Breaking Wave Off Kanagawa. Katsushika Hokusai 1831 (25.4 x 37.1 cm) colour woodblock print from Hokusai's series Thirty-six Views of Fuji, which are the high point of Japanese prints. The original is at the Hakone Museum in Japan. Edoxaban for the Treatment of Acute Symptomatic Venous Thromboembolism the HOKUSAI-VTE study On behalf of the HOKUSAI -VTE Investigators
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Edoxaban for the Treatment of Acute Symptomatic Venous Thromboembolism the HOKUSAI-VTE study
Edoxaban for the Treatment of Acute Symptomatic Venous Thromboembolism the HOKUSAI-VTE study. On behalf of the HOKUSAI -VTE Investigators. - PowerPoint PPT Presentation
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Breaking Wave Off Kanagawa. Katsushika Hokusai 1831 (25.4 x 37.1 cm) colour woodblock print from Hokusai's series Thirty-six Views of Fuji, which are the high point of Japanese prints. The original is at the Hakone Museum in Japan.
Harry Büller (Chair) Giancarlo Agnelli Pantep Angchaisuksiri Martin Banyai
Rupert Bauersachs Bonno van Bellen Julio Blüguermann Zoltán Boda
Henri Bounameaux Benjamin Brenner Tim Brighton Javier Diaz Castañon
Pavel Chechulov Yaromir Chlumský Alexander Cohen Bruce Davidson
Hervé Decousus Henry Eriksson Alexander Gallus Ivan Gudz
Barry Jacobson Lee Lai Heng Roger Lyons Karina Meijer
Erich Minar Manuel Monreal Mashio Nakamura Doyeun Oh
Gül Öngen Rajiv Parakh Franco Piovella Gary Raskob
Jeffery Rehm Per Morten Sandset Sebastian Schellong Mark Smith
German Sokurenko Witold Tomkowski Christian Torp-Pedersen Peter Verhamme
Chen Wang Yuqi Wang Jeff Weitz Phil Wells
Vyacheslav
Yanushko
Wei-Hsian Yin
Steering Management Coordination Committee (SMCC)
Study Committees
Data Monitoring Committee
Central Adjudication Committee 24/7 Medical Support Line
John Eikelboom (Chair) Martin Prins (chair) Peter Verhamme (Chair)
Mark Crowther Ludo Beenen Thomas VanasscheRobin Roberts Dees Brandjes Christophe Vandenbriele
Melvin MacGillavry Barbara Debaveye
Neil Kaplowitz Hans-Martin Otten Dominique Pessayre Ron Peters Yvo Roos Ton Slagboom
Argentina (47 patients, 10 centers) – C. Alvarez, Bahia Blanca (2); L.M. Amuchastegui, Cordoba (16); J. Blüguermann, Buenos Aires (1); A. Cassettari, Santa Fe (1); J. Ceressetto, Buenos Aires (3); Hrabar, Quilmes (7); S. Macin, Corrientes (4); C. Mahuad, Buenos Aires (2); P. Oberti, Buenos Aires (4); F. Santini, Mar del Plata (7). Australia (180 patients, 12 centers) – R.I. Baker, Perth (6); P. Blombery, Melbourne (5); T. Brighton, Sydney (6); P. Carroll, Redcliffe (16); B. Chong, Sydney (19); P. Coughlin, Box Hill (45); P. Crispin, Garran (17); J. Fletcher, Sydney (1); A. Gallus, Adelaide (10); D.J. Serisier, South Brisbane (5); H. Tran, N. Chan, L. Stafford, Melbourne (42); C. Ward, Sydney (8). Austria (168 patients, 7 sites) - M. Baghestanian, Vienna (27); P.A. Kyrle, L. Eischer, L. Traby, Vienna (43); P. Marschang, Innsbruck (16); R. Mathies, Feldkirch (18); E. Pilger, M. Brodmann, Graz (34); F. Roithinger, Moedling (19); A. Weltermann, Linz (11). Belarus (85 patients, 4 centers) - I. Adzerikho, E. Davidovskaya, Minsk (26); S. Gorokhovsky, B. Maslianski, Gomel (30); A. Kulik, Mogilev (19); A. Yanushka, Minsk (10). Belgium (177 patients, 9 centers) - P. De Vleeschauwer, Lier (19); E. Debing, Brussels (11); J. Duchateau, Duffel (20); M. Gustin, Liege (9); P. Hainaut, Brussels (27); J. Vandekerkhof, Hasselt (14); P. Verhamme, K. Peerlinck, Leuven (38); P. Verstraeten, Aalst (10); J.C. Wautrecht, S. Motte, Brussels (29). Brazil (93 patients, 11 centers) - J.M. Annichino-Bizzacchi, T.B.T. Mello, F.H. Menezes, Campinas (25); M. Burihan, São Paulo (2); M. Cavalcanti, Porto Alegre (3); J. Correa, São Bernardo do Campo/SP (20); F. Correa de Carvalho, São Paulo (3); A. Cukier, Sao Paulo (18); E. Manenti, Porto Alegre (3); E.R. Manenti, Porto Alegre (2); R. Sacilotto, Sao Paulo (7); J.M. Timi, Curitiba (4); B. van Bellen, São Paulo (6).
From January 2010 through October 2012, 439 centers in 37
countries enrolled 8292 patients Study sites
Canada (219 patients, 6 centers) - S.R. Kahn, Montreal (14); M. Kovacs, A. Lazo Langner, H. VanSpronsen, London Ontario (41); B. Ritchie, Edmonton (31); R. Shafai-Sarshar, Newmarket (1); S. Shivakumar, D. Anderson, K. Robinson, B. Gallant, Halifax (69); P. Wells, A. Karovitch, D. Scarvelis, M. Carrier, Ottawa (63). China (486 patients, 25 centers) - C.X. Bai, Shanghai (2); R.C. Chen, Guangzhou (14); Z.Z. Cheng, Qingdao (14); Y.C. Du, X.Y. Hu, Taiyuan (22); Y.Q. Gu, Beijing (18); Q.L. Hao, S.B. Sun, C. Wang, Kunming (41); L. Jiang, Jiangyin (4); C.J. Liu, Nanjing (2); C.W. Liu, Beijing (20); S. Liu, X.X. Wang, X.F. Ye, Beijing (56); Z. Ma, Shenyang (1); Z.Q. Qin, X.J. Qin, Nanning (36); H.Y. Tian, Xi'an (6); Y.Q. Wang, Z.Y. Shi, Shanghai (21); F.Q. Wen, Chengdu (3); Q. Wu, Tianjin (4); Y.H. Yang, T.G. Kuang, Beijing (25); H. Yang, Beijing (10); K.J. Ying, G.F. Ma, Hangzhou (34); Y.D. Yuan, J. Yu, X.W. Gong, Shijiazhuang (53); F.X. Zhang, Beijing (9); J. Zhang, S. X. Zhang, Yinchuan (23); J.W. Zhang, L. Zhang, Shanghai (35); J.C. Zhao, B. Huang, Chengdu (23); J. Zhao, Shanghai (10). Czech Republic (427 patients, 11 centers) - J. Chlumsky, D. Hola, Prague (54); J. Hirmerova, Plzen (9); M. Hutyra, Olomouc (9); Z. Klimsa, M. Holub, Jihlava (33); K. Kovarova, Ostava (93); P. Lang, M. Ryba, R. Podoubský, Liberec (50); P. Matoska, Ostrava Poruba (6); O. Mayer, Plzen-Bory (13); F. Patek, M. Tupa, Usti nad Labem (54); R. Spacek, R. Urbanova, S. Blazejova, Prague (61); M. Vitovec, Prague (45). Denmark (268 patients, 9 centers) - B. Andersen, Aarhus C (13); J. Brønnum-Schou, Copenhagen (46); H. Dominguez, Herlev (19); K. Egstrup, S. Auscher, Svendborg (26); J. Jeppesen, C. Asferg, J. Vishram, Glostrup (53); H. Nielsen, I. Galsgaard, M. Michaelsen, B. Haugaard-Nielsen, Kopenhagen (70); O. Ostergaard, Roskilde (12); S.H. Poulsen, Aarhus (3); C. Torp-Pedersen, Hellerup (26). Estonia (76 patients, 3 centers) S. Masik, M. Kadarik, Tallinn (23); S. Meriste, Tartu (7); M. Paumets, M. Laheäär, L. Raidjuk, Tallinn (46).
Study sites cont.
France (714 patients, 29 centers) - S. Accassat, A. Buchmuller, P. Mismetti, Saint Etienne (42); A. Achkar, Vernon (12); S. Aquilanti, A. Rifaï, Arras (34); N. Breuil, J. Schmidt, Clermont-Ferrand (31); D. Brisot, C. Brousse, P. Tarodo de la Fuentes, M. Chakra, Castelnau le lez (72); B. Crestani, Paris (2); I. Desormais, P. Lacroix, Limoges (35); J.M. Diamand, Grenoble (5); D. El Kouri, R. Clairand, Nantes (21); A. Elias, Toulon (9); E. Ferrari, D. Doyen, O. Chiche, Nice (53); C. Grange, Lyon Sud (15); H. Guenneguez, Gruchet st. Simeon (3); K. Lacut, F. Couturaud, D. Mottier, Brest (42); L. Leroux, Pessac (7); B. Lorcerie, E. De Maistre, S. Berthier, Dijon (66); I. Mahe, Colombes (15); M. Martin, Annecy (8); N. Meneveau, Besancon (19); G. Meyer, O. Sanchez, Paris (27); K. Montaclair, Le Mans (18); M. Pavic, Lyon (10); G. Pernod, B. Imbert, Grenoble (25); I. Quere, J.P. Galanaud, Montpellier (23); P.M. Roy, Angers (14); M.A. Sevestre, Amiens (4); G. Simoneau, Paris (7); D. Stephan, B. Aleil, C. Mirea, Strasbourg (76); A. Trinh-Duc, Agen (19). Germany (476 patients, 12 centers) P. Baron von Bilderling, Munchen (13); J. Beyer-Westendorf, S. Werth, C. Köhler, K. Halbritter, Dresden (90); C. Diehm, Karlsbad (19); C. Espinola-Klein, G. Weisser, Mainz (25); D. Franke, Magdeburg (69); H. Heuer, Dortmund (13); T. Horacek, G. Kahrmann, Witten (24); R. Kroening, Paderborn (41); H. Lawall, Hamburg (11); M. Roecken, Tübingen (5); S.M. Schellong, L. Pomper, B. Voigts, S. Bernhard, R. Frommhold, Dresden (144); C. Stellbrink, Bielefeld (22). Hungary (464 patients, 12 centers) - Z. Boda, P. Ilonczai, Z. Olah, K. Razso, A. Schlammadinger, Debrecen (118); K. Farkas, E. Kolossváry, I. Szabó, Budapest (51); Z. Frankfurter, Balassagyarmat (7); B. Gasztonyi, Zalaegerszeg (12); M. Gurzó, Z. Klucsik, Kecskemét (31); A. Kovacs, S. Szigeti, C. Varga, Szentes (50); A . Landi, Budapest (15); G. Nyirati, Baja (17); Zs. Pecsvarady, Kistarcsa (3); M. Riba, Z. Sámson, Szombathely (35); Gy. Sipos, M. Szigyártó, N. Sebő, T. Janossikné Szabó, Miskolc (112); K. Toth, Pecs (13).
Study sites cont.
India (515 patients, 39 centers) - S. Agarwal, Lucknow (6); J. Arneja, Nagpur (13); S. Babhulkar, Nagpur (6); R. Balaji, Hyberadad (7); D. Banker, Vadodara (12); N.K. Bhagavan, Bangalore (3); S. Bhonagiri, A. Mehta, Pune (25); V. Dayasagar Rao, Secunderbad A.P. (2); P. Desai, Vadodara (20); S.C. Desai, A.R. Chandrashekar, R. Singh, Bangalore (47); A. Deshpande, Aurangabad (4); A. Dharmadhikari, Nashik (11); N. Durairaj, Madurai (4); N. Ghaisas, Nashik (10); S. Gupta, Lucknow (14); R. Jain, Indore (4); R. Jindal, Mohali (8); D. Kamerkar, Pune (5); V.A. Kothiwale, Belgaum (17); A. Kothurkar, Pune (7); R. Kulkarni, Pune (6); S. Kumar, Hyberadad (1); B. Mody, Vadodara (7); K.N. Nagabhushan, Bangalore (4); H.K. Pandharpurkar, S. Joshi, Bangalore (24); R. Parakh, T. Grover, New Delhi (26); J. Patel, K. Patel, N. Dudhagra, Surat (53); N. Pawar, Nagpur (1); M. Penurkar, Pune (31); R. Pinjala, Hyderabad (3); K. Rai, New Delhi (3); B. Rao, Vishakapattnam (2); M. Raval, A. Raval, P. Mehta, Ahmedabad (52); A.G. Ravi Kishore, Bangalore (3); S. Saravanan, Chennai (4); P. Shetty, Bangalore (6); A. Srinivas, Mysore (4); K.R. Suresh, K. Sumanthraj, K.R. Girija, Bangalore (41); M. Vijan Vinod, Nashik (19). Israel (233 patients, 14 centers) - D. Gavish, B. Ashkenazy, Holon (22); A. Braester, Nahariya (14); Y. Caraco, Jerusalem (1); M. Elias, L. Goldstein, Afula (38); E. Grossman, Tel-Hashomer (6); M. lahav, Petah Tikva (20); M. Lishner, Kfar Saba (21); G. Lugassy, Ashkelon (3); A. Oliven, Haifa (20); R. Rachmilevitz, Haderra (10); I. Tzoran, B. Brenner, Haifa (28); S. Yeganeh, Tiberias (15); D. Zeltser, Tel Aviv (32); R. Zimlichman, Holon (3). Italy (153 patients, 12 centers) - W. Ageno, Varese (11); G. Barillari, S. Pasca, Udine (27); C. Bortoluzzi, Venezia (13); M. Cattaneo, Milano (10); A. Falanga, Bergamo (3); A. Ghirarduzzi, Reggio Emilia (17); C. Lodigiani, Rozzano (5); C. Picchi, D.I. Iosub, Pavia (34); E. Porreca, Francavilla Chieti (5); P. Prandoni, Padua (18); R. Quintavalla, Parma (6); S. Siragusa, Palermo (4).
Study sites cont.
Japan (209 patients, 29 centers) - T. Akita, Uchinada (10); T. Aoyama, Shimada (7); K. Fujimoto, Kumamoto (2); K. Hanzawa, Niigata (6); U. Ikeda, Matsumoto (4); H. Iwata, Nagakute (8); T. Kobayashi, Hatsukaichi (7); K. Kondo, Kitakyushu (12); T. Kurimoto, Nishinomiya (4); H. Maeda, Tokyo (15); M. Mo, Yokohama (10); M. Munemasa, Okayama (7); H. Murakami, Sapporo (6); Y. Nishi, Tokyo (8); T. Nishibe, Tokyo (7); K. Nishigami, Kumamoto (11); T. Nunohiro, Nagasaki (4); T. Obayashi, Musashino (4); T. Satoh, Mitaka (4); H. Satokawa, Fukushima (9); K. Shimizu, Sakura (15); H. Shiroma, Tomigusuku (10); M. Sonoda, Kagoshima (6); Y. Suzuki, Yonago (4); S. Taniguchi, Hirosaki (2); K. Tsujita, Kumamoto (7); N. Yamada, Tsu (5); C. Yasuda, Osakasayama (10); H. Yoshida, Sapporo (5). Korea (272 patients, 17 centers) - H.J. Chang, Seoul (18); W.I. Choi, K.Y. Kwon, B.H. Rho, Daegu (52); J.S. Choi, Cheonan (3); Y.S. Hong, Suwon (3); J.H. Joh, Seoul (22); D.J. Kim, Bucheon (3); H.S. Kim, Seoul (3); S.H. Kim, Busan (8); Y.K. Kim, K.U. Kim, Seoul (22); J.Y. Kim, Seoul (4); T.W. Kwon, Seoul (13); T.S. Lee, Seongnam (13); S.Y. Lim, Seoul (10); Y.C. Mun, Seoul (12); D.Y. Oh, Seongnam (18); K.H. Park, W.S. Yun, Daegu (57); H.I. Yoon, Seongnam (11). Mexico (126 patients, 7 centers) - J. Diaz-Castañon, Zapopan (5); L.F. Flota, Merida (28); J. Galindo, Monterrey (4); J. Gomez Lara, Guadalajara (15); C. Jerjes-Sanchez, Monterrey (25); A. Palomar-Lever, Mexico City (16); D. Rodriguez, I. Higareda, Guadalajara (33). Netherlands – (387 patients, 13 centers) - W.G. Boersma, C.S. de Graaff, L. Oudeman, E. Brans, Alkmaar (80); S.J.H. Bredie, Nijmegen (13); A. Dees, Rotterdam (10); F. Erdkamp, F. Peters, Sittard (29); R. Fijnheer, Amersfoort (3); V.E.A. Gerdes, Amsterdam (12); A. Griffioen, Hoofddorp (20); K-S.G. Jie, Heerlen (18); K. Meijer, H. Kooistra, S. Wiewel-Verschueren, Groningen (53); S. Middeldorp, P.W. Kamphuisen, J. van Es, E.S. Eerenberg, Amsterdam (61); J . Swart Heikens, Assen (27); H. Ten Cate, Maastricht (18); M. ten Wolde, R. Hes, S. Atalay, Almere (43). New Zealand (113 patients, 6 centers) - P. Harper, Palmerston North (12); E. Merriman, North Shore City (16); P. Ockelford, M.H. Hulton, Auckland (45); J. Phillips, Wellington (5); G. Royle, A. Ford, Auckland (21); M. Smith, Christchurch (14). Norway (30 patients, 2 centers) - W. Ghanima, H. Amundsen, Fredrikstad (22); P.M. Sandset, Oslo (8).
Study sites cont.
Philippines (32 patients, 3 centers) - M.T. Abola, Quezon City (19); M.S. Ganzon, Quezon City (6); A. Germar, Pasig City (7). Poland (43 patients, 4 centers) - P. Checinski, Poznan (17); A. Kwasniewski, Lubin (1); W. Tomkowski, Warsaw (16); T. Zechowicz, Olsztyn (9). Russia (519 patients, 23 centers) - K. Apartsin, Irkutsk (17); G. Arutyunov, Moscow (1); O. Barbarash, Kemerovo (10); Y. Burov, Saratov (21); P. Chechulov, E. Varaksina, St. Petersburg (40); M. Chernyatina, M. Gladchenko, L. Belikov, Kursk (51); A. Fokin, Chelyabinsk (13); A. Gubenko, Omsk (5); K. Igor, M. Olga, Novosibirsk (26); Y. Kazakov, A. Kazakov, Tver (23); V. Krasavin, Yaroslavl (13); K. Linev, Krasnoyarsk (2); V. Plechev, Ufa (5); P. Shesternya, Krasnoyarsk (9); V. Shkurin, Pskov (20); P. Shvalb, Ryazan (57); G. Sokurenko, Saint-Petersburg (8); I. Sonkin, A. Remizov, K. Chernykh, Saint-Petersburg (41); I. Staroverov, Yaroslavl (20); Y. Subbotin, Barnaul (32); M. Zeltser, A. Seletsky, A. Iliynykh, Sochi (53); A. Zilber, Petrozavodsk (3); N. Zubareva, I. Tkachenko, A. Pakhomova, Perm (49). Singapore (11 patients, 3 centers) - J. Raghuram, Singapore (1); H.J Ng, Singapore (9); K. Sin, Singapore (1). South Africa (365 patients, 12 centers) - D. Adler, F. Weber, R. van der Jagt, Johannesburg (52); M. Basson, Cape Town Western Cape (2); J. Becker, Pretoria (56); G. Ellis, Somerset West (27); R. Isaacs, Johannesburg (29); B. Jacobson, S. Louw, Johannesburg (130); Jansen van Rensburg, Centurion (9); H. Siebert, Pretoria (24); F. Skosana, Olivedale Randburg (8); J. van Marle, Lyttelton Pretoria (2); L. van Zyl, R. le Roux, Worcester (22); P. Williams, Johannesburg (4). Spain (27 patients, 3 centers) - F. Cereto, Barcelona (10); F. Garcia-Bragado, Girona (16); R. Tirado Miranda, Cabra (1). Sweden (60 patients, 5 centers) - A. Carlsson, Stockholm (4); H. Eriksson, M. Villegas-Scivetti, Gothenburg (24); E. Ottosson, Stockholm (11); A. Sjalander, Sundsvall (6); I. Torstensson, Kristianstad (15). Switzerland (49 patients, 5 centers) - M. Banyai, R. Afarideh, Lucerne (24); A. Gallino, Bellinzona (8); L. Mazzolai, Lausanne (7); M. Righini, Geneva (8); D. Staub, Basel (2).
Study sites cont.
Taiwan (141 patients, 8 centers) - C.J. Chen, Kaohsiung (9); C.E. Chiang, K.L. Wang, Taipei (32); K.M. Chiu, J. H. Huang, New Taipei City (25); W.T. Lai, Kaohsiung (3); P.Y. Pai, K.H. Lin, Taichung (27); J.H. Wang, Hualien (3); C.C. Wu, Taipei (9); W.H. Yin, C.L. Huang, Taipei (33). Thailand (42 patients, 3 centers) - P. Angchaisuksiri, Bangkok (25); M. Kulpraneet, Ong-Karuk (6); P. Rojnuckarin, Bangkok (11). Turkey (54 patients, 5 centers) - G. Öngen, B. Duman, Istanbul (23); S. Ozkan, Izmir (5); I. Savas, Ankara (6); T. Selçuk, Ankara (6); E. Tuncay, Istanbul (14). Ukraine (292 patients, 10 centers) - V. Gerasymov, Chernigiv (35); O. Gubka, Zaporizhzhya (18); I. Gudz, M. Voloshyn, Ivano-Frankivsk (46); P. Nikulnikov, A. Danylets, Kiev (37); V. Prasol, Kharkiv (63); V. Rusyn, Uzhgorod (7); O. Sergeev, Dnipropetrovsk (9); O. Shtutin, Donetsk (2); O. Skupyy, A. Tatarin, Vinnitsa (68); I. Venger, Ternopil (7). United Kingdom (116 centers, 6 centers) - A.T. Cohen, R. Patel, London (40); B.J. Hunt, London (12); P. Kesteven, L. Robson, Newcastle Upon Tyne (37); P. MacCallum, London (11); T. Nokes, Plymouth (8); P. Rose, Coventry (8). United States (623 patients, 50 centers) - P. Acs, L. Gordan, A. Bhatia, Gainesville, FL (20); M. Ali, Saint Petersburg, FL (1); D. Amin, J. Masson, E. Gavi, Clearwater, FL (53); E. Ayele, Los Alamitos, CA (8); O. Ayeni, Jonesboro, GA (11); R. Canosa, Lancaster, PA(26); D. Chavous, Palm Springs, CA (7); D. Chen, Tacoma, WA (16); A. Comerota, Toledo, OH (1); M. Concha, Sarasota, FL(30); M. Cunanan-Bush, Baltimore, MD (7); N. Daboul, Maumee, OH (25); S. Daggubati, New Braunfels, TX (20); N. Dang, Anaheim, CA (21); N. DiBella, Aurora, CO (7); A. Driver, Sellersville, PA (13); A. Dulgeroff, Lancaster, PA (7); J. Fraiz, Indianopolis, IN (26); A. Friedlander, Savannah, GA (6); A. Galvez, Park Ridge, IL (2); C. Jani, Albany, NY (3); S. Johnson, Salt Lake City, UT (7); P. Khandelwal, Odessa, TX (2); E. Kingsley, Las Vegas, NV (24); J. Kingsley, L. Hutchinson, Columbus, GA (21); R. Lavender, Little Rock, AR (5); R. Lyons, G. Guzley, San Antonio, TX (50); R. Martinez, Brandon, FL (21); A. Metjian, Durham, NC (11); J. Moran, Statesville, NC (9); V. Nadar, Harrisburg, PA (32); R. Pish, Uniontown, PA (10); J. Pullman, Butte, MT (9); A.J Quaranta, Norfolk, VA (9); C. Ravi, Randallstown, MD (8); M. Refaai, Rochester, NY (2); J. Rehm, Fredericksburg, VA (20); D. Richards, Tyler, TX (2); R. Richwine, Ft. Worth, TX (14); S. Sachdeva, Seattle, WA (2); A. Seibert, Mobile, AL (4); A. Sharma, Montgomery, AL (18); D. Stricklin, Paducah, KY (5); A. Tannenbaum, Cape Coral, FL (6); C. Tin-U, Sugarland, TX (6); K. Vora, Owensboro, KY (6); D. Watkins, Midland, TX (7); D. Willms, San Diego, CA (3)
Study sites cont.
BACK UP slides
Efficacy
Safety
Pre-specified subgroups of interest
• DVT and PE separately
• PE with right ventricular dysfunction
• Relative efficacy over quartiles of center TTR
• Relative efficacy/safety in 30 mg dose group
Relative Efficacy over quartiles of center TTR
Relative Efficacy/ Safety in 30 mg dose group
EdoxabanN = 733 (%)
Warfarin N = 719
(%)
Hazard ratio
(95 % CI)
First recurrent VTE 22 (3.0) 30 (4.2) 0.73 (0.42-1.26)
Clinically relevant non major or major bleeding
58 (7.9) 92 (12.8) 0.62 (0.44-0.86)
Outcome Edoxaban
no. / Total no. (%)
Warfarin
no. /Total no. (%)
ALT ≥ 3x ULN 81/3901 (2.1) 90/3903 (2.3)
ALT ≥ 5x ULN 26/3901 (0.7) 28/3903 (0.7)
ALT or AST ≥ 3x ULN + bilirubin ≥ 2x ULN
9/3878 (0.2) 4/3865 (0.1)
ALT or AST ≥ 3x ULN + concurrent bilirubin ≥ 2x ULN
6/3878 (0.2) 3/3865 (<0.1)
Number of subjects with events satisfying Hy’s Rule * per adjudication
0/3878 2/3865 (<0.1)
Liver failure 0/4118 1/4122
Percentages based on number of subjects with these tests available
Liver function tests: on-treatment period
* For a case to be considered to meet Hy’s Rule in the Hokusai study, a case must have ALT or AST ≥ 3 x ULN with concurrent TBL ≥ 2 x ULN and the CEC reviewer deems the nature of liver injury to be primarily hepatocellular and the injury attributable to study drug by excluding other known causes (e.g., viral hepatitis, Gilbert’s syndrome, concomitant use of / exposure to agents known to cause liver injury).