Malaysia

Prof Dr. Ainoon Othman

3401 / Ismail, Fuad

Protocol

Amendment 1 Global

Amendment 2 Global

06/AUG/2009 01/DEC/2010 08/AUG/2011

Medical Research and Ethics committee, Ministry of Health Malaysia, Institute of Health Management, Jalan Rumak Sukit, Bangsar – 69000, Kuala Lumpur, Malaysia

Dr. Chang Kian Meng

3402 / Muttalif, Haji Abd Razak

Protocol

Amendment 1 Global

Amendment 2 Global

02/OCT/2009 04/NOV/2010 04/JUL/2011

Medical Ethics Committee, Universiti Malaya Medical Centre, Jalan Universiti, 59100, Kuala Lumpur

Prof Looi Lai Meng

3403 / Liam, Chong Kin

Protocol

Amendment 1 Global

Amendment 2 Global

22/JUL/2009 26/JAN/2011 20/JUL/2011

Peru






ESSALUD – Comité de Ética em Investigación –Hospital Nacional Guillermo Almenara Irigoyen Av. Grau 800- Lima 13

Dr. Demetrio Molero Castro

2501 / Salas

Protocol

Amendment 1 Global

Amendment 2 Global

11/MAY/2010 03/AUG/2010 15/NOV/2011

Comité Institucional de Ética en Investigación del Instituto Nacional de Enfermedades. Avenida Angamos Este 2520, Surquillo. Lima 34.

Dr. Rolando Calderón Velasco

2503 / Dr Mas Lopez

Protocol

Amendment 1 Global

Amendment 2 Global

03/NOV/2009 03/SEP/2010 16/DEC/2011

ESSALUD – Comité de Ética en Investigación –Red Asistencial Arequipa

Dr. Antero Peralta Mestas

2504 / Alvarez Barreda

Protocol

Amendment 1 Global

Amendment 2 Global

06/APR/2010 13/OCT/2010

N/A – Site Closed

Peru






Address 1:

Dr. Tejada Zevallos

2505 / Lozada

Protocol

25/NOV/2009

Comité de Bioética de la Clínica Anglo

Amendment 1 Global

23/AUG/2010

Americana

Amendment 2 Global

24/NOV/2011

Address 2:

Dr. Salomón Zavala

Protocol

29/OCT/2009

Comité de Ética de la

Sarrio

Asociación Benéfica

Amendment 1 Global

12/AUG/2010

PRISMA

Amendment 2 Global

24/NOV/2011

Philippines

IRB or IEC


Centre number(s) /

Protocol and/or

Date of Final Approval

(name/address)

Investigator(s)

Amendment number(s)

(DD/MMM/YYYY)

Institutional Ethics and

Dr. Marsha Tolentino

3501 / Tudtud, Dennis

Protocol

10/JUN/2009

Review Board/

Perpetual Succour

Amendment 1 Global

21/JUL/2010

Hospital, Gorordo

Avenue, Lahug, Cebu

Amendment 2 Global

13/JUL/2011

City, Philippines 6000

Philippines






St. Luke’s Institutional Ethics Review Committee/ St. Luke’s Medical Center, No. 279 E. Rodriquez Sr., Blvd., Quezon City, Philippines 1102

Dr. Augusto Reyes

3502 / Caguioa, Priscilla

Protocol

Amendment 1 Global

Amendment 2 Global

09/SEP/2009 21/JUL/2010 13/JUL/2011

Institutional Review Board/ Makati Medical Center, #2 Amorsolo Street, Legaspi Village, Makati City, Philippines 1229

Dr. Saturnino P.Javier

3503 / Parra, Joseph

Protocol

Amendment 1 Global

Amendment 2 Global

07/DEC/2009 17/MAY/2011 08/AUG/2011

Romania






National Ethics Committee

Prof. Dr. Sava Dumitrescu

5401 – Dr. Lungulescu Dan

5402 – Dr. Cristina Cebotaru

Protocol

Amendment 1 Global

Amendment 2 Global

12/NOV/2009 30/SEP/2010 28/FEB/2012

Russia






Ethics Committee of St.-Petersburg City Clinical Oncology Dispensary 198255, Veteranov 56, Ave, St.Petersburg, Russia

Pavlysh A.D.

5501 / Dr. N. Karaseva

Protocol

Amendment 1 Global

Amendment 2 Global

15/DEC/2009 26 /JUL/2010 N/A

Ethics Committee of Scientific Research Institute of Oncology n.a. N.N. Petrov 197758, Leningradskaya str, 68, Pesochny, Saint-Petersburg, Russia

Mihnin A.E.

5503 / Prof. V. Moiseyenko

Protocol

Amendment 1 Global

Amendment 2 Global

28/DEC/2009 20/JUL/2010 N/A

Ethics Committee of Saint-Petersburg State Medical University n.a. acad. I.P. Pavlov 197101, Rentgena str.10, Saint-Petersburg, Russia

Yagmurov O.D.

5504 / Prof. S. Orlov

Protocol

Amendment 1 Global

Amendment 2 Global

30/NOV/2009 28/JUN/2010 30/JAN/2012

Russia






Ethics Committee of Russian Oncological research centre n.a. N.N. Blokhin RAMS115478, Kashirskoe shosse, 24, Moscow

Komov D.V.

5505 / Prof. V. Gorbunova

Protocol

Amendment 1 Global

Amendment 2 Global

22/DEC/2009 26/JUL/2010 23/JAN/2012

Ethics Committee of RCOD MoHRT Address: 420029, Sibirskiy tract, 29, Kazan, Russia

Karpenko L.G.

5506 / Prof. R. Khasanov

Protocol

Amendment 1 Global

Amendment 2 Global

01/DEC/2009 07/JUL/2010 23/JAN/2011

Ethics Committee of FSBI MRSC 249036, Koroleva str., Obninsk, 4, Russia

Andreev V.G.

5507 / Dr. Y. Ragulin

Protocol

Amendment 1 Global

Amendment 2 Global

29/JUL/2010 29/JUL/2010 20/JAN/2012

Taiwan






Joint Institutional Review Board (JIRB) / No. 5-1, Lane 331, Sec. 2, Shih-Pai Road, Taipei

Low-Tone Ho

N/A

Protocol

Amendment 1 Global

Amendment 2 Global

27/JUL/2009 02/AUG/2010 30/AUG/2011

National Taiwan University Hospital Research Ethics Committee / 7, Chung-Shan South Road, Taipei, Taiwan 100, R.O.C

Hong-Nerng Ho

3601 PI / Chih-Hsin Yang

Protocol

Amendment 1 Global

Amendment 2 Global

30/JUN/2009 22/JUL/2010 18/AUG/2011

Taipei Veterans General Hospital Institutional Review Board / 201, Shih-Pai Road, Sec. 2, Taipei, Taiwan 11217, R.O.C

Chen-Hsen Lee

3602 PI / Chun-Ming Tsai

Protocol

Amendment 1 Global

Amendment 2 Global

23/SEP/2009 02/NOV/2010 09/SEP/2011

Taiwan






Institutional Review Board of Tri-Service General Hospital, National Defense Medical Center / No.325, Sec. 2, Cheng-Kung Rd., Neihu 11490, Taipei, Taiwan, R.O.C

Chih-Shung Wong, M.D., Ph.D.

3603

PI / Ching-Liang Ho

Protocol

Amendment 1 Global

Amendment 2 Global

10/AUG/2009 15/AUG/2010 08/SEP/2011

The Institutional Review Board of Taichung Veterans General Hospital / 160, Sec. 3, Tai-Chung Kang Road, Taichung, Taiwan 40705, R.O.C

Wayne Huey-Herng Herng

Jeng-Yuan Hsu, MD

3604 / Gee-Chen Chang

Protocol

Amendment 1 Global

Amendment 2 Global

14/AUG/2009 27/AUG/2010 15/SEP/2011

The Institutional Review Board, China Medical University Hospital / No.2, Yuh-Der Road, Taichung, Taiwan, R.O.C

Martin M-T Fuh MD, DM Sci.

3605 / Te-Chun Hsia

Protocol

Amendment 1 Global

Amendment 2 Global

16/JUL/2009 22/JUL/2010 10/AUG/2011

Taiwan






Human Experiment and Ethics Committee, National Cheng Kung University Hospital / 138, Sheng-Li Rd., Tainan 704, Taiwan R.O.C

Ih-Jen Su M.D., Ph.D.

Chyun-Yu Yang M.D.

3606 / Wu-Chou Su

Protocol

Amendment 1 Global

Amendment 2 Global

15/SEP/2009 01/SEP/2010 02/SEP/2011

Institutional Review Board, Chang-Gung Medical Foundation / 199, Tung-Hwa North Road, Taipei, Taiwan 10507, R.O.C

Tsang-Tang Hsieh

3607 / Meng-Chih Lin 3609 / Ying-Huang Tsai

Protocol

Amendment 1 Global

Amendment 2 Global

08/SEP/2009 30/AUG/2010 02/NOV/2011

Institutional Review Board 1, Kaohsiung Medical University Chung-Ho Memorial Hospital / No.100, Tzyou 1st Road, Kaohsiung 807, Taiwan

Ming-Shyan Huang

Wan-Long Chuang, M.D., Ph.D.

3608 / Ming-Shyan Huang

Protocol

Amendment 1 Global

Amendment 2 Global

20/AUG/2009 26/OCT/2010 08/NOV/2011

Thailand






Ethics Committee of Faculty of Medicine Prince of songkla University

Assoc. Prof. Kitti Limapichat

3701 / Lucient Geater, Sarayut

Protocol

Amendment 1 Global

Amendment 2 Global

26/AUG/2009 18/NOV/2010 26/JUL/2011

Research Ethics Committee, Faculty of Medicine, Chiang Mai University

Professor Malai Muttarak, Dean of IEC

3702 / Thongprasert, Sumitra

Protocol

Amendment 1 Global

Amendment 2 Global

19/OCT/ 2009 21/OCT/2009 22/AUG/2011

The Khon Kaen University Ethics Committee for Human Research

Assoc. Prof. Jiraporn Srinakarin,

3703 / Phunmanee, Anakapong

Protocol

Amendment 1 Global

Amendment 2 Global

02/OCT/2009 29/SEP/2010 06/OCT/2011

Ethical Clearance Committee on Human Rights Related to Researches Involving Human Subjects Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Prof. Boonsong Ongphiphadhanakul

3704 / Sirisinha, Thitiya

Protocol

Amendment 1 Global

Amendment 2 Global

21/OCT/2009 20/OCT/2010 20/JUL/2011

Ukraine






IEC:Central Ethics committee of Ministry of health of Ukraine. Ukraine, 03680 Kyiv, 5, Narodnogo Opolcheniya str

Vasyl Kornatskyy

N/A

Protocol

Amendment 1 Global

Amendment 2 Global

08/OCT/2009 21/OCT/2010 18/AUG/2011

IRB: State expert centre of Ministry of health of Ukraine. Ukraine, 03151, Kiev, Ushynskogo str., 40

Vasyl Blikhar

N/A

Protocol

Amendment 1 Global

Amendment 2 Global

09/NOV/2009 17/NOV/2010 19/SEP/2011

United Kingdom






NRES Committee London – Hampstead Northwick Park Hospital REC Centre Level 7, Maternity Block Northwick Park Hospital Watford Road Harrow Middx HA1 3UJ

Dr Michael Pegg

4801/ Dr Sanjay kumar Popat

4802/Dr Mary O’Brien 4803/Dr Gary Middleton 4804/Dr Jeremy Steele 4805/Dr Sunil Upadhyay

4806/Dr Matthew Collinson

4807/Dr Riyaz Shah 4808/Dr Elizabeth Toy

Protocol

Amendment 1 Global

Amendment 2 Global

18/NOV/2009 17/JUN/2010 12/AUG/2011

US






Schulman Associates IRB 4445 Lake Forest Drive Suite 300 Cincinnati, Ohio 45242

Sharon Nelson, MSN, RN, CNS

2603/Robert Asbury 2605/Daniel S. Bradford 2606/Nagarajan Chandrasekaran 2607/Billy Clowney 2609/Mohamad Ghraowi 2616/Marc Saltman 2617/ John P. Thropay

Protocol

Amendment 1 Global

Amendment 2 Global

06/JUL/2009 01/JUL/2010 07/JUL/2011

Lehigh Valley Health Network IRB Research Participant Protection Office 17th and Chew Streets Allentown, PA 18102

Margaret Hoffman-Tepy, MD

2608/Friedman

Protocol

Amendment 1 Global

Amendment 2 Global

14/MAY/2009 24/AUG/2010

N/A (Site Closed 28/JAN/2011)

Mary Greeley Medical Center IRB 1111 Duff Avenue Ames, IA 50010

Dario Zaffarano,

2615/Prow

Protocol

Amendment 1 Global

Amendment 2 Global

21/JUL/2009 26/JUL/2010

N/A (Site Closed 3/MAR/2011


Ethics Committee

Chairperson

Investigator(s)

Date of approval of final protocol (after 4 amendments)

EC of Guangdong General Hospital, No.106 Zhongshan Er Road, Guangzhou, Guangdong Province, 510080, China

Zhang Nianjiao

Wu 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 Muyun

28/NOV/2013 06/JAN/2014 28/NOV/2013 28/NOV/2013

28/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/2013

EC of Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University, No. 241 Huaihai West Road, Shanghai 200030, China

Ni Youfang

Lu Shun

06/DEC/2013

EC of Shanghai Changhai Hospital, No. 168 Changhai Road, Shanghai, 200433, China

Xiang Yaojun

Li Qiang

21/NOV/2013

EC of 307 Hospital of PLA, No. 8 Dongda Street, Fengtai District, Beijing 100071, China

He Yuezhong

Liu Xiaoqing

10/DEC/2013

EC of Jiangsu Cancer Hospital, No. 42 Baiziting Street, Nanjing, 210000, China

Pan Liangxi

Feng Jifeng

12/DEC/2013

EC of Hebei Medical University Fourth Hospital, No.12 Jiankang Road, Shijiazhuang, Hebei Province, 050011, China

Li Lianrong

Liu Wei

18/NOV/2013

EC of the First Hospital of China Medical University, No. 155 Nanjingbei Street,

Heping District, Shenyang, Liaoning Province, 110001, China

Yu Xiaosong

Liu Yunpeng

22/NOV/2011a

EC of the First Hospital of Jilin University, No. 71 Xinmin Street, Changchun, Jilin Province, 130021, China

Tan Yuquan

Li Wei

27/DEC/2013

EC of Hubei Cancer Hospital, No. 16 South Zhuo Dao Quan Road, Wuhan City, Hubei Province

Hu Renchong

Yu Ding

30/SEP/2011a

EC of The Affiliated Hospital of Medical College Qingdao University, No. 59 Haier Rd, Qingdao, Shandong Province, 266000, China

Liang Jun

Liang Jun

26/NOV/2013

EC of Fujian Provincial Tumor Hospital, No. 91 Fuma Road Ding, Fuzhou, Fujian Province, 350014, China

Huang Ping

Huang Cheng

19/NOV/2013

EC of the Affiliated Cancer Hospital of Guangxi Medical University, No. 71 Hedi Road, Nanning City, Guangxi, Province, 210002, China

Li Yisheng

Zhu Xiaodong

18/NOV/2013

EC of Beijing Chest Hospital, No. 97 Bei Ma Chang, Tong Zhou District, Beijing, China, 101149

Li Yanshen

Zhu Yunzhong

21/NOV/2013

EC of Shanghai Changzheng Hospital, No. 415 Fengyang Road, Shanghai 200003, China

Cai Jianfei

Xiu Qingyu

05/NOV/2012a

EC of the 3rd Affiliated Hospital of Harbin Medical University, No. 150, Ha Ping Road, Harbin, 150081, China

Xu Xiuyu

Chen Gongyan

05/DEC/2013

aDate of approval of third protocol amendment; Abbreviations: EC, ethics committee.


France



Centre number / Investigator

Protocol and/or Amendment numbers


CPP SUD EST IV Centre Léon Bérard 28 rue Laennec 69373 LYON cedex

Dr ESPINOUSE

3301/PEROL 3302/BENNOUNA 3303/CHOUAID 3305/DUBOS-ARVIS 3306/HUCHOT 3307/ROTARSKI 3308/VERGNENEGRE 3309/MORO-SIBILOT

Amendment 1 (dated 29 Sep 2011)

08/NOV/2011


06/NOV/2012

Amendment 3 (dated 6 Mar 2013)

09/APR/2013

Local Amendment to implement PK substudy (dated 26 Sep 2013)

03/DEC/2013

Amendment 4 (dated 16 Dec 2013)

Info 15/JAN/2014

Amendment 5 (dated 29 Jul 2015)

08/SEP/2015

Korea






Samsung Medical Center Institutional Review Board /(06351), 81 Irwon-ro, Gangnam-gu, Seoul, Korea

Lee, Suk-Koo

8201

Park, Keunchil


23/JAN/2012


08/NOV/2012


15/MAY/2013


01/DEC/2013


07/MAR/2014


04/SEP/2015

Seoul National University Hospital Institutional Review Board /101 Daehak-ro, Jongno-gu, Seoul, 03080, Korea

Paick, Jae-Seung

8202

Kim, Dong-Wan


09/NOV/2011


11/NOV/2012


03/MAY/2013


N/A


18/MAR/2014


09/SEP/2015

Chungbuk National University Hospital Institutional Review Board /776, 1sunhwan-ro, Seowon-gu Cheongju-si, Chungcheongbuk-do, 28644, Korea

Shon, Bora

8203

Lee, Ki Hyeong


09/NOV/2011


14/NOV/2012


02/MAY/2013


03/DEC/2013


11/MAR/2014


22/SEP/2015

Gachon University Gil Medical Center Institutional Review

Jong-Hoon Kim

8204

Cho, EunKyung


29/DEC/2011

Amendment 2 (dated 11 Sep

13/NOV/2012

Board /21 , Namdong- daero 774 beon-gil, Namdong-gu Incheon, 405-760 Rep, of Korea

2012)


07/MAY/2013


N/A


18/MAR/2014


08/SEP/2015

Asan Medical Center Institutional Review Board /88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea

Jong Woo Chung

8205

Kim, Sang-We


14/NOV/2011


09/NOV/2012


26/APR/2013


28/NOV/2013


13/MAR/2014


24/SEP/2015

Severance Hospital, Institutional Review Board /50 -1, Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea

Seung Min Kim

8206

Cho, Byoung Chul


N/A


10/AUG/2012


10/MAY2013


N/A


08/MAR/2014


16/SEP/2015

Canada






McGill Faculty of Medicine 3655 Promenade Sir William Osler # 633 Montreal, QC H3G 1Y6

Harvey Sigman, MD Chair – Committee B

1001/Vera Hirsh


20/FEB/2012


26/NOV/2012


27/MAY/2013


24/FEB/2014


26/OCT/2015

UBC- BC Cancer Agency Fairmont Medical Bldg. Suite 902 750 West Broadway Vancouver, BC V5Z 1H8

Ken Swenerton, MD

1002/Janessa Laskin


02/MAR/2012


30/NOV/2012


19/AUG/2013

Amendment 4 (dated 16

03/APR/2014

Dec 2013)


23/SEP/2015

Ottawa Health Science Network Research Ethics Board 725 Parkdale Avenue Ottawa, ON K1Y 4E9

Raphael Saginur, MD

1003/Scott Laurie


19/APR/2012


25/JAN/2013


30/MAY/2013


05/MAR/2014


23/OCT/2015

UBC- BC Cancer Agency Fairmont Medical Bldg. Suite 902 750 West Broadway Vancouver, BC V5Z 1H8

Ken Swenerton, MD

1004/Christopher Lee


02/MAR/2012


30/NOV/2012


19/AUG/2013


03/APR/2014


23/SEP/2015

Health Research Ethics Board of Alberta (HREBA) Cancer Committee 1500-10104-103 Avenue NWEdmonton, AB T5J 4A7

Raul Urtasun, MD (Associate Chair)

1005/Sandeep Sangha


06/MAR/2012


19/NOV/2012


10/MAY/2013


24/FEB/2014


25/SEP/2015


10/DEC/2013

Lakeridge Health 1 Hospital Court Oshawa, ON L1G 2B9

John Montgomery, LLB (Bachelor of Law)

1006/Rafael Wierzbicki


05/DEC/2011


03/DEC/2012


06/MAY/2013


03/MAR/2014


05/OCT/2015


McGill Faculty of Medicine 3655 Promenade Sir William Osler # 633 Montreal, QC H3G 1Y6

Harvey Sigman, MD Chair – Committee B

1007/Vera Hirsh


20/FEB/2012


26/NOV/2012


27/MAY/2013


24/FEB/2014


26/OCT/2015

China






EC of Sun Yat-Sen

Peng, Wangqing

8601/Zhang, Li


13/JUN/2012


10/DEC/2012


20/JUN/2013


15/APR/2014


04/NOV/2015


09/OCT/2014

EC of Shanghai Chest Hospital

Zheng, Ning

8602/Lu,Shun


06/JUN/2012


27/NOV/2012


09/JUL/2013


23/APR/2014

Dec 2013)


10/NOV/2015


11/MAR/2014

EC of The First Hospital of China Medical University

Xiaosong YU Jian KANG

8603/Yupeng LIU


12/JUN/2012


29/JAN/2013


22/OCT/2013


23/JUL/2014


30/SEP/2015

EC of Zhongshan Hospital Fudan University

Wang, Yuqi

8604/Bai, Chunxue


20/JUN/2012


31/DEC/2012


24/JUN/2013


17/APR/2014

Dec 2013)


Not obtained yet

EC of Shanghai Chest Hospital

Zheng, Ning

8605/ Han, Baohui


06/JUN/2012


27/NOV/2012


09/JUL/2013


23/APR/2014


Not obtained yet

EC of Beijing Cancer Hospital

Jie LI

8606/Tongtong AN


15/MAY/2012


15/JAN/2013


18/JUN/2013


17/JUN/2014


26/DEC/2015

EC of The Affiliated Cancer Hospital, Guangxi Medical University

Lin, Yuan

8607/Song, Xiangqun


25/JUN/2012


07/MAR/2013


10/OCT/2013


14/MAR/2014


24/SEP/2015

EC of Cancer Hospital of Chinese Academy of Medical Sciences

Datong CHU

8608/Yuankai SHI


6/JUN/2012


25/MAR/2013


6/JUN/2013


5/MAY/2014


30/SEP/2015


21/AUG/2014

Germany



Centre numbers / Investigator



Leading ethics committee for Germany: Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen Robert-Koch-Straße 9-11 45147 Essen


4901 Dr. Martin Schuler 4902 Dr. Juergen Alt 4905 Dr. Martin Faehling

Protocol (dated 30 Aug 2011)

N/A as update necessary. First CTP Version to IRB was CTP Version 2.0.


11/JAN/2012


06/NOV/2012


23/APR/2013


N/A as CTP was not necessary to submit to IRB.


N/A as CTP was not necessary to submit to IRB.

Loc. AM 1

11/JAN/2012

Loc. AM 2

06/NOV/2012

Loc. AM 3

23/APR/2013

Loc. AM 4

28/NOV/2013

Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen Robert-Koch-Straße 9-11s 45147 Essen


4901 Dr. Martin Schuler

Approval of leading ethic committee takes effect.

Ethikkommission bei der Landesärztekammer Rheinland-Pfalz Deutschhausplatz 3 55116 Mainz

Prof. Dr. med. Dipl. Ing. Stephan Letzel

4902 Dr. Jürgen Alt


Ethikkommission bei der Landesärztekammer Baden- Württemberg Jahnstraße 40 70597 Stuttgart

Prof. Dr. med. Gerlinde Egerer

4905 Dr. Martin Faehling


Spain






Comité Ético Investigación Clínica Hospital 12 de Octubre/ Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)

Maria Ugalde Díez

3401 / Dr. Paz Ares 3402/ Dr. Ponce 3403 / Dr. López Brea 3404 / Dr. Cobo 3405 / Dr. Esteban


13/DEC/2011

Comité Ético Investigación Clínica Hospital 12 de Octubre/Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)

Maria Ugalde Díez



06/NOV/2012


Maria Ugalde Díez



28/MAY/2013


Maria Ugalde Díez

3401 / Dr. Paz Ares


29/NOV/2013


Maria Ugalde Díez

3404 / Dr. Cobo


28/JAN/2014


Maria Ugalde Díez

3401 / Dr.Paz Ares 3402/ Dr. Ponce 3403 / Dr. López Brea 3404 / Dr. Cobo 3405 / Dr. Esteban


25/FEB/2014

Comité Ético Investigación Clínica Hospital 12 de Octubre

Maria Ugalde Díez

3401 / Dr. Corral 3402/ Dr. Ponce3403 / Dr. López Brea


12/JAN/2016

/

3404 / Dr. Cobo

Av de Córdoba s/n 28041

3405 / Dr. Esteban

Madrid

(Reference Ethical Committee)

Hong Kong




Protocol and/or Amendment number


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, HK

Benny C. Y. Zee

8521 / Mok, Shu Kam Tony


06/JUN/2012


Benny C. Y. Zee



06/FEB/2013


Benny C. Y. Zee



09/JUN/2013

Joint 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, HK

Benny C. Y. Zee



21/MAR/2014

Joint 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, HK

Benny C. Y. Zee



02/OCT/2015

Institutional 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 Kong

Tang, Sydney

8522 / Lee, Ho Fun Victor


06/JUN/2012


Tang, Sydney



17/DEC/2012


Tang, Sydney



07/JUN/2013


Tang, Sydney



20/MAR/2013


Tang, Sydney



12/OCT/2015

Singapore






Domain Specific Review Board (DSRB) Nexus @One-North (South Tower), No. 3 Fusionopolis Link, #03-08, Singapore 138543

A/Prof Chng Wee Joo

6502



27/JAN/2012


17/DEC/2012


19/APR/2013


27/JAN/2014


12/NOV/2015

SingHealth CIRB Secretariat Office of Research Singapore Health Services Pte Ltd 168 Jalan Bukit Merah #06-08 Tower 3 Connection One Singapore 150168

A/Prof Lim Soon Thye

6501



10/NOV/2011


27/DEC/2012


16/APR/2013


23/NOV/2013


15/SEP/2015

Taiwan






Research Ethics Committee A National Taiwan Hospital

Hong-Nerng Ho Fu-Chang Tsai

8861 8861 8861 8861 8861


15/FEB/2012


14/NOV/2012


21/JUN/2013


17/MAR/2014


23/OCT/2015

Institutional Review Board Taipei Veterans General Hospital

Tung-Ping Su Shung-Tai Ho Fa-Yauh Lee

8862


13/FEB/2012


01/DEC/2012


07/JUN/2013


07/APR/2014


22/OCT/2015

Institutional Review Board B Chang Gung Medical Foundation

Tsang-Tang Hsieh

8863


09/APR/2012


19/DEC/2012


15/JUL/2013


28/MAY/2014


12/NOV/2015

Institutional Review Board of Taichung Veterans General Hospital

Jeng-Yuan Hsu

8864


08/MAR/2012


08/NOV/2012


06/MAY/2013


19/MAR/2014


15/OCT/2015

Institutional Review Board National Cheng Kung University Hospital

Chyun-Yu Yang

Thy-Sheng Lin, Vice Chairman

8866


06/JAN/2012


06/NOV/2012

(The chairman was backup of president, NCKUH, so not involved in the meeting)

Sep 2012)


01/JUL/2013


24/MAR/2014


19/OCT/2015

Australia






Sydney Local Health District Research Development Office Royal Prince Alfred Hospital Camperdown NSW 2050

Lesley Townsend Executive Officer Ethics Review Committee (RPAH Zone)

6101 - Michael Boyer, FRACP, MBBS, PhD


09/MAR/2012


19/DEC/2012


19/JUL/2013


12/MAR/2014

Sydney Local Health District Research Development Office Royal Prince Alfred Hospital Camperdown NSW 2050

Sharon Falleiro Executive Officer

Ethics Review Committee

(RPAH Zone)

6101 - Michael Boyer, FRACP, MBBS, PhD


25/SEP/2015

Bellberry HREC 229 Greenhill Road Dulwich SA 5065

Michael James Chair

6103 - Paul Mainwaring, FRACP, MD, MBBS


22/NOV/2011

Austin Health HREC Austin Hospital

Jill Davis Research Ethics Unit Manager

6102 - Brett Hughes, FRACP, MBBS

6104 - Phillip Parente,


01/MAR/2012

145 Studley Road PO Box 5555 Heidelberg VIC Australia 3084

FRACP, MBBS

6105 - Shane White, FRACP, MD, MBBS

6107 - Chee Lee, FRACP, PhD, MBBS

Sianna Panagiotopoulos Manager, Office for Research

6102 - Brett Hughes, FRACP, MBBS

6104 - Phillip Parente, FRACP, MBBS

6105 - Shane White, FRACP, MD, MBBS

6107 - Chee Lee, FRACP, PhD, MBBS


26/NOV/2012


04/APR/2013


31/MAR/2014


16/SEP/2016

Sir Charles Gairdner Group HREC Level 2 A Block, Hospital Ave, Nedlands, WA 6009

Jenny Westgarth- Taylor Delegate of the Chair

6106 - Michael Millward, FRACP, MBBS


23/FEB/2012


28/FEB/2013


30/APR/2013


13/MAR/2014

Sean Howarth Delegate of the Chair

6106 - Michael Millward, FRACP, MBBS


01/SEP/2015

Great Britain






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 9SY

Fiona Bain

4401 – Dr. Marianne Nicolson

4402 – Dr. Jason Lester

4404 – Prof. Allan Price

4405 – Dr. Gary Middleton Dr. Muthuveni Ezhil

4406 – Dr. Qamar Ghafoor


20/MAR/2012

Substantial Amendment 1

20/AUG/2012


17/OCT/2012


05/DEC/2012


30/APR/2013


04/OCT/2013


16/DEC/2013


07/APR/2013


17/OCT/2014


10/NOV/2015

Ireland






Clinical Research Ethics Committee of the Cork Teaching Hospitals Lancaster Hall 6 Little Hanover Street Cork

Dr. Michael O’Reilly

3531 – Dr. Sinéad Cuffe

3531 – Dr. Ken O’Byrne

3532 – Dr.Oscar Breathnach


07/DEC/2011

Non Substantial Amendment 1

22/AUG/2012


03/OCT/2012


10/JAN/2013


23/APR/2013


24/APR/2013


30/SEP/13


11/DEC/2013


07/APR/2014


24/SEP/2014


28/OCT/2015

Norway






REK Sør-Øst C Gullhaug torg 4 A, Nydalen, 0484 Oslo

Arvid Heiberg

4701 - Odd Terje Brustugun

4702 - Sveinung Sørhaug


06/FEB/2012




09/NOV/2012




09/APR/2013

REK Sør-Øst C Gullhaug torg 4 A, Nydalen, 0484 Oslo

Britt-Ingjerd Nesheim



Non substantial – not required


Non substantial – not required

IB v.12, 02JAN2012

Not required by EC

IB v.13, 11JUL2012

Not required by EC

Sweden






Regionala etikprövningsnämnden i Lund Box 133 221 00 LUND

Jan Rosenquist

4601 Ronny Öhman 4602 Anders Vikström 4603 Bengt Bergman 4604 Magnus Löfdahl


29/DEC/2011


Gunilla Hedesten Nordin

4601 Ronny Öhman 4602 Anders Vikström 4603 Bengt Bergman 4604 Magnus Löfdahl


22/NOV/2012


Jan Rosenquist

4601 Ronny Öhman 4602 Anders Vikström 4603 Bengt Bergman 4604 Karl Kölbeck


20/MAR/2013

Documents

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