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42 results on '"Ziemiecki, Ryan"'

1. Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study

Author

Johannes, Catherine B., Ziemiecki, Ryan, Pladevall-Vila, Manel, Ebert, Natalie, Kovesdy, Csaba P., Thomsen, Reimar W., Baak, Brenda N., García-Sempere, Aníbal, Kanegae, Hiroshi, Coleman, Craig I., Walsh, Michael, Andersen, Ina Trolle, Rodríguez Bernal, Clara, Robles Cabaniñas, Celia, Christiansen, Christian Fynbo, Farjat, Alfredo E., Gay, Alain, Gee, Patrick, Herings, Ron M. C., Hurtado, Isabel, Kashihara, Naoki, Kristensen, Frederik Pagh Bredahl, Liu, Fangfang, Okami, Suguru, Overbeek, Jetty A., Penning-van Beest, Fernie J. A., Yamashita, Satoshi, Yano, Yuichiro, Layton, J. Bradley, Vizcaya, David, and Oberprieler, Nikolaus G.

Published
2025
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2. Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting

Author

Danysh, Heather E., Johannes, Catherine B., Beachler, Daniel C., Layton, J. Bradley, Ziemiecki, Ryan, Arana, Alejandro, Dinh, Jade, Li, Ling, Calingaert, Brian, Pladevall-Vila, Manel, Hunt, Phillip R., Chen, Hungta, Karlsson, Cecilia, Johnsson, Kristina, and Gilsenan, Alicia

Published
2023
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8. Reactogenicity Differences between Adjuvanted, Protein-Based and Messenger Ribonucleic Acid (mRNA)-Based COVID-19 Vaccines.

Author

Rousculp, Matthew D., Hollis, Kelly, Ziemiecki, Ryan, Odom, Dawn, Marchese, Anthony M., Montazeri, Mitra, Odak, Shardul, Jackson, Laurin, Beyhaghi, Hadi, and Toback, Seth

Subjects
BOOSTER vaccines, MESSENGER RNA, COVID-19 vaccines, VACCINATION, COVID-19
Abstract

Participants in studies investigating COVID-19 vaccines commonly report reactogenicity events, and concerns about side effects may lead to a reluctance to receive updated COVID-19 vaccinations. A real-world, post hoc analysis, observational 2019nCoV-406 study was conducted to examine reactogenicity within the first 2 days after vaccination with either a protein-based vaccine (NVX-CoV2373) or an mRNA vaccine (BNT162b2 or mRNA-1273) in individuals who previously completed a primary series. Propensity score adjustments were conducted to address potential confounding. The analysis included 1130 participants who received a booster dose of NVX-CoV2373 (n = 303) or an mRNA vaccine (n = 827) during the study period. Within the first 2 days after vaccination, solicited systemic reactogenicity events (adjusted) were reported in 60.5% of participants who received NVX-CoV2373 compared with 84.3% of participants who received an mRNA vaccine; moreover, 33.9% and 61.4%, respectively, reported ≥3 systemic reactogenicity symptoms. The adjusted mean (95% CI) number of systemic symptoms was 1.8 (1.6–2.0) and 3.2 (3.0–3.4), respectively. Local reactogenicity events (adjusted) were reported in 73.4% and 91.7% of participants who received NVX-CoV2373 and mRNA vaccines, respectively; the adjusted mean (95% CI) number of local symptoms was 1.5 (1.33–1.61) and 2.4 (2.31–2.52), respectively. These results support the use of adjuvanted, protein-based NVX-CoV2373 as an immunization option with lower reactogenicity than mRNAs. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting

Author

Danysh, Heather E., primary, Johannes, Catherine B., additional, Beachler, Daniel C., additional, Layton, J. Bradley, additional, Ziemiecki, Ryan, additional, Arana, Alejandro, additional, Dinh, Jade, additional, Li, Ling, additional, Calingaert, Brian, additional, Pladevall-Vila, Manel, additional, Hunt, Phillip R., additional, Chen, Hungta, additional, Karlsson, Cecilia, additional, Johnsson, Kristina, additional, and Gilsenan, Alicia, additional

Published
2022
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13. Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting

Author

Johannes, Catherine B., primary, Beachler, Daniel C., additional, Layton, J. Bradley, additional, Danysh, Heather E., additional, Ziemiecki, Ryan, additional, Arana, Alejandro, additional, Dinh, Jade, additional, Li, Ling, additional, Calingaert, Brian, additional, Pladevall-Vila, Manel, additional, Hunt, Phillip R., additional, Chen, Hungta, additional, Karlsson, Cecilia, additional, Johnsson, Kristina, additional, and Gilsenan, Alicia, additional

Published
2022
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14. Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores.

Author

Osborne, Richard H., Nelson, Lauren M., Fehnel, Sheri, Williams, Nicole, Bender, Randall H., Ziemiecki, Ryan, Gymnopoulou, Efi, De Paepe, Els, Vandendijck, Yannick, Norcross, Lindsey, Heijnen, Esther, Ispas, Gabriela, Comeaux, Christy, Callendret, Benoit, Chan, Eric K. H., and Scott, Jane A.

Subjects
EXPERIMENTAL design, RESEARCH methodology, RESEARCH methodology evaluation, HEALTH outcome assessment, PSYCHOMETRICS, QUESTIONNAIRES, RESEARCH funding, DESCRIPTIVE statistics, RESPIRATORY syncytial virus infections, DATA analysis software, LONGITUDINAL method, EVALUATION, SYMPTOMS
Abstract

Background: The Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) is a patient-reported outcome measure designed to assess symptoms and impacts of respiratory syncytial virus (RSV) infection. This study evaluated the construct validity, reliability, and responsiveness of the RiiQ™ Respiratory and Systemic Symptoms Scale scores. Methods: Prospective data were analyzed from a total of 1795 participants, including from non-hospitalized patients with acute respiratory infection (ARI) and no coinfections enrolled in a Phase 2b RSV vaccine study (RSV-positive: n = 60; RSV-negative: n = 1615), and two observational studies of patients hospitalized with RSV (n = 20; n = 100). Descriptive statistics, confirmatory factor analysis (CFA), test–retest intraclass correlation coefficients (ICCs), construct validity correlations (between a clinician-assessed clinical questionnaire and the RiiQ™ symptoms scale), known-groups validity, and responsiveness (correlations of change scores) were evaluated. Results: Mean patient age ranged from 66.5 to 71.5 years and the majority of patients were female. Initial assessments in the vaccine trial (ARI Day 1) were suggestive of less severe illness than in the observational studies with hospitalized patients. CFA loadings (> 0.40) supported summary scores. ICCs exceeding the recommended threshold of 0.70 supported test–retest reliability for Respiratory and Systemic Symptoms, except in the small observational study. At the scale level, correlations were moderate to strong (|r| ≥ 0.3) and positive between the Respiratory Symptoms Scale and the related clinical questionnaire scores, reflecting measurement of similar symptoms in support of convergent validity. Correlations with change in Patient Global Impression of Severity > 0.30 supported responsiveness. Conclusions: Psychometric tests applied to the RiiQ™ Symptoms scales provide evidence of its reliability, construct validity, discriminating ability, and responsiveness for use in clinical studies to assess the onset and severity of RSV symptoms. [ABSTRACT FROM AUTHOR]

Published
2023
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19. 806-P: Risk of Acute Liver Injury in Real-World Use of Dapagliflozin

Author

JOHANNES, CATHERINE, primary, LAYTON, J. BRADLEY, additional, BEACHLER, DANIEL C., additional, ZIEMIECKI, RYAN M., additional, LI, LING, additional, DANYSH, HEATHER E., additional, DINH, JADE, additional, HUNT, PHILLIP R., additional, KARLSSON, CECILIA, additional, CHEN, HUNGTA, additional, and GILSENAN, ALICIA, additional

Published
2021
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21. 14-OR: Risk of Acute Kidney Injury in Real-World Use of Dapagliflozin

Author

JOHANNES, CATHERINE, primary, LAYTON, J. BRADLEY, additional, BEACHLER, DANIEL C., additional, ZIEMIECKI, RYAN M., additional, LI, LING, additional, DANYSH, HEATHER E., additional, DINH, JADE, additional, HUNT, PHILLIP R., additional, KARLSSON, CECILIA, additional, CHEN, HUNGTA, additional, and GILSENAN, ALICIA, additional

Published
2021
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23. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small cell lung cancer

Author

Ramaswamy Govindan, Senan, Suresh, Dickgreber, Nicolas, Provencio, Mariano, Wu, Yi-Long, Syrigos, Konstantinos, Parente, Barbara, Wilson, Michele, Ziemiecki, Ryan, Chouaki, Nadia, Hossain, Anwar, Antonio, Belén San, Winfree, Katherine, and Vokes, Everett E

Abstract

Objective: To analyze patient-reported swallowing difficulties, healthcare resource utilization, and associated costs during PROCLAIM study. Methods: Patients with Stage III nonsquamous non-small cell lung cancer received pemetrexed-cisplatin combined with concurrent thoracic radiotherapy followed by consolidation pemetrexed, or standard concurrent chemoradiotherapy with consolidation. Patient - reported swallowing function was measured using diary. Resource utilization (hospitalizations, transfusions, concomitant medications) was compared between treatment arms using Fisher’s exact test and independent t-test. Medical resource use costs were analyzed using nonparametric Wilcoxon rank sum test. Results: Patient-reported difficulty in swallowing function (diary score ≥4) was 33.8% in PemCis arm and 29% in EtoCis arm. Overall resource use, including hospitalizations, was similar between treatment arms; however, fewer patients in PemCis arm received transfusions and selected concomitant medications. Concurrent phase analyses were consistent with the overall study. Significantly lower percentage of patients (31.1% vs 40.8%) were hospitalized in PemCis arm. Total costs were significantly higher in PemCis arm. Other medical costs (excluding study treatment costs) during the concurrent phase were lower for patients in PemCis arm, due to significantly lower hospitalization costs and lower use of concomitant medications. Subgroup analysis yielded similar results. Conclusions: Patient-reported difficulty in swallowing post-baseline and resource utilization were consistent with previously reported safety outcomes. In the overall study, higher total costs for PemCis were driven by study drug cost. When adjusting for treatment duration, other monthly medical costs were favorable to PemCis. Patients on pemetrexed remained longer on therapy, suggesting better tolerability. ClinicalTrials.gov Identifier: NCT00686959

Published
2019
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24. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer

Author

Govindan, Ramaswamy, primary, Senan, Suresh, additional, Dickgreber, Nicolas, additional, Provencio, Mariano, additional, Wu, Yi-Long, additional, Syrigos, Konstantinos, additional, Parente, Barbara, additional, Wilson, Michele, additional, Ziemiecki, Ryan, additional, Chouaki, Nadia, additional, Hossain, Anwar, additional, San Antonio, Belén, additional, Winfree, Katherine, additional, and Vokes, Everett E., additional

Published
2019
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25. Variation in Cardiovascular Risk Related to Individual Antimuscarinic Drugs Used to Treat Overactive Bladder: A UK Cohort Study

Author

Arana, Alejandro, primary, Margulis, Andrea V., additional, McQuay, Lisa J., additional, Ziemiecki, Ryan, additional, Bartsch, Jennifer L., additional, Rothman, Kenneth J., additional, Franks, Billy, additional, D'Silva, Milbhor, additional, Appenteng, Kwame, additional, Varas-Lorenzo, Cristina, additional, and Perez-Gutthann, Susana, additional

Published
2018
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28. Comparison of the effectiveness of frontline chemoimmunotherapy regimens for follicular lymphoma used in the United States

Author

Nastoupil, Loretta J., primary, Sinha, Rajni, additional, Byrtek, Michelle, additional, Ziemiecki, Ryan, additional, Taylor, Michael, additional, Friedberg, Jonathan W., additional, Koff, Jean L., additional, Link, Brian K., additional, Cerhan, James R., additional, Dawson, Keith L., additional, and Flowers, Christopher R., additional

Published
2014
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29. Differences in disease characteristics, treatment patterns, and outcomes between men (M) and women (W) with follicular lymphoma (FL): Prospective evaluation of 2,650 U.S. patients (pts).

Author

Nabhan, Chadi, primary, Byrtek, Michelle, additional, Dawson, Keith Lamont, additional, Zhou, Xiaolei, additional, Ziemiecki, Ryan, additional, Zelenetz, Andrew David, additional, Friedberg, Jonathan W., additional, Cerhan, James Robert, additional, and Flowers, Christopher, additional

Published
2014
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30. Health-related quality of life and disease symptoms in postmenopausal women with hr+, her2- advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy

Author

Campone, Mario, Beck, Joseph Thaddeus, Gnant, Michael, Neven, Patrick, Pritchard, Kathleen, Bachelot, Thomas, Provencher, Louise, Rugo, Hope, Piccart-Gebhart, Martine, Hortobagyi, Gabriel N., Nunzi, Martina, Heng, Daniel Y C, Baselga, José, Komorowski, Anna, Noguchi, Shinzaburo, Horiguchi, Jun, Bennett, Lee, Ziemiecki, Ryan, Zhang, Jie, Cahana, Ayelet, Taran, Tetiana, Sahmoud, Tarek, Burris, Howard H.A., Campone, Mario, Beck, Joseph Thaddeus, Gnant, Michael, Neven, Patrick, Pritchard, Kathleen, Bachelot, Thomas, Provencher, Louise, Rugo, Hope, Piccart-Gebhart, Martine, Hortobagyi, Gabriel N., Nunzi, Martina, Heng, Daniel Y C, Baselga, José, Komorowski, Anna, Noguchi, Shinzaburo, Horiguchi, Jun, Bennett, Lee, Ziemiecki, Ryan, Zhang, Jie, Cahana, Ayelet, Taran, Tetiana, Sahmoud, Tarek, and Burris, Howard H.A.

Abstract

Objective: Everolimus (EVE)+exemestane (EXE; n = 485) more than doubled median progression-free survival versus placebo (PBO) + EXE (n = 239), with a manageable safety profile and no deterioration in health-related quality-of-life (HRQOL) in patients with hormone-receptor-positive (HR+) advanced breast cancer (ABC) who recurred or progressed on/after nonsteroidal aromatase inhibitor (NSAI) therapy. To further evaluate EVE + EXE impact on disease burden, we conducted additional post-hoc analyses of patient-reported HRQOL. Research design and methods: HRQOL was assessed using EORTC QLQ-C30 and QLQ-BR23 questionnaires at baseline and every 6 weeks thereafter until treatment discontinuation because of disease progression, toxicity, or consent withdrawal. Endpoints included the QLQ-C30 Global Health Status (QL2) scale, the QLQ-BR23 breast symptom (BRBS), and arm symptom (BRAS) scales. Between-group differences in change from baseline were assessed using linear mixed models with selected covariates. Sensitivity analysis using pattern-mixture models determined the effect of study discontinuation on/before week 24. Treatment arms were compared using differences of least squares mean (LSM) changes from baseline and 95% confidence intervals (CIs) at each timepoint and overall. Clinical trial registration: Clinicaltrials.gov: NCT00863655. Main outcome measures: Progression-free survival, survival, response rate, safety, and HRQOL. Results: Linear mixed models (primary model) demonstrated no statistically significant overall difference between EVE + EXE and PBO + EXE for QL2 (LSM difference = -1.91; 95% CI = -4.61, 0.78), BRBS (LSM difference = -0.18; 95% CI = -1.98, 1.62), or BRAS (LSM difference = -0.42; 95% CI = -2.94, 2.10). Based on pattern-mixture models, patients who dropped out early had worse QL2 decline on both treatments. In the expanded pattern-mixture model, EVE + EXE-treated patients who did not drop out early had stable BRBS and BRAS relative to PBO + EXE. Key li, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2013

31. Patient-reported physical, emotional, and social functioning in advanced breast cancer: Insights from BOLERO-2.

Author

Yardley, Denise Aysel, primary, Hortobagyi, Gabriel N., additional, Lebrun, Fabienne, additional, Beck, J. Thaddeus, additional, Neven, Patrick, additional, Baselga, Jose, additional, Petrakova, Katarina, additional, Dakhil, Shaker R., additional, Sabatini, Silvia, additional, Komorowski, Anna, additional, Chouinard, Edmond Emilien, additional, Young, Robyn R., additional, Gnant, Michael, additional, Pritchard, Kathleen I., additional, Zhang, Jie, additional, Ziemiecki, Ryan, additional, Brechenmacher, Thomas, additional, Taran, Tanya, additional, Sahmoud, Tarek, additional, and Noguchi, Shinzaburo, additional

Published
2013
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32. Health-related quality of life and disease symptoms in postmenopausal women with HR+, HER2−advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy

Author

Campone, Mario, primary, Beck, J. Thaddeus, additional, Gnant, Michael, additional, Neven, Patrick, additional, Pritchard, Kathleen I., additional, Bachelot, Thomas, additional, Provencher, Louise, additional, Rugo, Hope S., additional, Piccart, Martine, additional, Hortobagyi, Gabriel N., additional, Nunzi, Martina, additional, Heng, Daniel Y.C., additional, Baselga, José, additional, Komorowski, Anna, additional, Noguchi, Shinzaburo, additional, Horiguchi, Jun, additional, Bennett, Lee, additional, Ziemiecki, Ryan, additional, Zhang, Jie, additional, Cahana, Ayelet, additional, Taran, Tetiana, additional, Sahmoud, Tarek, additional, and Burris, Howard A., additional

Published
2013
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40. Assessment of asthma control in primary care

Author

Mintz, Matthew, primary, Gilsenan, Alicia W., additional, Bui, Christine L., additional, Ziemiecki, Ryan, additional, Stanford, Richard H., additional, Lincourt, William, additional, and Ortega, Hector, additional

Published
2009
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41. Comparison of the effectiveness of frontline chemoimmunotherapy regimens for follicular lymphoma used in the United States.

Author

Nastoupil, Loretta J., Sinha, Rajni, Byrtek, Michelle, Ziemiecki, Ryan, Taylor, Michael, Friedberg, Jonathan W., Koff, Jean L., Link, Brian K., Cerhan, James R., Dawson, Keith L., and Flowers, Christopher R.

Subjects
LYMPHOMA treatment, CYCLOPHOSPHAMIDE, RITUXIMAB, DOXORUBICIN, VINCRISTINE, PREDNISONE
Abstract

To compare the effectiveness of frontline rituximab-chemotherapy regimens in clinical practice, we examined outcomes for patients with low-grade, stage III/IV follicular lymphoma receiving rituximab (R) with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), R with cyclophosphamide, vincristine and prednisone (R-CVP) or R with a fludarabine-based regimen (R-Flu) as frontline therapy. In total, 611 patients meeting these criteria were identified in the National LymphoCare Study: 47% receiving R-CHOP ( n = 287), 31% receiving R-CVP ( n = 187) and 22% receiving R-Flu ( n = 137). Overall response rates were high (R-CVP 87%, R-CHOP 93%, R-Flu 94%; p = 0.017). Median follow-up was 7.4 years. R-CVP was associated with lower 5-year overall survival (R-CVP 76%, R-CHOP 86%, R-Flu 86%; p = 0.021) and progression-free survival (R-CVP 49%, R-CHOP 58%, R-Flu 64%; p = 0.029). There were no significant differences in survival in Cox models adjusted for baseline clinical factors, practice region/setting and post-treatment R maintenance/observation. [ABSTRACT FROM AUTHOR]

Published
2015
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42. Health-related quality of life and disease symptoms in postmenopausal women with HR(+), HER2(-) advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy.

Author

Campone M, Beck JT, Gnant M, Neven P, Pritchard KI, Bachelot T, Provencher L, Rugo HS, Piccart M, Hortobagyi GN, Nunzi M, Heng DY, Baselga J, Komorowski A, Noguchi S, Horiguchi J, Bennett L, Ziemiecki R, Zhang J, Cahana A, Taran T, Sahmoud T, and Burris HA 3rd

Subjects
Adult, Aged, Androstadienes adverse effects, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms metabolism, Disease Progression, Disease-Free Survival, Everolimus, Female, Health Status, Humans, Immunosuppressive Agents therapeutic use, Middle Aged, Placebos therapeutic use, Receptor, ErbB-2 metabolism, Receptors, Estrogen metabolism, Receptors, Progesterone metabolism, Sirolimus adverse effects, Sirolimus therapeutic use, Surveys and Questionnaires, Treatment Outcome, Androstadienes therapeutic use, Breast Neoplasms drug therapy, Quality of Life, Sirolimus analogs & derivatives
Abstract

Objective: Everolimus (EVE)+exemestane (EXE; n = 485) more than doubled median progression-free survival versus placebo (PBO) + EXE (n = 239), with a manageable safety profile and no deterioration in health-related quality-of-life (HRQOL) in patients with hormone-receptor-positive (HR(+)) advanced breast cancer (ABC) who recurred or progressed on/after nonsteroidal aromatase inhibitor (NSAI) therapy. To further evaluate EVE + EXE impact on disease burden, we conducted additional post-hoc analyses of patient-reported HRQOL., Research Design and Methods: HRQOL was assessed using EORTC QLQ-C30 and QLQ-BR23 questionnaires at baseline and every 6 weeks thereafter until treatment discontinuation because of disease progression, toxicity, or consent withdrawal. Endpoints included the QLQ-C30 Global Health Status (QL2) scale, the QLQ-BR23 breast symptom (BRBS), and arm symptom (BRAS) scales. Between-group differences in change from baseline were assessed using linear mixed models with selected covariates. Sensitivity analysis using pattern-mixture models determined the effect of study discontinuation on/before week 24. Treatment arms were compared using differences of least squares mean (LSM) changes from baseline and 95% confidence intervals (CIs) at each timepoint and overall., Clinical Trial Registration: Clinicaltrials.gov: NCT00863655., Main Outcome Measures: Progression-free survival, survival, response rate, safety, and HRQOL., Results: Linear mixed models (primary model) demonstrated no statistically significant overall difference between EVE + EXE and PBO + EXE for QL2 (LSM difference = -1.91; 95% CI = -4.61, 0.78), BRBS (LSM difference = -0.18; 95% CI = -1.98, 1.62), or BRAS (LSM difference = -0.42; 95% CI = -2.94, 2.10). Based on pattern-mixture models, patients who dropped out early had worse QL2 decline on both treatments. In the expanded pattern-mixture model, EVE + EXE-treated patients who did not drop out early had stable BRBS and BRAS relative to PBO + EXE., Key Limitations: HRQOL data were not collected after disease progression., Conclusions: These analyses confirm that EVE + EXE provides clinical benefit without adversely impacting HRQOL in patients with HR(+) ABC who recurred/progressed on prior NSAIs versus endocrine therapy alone.

Published
2013
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