Publications by authors named "Mark D Rothmann"

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A Perspective on the Appropriate Implementation of ICH E9(R1) Addendum Strategies for Handling Intercurrent Events.
Thomas R Fleming, Kevin J Carroll, Janet T Wittes, Scott S Emerson, Mark D Rothmann

Stat Med· May 2025

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Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek.
Lisa Meier McShane, Mark D Rothmann, Thomas R Fleming

Clin Trials· August 2023

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Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.
Thomas R Fleming, Christine E Garnett, Laurie S Conklin, Solange Corriol-Rohou, Sudharshan Hariharan, Mark D Rothmann

Ther Innov Regul Sci· January 2023

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U.S. Food and Drug Administration approval summary: omacetaxine mepesuccinate as treatment for chronic myeloid leukemia.
Firoozeh Alvandi, Virginia E Kwitkowski, Chia-Wen Ko, Mark D Rothmann, Stacey Ricci

Oncologist· January 2014

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U.s. Food and Drug Administration approval: carfilzomib for the treatment of multiple myeloma.
Thomas M Herndon, Albert Deisseroth, Edvardas Kaminskas, Robert C Kane, Kallappa M Koti, Mark D Rothmann

Clin Cancer Res· September 2013

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U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.
Albert Deisseroth, Edvardas Kaminskas, Joseph Grillo, Wei Chen, Haleh Saber, Mark D Rothmann

Clin Cancer Res· June 2012

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Testing in a Prespecified Subgroup and the Intent-to-Treat Population.
Mark D Rothmann, Jenny J Zhang, Laura Lu, Thomas R Fleming

Drug Inf J· March 2012

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Some essential considerations in the design and conduct of non-inferiority trials.
Thomas R Fleming, Katherine Odem-Davis, Mark D Rothmann, Yuan Li Shen

Clin Trials· August 2011

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U.S. Food and drug administration approval: rituximab in combination with fludarabine and cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia.
Sandra J Casak, Steven J Lemery, Yuan Li Shen, Mark D Rothmann, Aakanksha Khandelwal

Oncologist· June 2011

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U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Steven J Lemery, Jenny Zhang, Mark D Rothmann, Jun Yang, Justin Earp

Clin Cancer Res· September 2010

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Missing data in biologic oncology products.
Mark D Rothmann, Kallappa Koti, Kyung Yul Lee, Hong Laura Lu, Yuan Li Shen

J Biopharm Stat· November 2009

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Issues in using progression-free survival when evaluating oncology products.
Thomas R Fleming, Mark D Rothmann, Hong Laura Lu

J Clin Oncol· June 2009

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Continuing reassessment of the risks of erythropoiesis-stimulating agents in patients with cancer.
Vinni Juneja, Patricia Keegan, Joseph E Gootenberg, Mark D Rothmann, Yuan Li Shen

Clin Cancer Res· June 2008

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Inferences on a life distribution by sampling from the ages or the ages at death.
Mark D Rothmann

Lifetime Data Anal· September 2006

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On non-inferiority analysis based on delta-method confidence intervals.
Mark D Rothmann, Hsiao-Hui Tsou

J Biopharm Stat· August 2003

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