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2. 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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3. 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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7. Five hematologic tests and treatments to question

Author

Hicks, Lisa K., Bering, Harriet, Carson, Kenneth R., Haynes, Adam E., Kleinerman, Judith, Kukreti, Vishal, Ma, Alice, Mueller, Brigitta U., O’Brien, Sarah H., Panepinto, Julie A., Pasquini, Marcelo C., Rajasekhar, Anita, Sarode, Ravi, and Wood, William A.

Published
2014
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9. The 2011–2016 Transdisciplinary Research on Energetics and Cancer (TREC) Initiative: Rationale and Design

Author

Patterson, Ruth E., Colditz, Graham A., Hu, Frank B., Schmitz, Kathryn H., Ahima, Rexford S., Brownson, Ross C., Carson, Kenneth R., Chavarro, Jorge E., Chodosh, Lewis A., Gehlert, Sarah, Gill, Jeff, Glanz, Karen, Haire-Joshu, Debra, Herbst, Karen Louise, Hoehner, Christine M., Hovmand, Peter S., Irwin, Melinda L., Jacobs, Linda A., James, Aimee S., Jones, Lee W., Kerr, Jacqueline, Kibel, Adam S., King, Irena B., Ligibel, Jennifer A., Meyerhardt, Jeffrey A., Natarajan, Loki, Neuhouser, Marian L., Olefsky, Jerrold M., Proctor, Enola K., Redline, Susan, Rock, Cheryl L., Rosner, Bernard, Sarwer, David B., Schwartz, J. Sanford, Sears, Dorothy D., Sesso, Howard D., Stampfer, Meir J., Subramanian, S. V., Taveras, Elsie M., Tchou, Julia, Thompson, Beti, Troxel, Andrea B., Wessling-Resnick, Marianne, Wolin, Kathleen Y., and Thornquist, Mark D.

Published
2013

12. Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports project

Author

Carson, Kenneth R., Evens, Andrew M., Richey, Elizabeth A., Habermann, Thomas M., Focosi, Daniele, Seymour, John F., Laubach, Jacob, Bawn, Susie D., Gordon, Leo I., Winter, Jane N., Furman, Richard R., Vose, Julie M., Zelenetz, Andrew D., Mamtani, Ronac, Raisch, Dennis W., Dorshimer, Gary W., Rosen, Steven T., Muro, Kenji, Gottardi-Littell, Numa R., Talley, Robert L., Sartor, Oliver, Green, David, Major, Eugene O., and Bennett, Charles L.

Published
2009
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14. 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

15. 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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16. 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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17. 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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18. Long-term outcome of individuals with pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project

Author

Bennett, Charles L., Cournoyer, Denis, Carson, Kenneth R., Rossert, Jerome, Luminari, Stefano, Evens, Andrew M., Locatelli, Francesco, Belknap, Steven M., McKoy, June M., Lyons, E. Alison, Kim, Benjamin, Sharma, Rishi, Costello, Stacey, Toffelmire, Edwin B., Wells, George A., Messner, Hans A., Yarnold, Paul R., Trifilio, Steven M., Raisch, Dennis W., Kuzel, Timothy M., Nissenson, Allen, Lim, Lay-Cheng, Tallman, Martin S., and Casadevall, Nicole

Published
2005
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27. 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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28. Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval

Author

Khozin, Sean, primary, Carson, Kenneth R., additional, Zhi, Jizu, additional, Tucker, Melisa, additional, Lee, Shannon E., additional, Light, David E., additional, Curtis, Melissa D., additional, Bralic, Marta, additional, Kaganman, Irene, additional, Gossai, Anala, additional, Hofmeister, Philip, additional, Torres, Aracelis Z., additional, Miksad, Rebecca A., additional, Blumenthal, Gideon Michael, additional, Pazdur, Richard, additional, and Abernethy, Amy P., additional

Published
2018
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38. Impact of sarcopenia on treatment tolerance in United States veterans with diffuse large B-cell lymphoma treated with CHOP-based chemotherapy

Author

Xiao, Daphne Y., Luo, Suhong, O’Brian, Katiuscia, Ganti, Arun, Riedell, Peter, Sanfilippo, Kristen M., Lynch, Ryan C., Liu, Weijian, and Carson, Kenneth R.

Subjects
Male, Sarcopenia, Neutropenia, Maximum Tolerated Dose, Middle Aged, Article, United States, Hospitalization, Treatment Outcome, Doxorubicin, Vincristine, Antineoplastic Combined Chemotherapy Protocols, Humans, Prednisone, Lymphoma, Large B-Cell, Diffuse, human activities, Cyclophosphamide, Aged, Veterans
Abstract

While sarcopenia has been associated with decreased overall survival in diffuse large B-cell (DLBCL) patients, the impact of sarcopenia on treatment tolerance has not been well-studied. We evaluated the association of sarcopenia with febrile neutropenia hospitalization, treatment-related mortality, and ability to complete standard number of cycles in a retrospective cohort of United States veterans diagnosed with DLBCL between 1998 and 2008 and treated with cyclophosphamide, doxorubicin, vincristine, and prednisone, with or without rituximab. Baseline body composition parameters were evaluated using computed tomography analysis. In total, 522 patients were included in the study, of whom 245 (47%) had baseline sarcopenia. After controlling for other variables, baseline sarcopenia was independently associated with increased risk of febrile neutropenia hospitalization (adjusted Odds Ratio (aOR) 1.64, 95% confidence interval (CI) 1.01-2.65) and inability to complete standard number of treatment cycles (aOR 1.49, 95% CI 1.02-2.16) compared with no baseline sarcopenia. There was a non-statistically significant trend toward higher treatment-related mortality in sarcopenic patients than non-sarcopenic patients (aOR 1.77, 95% CI 0.92-3.41). Sarcopenia is associated with increased risk of treatment intolerance and may be useful in guiding treatment planning and supportive care measures. Am. J. Hematol. 91:1002-1007, 2016. © 2016 Wiley Periodicals, Inc.

Published
2016

39. Post-MGUS Diagnosis Serum Monoclonal-Protein Velocity and the Progression of Monoclonal Gammopathy of Undetermined Significance to Multiple Myeloma.

Author

Su-Hsin Chang, Gumbel, Jason, Suhong Luo, Thomas, Theodore S., Sanfilippo, Kristen M., Jingqin Luo, Colditz, Graham A., and Carson, Kenneth R.

Abstract

Background: Multiple myeloma is a common hematologic malignancy consistently preceded by monoclonal gammopathy of undetermined significance (MGUS). Little is known about postdiagnosis clinical predictors of progression of MGUS to multiple myeloma to guide MGUS management. This study aimed to investigate whether the rate of rise in serum monoclonal protein concentration during the year after MGUS diagnosis--M-protein velocity--predicts progression of MGUS to multiple myeloma. Methods: Data from the U.S. Veterans Health Administration system were used. A retrospective cohort of patients with MGUS who progressed to multiple myeloma were matched on age at MGUS diagnosis and race in a 1:4 ratio to the patients with MGUS using incidence density sampling. Kaplan-Meier curves were plotted. Univariable and multivariable conditional logistic regression analyses were fitted from the matched risk sets. Results: A total of 128 cases and 490 matched controls were included. The case group contained a higher percentage of patients with M-protein velocity >0.1 g/dL/year than the control group (44.5% vs. 28.2%, P <0.0001). M-protein velocity of >0.1 g/dL during the year following MGUS diagnosis was positively associated with progression of MGUS to multiple myeloma (multivariable-adjusted odds ratio = 2.15; 95% confidence interval, 1.37-3.35). Conclusions: Patients with a positive M-protein velocity during the year after MGUS diagnosis may be considered for more frequent monitoring for early detection and timely treatment of multiple myeloma. Future prevention studies could target these patients for intervention evaluation. Impact: Our results suggest a new clinical predictor of progression to multiple myeloma following MGUS diagnosis, which has potential to identify high-risk patients for management and prevention. [ABSTRACT FROM AUTHOR]

Published
2019
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40. Real‐World Outcomes of Patients with Metastatic Non‐Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval.

Author

Khozin, Sean, Carson, Kenneth R., Zhi, Jizu, Tucker, Melisa, Lee, Shannon E., Light, David E., Curtis, Melissa D., Bralic, Marta, Kaganman, Irene, Gossai, Anala, Hofmeister, Philip, Torres, Aracelis Z., Miksad, Rebecca A., Blumenthal, Gideon Michael, Pazdur, Richard, and Abernethy, Amy P.

Subjects
LUNG cancer diagnosis, THERAPEUTIC use of monoclonal antibodies, LUNG cancer prognosis, AGE distribution, CANCER patient medical care, CELL receptors, CONFIDENCE intervals, EPIDERMAL growth factor, IMMUNOTHERAPY, LONGITUDINAL method, LUNG cancer, METASTASIS, GENETIC mutation, SURVIVAL, DRUG approval, TREATMENT effectiveness, RETROSPECTIVE studies, ELECTRONIC health records, ANAPLASTIC lymphoma kinase
Abstract

Copyright of Oncologist is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2019
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43. Differential Outcome of Patients with Primary Refractory Vs. Relapsed Peripheral T-Cell Lymphoma: Analysis from a Prospective Multicenter US Cohort Study

Author

Lansigan, Frederick, primary, Horwitz, Steven M, additional, Pinter-Brown, Lauren C, additional, Carson, Kenneth R, additional, Shustov, Andrei R, additional, Rosen, Steven T., additional, Pro, Barbara, additional, Hsi, Eric D., additional, Federico, Massimo, additional, Gisselbrecht, Christian, additional, Schwartz, Marc, additional, Bellm, Lisa A, additional, Acosta, Mark, additional, and Foss, Francine M., additional

Published
2016
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47. Longitudinal Body Composition Changes in Diffuse Large B-cell Lymphoma Survivors: A Retrospective Cohort Study of United States Veterans

Author

Xiao, Daphne Y., primary, Luo, Suhong, additional, O’Brian, Katiuscia, additional, Sanfilippo, Kristen M., additional, Ganti, Arun, additional, Riedell, Peter, additional, Lynch, Ryan C., additional, Liu, Weijian, additional, Kahl, Brad S., additional, Cashen, Amanda F., additional, Fehniger, Todd A., additional, and Carson, Kenneth R., additional

Published
2016
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48. Identifying existing Choosing Wisely recommendations of high relevance and importance to hematology

Author

Hicks, Lisa K., primary, Rajasekhar, Anita, additional, Bering, Harriet, additional, Carson, Kenneth R., additional, Kleinerman, Judith, additional, Kukreti, Vishal, additional, Ma, Alice, additional, Mueller, Brigitta U., additional, O'Brien, Sarah H., additional, Panepinto, Julie A., additional, Pasquini, Marcelo C., additional, Sarode, Ravi, additional, and Wood, William A., additional

Published
2016
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49. Progressive multifocal leukoencephalopathy associated with brentuximab vedotin therapy: a report of 5 cases from the Southern Network on Adverse Reactions (SONAR) project

Author

Carson, Kenneth R., Newsome, Scott D., Kim, Ellen J., Wagner-Johnston, Nina D., von Geldern, Gloria, Moskowitz, Craig H., Moskowitz, Alison J., Rook, Alain H., Jalan, Pankaj, Loren, Alison W., Landsburg, Daniel, Coyne, Thomas, Tsai, Donald, Raisch, Dennis W., Norris, LeAnn B., Bookstaver, P Brandon, Sartor, Oliver, and Bennett, Charles L.

Subjects
Adult, Brentuximab Vedotin, Immunoconjugates, Lymphoma, Primary Cutaneous Anaplastic Large Cell, Mycosis Fungoides, Leukoencephalopathy, Progressive Multifocal, Humans, Middle Aged, Hodgkin Disease, Article, Aged
Abstract

Brentuximab vedotin (BV) is an anti-CD30 monoclonal antibody-drug conjugate that was approved in 2011 for the treatment of patients with anaplastic large cell and Hodgkin lymphomas. The product label indicates that 3 patients who were treated with BV developed progressive multifocal leukoencephalopathy (PML), a frequently fatal JC virus-induced central nervous system infection. Prior immunosuppressive therapy and compromised immune systems were postulated risk factors. In the current study, the authors reported 5 patients who developed BV-associated PML, including 2 immunocompetent patients.Case information was obtained from clinicians (4 patients) or a US Food and Drug Administration database (1 patient).All 5 patients had lymphoid malignancies. Two patients with cutaneous T-cell lymphomas had not previously received chemotherapy. PML developed after a median of 3 BV doses (range, 2 doses-6 doses) and within a median of 7 weeks after BV initiation (range, 3 weeks-34 weeks). Presenting findings included aphasia, dysarthria, confusion, hemiparesis, and gait dysfunction; JC virus in the cerebrospinal fluid (2 patients) or central nervous system biopsy (3 patients); and brain magnetic resonance imaging scans with white matter abnormalities (5 patients). Four patients died at a median of 8 weeks (range, 6 weeks-16 weeks) after PML diagnosis. The sole survivor developed immune reconstitution inflammatory syndrome.PML can develop after a few BV doses and within weeks of BV initiation. Clinicians should be aware of this syndrome, particularly when neurologic changes develop after the initiation of BV treatment. The decision to administer BV to patients with indolent cutaneous lymphomas should be based on consideration of risk-benefit profiles and of alternative options.

Published
2013

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