Novel oral anticoagulants and reversal agents: Considerations for clinical development von Sarich, Troy C., PhD, Seltzer, Jonathan H., MD, Berkowitz, Scott D., MD, Costin', James, MD, Curnutte, John T., MD, Gibson, C. Michael, MD, Hoffman, Maureane, MD, PhD, Kaminskas, Edvardas, MD, Krucoff, Mitchell W., MD, Levy, Jerrold H., MD, Mintz, Paul D., MD, Reilly, Paul A., PhD, Sager, Philip T., MD, Singer, Daniel E., MD, Stockbridge, Norman, MD, PhD, Weitz, Jeffrey I., DM, Kowey, Peter R., MD

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NOAC Monitoring, Reversal Agents, and Post-Approval Safety and Effectiveness Evaluation: A Cardiac Safety Research Consortium Think Tank von Reiffel, James A., M.D, Weitz, Jeffrey I., M.D, Reilly, Paul, PhD, Kaminskas, Edvardas, M.D, Sarich, Troy, PhD, Sager, Philip, M.D, Seltzer, Jonathan, M.D

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Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes von Greene, Stephen J., Vaduganathan, Muthiah, Khan, Muhammad Shahzeb, Bakris, George L., Weir, Matthew R., Seltzer, Jonathan H., Sattar, Naveed, McGuire, Darren K., Januzzi, James L., Stockbridge, Norman, Butler, Javed

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Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants? von Chan, Noel, Sager, Philip T., Lawrence, Jack, Ortel, Thomas's, Reilly, Paul, Berkowitz, Scott, Kubitza, Dagmar, Eikelboom, John, Florian, Jeffry, Stockbridge, Norman, Rose, Martin, Temple, Robert, Seltzer, Jonathan H.

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Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and Best Practices.... von Seltzer, Jonathan H, MD, MA, MBA, Heise, Ted, Phd, RAC, Carson, Peter, MD, Canos, Daniel, PhD, MPH, Hiatt, Jo Carol, MD, MBA, Vranckx, Pascal, MD, PhD, Christen, Thomas, MD, PhD, Cutlip, Donald E, MD

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Assessing cardiac safety in oncology drug development von Seltzer, Jonathan H, Gintant, Gary, Amiri-Kordestani, Laleh, Singer, Jack, Koplowitz, Luana Pesco, Moslehi, Javid J, Barac, Ana, Yu, Anthony F.

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Commentary: In the Rising Era of Big Data, Small Steps are Key von Heller, Nina, Seltzer, Jonathan H.

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Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document von Spitzer, Ernest, McFadden, Eugene, Vranckx, Pascal, Garcia-Garcia, Hector M, Seltzer, Jonathan H, Held, Claes, de Vries, Ton, Menon, Venu, Brown, Kimberly J, Soliman, Osama I I, Onuma, Yoshinobu, Lopes, Renato D, Stone, Gregg W, Cutlip, Donald E, Serruys, Patrick W

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Defining the path ahead for NOAC use in the pediatric population: A Cardiac Safety Research Consortium Think Tank von Seltzer, Jonathan H., Farrell, Ann, Goldenberg, Neil, Hornik, Christoph, Keene, Daniel, Krucoff, Mitchell W., Lipardi, Concetta, Massicotte, Patricia, Mentzer, Dirk, Monagle, Paul, Thornburg, Courtney, Revkin, James H., Walker, Shetarra, Gajjar, Diptee

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Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week von Januzzi, Jr, James L, Canty, John M, Das, Saumya, DeFilippi, Christopher R, Gintant, Gary A, Gutstein, David E, Jaffe, Allan, Kaushik, Emily P, Leptak, Christopher, Mehta, Cyrus, Pina, Ileana, Povsic, Thomas J, Rambaran, Curtis, Rhyne, Rhonda F, Salas, Maribel, Shi, Victor C, Udell, Jacob A, Unger, Ellis F, Zabka, Tanja S, Seltzer, Jonathan H

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Cardiac safety research consortium “shock II” think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock von Samsky, Marc D., Krucoff, Mitchell W., Morrow, David A., Abraham, William T., Aguel, Fernando, Althouse, Andrew D., Chen, Eric, Cigarroa, Joaquin E., DeVore, Adam D., Farb, Andrew, Gilchrist, Ian C., Henry, Timothy D., Hochman, Judith S., Kapur, Navin K., Morrow, Valarie, Ohman, E. Magnus, O'Neill, William W., Piña, Ileana L, Proudfoot, Alastair G., Sapirstein, John S., Seltzer, Jonathan H., Senatore, Fred, Shinnar, Meir, Simonton, Charles A., Tehrani, Behnam N., Thiele, Holger, Truesdell, Alexander G., Waksman, Ron, Rao, Sunil V.

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Corrigendum to “Assessing cardiac safety in oncology drug development” [Am Heart J 214 (2019) 125-133] von Seltzer, Jonathan H., Gintant, Gary, Amiri-Kordestani, Laleh, Singer, Jack, Koplowitz, Luana Pesco, Moslehi, Javid J., Barac, Ana, Yu, Anthony F.

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Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee von Januzzi, James L, Garasic, Joseph M, Kasner, Scott E, McDonald, Vickie, Petrie, Mark C, Seltzer, Jonathan, Mauro, Michael, Croce, Kevin, Berman, Ellin, Deininger, Michael, Hochhaus, Andreas, Pinilla-Ibarz, Javier, Nicolini, Franck, Kim, Dong-Wook, DeAngelo, Daniel J, Kantarjian, Hagop, Xu, Jing, Hall, Tracey, Srivastava, Shouryadeep, Naranjo, Daniel, Cortes, Jorge

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Interdisciplinary Safety Evaluation and Quantitative Safety Monitoring: Introduction to a Series of Papers von Seltzer, Jonathan H, Li, Judy, Wang, William

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Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: A report from the Cardiac Safety Research Consortium von Seltzer, Jonathan H., MD, MBA, MA, Turner, J. Rick, PhD, Geiger, Mary Jane, MD, PhD, Rosano, Giuseppe, MD, PhD, Mahaffey, Kenneth W., MD, White, William B., MD, Sabol, Mary Beth, MD, Stockbridge, Norman, MD, PhD, Sager, Philip T., MD

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Cardiovascular Safety Outcome Trials: A meeting report from the Cardiac Safety Research Consortium von Sager, Philip T., MD, Seltzer, Jonathan, MD, Turner, J. Rick, PhD, Anderson, Jeffrey L., MD, Hiatt, William R., MD, Kowey, Peter, MD, Prochaska, Judith J., PhD, MPH, Stockbridge, Norman, MD, PhD, White, William B., MD

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The Diagnosis of Cardiac Arrhythmias: A Prospective Multi-Center Randomized Study Comparing Mobile Cardiac Outpatient Telemetry Versus Standard Loop Event Monitoring von ROTHMAN, STEVEN A., LAUGHLIN, JAMES C., SELTZER, JONATHAN, WALIA, JASJIT S., BAMAN, RAKESH I., SIOUFFI, SAMER Y., SANGRIGOLI, ROBERT M., KOWEY, PETER R.

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A Path Forward for Regenerative Medicine: Navigating Regulatory Challenges: Summary of Findings From the Cardiac Safety Research Consortium/Texas Heart Institute International Symp... von Fanaroff, Alexander C, Morrow, Valarie, Krucoff, Mitchell W, Seltzer, Jonathan H, Perin, Emerson C, Taylor, Doris A, Miller, Leslie W, Zeiher, Andreas M, Fernández-Avilés, Francisco, Losordo, Douglas W, Henry, Timothy D, Povsic, Thomas J

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Correction: Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee von Januzzi, James L, Garasic, Joseph M, Kasner, Scott E, McDonald, Vickie, Petrie, Mark C, Seltzer, Jonathan, Mauro, Michael, Croce, Kevin, Berman, Ellin, Deininger, Michael, Hochhaus, Andreas, Pinilla-Ibarz, Javier, Nicolini, Franck, Kim, Dong-Wook, DeAngelo, Daniel J, Kantarjian, Hagop, Xu, Jing, Hall, Tracey, Srivastava, Shouryadeep, Naranjo, Daniel, Cortes, Jorge

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Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions von Ball, Greg, Kurek, Raffael, Hendrickson, Barbara A., Buchanan, James, Wang, William W., Duke, Susan P., Bhattacharyya, Amit, Li, Mengchun, O’Brien, Dennis, Weigel, Judith, Wang, Wenquan, Jiang, Qi, Ahmad, Faiz, Seltzer, Jonathan H., Herrero-Martinez, Esteban, Tremmel, Lothar

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