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31 results on '"Sobel, Rachel E."'

3. Comparative effectiveness of linvoseltamab versus standard-of-care (SOC) treatment (tx) in real-world patients (pts) in the United States (US) with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM).

Author

Kumar, Shaji, primary, Weisel, Katja C, additional, Ma, Qiufei, additional, Hampp, Christian, additional, Humblet, Olivier, additional, Shokoohi, Mostafa, additional, Bonar, Nicolle, additional, Spin, Paul, additional, Harnett, James, additional, Ge, Wenzhen, additional, Jalbert, Jessica J, additional, Sobel, Rachel E, additional, Kroog, Glenn Scott, additional, Rodriguez-Lorenc, Karen, additional, and Jagannath, Sundar, additional

Published
2024
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7. PB2281: TRIAL IN PROGRESS: FOLLICULAR LYMPHOMA OUTCOMES IN RELAPSED/REFRACTORY PATIENTS TREATED WITH SYSTEMIC THERAPY IN A REAL-WORLD ASSESSMENT (FLORA)

Author

Damaj, Gandhi Laurent, primary, Bachy, Emmanuel, additional, MA, Qiufei, additional, Hampp, Christian, additional, Harnett, James, additional, Sobel, Rachel E, additional, Jalbert, Jessica J, additional, Quek, Ruben Gw, additional, Wei, Wenhui, additional, Wu, Ning, additional, Mastey, Vera, additional, Wang, Joy, additional, Bajwa, Anit, additional, Maissenhaelter, Benedikt, additional, van Gils, Chantal, additional, Aggarwal, Shivani, additional, Chaudhry, Aafia, additional, Mohamed, Hesham, additional, Ambati, Srikanth, additional, and Thieblemont, Catherine, additional

Published
2023
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8. PB2357: TRIAL IN PROGRESS: OUTCOMES IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA TREATED WITH SYSTEMIC THERAPY FROM REAL-WORLD EXPERIENCE (ORCHID)

Author

Thieblemont, Catherine, primary, MA, Qiufei, additional, Hampp, Christian, additional, Harnett, James, additional, Sobel, Rachel E, additional, Jalbert, Jessica J, additional, Quek, Ruben Gw, additional, Wei, Wenhui, additional, Wu, Ning, additional, Mastey, Vera, additional, Wang, Joy, additional, Bajwa, Anit, additional, Maissenhaelter, Benedikt, additional, Gils, Chantal van, additional, Aggarwal, Shivani, additional, Chaudhry, Aafia, additional, Mohamed, Hesham, additional, Ambati, Srikanth, additional, Bachy, Emmanuel, additional, and Damaj, Gandhi Laurent, additional

Published
2023
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11. Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls

Author

Curtis, Lesley H., primary, Sola‐Morales, Oriol, additional, Heidt, Julien, additional, Saunders‐Hastings, Patrick, additional, Walsh, Laura, additional, Casso, Deborah, additional, Oliveria, Susan, additional, Mercado, Tiffany, additional, Zusterzeel, Robbert, additional, Sobel, Rachel E., additional, Jalbert, Jessica J., additional, Mastey, Vera, additional, Harnett, James, additional, and Quek, Ruben G. W., additional

Published
2023
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14. Trial in Progress: Outcomes in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with Systemic Therapy from Real-World Experience (ORCHID)

Author

Thieblemont, Catherine, primary, Ma, Qiufei, additional, Hampp, Christian, additional, Harnett, James, additional, Sobel, Rachel E., additional, Jalbert, Jessica J., additional, Quek, Ruben G.W., additional, Wei, Wenhui, additional, Wu, Ning, additional, Mastey, Vera, additional, Wang, Joy, additional, Bajwa, Anit, additional, Maissenhaelter, Benedikt, additional, van Gils, Chantal, additional, Aggarwal, Shivani, additional, Chaudhry, Aafia, additional, Mohamed, Hesham, additional, Ambati, Srikanth R., additional, Bachy, Emmanuel, additional, and Damaj, Gandhi Laurent, additional

Published
2022
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15. Trial in Progress: Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated with Systemic Therapy in a Real-World Assessment (FLORA)

Author

Bachy, Emmanuel, primary, Damaj, Gandhi Laurent, additional, Ma, Qiufei, additional, Hampp, Christian, additional, Harnett, James, additional, Sobel, Rachel E., additional, Jalbert, Jessica J., additional, Quek, Ruben G.W., additional, Wei, Wenhui, additional, Wu, Ning, additional, Mastey, Vera, additional, Wang, Joy, additional, Bajwa, Anit, additional, Maissenhaelter, Benedikt, additional, van Gils, Chantal, additional, Aggarwal, Shivani, additional, Chaudhry, Aafia, additional, Mohamed, Hesham, additional, Ambati, Srikanth R., additional, and Thieblemont, Catherine, additional

Published
2022
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19. A web-based survey of UK pharmacists to assess the effectiveness of Viagra Connect® additional risk minimisation measures.

Author

Lem, Joanna, Collins, Janine, Maguire, Terry, and Sobel, Rachel E.

Subjects
SILDENAFIL, PHARMACISTS, INTERNET surveys, PHARMACY, DESCRIPTIVE statistics
Abstract

Background To support reclassification in the UK of sildenafil citrate (50 mg) from prescription-only medicine to a pharmacy medicine (P status) under the brand name "Viagra Connect®", additional risk minimisation measures were implemented that included training materials and an optional checklist to assist community pharmacists in the safe supply of Viagra Connect® to suitable patients. Objective To evaluate the effectiveness of Viagra Connect® additional risk minimisation measures by assessing community pharmacists' participation in training, their knowledge of key risk messages, and utilisation of the checklist. Setting A post-authorisation safety study implemented as a web-based survey, conducted in a representative population of UK community pharmacists. Method A random sample of community pharmacists who received at least 1 request to supply Viagra Connect® within the past 6 months completed an online questionnaire of 33 closed-ended questions/statements with multiple-choice responses. Data were summarised using descriptive statistics. Main outcome measure Knowledge of key risk messages and dispensing practices communicated in the additional risk minimisation measures. Results The survey was completed by 345 community pharmacists. Respondents displayed a high level of knowledge of key risk messages, with ≥80 % selecting correct answers for 43/51 items. Nearly all respondents (90.1 %) reported that the training materials were useful/very useful, and reported using the checklist at the point of supply (91.9 %). Counselling of patients who requested Viagra Connect® was generally considered a positive exercise. Conclusions The Viagra Connect® additional risk minimisation measures were effective for education of community pharmacists and to ensure safe supply of Viagra Connect® behind-the-counter to patients. [ABSTRACT FROM AUTHOR]

Published
2022
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20. The utility of real‐world evidence for benefit‐risk assessment, communication, and evaluation of pharmaceuticals: Case studies

Author

Radawski, Christine A., primary, Hammad, Tarek A., additional, Colilla, Susan, additional, Coplan, Paul, additional, Hornbuckle, Kenneth, additional, Freeman, Emily, additional, Smith, Meredith Y., additional, Sobel, Rachel E., additional, Bahri, Priya, additional, Arias, Ariel E., additional, and Bennett, Dimitri, additional

Published
2020
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24. A Case Study of the Incremental Utility for Disease Identification of Natural Language Processing in Electronic Medical Records.

Author

Weiss, Lisa S., Zhou, Xiaofeng, Walker, Alexander M., Ananthakrishnan, Ashwin N., Shen, Rongjun, Sobel, Rachel E., Bate, Andrew, and Reynolds, Robert F.

Subjects
NATURAL language processing, ELECTRONIC health records, MEDICAL informatics, LIVER disease diagnosis, PUBLIC health surveillance
Abstract

Background: Information exists as unstructured medical text in healthcare databases. Such information is not routinely considered in safety surveillance but typically relies solely on structured (coded) data. Natural language processing (NLP) may allow the capture of concepts from unstructured data and thus enhance safety surveillance capability.Objectives: We sought to assess the added contribution of unstructured data extracted from medical text by NLP for detecting acute liver dysfunction (ALD) in patients with inflammatory bowel disease (IBD).Methods: Using a previously developed rule, we evaluated structured and unstructured NLP-extracted terms from a commercially available electronic medical record (EMR) system. The rule was intended to identify ALD diagnosis and timing of onset and was the result of three iterations of rule development using 150 ALD candidate cases. We evaluated the performance of the rule with or without NLP among all candidate cases and among 50 new cases with clinical adjudication.Results: NLP terms were necessary for the diagnosis of 9% of cases and for ruling out 3% of false-positive cases. Inclusion of NLP terms led to an identification of an additional  9% of ALD-onset dates, with consequent earlier recognition in 5%.Conclusions: NLP-derived terms in one large commercially available EMR system modestly improved the sensitivity and specificity in the identification of ALD and identified earlier onset. [ABSTRACT FROM AUTHOR]

Published
2018
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25. Novel Method to Collect Medication Adverse Events in Juvenile Arthritis: Results From the Childhood Arthritis and Rheumatology Research Alliance Enhanced Drug Safety Surveillance Project

Author

Ringold, Sarah, primary, Hendrickson, Audrey, additional, Abramson, Leslie, additional, Beukelman, Timothy, additional, Blier, Peter R., additional, Bohnsack, John, additional, Chalom, Elizabeth C., additional, Gewanter, Harry L., additional, Gottlieb, Beth, additional, Hollister, Roger, additional, Hsu, Joyce, additional, Hudgins, Andrea, additional, Ilowite, Norman T., additional, Klein-Gitelman, Marisa, additional, Lindsley, Carol, additional, Lopez Benitez, Jorge M., additional, Lovell, Daniel J., additional, Mason, Tom, additional, Milojevic, Diana, additional, Moorthy, Lakshmi N., additional, Nanda, Kabita, additional, Onel, Karen, additional, Prahalad, Sampath, additional, Rabinovich, C. Egla, additional, Ray, Linda, additional, Rouster-Stevens, Kelly, additional, Ruth, Natasha, additional, Shishov, Michael, additional, Spalding, Steven, additional, Syed, Reema, additional, Stoll, Matthew, additional, Vehe, Richard K., additional, Weiss, Jennifer E., additional, White, Andrew J., additional, Wallace, Carol A., additional, and Sobel, Rachel E., additional

Published
2015
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26. Using Registries to Identify Adverse Events in Rheumatic Diseases

Author

Lionetti, Geraldina, primary, Kimura, Yukiko, additional, Schanberg, Laura E., additional, Beukelman, Timothy, additional, Wallace, Carol A., additional, Ilowite, Norman T., additional, Winsor, Jane, additional, Fox, Kathleen, additional, Natter, Marc, additional, Sundy, John S., additional, Brodsky, Eric, additional, Curtis, Jeffrey R., additional, Del Gaizo, Vincent, additional, Iyasu, Solomon, additional, Jahreis, Angelika, additional, Meeker-O’Connell, Ann, additional, Mittleman, Barbara B., additional, Murphy, Bernard M., additional, Peterson, Eric D., additional, Raymond, Sandra C., additional, Setoguchi, Soko, additional, Siegel, Jeffrey N., additional, Sobel, Rachel E., additional, Solomon, Daniel, additional, Southwood, Taunton R., additional, Vesely, Richard, additional, White, Patience H., additional, Wulffraat, Nico M., additional, and Sandborg, Christy I., additional

Published
2013
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30. NAION and treatment of erectile dysfunction: reply from Pfizer.

Author

Sobel, Rachel E. and Cappelleri, J. C.

Subjects
*LETTERS to the editor, *RETINAL diseases
Abstract

A letter to the editor is presented in response to the article "Secondary Paracentral Retinal Holes following Internal Limiting Membrane Removal," by P. Steven, H. Laqua, D. Wong and colleagues in the 2006 issue.

Published
2006
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31. Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the Phase 4 registry.

Author

Sobel RE, Lovell DJ, Brunner HI, Weiss JE, Morris PW, Gottlieb BS, Chalom EC, Jung LK, Onel KB, Petiniot L, Goldsmith DP, Nanda K, Shishov M, Abramsky S, Young JP, and Giannini EH

Subjects
Adolescent, Celecoxib, Child, Child, Preschool, Female, Humans, Male, Medication Therapy Management, Patient Safety, Pyrazoles administration & dosage, Registries, Sulfonamides administration & dosage, Time, United States, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Anti-Inflammatory Agents, Non-Steroidal classification, Arthritis, Juvenile drug therapy, Drug-Related Side Effects and Adverse Reactions diagnosis, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions etiology, Pyrazoles adverse effects, Sulfonamides adverse effects
Abstract

Background: This study aimed to assess long-term safety and developmental data on juvenile idiopathic arthritis (JIA) patients treated in routine clinical practice with celecoxib or nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs)., Methods: Children aged ≥2 to <18 years with rheumatoid-factor-positive or -negative polyarthritis, persistent or extended oligoarthritis, or systemic arthritis were enrolled into this prospective, observational, multicenter standard-of-care registry. Eligible patients were newly or recently prescribed (≤6 months) an nsNSAID or celecoxib. Enrolled patients were followed to the end of the study, whether they remained on the original NSAID, switched, or discontinued therapy altogether. All adverse events (AEs) regardless of severity were captured in the database., Results: A total of 274 patients (nsNSAID, n = 219; celecoxib, n = 55) were observed for 410 patient-years of observation. Naproxen, meloxicam, and nabumetone were the most frequently used nsNSAIDs. At baseline, the celecoxib group was older, had a numerically longer median time since diagnosis, and a numerically higher proportion of patients with a history of gastrointestinal-related NSAID intolerance. AEs reported were those frequently observed with NSAID treatment and were similar across groups (nsNSAIDs: 52.0%; celecoxib: 52.9%). Twelve unique patients experienced a total of 18 serious AEs; the most frequent were infections, and none was attributed to NSAID use., Conclusions: The safety profile of celecoxib and nsNSAIDs appears similar overall. The results from this registry, ongoing pharmacovigilance, and the phase 3 trial that led to the approval of celecoxib for children with JIA provide evidence that the benefit-risk for celecoxib treatment in JIA remains positive., Trial Registration: ClinicalTrials.gov identifier NCT00688545.

Published
2014
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