Supplementary webappendixThis webappendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors.
Supplement to: Chan FKL, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet 2010; published online June 17. DOI:10.1016/S0140-6736(10)60673-3.
Appendices
A. Primary endpoint: Adjudication criteria for clinically significant events through the GI tract
With lesion Without lesion
a) GD haemorrhage
• Endoscopic evidence of GD
ulceration or erosion or other likely
causative lesion, and clinical
evidence of recent haemorrhage
b) Gastric outlet obstruction
• Clinical, surgical, endoscopic, or
radiographic evidence with symptoms
consistent with obstruction
c) GD, small bowel, or large bowel perforation
• Clinical, surgical, or radiographic
confirmation associated with
symptoms consistent with perforation
d) Small bowel haemorrhage
• Frank melena or PR blood loss with
likely causative lesion on small bowel
investigation
e) Large bowel haemorrhage
Frank melena or PR blood loss with no
evidence of source on EGD and likely
causative lesion on colonoscopy.
Haemorrhoidal haemorrhage is included
g) Acute GI haemorrhage of unknown origin, including presumed small bowel haemorrhage
• Frank haematemesis, melena, or PR
blood loss, with no evidence of likely
causative lesion on EGD or
colonoscopy (or small bowel
investigation)
h) Clinically significant anaemia of presumed occult GI origin, including possible small bowel blood loss
• No overt clinical evidence of acute GI
haemorrhage but with fall in Hct
≥10% points and/or Hgb of ≥2 g/dL
from baseline, with no evidence of
likely causative lesion on EGD or
colonoscopy (or small bowel
investigation) with:
o no non-GI source of anaemia
identified, and
o in RA patients, disease
activity should be stable
1
if associated with a clinically significant
drop in Hct ≥10% points and/or Hgb of
≥2 g/dL from baseline
f) Clinically significant anaemia of defined GI origin
• No clinical evidence of acute GI
haemorrhage but with fall in Hct
≥10% points and/or Hgb of ≥2 g/dL
from baseline, with likely causative
lesion on colonoscopy or EGD (or
small bowel investigation) with
o no non-GI source of anaemia,
and
o in RA patients, disease
activity should be stable
GD=gastroduodenal; GI=gastrointestinal; PR=post-rectal;
EGD=oesophagogastroduodenoscopy; Hgb=haemoglobin; Hct=haematocrit;
RA=rheumatoid arthritis.
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B. Gastrointestinal and cardiovascular events committee members
Member Affiliation Committee
Jay Goldstein (GEC
Chair)
University of Illinois at Chicago, Chicago, Illinois,
USA
GEC
Francis Chan Chinese University of Hong Kong, Prince of Wales
Hospital, Hong Kong
GEC
Angel Lanas Universidad de Zaragoza, I+CS, CIBERehd.
Zaragoza, Spain
GEC
James Scheiman University of Michigan Medical Center
Ann Arbor, Michigan, USA
GEC
William B. White
(CEC Chair)
University of Connecticut Health Center,
Farmington, Connecticut, USA
CEC
Philip Gorelick University of Illinois at Chicago, Chicago, Illinois,
USA
CEC
Jeffrey Borer Weill Medical College of Cornell University New
York Presbyterian Hospital, New York, New York,
USA
CEC
GEC: gastrointestinal executive committee. CEC: cardiovascular executive committee.
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C. Study investigators
Country Centre Principal investigator Country Centre Principal investigator
Belgium 1177 Prof. Piet P. M. M. Geusens China 1123 Dr. Fengchun Zhang
1225 Prof. Michel Malaise 1124 Dr. ZhanGuo Li
1226 Prof. Guy Vanderstraeten 1127 Dr. Chunde Bao
1229 Dr. Jan L. A. Lenaerts 1128 Dr. HeJian Zou
1364 Dr. Daniel W. Vantroyen 1130 Dr. JieRuo Gu
Brazil 1037 Dr. Cristiano Zerbini 1132 Dr. NanPing Yang
1038 Dr. Flora M. D. Marcolino 1134 Dr. Lu Gong
1039 Dr. Sebastiao C.
Radominski
1135 Dr. LingYun Sun
1041 Dr. Ricardo Machado
Xavier
1138 Dr. WenCheng Qi
1188 Dr. Antonio Carlos Ximenes 1382 Yi Zheng
1192 Dr. Ana Melazzi 1383 Dr. Feng Huang
1193 Dr. Luciana Teixeira Pinto Colombia 1027 Dr. Diego Luis Saaibi
Solano
Canada 1105 Dr. Carter J. Thorne 1028 Dra. Noemi Casas
1180 Dr. Timothy G. McCarthy 1029 Dr. Edgardo David
Tobias
1211 Dr. Louis Bessette 1032 Dr. Philippe Chalem
1213 Dr. Patrick Liang 1033 Dr. Ruben Hernandez
1214 Dr. Majed Khraishi 1034 Mauricio Abello
1219 Dr. Michael R. Starr 1036 Jose Fernando Molina
4
1307 Dr. Jude F. Rodrigues 1221 Dr. Juan J. Jaller Raad
1314 Dr. William G. Bensen Costa Rica 1011 Dr. Jorge Cortes
1012 Dr. Pablo Monge-
Zeledon
1013 Dr. Javier Cespedes-
Vargas
1014 Dr. Ricardo Saenz
1249 Dr. Raul Alpizar
Croatia 1316 Simeon Grazio
1317 Tatjana Kehler
1318 Prof. Jadranka Vergles
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Country Centre Principal investigator Country Centre Principal investigator
Czech
Republic
1001 Dr. Sevda Augustinova Lithuania 1053 Dr. Egle Zebiene
1002 Dr. Tomas Vanasek 1055 Dr. Gintautas
Gumbrevicius
1003 Dr. Vit Smajstrla 1058 Dr. Ruta Radzeviciene
1004 Prof. Jiri Vencovsky 1059 Dr. Arturas Kiziela
1005 Dr. Filip Zavada 1293 Dr. Gediminas Urbonas
1010 Dr. Hana Brabcova Netherlands1176 Dr. A. H. Gerards
1263 Dr. Marie Sedlackova 1250 Dr. Jan D. Moolenburgh
1268 Dr. Ludmila Sustova 1315 Dr. W. M. de Beus
Ecuador 1200 Dr. Ivan Manuel Moreno Panama 1021 Dr. Generoso Guerra-
Bautista
1201 Dr. Claudio Miguel Galarza Peru 1007 Dr. Manuel Gustavo
Leon
1202 Luis A. Zurita 1008 Dr. Risto Perich
1203 Dr. Mario Javier Moreno 1024 Dr. Luis Rasec Morales
1204 Dr. Romulo Abad Villacis 1025 Dr. Rita Kuroiwa
Estonia 1311 Dr. Eve Kai Raussi 1230 Dr. Armando Augusto
Calvo
1312 Dr. Andres Pille Portugal 1167 Dr. Guilherme
Figueiredo
1333 Dr. Kristi Lupkina 1170 Dr. Rui André
France 1157 Prof. Marc Bardou 1171 Prof. Mário Viana
Queiroz
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1189 Prof. Patrice Fardellone 1172 Dr. Sérgio Alcino
Germany 1065 Dr. med. Andreas Kapelle 1173 Dr. Augusto Faustino
1066 Dr. med. Thomas Jung Russia 1269 Dr. Eugeny Nasonov
1067 Prof. Dr. Herbert Kellner 1270 Dr. Prof. Grigory
Aroutyunov
1068 Dr. med. Andreas Wagenitz 1271 Eduard G. Pichlak
1234 Dr. med. Rolf Jacob 1272 Lubov N. Matkevich
1235 Dr. med. Georg P. Dahmen 1273 Tatyana V. Korolyova
1236 Dr. Christiane Klein 1274 Vadim I. Mazurov
1237 Dr. med. Ernest Schell 1277 Alexandr V. Orlov-
Morozov
1238 Ulrich Schramm 1370 Prof. Olga G.
Smolenskaya
1365 Reiner Lehmann 1373 Dr. Lyudmila P. Egorova
1366 Rene Martz 1374 Prof. Svetlana
Malichenko
Greece 1198 Prof. Loukas Settas 1378 Dr. Irina Marusenko
Guatemala 1015 Dr Abraham Garcia-
Kutzbach
1379 Natalia Petrochenkova
1016 Dr. Eduardo Samayoa-
Grajeda
1017 Dr. Erick J. Rosal-Palomo
1018 Dr. Henry E. Briones-
Alvarado
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Serbia 1336 Prof. Dr. Branislav Bobic Singapore 1120 Prof. Kwong Ming Fock
1337 Prof. Dr. Aleksandar Dimic 1121 Dr. Heng Boon Yim
1338 Prof. Dr. Nemanja
Damjanov
1122 A/Prof. Khek Ho
1019 Dra. Mayra Cifuentes-
Alvarado
South
Africa
1179 Herbert R. Schneider
1020 Dr. Ruddy Rivera-Lara 1181 Dr. N. Aboo
Hong
Kong
1106 Prof. Francis K. L. Chan 1183 Christoffel J. Van
Rensburg
1107 Hon. Yuen 1185 Dr. Catherine Spargo
India 1354 Dr. Sarvajeet Pal 1275 Prof. Asgar A. Kalla
1355 Dr. Sandeep Puri 1302 Dr. Barend van
Rensburg
1356 Naresh Shetty 1367 Dr. Kathleen Coetzee
1358 Dr. Rajagopalan Iyer
Narayana
1368 Dr. Soraya Cassimjee
1362 Dr. Chandrashekara
Srikantiah
1369 Dr. Faruq K. Khatib
Korea 1339 Prof. Myung-Chul Lee
1340 Prof. Seong-Il Bin
1341 Prof. Jung-Man Kim
1342 Prof. Young-Wan Moon
1343 Choong-Hyeok Choi
Latvia 1147 Dr. Daina Andersone
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Country Centre Principal investigator Country Centre Principal investigator
Spain 1075 Emilio Martin Mola UK 1253 Dr. Emmanuel George
1084 Luis Rodrigo 1258 Dr. Nell Victoria Wyatt
1086 Manuel Moreto 1260 Dr. Rory C F Symons
1089 Angel Ferrandez 1262 Dr. Jaykumar Purohit
1093 Jose Mª Pique Badia 1264 Dr. Ian Stephen Farmer
1094 Juan Mones 1265 Dr. Mark David Blagden
1097 Xavier Calvet 1266 Dr. Jennifer Ann
Litchfield
1163 Jose M. Hernandez 1267 Dr. Alison J. Graham
1347 Luís De Teresa 1278 Dr. Lawrence Martin
Adler
1363 Santiago Palacios 1279 Dr. Rory Alan Reed
Sweden 1108 Dr. Carl-Peter Anderberg 1281 Dr. Simon Keith Holgate
1114 Yelverton Tegner 1282 Dr. Philip Marazzi
1209 Jan Ericson 1283 Dr. Thomas Gray
Maxwell
Taiwan 1140 Dr. Joung-liang Lan 1284 Dr. Juan Ochoa
1141 Dr. Kuang-Hui Yu 1285 Dr. Kevin Stanton-King
1142 Dr. Chun-Kai Chiu 1286 Dr Amrit P S Takhar
Ukraine 1288 Olena Levchenko 1287 Dr. Anthony T.S. Wright
1289 Prof. Olga M. Girina 1290 Dr. Raffi Assadourian
1294 Andriy Petrov 1291 Dr. Angus Carnegy
1295 Susanna A. Tykhonova 1292 Dr. Julian Thompson
1296 Sergiy Kolomyyts 1301 Dr. Mark Alan Pugsley
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1306 Andriy Bazylevych 1353 Dr. Fiona Kingston
1319 Volodymyr M. Kovalenko 1371 Dr. Brian D. Calder
1320 Prof. Oleksandr I. Dyadyk 1372 David Hay
1321 Prof. Vadym Vizir
1322 Prof. Georgiy V. Dzyak
1324 Lyudmyla G. Kononenko
1325 Vira Iosypivna Tseluyko
1326 Prof. Grygoriy A. Ignatenko
1328 Dr. Oleksiy Korzh
1329 Mr. Mykhaylo Vlasenko
1330 Anatoliy S. Svyntsytskiy
1331 Dr. Roman Yatsyshyn
1332 Dr. Andriy Yagensky
1334 Dr. Olga O. Voloshyna
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D. Data safety monitoring committee
Member Affiliation
Loren Laine (Chair) University of Southern California School of
Medicine, Los Angeles, California, USA
Claire Bombardier Toronto General Hospital, Toronto, Canada
Charles Hennekens University of Miami Miller School of Medicine,
Boca Raton, Florida, USA
Dave DeMets University of Wisconsin, Madison, Wisconsin,
USA
Colin Baigent Clinical Trial Service Unit, Oxford, UK
Wen-Hua Hsieh Harvard Clinical Research Institute, Inc. Boston,
Massachusetts, USA
Songtao Jiang Harvard Clinical Research Institute, Inc. Boston,
Massachusetts, USA
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E. Steering committee.
Member Affiliation
Francis Chan (Steering Chair) Chinese University of Hong Kong, Prince of Wales
Hospital, Hong Kong
David Peura (Executive
Chair)
University of Virginia Health System, Earlysville,
Virginia, USA
Charles Melbern Wilcox Birmingham, Alabama, USA
Manuela Berger Pfizer Inc., New York, NY
Jay Goldstein University of Illinois at Chicago, Chicago, Illinois, USA
Angel Lanas Universidad de Zaragoza, I+CS, CIBERehd,
Zaragoza, Spain
James Scheiman University of Michigan Medical Center
Ann Arbor, Michigan, USA
Cristiano Zerbini
Hospital Heliopolis, São Paulo, Brazil
Marc Bardou Laboratory of Cardiovascular Physiopathology and
Pharmacology, Dijon Cedex, France
Ingvar Bjarnason St Thomas' School of Medicine, London, UK
Herbert Kellner Ludwig-Maximilians University, Munich, Germany
Kwong-Ming Fock Changi General Hospital, Singapore
Herbert Rodney Schneider Milpark Hospital, Johannesburg, South Africa
Martin. A.F.J. van de Laar University of Twente, Enschede, The Netherlands
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