Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms von Kluetz, Paul G, Slagle, Ashley, Papadopoulos, Elektra J, Johnson, Laura Lee, Donoghue, Martha, Kwitkowski, Virginia E, Chen, Wen-Hung, Sridhara, Rajeshwari, Farrell, Ann T, Keegan, Patricia, Kim, Geoffrey, Pazdur, Richard

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FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma von Lee, Hyon-Zu, Kwitkowski, Virginia E, Del Valle, Pedro L, Ricci, M Stacey, Saber, Haleh, Habtemariam, Bahru A, Bullock, Julie, Bloomquist, Erik, Li Shen, Yuan, Chen, Xiao-Hong, Brown, Janice, Mehrotra, Nitin, Dorff, Sarah, Charlab, Rosane, Kane, Robert C, Kaminskas, Edvardas, Justice, Robert, Farrell, Ann T, Pazdur, Richard

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FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma von Kwitkowski, Virginia E., Prowell, Tatiana M., Ibrahim, Amna, Farrell, Ann T., Justice, Robert, Mitchell, Shan Sun, Sridhara, Rajeshwari, Pazdur, Richard

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Combination Targeted Therapy With Sorafenib and Bevacizumab Results in Enhanced Toxicity and Antitumor Activity von AZAD, Nilofer S, POSADAS, Edwin M, LIANG CAO, MCNALLY, Deborah, CHOW, Catherine, CHEN, Helen X, WRIGHT, John J, KOHN, Elise C, KWITKOWSKI, Virginia E, STEINBERG, Seth M, JAIN, Lokesh, ANNUNZIATA, Christina M, MINASIAN, Lori, SAROSY, Gisele, KOTZ, Herbert L, PREMKUMAR, Ahalya

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U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma von DE CLARO, R. Angelo, MCGINN, Karen, ROTHMANN, Mark, SHAPIRO, Marjorie, BORREGO, Francisco, CLOUSE, Kathleen, XIAO HONG CHEN, BROWN, Janice, AKINSANYA, Lara, KANE, Robert, KAMINSKAS, Edvardas, FARRELL, Ann, KWITKOWSKI, Virginia, PAZDUR, Richard, BULLOCK, Julie, KHANDELWAL, Aakanksha, HABTEMARIAM, Bahru, OUYANG, Yanli, SABER, Haleh, LEE, Kyung, KOTI, Kallappa

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U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia von Alvandi, Firoozeh, Kwitkowski, Virginia E., Ko, Chia‐Wen, Rothmann, Mark D., Ricci, Stacey, Saber, Haleh, Ghosh, Debasis, Brown, Janice, Pfeiler, Erika, Chikhale, Elsbeth, Grillo, Joseph, Bullock, Julie, Kane, Robert, Kaminskas, Edvardas, Farrell, Ann T., Pazdur, Richard

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FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease von King-Kallimanis, Bellinda L., Wroblewski, Tanya, Kwitkowski, Virginia, De Claro, R. Angelo, Gwise, Thomas, Bhatnagar, Vishal, Farrell, Ann T., Kluetz, Paul G.

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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response von Kluetz, Paul G, Papadopoulos, Elektra J, Johnson, Laura Lee, Donoghue, Martha, Kwitkowski, Virginia E, Chen, Wen-Hung, Sridhara, Rajeshwari, Farrell, Ann T, Keegan, Patricia, Kim, Geoffrey, Pazdur, Richard

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Development of a harmonized patient-reported outcome questionnaire to assess myelofibrosis symptoms in clinical trials von Gwaltney, Chad, Paty, Jean, Kwitkowski, Virginia E., Mesa, Ruben A., Dueck, Amylou C., Papadopoulos, Elektra J., Wang, Lixia, Feliciano, Joseph, Coons, Stephen Joel

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U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia von LEE, Hyon-Zu, MILLER, Barry W, KO, Chia-Wen, LEI NIE, SHAPIRO, Marjorie, TOLNAY, Mate, KANE, Robert C, KAMINSKAS, Edvardas, JUSTICE, Robert, FARRELL, Ann T, PAZDUR, Richard, KWITKOWSKI, Virginia E, RICCI, Stacey, DELVALLE, Pedro, SABER, Haleh, GRILLO, Joseph, BULLOCK, Julie, FLORIAN, Jeffry, MEHROTRA, Nitin

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U.S. Food and Drug Administration approval summary: Eltrombopag for the treatment of pediatric patients with chronic immune (idiopathic) thrombocytopenia von Ehrlich, Lori A., Kwitkowski, Virginia E., Reaman, Gregory, Ko, Chia‐Wen, Nie, Lei, Pazdur, Richard, Farrell, Ann T.

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Pain palliation measurement in cancer clinical trials: The US Food and Drug Administration perspective von Basch, Ethan, Trentacosti, Ann Marie, Burke, Laurie B., Kwitkowski, Virginia, Kane, Robert C., Autio, Karen A., Papadopoulos, Elektra, Stansbury, James P., Kluetz, Paul G., Smith, Harry, Justice, Robert, Pazdur, Richard

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Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation von Kanapuru, Bindu, Singh, Harpreet, Kwitkowski, Virginia, Blumenthal, Gideon, Farrell, Ann T., Pazdur, Richard

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FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim‐Chester Disease with the BRAFV600 Mutation von Oneal, Patricia A., Kwitkowski, Virginia, Luo, Lola, Shen, Yuan Li, Subramaniam, Sriram, Shord, Stacy, Goldberg, Kirsten B., McKee, Amy E., Kaminskas, Edvardas, Farrell, Ann, Pazdur, Richard

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Commentary on Heath et al von Kwitkowski, Virginia, Daniels, Selena, Reaman, Gregory, Farrell, Ann, Kluetz, Paul

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Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience von Kanapuru, Bindu, Singh, Harpreet, Myers, Adrian, Beaver, Julia A., Kwitkowski, Virginia Elaine, Farrell, Ann T., Pazdur, Richard

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A prospective analysis of imatinib‐induced c‐kit modulation in ovarian cancer von Posadas, Edwin M., Kwitkowski, Virginia, Kotz, Herbert L., Espina, Virginia, Minasian, Lori, Tchabo, Nana, Premkumar, Ahalya, Hussain, Mahrukh M., Chang, Richard, Steinberg, Seth M., Kohn, Elise C.

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FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAF V600 Mutation von Oneal, Patricia A, Kwitkowski, Virginia, Luo, Lola, Shen, Yuan Li, Subramaniam, Sriram, Shord, Stacy, Goldberg, Kirsten B, McKee, Amy E, Kaminskas, Edvardas, Farrell, Ann, Pazdur, Richard

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‘Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials’- Authors Response to Letter von Kluetz, Paul G., Papadopoulos, Elektra J., Johnson, Laura Lee, Donoghue, Martha, Kwitkowski, Virginia E., Chen, Wen-Hung, Sridhara, Rajeshwari, Farrell, Ann T., Keegan, Patricia, Kim, Geoffrey, Pazdur, Richard

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A phase II and pharmacodynamic study of gefitinib in patients with refractory or recurrent epithelial ovarian cancer von Posadas, Edwin M., Liel, Meghan S., Kwitkowski, Virginia, Minasian, Lori, Godwin, Andrew K., Hussain, Mahrukh M., Espina, Virginia, Wood, Bradford J., Steinberg, Seth M., Kohn, Elise C.

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