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Record W4223439574 · doi:10.1016/s0140-6736(22)00456-1

Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

2022· article· en· W4223439574 on OpenAlexaff
Jonathan P. Piccini, Valeria Caso, Stuart J. Connolly, Keith A.A. Fox, Jonas Oldgren, W. Schuyler Jones, Diana A. Gorog, Václav Durdil, Thomas Viethen, Christoph Neumann, Hardi Mundl, Manesh R. Patel, Johann Auer, Martin Hubauer, Sead Pandzic, Eva Preishuber, Carina Primus-Grabscheit, Dietmar Reitgruber, Florian Schmalzer, Christopher Adlbrecht, Andreas Schober, Johannes Hajos, Christoph Keil, Alexandra Schratter, Matthias Frick, Magdalena Benda, Maximilian Mächler, Beatrix Mutschlechner, Christoph H. Saely, Lukas Sprenger, Michael Lichtenauer, Miriam Eber, Uta C. Hoppe, Tobias Kolbitsch, Peter Jirak, Moritz Mirna, Robert Schönbauer, Jutta Bergler‐Klein, Christian Hengstenberg, Stefan Stojković, Martin Manninger-Wünscher, Ursula Rohrer, Markus Stühlinger, Wilfried Schgoer, Jana M. Schwarzl, Helmut Pürerfellner, Michael Derndorfer, Christian Ebner, Veronika Eder, Γεώργιος Κόλλιας, Thomas Sturmberger, Stefan Sieghartsleitner, Johan Vijgen, Peter Koopman, Karl Dujardin, Wim Anné, Michel De Ceuninck, René Tavernier, Mattias Duytschaever, Sébastien Knecht, Luc Missault, Yves Vandekerckhove, Tom Rossenbacker, Bavo Ector, Filip Charlier, Philippe Debruyne, Willem Dewilde, Luc Janssens, John Roosen, Bart Vankelecom, Hein Heidbüchel, Michiel Delesie, G. M. M. Vervoort, Hans Rombouts, Thomas Vanassche, Matthias M. Engelen, Peter Verhamme, Rik Willems, Christian Constance, Nicolas Pranno, Jafna L. Cox, Iqbal Bata, Laurent Macle, Martín Aguilar, J. Tourigny, Marc Dubuc, Katia Dyrda, Peter G. Guerra, Paul Khairy, Blandine Mondésert, Léna Rivard, Denis Roy, Rafik Tadros, Mario Talajic, Bernard Thibault, Isabelle Nault, L. Blier, Jean Champagne, Franck Molin, Gilles O’Hara, François Philippon, Benoît Plourde, J. Sarrazin, Christian E. W. Steinberg, Zdeněk Coufal, David Balazsik, M Mikulica, Jakub Zápeca, Ondřej Čermák, Tomas Drasnar, Matej Falc, Josef Hornof, Blazej Racz, Danica Weissova, Hana Línková, Eva Pašková, Robért Petr, Andrea Širáková, Jiří Kettner, Ales Benak, Martin Holek, Ivo Podpera, Monika Podperova, V. Vančura, Tomas Jandik, Jiřı́ Šmı́d, Vratislav Dedek, J. Banik, Tomáš Hnát, Nicolas Lellouche, Ségolène Rouffiac, Guillaume Taldir, Valentin Bridonneau, Philippe Couffon, M. Daudin, Cécile Hamon, Jonathan Lacaze, A Quentin, Christophe Thébault, Emmanuel Boiffard, Olivier Billon, Fabien Miette, Hervé Pouliquen, Guillaume Turlotte, Hervé Gorka, Franck Albert, Sandrine Bayle, R. Bensaid, Madalina Dasoveanu, Thibaud Demichili, Téodora Dutoiu, Cliff Khalil, Caterina Loghin, Grégoire Rangé, Laurent Roussel, Pierre Socié, Christophe Thuaire, Fabrice Extramiana, Vincent Algalarrondo, Haten Boughanmi, Noreddine El Mansour, Usman Mohammad, Romain Sellier, Meyer Elbaz, Clémence Laperche, Philippe Maury, Róbert Gábor Kiss, Tünde Borsányi, Zoltán Gingl, Balaza Polgar, Béla Benczúr, A. Bodor, Tamas Hepp, Éva Maláti, László Nagy, Norbert Erdei, Jozsef Kapus, Katalin Kapus, Brigitta Tóth, Andras Matoltsy, Tunde Kiss, Béla Merkely, Szilvia Herczeg, Orsolya Kiss, Zoltán Salló, Kálmán Tóth, Tamás Habon, Miklós Rábai, Kinga Tótsimon, Z Zilahi, G. Bencze, János Sánta, Dániel Aradi, Barbara Kelemen, Leonardo Bolognese, Martina Nesti, Pasquale Notarstefano, Simona D’Orazio, Franco Cosmi, Cecilia Becattini, Giancarlo Agnelli, Belinda Broccatelli, Maria Giulia Mosconi, Maurizio Paciaroni, Chiara Urbini, Vito Maurizio Parato, Camilla Notaristefani, Michele Scarano, Pietro Ameri, G. Ghigliotti, Giulia Guglielmi, Roberta Lotti, Andrea Merlo, María Lorenza Muiesan, Andrea Abondio, Caterina Berasi, Elena Mattiuzzo, Claudio Mutti, Massimo Salvetti, Pasquale Pignatelli, Danilo Menichelli, Daniele Pastori, Eiji Tamiya, Takahiro Μatsumoto, Tomosato Takabe, Shoichi Yamamoto, Haruyo Yamashita, Shinichi Higashiue, Onichi Furuya, Norihiko Hiramatsu, Kensuke Kasuga, Saburo Kojima, Masatoshi Komooka, Satoshi Kuroyanagi, Makoto Matsuura, Tetsushi Takemoto, Shuji Yamamoto, Katusmi Saito, Takuro Abe, Issei Ishida, Yuji Iwanami, Shohei Kataoka, Tetsu Moriyama, Akira Murohashi, Akihito Sasaki, Yuichiro Nakamura, Tetsuya Ueno, Akira Shimane, Tomoyo Hamana, Hirotoshi Ichibori, Tomohiro Inoue, Mitsuaki Itoh, Seigo Iwane, Hiroya Kawai, Tatsuya Kokawa, Akiko Masumoto, Koki Matsuo, Taishi Miyata, Shinsuke Nakano, Shogo Oishi, Tetsuari Onishi, Takahiro Sawada, Takayuki Saito, Mitsuhiko Shoda, Nobuyuki Takahashi, Tomofumi Takaya, Yasuyo Taniguchi, Shota Tsukamoto, Yasue Tsukishiro, Yoshiro Tsukiyama, Hiroshi Tsunamoto, Kenzo Uzu, Hiroyuki Yamamoto, Tetsuya Yamamoto, Kiminobu Yokoi, Chiaki Yoshida, Nobuhiro Watanabe, Tetsuo Betsuyaku, Kumiko Adachi, Kouichi Awane, Daisuke Goto, Mamoru Sakakibara, Masashi Watanabe, Hideki Ueno, Yoshitaka Hiroe, Koshi Matsuo, K. Ayata, Ko Fukuda, Yoshiki Hata, Katsushi Hashimoto, Hiroaki Matsumi, Akira Nikaido, Shuichi Okamoto, Iveta Sime, V Stirna, Ilze Reinholde, Silvija Hansone, Anita Kozlovska, Janina Romanova, Dace Klincare, Natalja Pontaga, Igors Dirmans, Artis Kalniņš, Dana Upīte, A. Gersamija, Arturs Teleznikovs, Nadezda Rozkova, Jelena Safro, Ignasi Anguera Camós, Paolo Dallaglio, Rafael Salguero‐Bodes, Fernando Arnbas, Luís Miguel Borrego, Álvaro Marco, Javier Ramos Jiménez, Juan José Gómez‐Doblas, Alejandro Pérez Cabeza, Ignacio Ferreira González, Javier Limeres Freire, Mercè López-Grau, Xavier Viñolas Prat, Zoraida Moreno Weidmann, Maria Concepcion Alonso Martin, Bieito Campos, Javier Mauricio Mogro Carranza, Francisco Javier Méndez Zurita, Enrique Rodríguez Font, Carlos Eduardo Gonzales Matos, Víctor Hernando, Carl-Johan Lindholm, Jörgen Thulin, Håkan Wallén, Kristina Hagwall, Ken Eliasson, Martin Lundvall, B Kjellman, Markus Lind, Lars Johansson, Niclas Svedberg, Stefan Berglund, Julia Söderberg, C. Zedigh, Thomas Mooe, Mattias Axelsson, Emil Binsell, Daniel Huber, Christian Müller, Isabelle Danier, Michael Kühne, Bernhard Okamura, Hadrien Schoepfer, Cornelia Simmen, Tobias Reichlin, Laurève Chollet, Anna Lam, Severin Wittmer, Hans Rickli, C. Gall, Greta Hametner, Stephanie Intorp, Daniel Luescher, Laurent Haegeli, Jan Christopher Berg, Ramin Ebrahimi, Angelo Auricchio, Carmela Crljenica, T Moccetti, Elena Pasotti, Iveta Petrova, Mariagrazia Rossi, François Mach, Mehdi Namdar, Joris de Groot, Virginnio Proost, Joline Neefs, Dominik Linz, Twan van Stipdonk, Dennis W. den Uijl, Marco Alings, Jeroen Schaap, Dolf Segers, Noëmi T.A.E. Wouters, Louis Bartels, Robert G Tieleman, Ron Pisters, Tim de Vries, Jaap Selig, Aaf F.M. Kuijper, Pieter T. Bot, Mitran Keijzers, Gerardus Verdel, Raymond Tukkie, Ewout van den Bos, Floris Kauer, Rohit M. Oemrawsingh, J. Stevenhagen, Jan van Es, Gregory Y.H. Lip, Dhiraj Gupta, Agnieszka Kotalczyk, Anthony Gunstone, Richard David Brixey, Danial Dinarvand, Ying X. Gue, Rahim Kanji, Vassilios Memtsas, Roxy Senior, Gabriel Bioh, Yuk-ki Wong, Nick Child

Bibliographic record

VenueThe Lancet · 2022
Typearticle
Languageen
FieldMedicine
TopicCoagulation, Bradykinin, Polyphosphates, and Angioedema
Canadian institutionsHamilton Health SciencesMcMaster UniversityPopulation Health Research Institute
FundersNovo Nordisk FondenBayer
KeywordsApixabanAtrial fibrillationMedicineDouble blindInternal medicineCardiologyGastroenterologySurgeryWarfarinRivaroxabanPathologyPlacebo

Abstract

fetched live from OpenAlex
No abstract in any covered source. Its absence is recorded, not treated as a negative.

No abstract. This is not a gap in this database; OpenAlex has none either. 23.3% of the frame is in this state, and the screen finds HALF as much metaresearch here, so the absence is a measured bias rather than a missing field.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.006
Threshold uncertainty score0.021

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.002
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0040.002
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0020.004
Insufficient payload (model declined to judge)0.0060.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.056
GPT teacher head0.310
Teacher spread0.254 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations311
Published2022
Admission routes1
Has abstractno

Explore more

Same venueThe LancetSame topicCoagulation, Bradykinin, Polyphosphates, and AngioedemaFrench-language works237,207