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320 results on '"Carson, Kenneth R."'

9. Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997–2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR)

Author

Bennett, Charles L., Hoque, Shamia, Olivieri, Nancy, Taylor, Matthew A., Aboulafia, David, Lubaczewski, Courtney, Bennett, Andrew C., Vemula, Jay, Schooley, Benjamin, Witherspoon, Bartlett J., Godwin, Ashley C, Ray, Paul S., Yarnold, Paul R., Ausdenmoore, Henry C., Fishman, Marc, Herring, Georgne, Ventrone, Anne, Aldaco, Juan, Hrushesky, William J., Restaino, John, Thomsen, Henrik S., Marx, Robert, Migliorati, Cesar, Ruggiero, Salvatore, Nabhan, Chadi, Carson, Kenneth R., McKoy, June M., Yang, Y. Tony, Schoen, Martin W., Knopf, Kevin, Martin, Linda, Sartor, Oliver, Rosen, Steven, and Smith, William K.

Published
2021
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12. A SONAR report on Nirmatrelvir/ritonavir-associated rebound COVID-19: Using new databases for evaluating new diseases.

Author

Bennett, Charles L., Magagnoli, Joseph, Gundabolu, Krishna, Georgantopoulos, Peter, Lebby, Akida, Watson, Gretchen, Knopf, Kevin, Martin, Linda, Carson, Kenneth R., Hrushesky, William J., Nabhan, Chadi, Zyszkowski, Edward, Smith, Edward B., Gale, Robert Peter, and Rosen, Steven T.

Subjects
COVID-19 pandemic, VACCINATION status, COVID-19, COVID-19 testing, DATABASES, SOCIAL media, TONOMETERS
Abstract

Introduction: In May 2022, the Centers for Disease Control and Prevention disseminated an alert advising that "a few" persons with Nirmatrelvir/ritonavir (NM/R)-associated rebound of COVID-19 infection had been identified. Three case reports appearing as pre-print postings described the first cases. Analyses in March 2023 by NM/R's manufacturer and the Food and Drug Administration (FDA) reported no association between NM/R and COVID-19 rebound in a large phase 3 randomized clinical trial. Our study evaluated if social media databases or electronically disseminated new articles might provide insights related to the putative new toxicity, NM/R-associated COVID-19 rebound. Methods: Information on NM/R-associated COVID-19 rebound cases was abstracted from preprint postings of non-peer-reviewed manuscripts, social media websites, electronically disseminated print and television media reports, a new FDA adverse event database for drugs that received Emergency Use Approval, and news articles in scientific journals. Results: Thirty-five persons experienced presumed or documented NM/R-associated COVID-19 rebound, based on information described in preprint services (n = 27), Twitter postings and related news articles (n = 7), and news articles without related Twitter reports (n = 1). These reports included information on dates of initial COVID-19 illness and rebound onset, COVID-19 testing, vaccine status, presentation, and outcome. A new FDA safety database identified 12,500 possible cases of this toxicity, but the quality of these data was poor. Preprint postings preceded peer-reviewed publications describing the same cases by four months. Social media websites including Instagram, Reddit, YouTube, the Center for Disease Control and Prevention's (CDC) Health Alert Network, CDC Twitter, and Facebook did not provide clinically meaningful information on individual cases. Conclusion: Preprint services and Twitter facilitated identification of the largest case series of NM/R-associated COVID-19 rebound. The cases were reported in non-peer-reviewed media several weeks prior to the first peer-reviewed electronically disseminated publication of one person with this diagnosis. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Congressional Investigation of RevAssist-Linked and General Pricing Strategies for Lenalidomide.

Author

Bennett, Charles L., Gibbons, Jason B., Trujillo, Antonio, Carson, Kenneth R., Knopf, Kevin, Nabhan, Chadi, Rosen, Steven T., and Aboulafia, David M.

Subjects
HEALTH services accessibility, POLICY sciences, PATIENT safety, COST analysis, CARBOCYCLIC acids, COMMUNICATION, PATENTS, GENERIC drugs, MEDICAL care costs
Abstract

The article reports on the investigation by the U.S. Congress on the pricing and market protection by drug makers of anti-multiple myeloma agent lenalidomide. Topics mentioned include the impact of the tactics used by drug makers on patients and Medicare, the use of risk evaluation and mitigation strategy, called RevAssist, to prevent generic competition and the factors that influenced the pricing activity of lenalidomide.

Published
2024
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16. Clinical and Genomic Characteristics of Small Cell Lung Cancer in Never Smokers: Results From a Retrospective Multicenter Cohort Study

Author

Thomas, Anish, Mian, Idrees, Tlemsani, Camille, Pongor, Lorinc, Takahashi, Nobuyuki, Maignan, Kathleen, Snider, Jeremy, Li, Gerald, Frampton, Garrett, Ali, Siraj, Kim, Sehyun, Nichols, Samantha, Rajapakse, Vinodh, Guha, Udayan, Sharon, Elad, Fujimoto, Junya, Moran, Cesar A., Wistuba, Ignacio I., Wei, Jun S., Khan, Javed, Szabo, Eva, Torres, Aracelis Z., and Carson, Kenneth R.

Published
2020
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20. Analysis of Peripheral T-cell Lymphoma Diagnostic Workup in the United States

Author

Hsi, Eric D., Horwitz, Steven M., Carson, Kenneth R., Pinter-Brown, Lauren C., Rosen, Steven T., Pro, Barbara, Federico, Massimo, Gisselbrecht, Christian, Schwartz, Marc, Bellm, Lisa A., Acosta, Mark, Collie, Angela M., Gruver, Aaron M., Grzywacz, Bartosz J., Turakhia, Samir, Shustov, Andrei R., Advani, Ranjana H., Feldman, Tatyana, Lechowicz, Mary Jo, Smith, Sonali M., Lansigan, Frederick, Tulpule, Anil, Craig, Michael D., Greer, John P., Kahl, Brad S., Leach, Joseph W., Morganstein, Neil, Casulo, Carla, Park, Steven I., and Foss, Francine M.

Published
2017
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25. Characteristics and clinical outcomes of patients with ALK‐positive anaplastic large cell lymphoma: Report from the prospective international T‐cell lymphoma project

Author

Chiattone, Carlos, primary, Civallero, Monica, additional, Fischer, Thais, additional, Miranda, Eliana, additional, Manni, Martina, additional, Zing, Natalia P. C., additional, Pileri, Stefano A., additional, Montoto, Silvia, additional, Horwitz, Steven M., additional, Cabrera, Maria Elena, additional, De Souza, Carmino A., additional, Nagler, Arnon, additional, Luminari, Stefano, additional, Ferreri, Andrés J. M., additional, Carson, Kenneth R., additional, Re, Alessandro, additional, Rigacci, Luigi, additional, Nassi, Luca, additional, Stepanishyna, Yana, additional, Federico, Massimo, additional, and Inghirami, Giorgio, additional

Published
2022
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26. Survival of veterans treated with enzalutamide and abiraterone for metastatic castrate resistant prostate cancer based on comorbid diseases

Author

Schoen, Martin W., primary, Carson, Kenneth R., additional, Eisen, Seth A., additional, Bennett, Charles L., additional, Luo, Suhong, additional, Reimers, Melissa A., additional, Knoche, Eric M., additional, Whitmer, Alison L., additional, Yan, Yan, additional, Drake, Bettina F., additional, and Sanfilippo, Kristen M., additional

Published
2022
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29. A phase II study of cyclophosphamide, etoposide, vincristine and prednisone (CEOP) Alternating with Pralatrexate (P) as front line therapy for patients with peripheral T-cell lymphoma (PTCL): final results from the T- cell consortium trial

Author

Advani, Ranjana H., Ansell, Stephen M., Lechowicz, Mary J., Beaven, Anne W., Loberiza, Fausto, Carson, Kenneth R., Evens, Andrew M., Foss, Francine, Horwitz, Steven, Pro, Barbara, Pinter-Brown, Lauren C., Smith, Sonali M., Shustov, Andrei R., Savage, Kerry J., and Vose, Julie M.

Published
2016
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30. Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men

Author

Kraus, Albert L., primary, Yu‐Kite, Michelle, additional, Mardekian, Jack, additional, Cotter, Matthew J., additional, Kim, Sindy, additional, Decembrino, Jaclyn, additional, Snow, Tamara, additional, Carson, Kenneth R., additional, Motyl Rockland, Jillian, additional, Gossai, Anala, additional, Wilner, Keith, additional, Wang, Diane D., additional, Huang Bartlett, Cynthia, additional, Oharu, Norihiko, additional, Schnell, Patrick, additional, VanArsdale, Todd, additional, Lu, Dongrui R., additional, and Tursi, Jennifer M., additional

Published
2021
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31. Characteristics and Outcome of Extranodal NK/T-cell Lymphoma in North America: A Retrospective Multi-Institutional Experience

Author

Bennani, Nora N., primary, Tun, Aung M., additional, Carson, Kenneth R, additional, Geiger, Jessica L, additional, Maeda, Lauren S, additional, Savage, Kerry J, additional, Rose, Jim, additional, Pinter-Brown, Lauren, additional, Lunning, Matthew A, additional, Abramson, Jeremy S, additional, Bartlett, Nancy L, additional, Vose, Julie M, additional, Evens, Andrew M, additional, Smith, Sonali M, additional, Horwitz, Steven M, additional, Ansell, Stephen M., additional, and Advani, Ranjana H, additional

Published
2021
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32. Mogamulizumab-associated rash frequently mimics cutaneous T-cell lymphoma recurrence but heralds a positive response to therapy: an updated single-center case series

Author

Trum, Nicholas A., primary, Zain, Jasmine, additional, Martinez, Xochiquetzal U., additional, Parekh, VIshwas, additional, Afkhami, Michelle, additional, Abdulla, Farah, additional, Carson, Kenneth R., additional, Rosen, Steven T., additional, Bennett, Charles L., additional, and Querfeld, Christiane, additional

Published
2021
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34. Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997–2019):A qualitative analysis from the Southern Network on Adverse Reactions (SONAR)

Author

Bennett, Charles L., Hoque, Shamia, Olivieri, Nancy, Taylor, Matthew A., Aboulafia, David, Lubaczewski, Courtney, Bennett, Andrew C., Vemula, Jay, Schooley, Benjamin, Witherspoon, Bartlett J., Godwin, Ashley C., Ray, Paul S., Yarnold, Paul R., Ausdenmoore, Henry C., Fishman, Marc, Herring, Georgne, Ventrone, Anne, Aldaco, Juan, Hrushesky, William J., Restaino, John, Thomsen, Henrik S., Marx, Robert, Migliorati, Cesar, Ruggiero, Salvatore, Nabhan, Chadi, Carson, Kenneth R., McKoy, June M., Yang, Y. Tony, Schoen, Martin W., Knopf, Kevin, Martin, Linda, Sartor, Oliver, Rosen, Steven, Smith, William K., Bennett, Charles L., Hoque, Shamia, Olivieri, Nancy, Taylor, Matthew A., Aboulafia, David, Lubaczewski, Courtney, Bennett, Andrew C., Vemula, Jay, Schooley, Benjamin, Witherspoon, Bartlett J., Godwin, Ashley C., Ray, Paul S., Yarnold, Paul R., Ausdenmoore, Henry C., Fishman, Marc, Herring, Georgne, Ventrone, Anne, Aldaco, Juan, Hrushesky, William J., Restaino, John, Thomsen, Henrik S., Marx, Robert, Migliorati, Cesar, Ruggiero, Salvatore, Nabhan, Chadi, Carson, Kenneth R., McKoy, June M., Yang, Y. Tony, Schoen, Martin W., Knopf, Kevin, Martin, Linda, Sartor, Oliver, Rosen, Steven, and Smith, William K.

Abstract

Background: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting. Methods: We reviewed clinician identified very serious ADRs published between 1997 and 2019. Drugs and devices associated with reports of very serious ADRs were identified. Included drugs or devices had market removal discussed at Food and Drug Advisory (FDA) Advisory Committee meetings, were published by clinicians, had sales > $1 billion, were associated with CTCAE Grade 4 or 5 toxicity effects, and had either >$1 billion in settlements or >1,000 injured patients. Data sources included journals, Congressional transcripts, and news reports. We reviewed data on: 1) timing of ADR reports, Boxed warnings, and product withdrawals, and 2) patient, clinician, and manufacturer impacts. Binomial analysis was used to compare sales pre- and post-FDA Advisory Committee meetings. Findings: Twenty very serious ADRs involved fifteen drugs and one device. Legal settlements totaled $38.4 billion for 753,900 injured persons. Eleven of 18 clinicians (61%) reported harms, including verbal threats from manufacturer (five) and loss of a faculty position (one). Annual sales decreased 94% from $29.1 billion pre-FDA meeting to $4.9 billion afterwards (p<0.0018). Manufacturers of four drugs paid $1.7 billion total in criminal fines for failing to inform the FDA and physicians about very serious ADRs. Following FDA approval, the median time to ADR reporting was 7.5 years (Interquartile range 3,13 years). Twelve drugs received Box warnings and one drug received a warning (median, 7.5 years following ADR reporting (IQR 5,11 years). Six

Published
2021

35. The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy‐Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

Author

Bennett, Charles L., primary, Nagai, Sumimasa, additional, Bennett, Andrew C., additional, Hoque, Shamia, additional, Nabhan, Chadi, additional, Schoen, Martin W., additional, Hrushesky, William J., additional, Luminari, Stefano, additional, Ray, Paul, additional, Yarnold, Paul R., additional, Witherspoon, Bart, additional, Riente, Josh, additional, Bobolts, Laura, additional, Brusk, John, additional, Tombleson, Rebecca, additional, Knopf, Kevin, additional, Fishman, Marc, additional, Yang, Y. Tony, additional, Carson, Kenneth R., additional, Djulbegovic, Benjamin, additional, Restaino, John, additional, Armitage, James O., additional, and Sartor, Oliver A., additional

Published
2021
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37. Prevalence of High Tumor Mutational Burden and Association With Survival in Patients With Less Common Solid Tumors

Author

Shao, Changxia, primary, Li, Gerald, additional, Huang, Lingkang, additional, Pruitt, Scott, additional, Castellanos, Emily, additional, Frampton, Garrett, additional, Carson, Kenneth R., additional, Snow, Tamara, additional, Singal, Gaurav, additional, Fabrizio, David, additional, Alexander, Brian M., additional, Jin, Fan, additional, and Zhou, Wei, additional

Published
2020
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38. End of an era of administering erythropoiesis stimulating agents among Veterans Administration cancer patients with chemotherapy-induced anemia

Author

Hoque, Shamia, primary, Chen, Brian J., additional, Schoen, Martin W., additional, Carson, Kenneth R., additional, Keller, Jesse, additional, Witherspoon, Bartlett J., additional, Knopf, Kevin B., additional, Yang, Y. Tony, additional, Schooley, Benjamin, additional, Nabhan, Chadi, additional, Sartor, Oliver, additional, Yarnold, Paul R., additional, Ray, Paul, additional, Bobolts, Laura, additional, Hrushesky, William J., additional, Dickson, Michael, additional, and Bennett, Charles L., additional

Published
2020
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40. Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men.

Author

Kraus, Albert L., Yu‐Kite, Michelle, Mardekian, Jack, Cotter, Matthew J., Kim, Sindy, Decembrino, Jaclyn, Snow, Tamara, Carson, Kenneth R., Motyl Rockland, Jillian, Gossai, Anala, Wilner, Keith, Wang, Diane D., Huang Bartlett, Cynthia, Oharu, Norihiko, Schnell, Patrick, VanArsdale, Todd, Lu, Dongrui R., and Tursi, Jennifer M.

Subjects
PROGRESSION-free survival, MALE breast cancer, METASTATIC breast cancer, HORMONE therapy, ELECTRONIC health records, EPIDERMAL growth factor receptors
Abstract

This report examined the benefits and risks of palbociclib plus endocrine therapy (ET) in men with hormone receptor‒positive (HR+)/human epidermal growth factor receptor 2−negative (HER2−) metastatic breast cancer (MBC). Palbociclib was evaluated using three independent data sources: real‐world data from pharmacy and medical claims, a de‐identified real‐world data source derived from electronic health records (EHRs), and a global safety database. From medical and pharmacy records, 1,139 men with MBC were identified; in the first‐line setting, median duration of treatment was longer with palbociclib plus ET (n = 37, 8.5 months, 95% confidence interval (CI), 4.4‒13.0) than ET alone (n = 214, 4.3 months, 95% CI, 3.0‒5.7) and specifically, was longer with palbociclib plus letrozole (n = 26, 9.4 months, 95% CI, 4.4‒14.0) than letrozole alone (n = 63, 3.0 months, 95% CI, 1.8‒4.8). In the EHR‐derived database, 59 men received treatment for MBC; real‐world response across all lines of therapy in the metastatic setting was reported in 4 of 12 patients (33.3%) in the palbociclib plus ET group vs. 1 of 8 (12.5%) patients in the ET group. Review of the global safety database did not identify any new safety signals in palbociclib‐treated men. Real‐world data indicated that men with MBC benefit from palbociclib plus ET, with a safety profile consistent with previous observations in women with MBC. Collective data on palbociclib in women and men in this report, including clinical trial data, real‐world data, and a well‐established risk/benefit profile, led to US approval of an expansion of the palbociclib indication to include men with MBC. [ABSTRACT FROM AUTHOR]

Published
2022
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41. Consequences to Patients, Clinicians, and Manufacturers When Titanic Adverse Drug Reactions are Identified (1997- 2019): A Report from the Southern Network on Adverse Reactions (SONAR)

Author

Bennett, Charles L., primary, Hoque, Shamia, additional, Aboulafia, David, additional, Lubaczewski, Courtney, additional, Bennett, Andrew C., additional, Vemula, Jay, additional, Schooley, Benjamin, additional, Taylor, Matthew A., additional, Witherspoon, Bartlett J., additional, Godwin, Ashley, additional, Ray, Paul S., additional, Yarnold, Paul R., additional, Ausdenmoore, Henry C., additional, Herring, Georgine, additional, Ventrone, Anne, additional, Hrushesky, William J., additional, Restaino, John, additional, Thomsen, Henrik S., additional, Marx, Robert, additional, Migliorati, Cesar, additional, Ruggiero, Salvatore, additional, Nabhan, Chadi, additional, Carson, Kenneth R., additional, McKoy, June, additional, Yang, Y. Tony, additional, Smith, William K., additional, Schooley, Martin, additional, Knopf, Kevin, additional, Martin, Linda, additional, Sartor, Oliver, additional, and Rosen, Steven, additional

Published
2020
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50. Predicting venous thromboembolism in multiple myeloma: development and validation of the IMPEDE VTE score

Author

Sanfilippo, Kristen M., primary, Luo, Suhong, additional, Wang, Tzu‐Fei, additional, Fiala, Mark, additional, Schoen, Martin, additional, Wildes, Tanya M., additional, Mikhael, Joseph, additional, Kuderer, Nicole M., additional, Calverley, David C., additional, Keller, Jesse, additional, Thomas, Theodore, additional, Carson, Kenneth R., additional, and Gage, Brian F., additional

Published
2019
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