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Record W2899608945 · doi:10.1016/s2213-2600(18)30406-5

Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial

2018· article· en· W2899608945 on OpenAlexaff
William W. Busse, Eugene R. Bleecker, J Mark FitzGerald, Gary T. Ferguson, Peter Barker, Stephanie Sproule, Richard F. Olsson, Ubaldo J. Martin, Mitchell Goldman, Anahí Yañez, Marcelo Fernández, Alberto Tolcachier, Juan Belloni, Jorge Taborda, Maria De Salvo, Jorge Máspero, Carlos Victorio, Miguel Chirino Navarta, Mónica Grilli, Pablo Alejandro Rodríguez, María Otaola, Victor Hugo Cambursano, Patricia Malamud, Ana Stok, German Arce, Osiris Roza, Fernando Scherbovsky, Pedro Carlos Elias, Maria Salazan Saez, Matthew Peters, John W. Upham, Peter G. Gibson, Francis Thien, John Aubrey Douglass, Paul Thomas, Philip G. Bardin, Dimitar Sajkov, Mark Hew, David Langton, Andreia Luisa Francisco Pez, Carlos Cézar Fritscher, Jorge Lima Hetzel, Waldo Mattos, Rafaël Stelmach, Martti Antila, Ana Luísa Godoy Fernandes, Hristo Metev, Yavor Ivanov, Aneliya Bogdanova, Ana Dancheva Markova, M Peneva, Rumyana Veselinova, Tatyana Petkova, Vanushka Petrova, E Shopova, Yuliya Ivanova, Rumyana Yotsova, Ginka Kirkova, Galina Petrova, Svetoslav Dachev, Kostadinka Sotirova, Mariyana Stoyanova, Oleg Yakov, Vanya Ilieva-Fartunova, Catherine Lemière, Michel Laviolette, William H. Yang, Bonavuth Pek, William Patrick Killorn, Claude Poirier, Guy Chouinard, Lyle Melenka, Richard Leigh, Parameswaran Nair, Delbert Dorscheid, James G. Martin, Juana Pavie, Andres Rosenblut, Claudia Cartagena, Carlos Quilodran, Silvia Muñoz, Ivana Malkusova, Stanislav Holub, Jaroslav Mareš, Radovan Kozel, Daniela Kopecka, Vladimir Zindr, Pavel Cerva, Pascal Chanez, Arnaud Bourdin, Gilles Devouassoux, Camille Taillé, Frédéric de Blay, François Goupil, Christophe Leroyer, Delphine Gourcerol, T. Didi, A. Didier, Gilles Garcia, Philippe Bonniaud, Riazate Rossanaly Vasram, Marek Lommatzsch, Ulf Harnest, Anneliese Linnhoff, Claus Keller, Gerhard Hoheisel, Karin Förster, Thomas Schultz, Isabelle Schenkenberger, Joachim Kirschner, Tibor Schmoller, Stefan Zielen, Marc Kornmann, Ekkehard Beck, Lutz Volgmann, Rolf Dichmann, A. Overlack, Jörg Winkler, Petra Mikloweit, Sabine Ballenberger, M. Rolke, Stephanie Korn, Helmut Pabel, Martin Hoffmann, Jan Feimer, Klaus F. Rabe, Regina Deckelmann, Tobias Welte, Hiroyuki Ohbayashi, Soichiro Hozawa, Terufumi Shimoda, Makoto Yoshida, Toshikazu Nagakura, Tadashi Kamei, Yasuyuki Sano, Shinichiro Kagami, Hisaho Takahashi, Michiko Haida, Goro Kimura, Hiroyuki Nakamura, Yasuo To, Masaharu Shinkai, Tadasuke Shimokawaji, Makoto Kudo, Noriharu Shijyubo, Takao Tochigi, Motokazu Kato, Akihiko Tanaka, Yasuhiro Gon, Norihisa Sasaki, Tetsuro Ohdaira, Chiharu Omori, Toshiki Takahashi, Satomi Takeuchi, Kiyotaka Nakajima, Hironi Makita, Masahiro Kaneko, Kenjiro Furuta, Masami Taniguchi, Yoshito Inobe, Hiroshi Miki, Yoichi Nakamura, Naoki Miyazawa, Shuichi Yano, Masayuki Iijima, Tsuyoshi Yamato, Alberto Matsuno, Efraín Felix, Alfredo Guerreros, Alejandro Daly, Fernando Rodriguez Chariarse, Danilo Salazar, S. Serrano castro, William Chavez, Rolando Estrella, Teresita O. Aquino, Tito Atienza, Ronnie Samoro, Marie Grace Dawn Isidro, Piotr Kuna, Adam Antczak, Michał Bednarek, Danuta Mądra-Rogacka, Teresa Hofman, Marek Jutel, Ewa Pisarczyk-Bogacka, Agata Kot‐Wasik, Robert Mróz, Małgorzata Czupryńska-Borkowska, Malgorzata Zurowska Żurowska-Gębala, Andrzej Dyczek, Grażyna Jasieniak-Pinis, Piotr Wojnowski, Ewa Trębas-Pietraś, Małgorzata Dobryniewska, Marcin Stobiecki, Marzenna Tarnowska-Matusiak, Andrzej Kolczyński, Tomasz Kachel, Zbigniew Bartuzi, Bernadetta Majorek‐Olechowska, Paweł Śliwiński, Violetta Balicka, Elżbieta Hajoł, Jacek Stachera, Marta Rachel, Marek Michnar, J Tałałaj, Ewa Springer, Piotr Napora, Tomasz Grzelewski, Renata Bijata-Bronisz, Anna Świderska, Grzegorz Mincewicz, Zbigniew Sankowski, Tomasz Fijołek, A Kwaśniewski, Joanna Jerzyńska, Jerzy Cygler, Ryszard Olesiejuk, Iwona Von Steiner, Wojciech Machowiak, Krzysztof Filipek, Piotr Piskorz, Ewa Uhryn, Marita Nittner‐Marszalska, Elżbieta Rybicka-Liszewska, Anna Bodzenta­‐Łukaszyk, Marta Chełmińska, Izabella Krupa‐Borek, Wojciech Skucha, Anna Płoszczuk, T Mihăescu, Ioan Dorin Petrui, Ghiulten Apti, Claudia Toma, Ana Trailescu, Sergei Sokurenko, В. И. Трофимов, И. В. Лещенко, Н. Л. Шапорова, Inna G. Ilyashevich, Irina Stitsenko, А. A. Vizel, Yulia Ilkovich, D. A. Tikhanov, С. А. Гончарова, Andrey Ezhov, Г. Л. Игнатова, Н. В. Изможерова, Н. Г. Бердникова, Ludmila Goryachkina, Veronika Popova, Л. З. Болиева, А. П. Ребров, Vladimir Nosov, O. V. Magnitskaya, С. В. Недогода, Vladimir Abrosimov, Artem Molotkov, Galina Reshedko, Mikhail Smirnov, М. Ф. Осипенко, Elena Pavlysh, S. Е. Myasoedova, Liudmila G. Lenskaya, V. Chistyakov, Еlena A. Vishneva, Liliya Uon, Anna Zateyschikova, Svetlana Laleko, Tatiana Pak, Axel Bruning, Visvakuren Naidoo, Jeevren Reddy, Richard N. van Zyl-Smit, Hae‐Sim Park, Young-Joo Cho, Sang‐Heon Cho, Sang Haak Lee, Byung‐Jae Lee, Ju Sang Kim, You Sook Cho, Choon‐Sik Park, Mi-Kyeong Kim, Young‐Il Koh, Joo‐Hee Kim, Sook Young Lee, Sang Pyo Lee, Jung‐Won Park, Kwang Ha Yoo, Hyoung Kyu Yoon, Jaechun Lee, Gyu Young Hur, Soo Keol Lee, Hee-Kyoo Kim, David Ramos‐Barbón, Elena Laffond, Eva Martínez Moragón, Miguel Arias Guillén, Alberto Saura Vinuesa, Fernando Sánchez-Toril López, José Luis Velasco Garrido, Borja G. Cosío, Luis Pérez de Llano, Antonio Luis Valero Santiago, Myriam Calle Rubio, Leif Bjermer, Bo Lundbäck, Bilun Gemicioğlu, Sevim Bavbek, Dane Ediger, Munevver Erdinc, Ismail Hanta, Sibel Naycı, Sibel Arınç, Liudmyla Iashyna, Yuriy Mostovoy, Мykola Ostrovskyy, Lesia Kuryk, Ivan Lemko, Tetyana Ospanova, L V Moskalenko, Oleksii Korzh, Viktor Blazhko, Olena Krakhmalova, Liliia Romaniuk, Yevgeniya Dytyatkovs'ka, Oleh Yakovenko, Volodymyr Gavrysyuk, Hassan Burhan, Dinesh Saralaya, Stephen L. Scott, Alyn H. Morice, Ewart Jackson-Voyzey, Thida Win, Shuab Nasser, Richard Harrison, Rekha Chaudhuri, Monica Nordstrom, Pradip De, Matthew Masoli, Adel Mansur, Anthony Gunstone, Robert Niven, Timothy Harrison, Suresh Babu, Subodh Bhuchar, Shahrukh Kureishy, John Zwetchkenbaum, Lawrence Kaplan, Santiago Reyes, Faisal Fakih, Marvin Heuer, Ryan Klein, Michael Marcus, Iftikhar Hussain, Tonny Tanus, Hengameh Raissy, Sady Alpizar, Hector Rodriguez, Gerald J. Gleich, Tracy Bridges, Joe Pouzar, Gary C. Steven, Jonathan Matz, Shana Krstevska, Dama Ziworitin, Adolfo Kaplan, James L. Sublett, James DeAngelo, Amy Darter, John Agaiby, John Hagan, Enrique Davis, Dareen Siri, Charlene McEvoy, Chrisette Dharma, Najmuddin Karimjee, Steven Kelsen, Manuel Frade, Amy Silverthorn, Joel N. Kline, Francis Averill, José Miguel Robaina Ruiz, Emory Robinette, Zeeshan Shaikh, Carlos Aguilar, William Nish, Germán Álvarez, Younus Ismail, Purvi Parikh, Mila A. Leong, Dennis Murphy, Francisco García, Alan B. Goldsobel, Antonio Blanco, Edward J. Campbell, Guido O. Pérez, Geoffrey Chupp, Toby Bates, Vandely Perez, Sally E. Wenzel, Kartik Shenoy, Rohit Katial, David I. Bernstein, Neil Parikh, William Sims, David Pham, Anu George, Richard Beasley, Gilberto Perez, Robert I. Garver, Miriam Garcia-Portela, Stephen T.C. Wong, Weily Soong, R. Guillot, Golda Hudes, Ahmed A. Arif, Josefa Binker, Manuel Villareal, Ulrike Ziegner, Joseph Ojile, S. Goswami, Carlos Piniella, I Segal, Heidi Zafra, Mitchell Lee, Martha Tarpay, John Panuto, Rajan Merchant, Peter Springsteen, Timothy Scialla, Paul Shapero, Karen Allen, Mark Moss, Humberto Cruz, Jeffrey Rumbyrt, Amy Boyd, Robert Nathan, Jonathan A. Bernstein, Joshua Jacobs, Elliot Ginchansky, JM Johnston, Barbara D. Baxter, Thomas Johnson, Stephen Apaliski, Clinton N. Corder, David Fuentes, Joseph D. Diaz, Ngo Quy Chau, Lan Le

Bibliographic record

VenueThe Lancet Respiratory Medicine · 2018
Typearticle
Languageen
FieldMedicine
TopicAsthma and respiratory diseases
Canadian institutionsUniversity of CalgaryFrancophone University AssociationVancouver General HospitalUniversity of British Columbia
FundersKyowa Hakko KirinPearl TherapeuticsAstraZeneca
KeywordsBenralizumabMedicinePlaceboTolerabilityClinical endpointInternal medicineAdverse effectAsthmaClinical trialDosingMepolizumabEosinophilPathology

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)0.005
metaresearch head score (Gemma)0.003
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 score0.005
Threshold uncertainty score0.024

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0050.003
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0030.004
Bibliometrics0.0000.000
Science and technology studies0.0010.001
Scholarly communication0.0020.001
Open science0.0010.001
Research integrity0.0020.005
Insufficient payload (model declined to judge)0.0020.001

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 head0.026
GPT teacher head0.307
Teacher spread0.281 · 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
Published2018
Admission routes1
Has abstractno

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