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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
Amendment 1 Global Amendment 2 Global
25/SEP/2009 23/JUL/2010
N/A – Site was already closed
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 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
Amendment 1 Global Amendment 2 Global
Protocol
Amendment 1 Global Amendment 2 Global
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
Amendment 1 Global Amendment 2 Global
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
Amendment 1 Global Amendment 2 Global
14/DEC/2009 19/AUG/2010
N/A – Sites were already closed
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 Docencia e Investigación de ISIS Centro Especializado . (S3000FFU) Urquiza 3077 - Santa Fé
Dr. Samuel Seireff NAP
2109 / Blajman
Protocol
Amendment 1 Global Amendment 2 Global
27/OCT/2009 22/JUN/2010
N/A – Sites were already closed
“Comité de Docencia e Investigación” Oroño 1085 – Rosario – Santa Fé – S2000DKS
Dr. Daniel Sarcuno
2110 / Fein
Protocol
Amendment 1 Global Amendment 2 Global
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
Amendment 1 Global Amendment 2 Global
08/JUN/2010 22/SEP/2010
N/A – Sites were already closed
“Comité de Docencia e Investigación” French 2673- CABA – C1425AWC
Dra. Graciela Barreiro
Prof. Dra. Clelia Magaril
2112 / Carraro
Protocol
Amendment 1 Global Amendment 2 Global
04/MAR/2010 08/JUL/2010 01/NOV/2011
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)
CECIC – Comité de Ética de CER Investigaciones Clinicas Vicente López 1441 (B1878DVB) Quilmes – Buenos Aires
Dr. Damián Del Percio NAP
2114 / Varela
Protocol
Amendment 1 Global Amendment 2 Global
23/APR/2010 11/AUG/2010
N/A – Sites were already closed
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
Amendment 1 Global Amendment 2 Global
27/MAY/2010 24/AUG/2010 26/JAN/2012
Australia
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)
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
Amendment 1 Global Amendment 2 Global
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
Amendment 1 Global Amendment 2 Global
17/SEP/2009 09/AUG/2010 08/AUG/2011
Australia
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)
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
Amendment 1 Global Amendment 2 Global
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
Amendment 1 Global Amendment 2 Global
04/MAR/2010
25/OCT/2010
N/A (no active patients)
Australia
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)
Hunter New England Human Research Ethics Committee Calvary Mater New Castle Edith Street Waratah, NSW, 2298 Australia
Dr Nicole Gerrand
2705 / Abell
Protocol
Amendment 1 Global Amendment 2 Global
21/DEC/2009
04/JUN/2010
N/A (no active patients)
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
Amendment 1 Global Amendment 2 Global
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
Amendment 1 Global Amendment 2 Global
13/OCT/2009 03/AUG/2010 18/OCT/2011
Australia
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)
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
Amendment 1 Global Amendment 2 Global
09/OCT/2009
13/OCT/2010
N/A (no active patients)
Sydney South West Area Health Service
Lesley Townsend
2711 / Boyer
Protocol
Amendment 1 Global Amendment 2 Global
17/DEC/2009 05/AUG/2010 23/SEP/2011
Austria
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)
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
Amendment 1 Global Amendment 2 Global
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
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)
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
Approval of Leading Ethics Committee takes effect.
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
Approval of Leading Ethics Committee takes effect.
Belgium
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)
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
Amendment 1 Global Amendment 2 Global
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
Approval of Leading Ethics Committee takes effect.
Comité d’Ethique de l’hôpital Universitaire Saint-Pierre Rue Haute, 322 1000 Bruxelles
Professor P. HERMANS
4103 / Ninane
Approval of Leading Ethics Committee takes effect.
Belgium
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 d'Ethique Clinique Ste Elisabeth Namur Place Louise Godin 15 B-5000 Namur
Doctor I. MATHIEU
4104 / Vuylsteke
Approval of Leading Ethics Committee takes effect.
Ethisch Comité Universitair Ziekenhuis De Pintelaan, 185 9000 GENT
Professor Dr. R. RUBENS
4105 / Surmont
Approval of Leading Ethics Committee takes effect.
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
Approval of Leading Ethics Committee takes effect.
Brazil
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)
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
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)
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
Amendment 1 Global Amendment 2 Global
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
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)
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
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)
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
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)
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
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)
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
Amendment 1 Global Amendment 2 Global
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
IRB or IEC Chairperson
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
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)
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
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)
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
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)
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
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)
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
Approval of Leading Ethics Committee takes effect.
Ethikkommission der Bayrischen Landesärztekammer Mühlbaurstrasse 16 81677 München
Prof. Dr. Joerg Hasford
4303 / von Pawel
Approval of Leading Ethics Committee takes effect.
Germany
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)
Ethikkommission des Landes Berlin Landesamt fir Gesundheit und Soziales Sächsische Str. 28 10707 Berlin
Franz Allert
4304 / Keilholz
Approval of Leading Ethics Committee takes effect.
Ethikkommission der Medizinischen Fakultät der Universität Duisburg-Essen Universitätsklinikum Essen Robert-Koch-Straße 9-11 45147 Essen
Prof. Dr. med. Werner Havers
4305 / Schuler
Approval of Leading Ethics Committee takes effect.
Ethikkommission der Medizinischen Hochschule Hannover Carl-Neuberg-Straße 1 30625 Hannover
Prof. Dr. Hans-Dieter Tröger
4306 / Dickgreber
Approval of Leading Ethics Committee takes effect.
Germany
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)
Medizinische Ethikkommission II Fakultät für klinische Medizin Mannheim Maybachstrasse 14 – 16 68169 Mannheim
Prof. Dr. med. Jens P. Striebel
4307 / Manegold
Approval of Leading Ethics Committee takes effect.
Ethik-Kommission der Medizinischen Fakultät der Goerg-August- Universität Göttingen Robert-Koch-Strasse 40 3075 Göttingen
Prof. Dr. med. Jürgen Brockmöller
4308 / Griesinger
Approval of Leading Ethics Committee takes effect.
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
Approval of Leading Ethics Committee takes effect.
Germany
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)
Ethikkommission bei der Landesärztekammer Rheinland-Pfalz Deutschhausplatz 3 55131 Mainz
Prof. Dr. Stephan Letzel
4310 / Wehler
Approval of Leading Ethics Committee takes effect.
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
Approval of Leading Ethics Committee takes effect.
Ethikkommission der Medizinischen Fakultät Heidelberg Amalienstraße 5 69126 Heidelberg
Prof. Dr. Med. Thomas Strowitzki
4312 / Thomas
Approval of Leading Ethics Committee takes effect.
Hong Kong
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)
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
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)
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
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)
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
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)
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
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)
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
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol and/or Amendment number(s)
Date of Final Approval (DD/MMM/YYYY)
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
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol and/or Amendment number(s)
Date of Final Approval (DD/MMM/YYYY)
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
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol 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, 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
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol 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, 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
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol 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, 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
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol 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, 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 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)
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 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)
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 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)
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
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)
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
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)
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
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)
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
IRB or IEC Chairperson
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
Table S7 Details of approving ethics committees and all participating principal investigators for the LUX-Lung 6 trial
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.
Table S8 Details of approving ethics committees and all participating principal investigators for the LUX-Lung 7 trial
France
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre number / Investigator
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
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
Amendment 2 (dated 11 Sep 2012)
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
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre number / Investigator
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
Samsung Medical Center Institutional Review Board /(06351), 81 Irwon-ro, Gangnam-gu, Seoul, Korea
Lee, Suk-Koo
8201
Park, Keunchil
Amendment 1 (dated 29 Sep 2011)
23/JAN/2012
Amendment 2 (dated 11 Sep 2012)
08/NOV/2012
Amendment 3 (dated 6 Mar 2013)
15/MAY/2013
Local Amendment to implement PK substudy (dated 26 Sep 2013)
01/DEC/2013
Amendment 4 (dated 16 Dec 2013)
07/MAR/2014
Amendment 5 (dated 29 Jul 2015)
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
Amendment 1 (dated 29 Sep 2011)
09/NOV/2011
Amendment 2 (dated 11 Sep 2012)
11/NOV/2012
Amendment 3 (dated 6 Mar 2013)
03/MAY/2013
Local Amendment to implement PK substudy (dated 26 Sep 2013)
N/A
Amendment 4 (dated 16 Dec 2013)
18/MAR/2014
Amendment 5 (dated 29 Jul 2015)
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
Amendment 1 (dated 29 Sep 2011)
09/NOV/2011
Amendment 2 (dated 11 Sep 2012)
14/NOV/2012
Amendment 3 (dated 6 Mar 2013)
02/MAY/2013
Local Amendment to implement PK substudy (dated 26 Sep 2013)
03/DEC/2013
Amendment 4 (dated 16 Dec 2013)
11/MAR/2014
Amendment 5 (dated 29 Jul 2015)
22/SEP/2015
Gachon University Gil Medical Center Institutional Review
Jong-Hoon Kim
8204
Cho, EunKyung
Amendment 1 (dated 29 Sep 2011)
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)
Amendment 3 (dated 6 Mar 2013)
07/MAY/2013
Local Amendment to implement PK substudy (dated 26 Sep 2013)
N/A
Amendment 4 (dated 16 Dec 2013)
18/MAR/2014
Amendment 5 (dated 29 Jul 2015)
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
Amendment 1 (dated 29 Sep 2011)
14/NOV/2011
Amendment 2 (dated 11 Sep 2012)
09/NOV/2012
Amendment 3 (dated 6 Mar 2013)
26/APR/2013
Local Amendment to implement PK substudy (dated 26 Sep 2013)
28/NOV/2013
Amendment 4 (dated 16 Dec 2013)
13/MAR/2014
Amendment 5 (dated 29 Jul 2015)
24/SEP/2015
Severance Hospital, Institutional Review Board /50 -1, Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea
Seung Min Kim
8206
Cho, Byoung Chul
Amendment 1 (dated 29 Sep 2011)
N/A
Amendment 2 (dated 11 Sep 2012)
10/AUG/2012
Amendment 3 (dated 6 Mar 2013)
10/MAY2013
Local Amendment to implement PK substudy (dated 26 Sep 2013)
N/A
Amendment 4 (dated 16 Dec 2013)
08/MAR/2014
Amendment 5 (dated 29 Jul 2015)
16/SEP/2015
Canada
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre number / Investigator
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
McGill Faculty of Medicine 3655 Promenade Sir William Osler # 633 Montreal, QC H3G 1Y6
Harvey Sigman, MD Chair – Committee B
1001/Vera Hirsh
Amendment 1 (dated 29 Sep 2011)
20/FEB/2012
Amendment 2 (dated 11 Sep 2012)
26/NOV/2012
Amendment 3 (dated 6 Mar 2013)
27/MAY/2013
Amendment 4 (dated 16 Dec 2013)
24/FEB/2014
Amendment 5 (dated 29 Jul 2015)
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
Amendment 1 (dated 29 Sep 2011)
02/MAR/2012
Amendment 2 (dated 11 Sep 2012)
30/NOV/2012
Amendment 3 (dated 6 Mar 2013)
19/AUG/2013
Amendment 4 (dated 16
03/APR/2014
Dec 2013)
Amendment 5 (dated 29 Jul 2015)
23/SEP/2015
Ottawa Health Science Network Research Ethics Board 725 Parkdale Avenue Ottawa, ON K1Y 4E9
Raphael Saginur, MD
1003/Scott Laurie
Amendment 1 (dated 29 Sep 2011)
19/APR/2012
Amendment 2 (dated 11 Sep 2012)
25/JAN/2013
Amendment 3 (dated 6 Mar 2013)
30/MAY/2013
Amendment 4 (dated 16 Dec 2013)
05/MAR/2014
Amendment 5 (dated 29 Jul 2015)
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
Amendment 1 (dated 29 Sep 2011)
02/MAR/2012
Amendment 2 (dated 11 Sep 2012)
30/NOV/2012
Amendment 3 (dated 6 Mar 2013)
19/AUG/2013
Amendment 4 (dated 16 Dec 2013)
03/APR/2014
Amendment 5 (dated 29 Jul 2015)
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
Amendment 1 (dated 29 Sep 2011)
06/MAR/2012
Amendment 2 (dated 11 Sep 2012)
19/NOV/2012
Amendment 3 (dated 6 Mar 2013)
10/MAY/2013
Amendment 4 (dated 16 Dec 2013)
24/FEB/2014
Amendment 5 (dated 29 Jul 2015)
25/SEP/2015
Local Amendment to implement PK substudy (dated 26 Sep 2013)
10/DEC/2013
Lakeridge Health 1 Hospital Court Oshawa, ON L1G 2B9
John Montgomery, LLB (Bachelor of Law)
1006/Rafael Wierzbicki
Amendment 1 (dated 29 Sep 2011)
05/DEC/2011
Amendment 2 (dated 11 Sep 2012)
03/DEC/2012
Amendment 3 (dated 6 Mar 2013)
06/MAY/2013
Amendment 4 (dated 16 Dec 2013)
03/MAR/2014
Amendment 5 (dated 29 Jul 2015)
05/OCT/2015
Local Amendment to implement PK substudy (dated 26 Sep 2013)
McGill Faculty of Medicine 3655 Promenade Sir William Osler # 633 Montreal, QC H3G 1Y6
Harvey Sigman, MD Chair – Committee B
1007/Vera Hirsh
Amendment 1 (dated 29 Sep 2011)
20/FEB/2012
Amendment 2 (dated 11 Sep 2012)
26/NOV/2012
Amendment 3 (dated 6 Mar 2013)
27/MAY/2013
Amendment 4 (dated 16 Dec 2013)
24/FEB/2014
Amendment 5 (dated 29 Jul 2015)
26/OCT/2015
China
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre number / Investigator
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
EC of Sun Yat-Sen
Peng, Wangqing
8601/Zhang, Li
Amendment 1 (dated 29 Sep 2011)
13/JUN/2012
Amendment 2 (dated 11 Sep 2012)
10/DEC/2012
Amendment 3 (dated 6 Mar 2013)
20/JUN/2013
Amendment 4 (dated 16 Dec 2013)
15/APR/2014
Amendment 5 (dated 29 Jul 2015)
04/NOV/2015
Local Amendment to implement PK substudy (dated 26 Sep 2013)
09/OCT/2014
EC of Shanghai Chest Hospital
Zheng, Ning
8602/Lu,Shun
Amendment 1 (dated 29 Sep 2011)
06/JUN/2012
Amendment 2 (dated 11 Sep 2012)
27/NOV/2012
Amendment 3 (dated 6 Mar 2013)
09/JUL/2013
Amendment 4 (dated 16
23/APR/2014
Dec 2013)
Amendment 5 (dated 29 Jul 2015)
10/NOV/2015
Local Amendment to implement PK substudy (dated 26 Sep 2013)
11/MAR/2014
EC of The First Hospital of China Medical University
Xiaosong YU Jian KANG
8603/Yupeng LIU
Amendment 1 (dated 29 Sep 2011)
12/JUN/2012
Amendment 2 (dated 11 Sep 2012)
29/JAN/2013
Amendment 3 (dated 6 Mar 2013)
22/OCT/2013
Amendment 4 (dated 16 Dec 2013)
23/JUL/2014
Amendment 5 (dated 29 Jul 2015)
30/SEP/2015
EC of Zhongshan Hospital Fudan University
Wang, Yuqi
8604/Bai, Chunxue
Amendment 1 (dated 29 Sep 2011)
20/JUN/2012
Amendment 2 (dated 11 Sep 2012)
31/DEC/2012
Amendment 3 (dated 6 Mar 2013)
24/JUN/2013
Amendment 4 (dated 16
17/APR/2014
Dec 2013)
Amendment 5 (dated 29 Jul 2015)
Not obtained yet
EC of Shanghai Chest Hospital
Zheng, Ning
8605/ Han, Baohui
Amendment 1 (dated 29 Sep 2011)
06/JUN/2012
Amendment 2 (dated 11 Sep 2012)
27/NOV/2012
Amendment 3 (dated 6 Mar 2013)
09/JUL/2013
Amendment 4 (dated 16 Dec 2013)
23/APR/2014
Amendment 5 (dated 29 Jul 2015)
Not obtained yet
EC of Beijing Cancer Hospital
Jie LI
8606/Tongtong AN
Amendment 1 (dated 29 Sep 2011)
15/MAY/2012
Amendment 2 (dated 11 Sep 2012)
15/JAN/2013
Amendment 3 (dated 6 Mar 2013)
18/JUN/2013
Amendment 4 (dated 16 Dec 2013)
17/JUN/2014
Amendment 5 (dated 29 Jul 2015)
26/DEC/2015
EC of The Affiliated Cancer Hospital, Guangxi Medical University
Lin, Yuan
8607/Song, Xiangqun
Amendment 1 (dated 29 Sep 2011)
25/JUN/2012
Amendment 2 (dated 11 Sep 2012)
07/MAR/2013
Amendment 3 (dated 6 Mar 2013)
10/OCT/2013
Amendment 4 (dated 16 Dec 2013)
14/MAR/2014
Amendment 5 (dated 29 Jul 2015)
24/SEP/2015
EC of Cancer Hospital of Chinese Academy of Medical Sciences
Datong CHU
8608/Yuankai SHI
Amendment 1 (dated 29 Sep 2011)
6/JUN/2012
Amendment 2 (dated 11 Sep 2012)
25/MAR/2013
Amendment 3 (dated 6 Mar 2013)
6/JUN/2013
Amendment 4 (dated 16 Dec 2013)
5/MAY/2014
Amendment 5 (dated 29 Jul 2015)
30/SEP/2015
Local Amendment to implement PK substudy (dated 26 Sep 2013)
21/AUG/2014
Germany
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigator
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
Leading ethics committee for Germany: Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen Robert-Koch-Straße 9-11 45147 Essen
Prof. Dr. med. Werner Havers
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.
Amendment 1 (dated 29 Sep 2011)
11/JAN/2012
Amendment 2 (dated 11 Sep 2012)
06/NOV/2012
Amendment 3 (dated 6 Mar 2013)
23/APR/2013
Amendment 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 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
Prof. Dr. med. Werner Havers
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
Approval of leading ethic committee takes effect.
Ethikkommission bei der Landesärztekammer Baden- Württemberg Jahnstraße 40 70597 Stuttgart
Prof. Dr. med. Gerlinde Egerer
4905 Dr. Martin Faehling
Approval of leading ethic committee takes effect.
Spain
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
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
Amendment 1 (dated 29 Sep 2011)
13/DEC/2011
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
Amendment 2 (dated 11 Sep 2012)
06/NOV/2012
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
Amendment 3 (dated 6 Mar 2013)
28/MAY/2013
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
Local Amendment to implement PK substudy (dated 26 Sep 2013)
29/NOV/2013
Comité Ético Investigación Clínica Hospital 12 de Octubre/Av de Córdoba s/n 28041 Madrid(Reference Ethical Committee)
Maria Ugalde Díez
3404 / Dr. Cobo
Local Amendment to implement PK substudy (dated 26 Sep 2013)
28/JAN/2014
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
Amendment 4 (dated 16 Dec 2013)
25/FEB/2014
Comité Ético Investigación Clínica Hospital 12 de Octubre
Maria Ugalde Díez
3401 / Dr. Corral 3402/ Dr. Ponce3403 / Dr. López Brea
Amendment 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 Kong
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigator
Protocol and/or Amendment number
Date 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, HK
Benny C. Y. Zee
8521 / Mok, Shu Kam Tony
Amendment 1 (dated 29 Sep 2011)
06/JUN/2012
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
Amendment 2 (dated 11 Sep 2012)
06/FEB/2013
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
Amendment 3 (dated 6 Mar 2013)
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
8521 / Mok, Shu Kam Tony
Amendment 4 (dated 16 Dec 2013)
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
8521 / Mok, Shu Kam Tony
Amendment 5 (dated 29 Jul 2015)
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
Amendment 1 (dated 29 Sep 2011)
06/JUN/2012
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
Amendment 2 (dated 11 Sep 2012)
17/DEC/2012
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
Amendment 3 (dated 6 Mar 2013)
07/JUN/2013
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
Amendment 4 (dated 16 Dec 2013)
20/MAR/2013
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
Amendment 5 (dated 29 Jul 2015)
12/OCT/2015
Singapore
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
Domain Specific Review Board (DSRB) Nexus @One-North (South Tower), No. 3 Fusionopolis Link, #03-08, Singapore 138543
A/Prof Chng Wee Joo
6502
Protocol (dated 30 Aug 2011)
Amendment 1 (dated 29 Sep 2011)
27/JAN/2012
Amendment 2 (dated 11 Sep 2012)
17/DEC/2012
Amendment 3 (dated 6 Mar 2013)
19/APR/2013
Amendment 4 (dated 16 Dec 2013)
27/JAN/2014
Amendment 5 (dated 29 Jul 2015)
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
Protocol (dated 30 Aug 2011)
Amendment 1 (dated 29 Sep 2011)
10/NOV/2011
Amendment 2 (dated 11 Sep 2012)
27/DEC/2012
Amendment 3 (dated 6 Mar 2013)
16/APR/2013
Amendment 4 (dated 16 Dec 2013)
23/NOV/2013
Amendment 5 (dated 29 Jul 2015)
15/SEP/2015
Taiwan
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigator
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
Research Ethics Committee A National Taiwan Hospital
Hong-Nerng Ho Fu-Chang Tsai
8861 8861 8861 8861 8861
Amendment 1 (dated 29 Sep 2011)
15/FEB/2012
Amendment 2 (dated 11 Sep 2012)
14/NOV/2012
Amendment 3 (dated 6 Mar 2013)
21/JUN/2013
Amendment 4 (dated 16 Dec 2013)
17/MAR/2014
Amendment 5 (dated 29 Jul 2015)
23/OCT/2015
Institutional Review Board Taipei Veterans General Hospital
Tung-Ping Su Shung-Tai Ho Fa-Yauh Lee
8862
Amendment 1 (dated 29 Sep 2011)
13/FEB/2012
Amendment 2 (dated 11 Sep 2012)
01/DEC/2012
Amendment 3 (dated 6 Mar 2013)
07/JUN/2013
Amendment 4 (dated 16 Dec 2013)
07/APR/2014
Amendment 5 (dated 29 Jul 2015)
22/OCT/2015
Institutional Review Board B Chang Gung Medical Foundation
Tsang-Tang Hsieh
8863
Amendment 1 (dated 29 Sep 2011)
09/APR/2012
Amendment 2 (dated 11 Sep 2012)
19/DEC/2012
Amendment 3 (dated 6 Mar 2013)
15/JUL/2013
Amendment 4 (dated 16 Dec 2013)
28/MAY/2014
Amendment 5 (dated 29 Jul 2015)
12/NOV/2015
Institutional Review Board of Taichung Veterans General Hospital
Jeng-Yuan Hsu
8864
Amendment 1 (dated 29 Sep 2011)
08/MAR/2012
Amendment 2 (dated 11 Sep 2012)
08/NOV/2012
Amendment 3 (dated 6 Mar 2013)
06/MAY/2013
Amendment 4 (dated 16 Dec 2013)
19/MAR/2014
Amendment 5 (dated 29 Jul 2015)
15/OCT/2015
Institutional Review Board National Cheng Kung University Hospital
Chyun-Yu Yang
Thy-Sheng Lin, Vice Chairman
8866
Amendment 1 (dated 29 Sep 2011)
06/JAN/2012
Amendment 2 (dated 11
06/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/2013
Amendment 4 (dated 16 Dec 2013)
24/MAR/2014
Amendment 5 (dated 29 Jul 2015)
19/OCT/2015
Australia
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
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
Amendment 1 (dated 29 Sep 2011)
09/MAR/2012
Amendment 2 (dated 11 Sep 2012)
19/DEC/2012
Amendment 3 (dated 6 Mar 2013)
19/JUL/2013
Amendment 4 (dated 16 Dec 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
Amendment 5 (dated 29 Jul 2015)
25/SEP/2015
Bellberry HREC 229 Greenhill Road Dulwich SA 5065
Michael James Chair
6103 - Paul Mainwaring, FRACP, MD, MBBS
Amendment 1 (dated 29 Sep 2011)
22/NOV/2011
Austin Health HREC Austin Hospital
Jill Davis Research Ethics Unit Manager
6102 - Brett Hughes, FRACP, MBBS
6104 - Phillip Parente,
Amendment 1 (dated 29 Sep 2011)
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
Amendment 2 (dated 11 Sep 2012)
26/NOV/2012
Amendment 3 (dated 6 Mar 2013)
04/APR/2013
Amendment 4 (dated 16 Dec 2013)
31/MAR/2014
Amendment 5 (dated 29 Jul 2016)
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
Amendment 1 (dated 29 Sep 2011)
23/FEB/2012
Amendment 2 (dated 11 Sep 2012)
28/FEB/2013
Amendment 3 (dated 6 Mar 2013)
30/APR/2013
Amendment 4 (dated 16 Dec 2013)
13/MAR/2014
Sean Howarth Delegate of the Chair
6106 - Michael Millward, FRACP, MBBS
Amendment 5 (dated 29 Jul 2015)
01/SEP/2015
Great Britain
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol and/or Amendment numbers
Date 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 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
Amendment 1 (dated 29 Sep 2011)
20/MAR/2012
Substantial Amendment 1
20/AUG/2012
Amendment 2 (dated 11 Sep 2012)
17/OCT/2012
Substantial Amendment 3
05/DEC/2012
Amendment 3 (dated 6 Mar 2013)
30/APR/2013
Substantial Amendment 5
04/OCT/2013
Substantial Amendment 6
16/DEC/2013
Amendment 4 (dated 16 Dec 2013)
07/APR/2013
Substantial Amendment 8
17/OCT/2014
Amendment 5 (dated 29 Jul 2015)
10/NOV/2015
Ireland
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigators
Protocol and/or Amendment numbers
Date of Final Approval (DD/MMM/YYYY)
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
Amendment 1 (dated 29 Sep 2011)
07/DEC/2011
Non Substantial Amendment 1
22/AUG/2012
Amendment 2 (dated 11 Sep 2012)
03/OCT/2012
Substantial Amendment 3
10/JAN/2013
Amendment 3 (dated 6 Mar 2013)
23/APR/2013
Substantial Amendment 5
24/APR/2013
Substantial Amendment 6
30/SEP/13
Substantial Amendment 7
11/DEC/2013
Amendment 4 (dated 16 Dec 2013)
07/APR/2014
Substantial Amendment 8
24/SEP/2014
Amendment 5 (dated 29 Jul 2015)
28/OCT/2015
Norway
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre numbers / Investigator
Protocol and/or Amendment number
Date of Final Approval (DD/MMM/YYYY)
REK Sør-Øst C Gullhaug torg 4 A, Nydalen, 0484 Oslo
Arvid Heiberg
4701 - Odd Terje Brustugun
4702 - Sveinung Sørhaug
Amendment 1 (dated 29 Sep 2011)
06/FEB/2012
4701 - Odd Terje Brustugun
4702 - Sveinung Sørhaug
Amendment 2 (dated 11 Sep 2012)
09/NOV/2012
4701 - Odd Terje Brustugun
4702 - Sveinung Sørhaug
Amendment 3 (dated 6 Mar 2013)
09/APR/2013
REK Sør-Øst C Gullhaug torg 4 A, Nydalen, 0484 Oslo
Britt-Ingjerd Nesheim
4701 - Odd Terje Brustugun
Amendment 4 (dated 16 Dec 2013)
Non substantial – not required
Amendment 5 (dated 29 Jul 2015)
Non substantial – not required
IB v.12, 02JAN2012
Not required by EC
IB v.13, 11JUL2012
Not required by EC
Sweden
IRB or IEC (name/address)
IRB or IEC Chairperson
Centre number / Investigator
Protocol and/or Amendment number
Date of Final Approval (DD/MMM/YYYY)
Regionala etikprövningsnämnden i Lund Box 133 221 00 LUND
Jan Rosenquist
4601 Ronny Öhman 4602 Anders Vikström 4603 Bengt Bergman 4604 Magnus Löfdahl
Amendment 1 (dated 29 Sep 2011)
29/DEC/2011
Regionala etikprövningsnämnden i Lund Box 133 221 00 LUND
Gunilla Hedesten Nordin
4601 Ronny Öhman 4602 Anders Vikström 4603 Bengt Bergman 4604 Magnus Löfdahl
Amendment 2 (dated 11 Sep 2012)
22/NOV/2012
Regionala etikprövningsnämnden i Lund Box 133 221 00 LUND
Jan Rosenquist
4601 Ronny Öhman 4602 Anders Vikström 4603 Bengt Bergman 4604 Karl Kölbeck
Amendment 3 (dated 6 Mar 2013)
20/MAR/2013
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