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.

2

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.

3

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

5

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

6

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

7

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

8

1148 Prof. Aivars Lejnieks

1149 Dr. Lelda Dimdina

9

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

10

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

11

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

12

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

13