Selection from HEOR Bibliography
| Search criteria | ||||
| Drug safety |
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| Empagliflozin cardiovascular and renal effectiveness and safety compared to dipeptidyl peptidase-4 inhibitors across 11 countries in Europe and Asia: Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study | ||||
| Avraham Karasik (1), Stefanie Lanzinger (2,3), Elise Chia-Hui Tan (4), Daisuke Yabe (5,6,7 8), Dae Jung Kim (9), Wayne H-H Sheu (10), Cheli Melzer-Cohen (1), Reinhard W. Holl (2), Kyoung-Hwa Ha (9), Kamlesh Khunti (11), Francesco Zaccardi (11), Anuradhaa Subramanian (12), Krishnarajah Nirantharakumar (12,13,14), Thomas Nyström (15), Leo Niskanen (16), Majken Linnemann Jensen (17), Fabian Hoti (18), Riho Klement (19), Anouk Déruaz-Luyet (20), Moe H.Kyaw (21), Lisette Koeneman (22), Dorte Vistisen (23, 24) Bendix Carstensen (23), Sigrun Halvorsen (25), Gisle Langslet (26), Soulmaz Fazeli Farsani (20), Elisabetta Patorno (27), Júlio Núñez (28), EMPRISE Europe and Asia Study Group | ||||
| "1 Maccabi Institute for Research and Innovation Center, Tel Aviv University, Tel Aviv, Israel 2 Institute for Epidemiology and Medical Biometry, ZIBMT, Ulm University, Ulm, Germany 3 German Centre for Diabetes Research (DZD), München-Neuherberg, Germany 4 Department of Health Service Administration, China Medical University, Taichung, Taiwan 5 Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kyoto, Japan 6 Department of Diabetes, Metabolism and Endocrinology/Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan 7 Center for Healthcare Information Technology, Tokai National Higher Education and Research System, Nagoya, Japan 8 Preemptive Food Research Center, Gifu University Institute for Advanced Study, Gifu, Japan 9 Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea 10 Division of Endocrinology and Metabolism, Taipei Veterans General Hospital, Taipei, Taiwan 11 Leicester Real World Evidence Unit, Leicester Diabetes Centre, University of Leicester, Leicester, UK 12 Institute of Applied Health Research, University of Birmingham, Birmingham, UK 13 Midlands Health Data Research UK, Birmingham, UK 14 DEMAND Hub, University of Birmingham, Birmingham, UK 15 Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Sweden 16 Päijät-Häme Joint Authority for Health and Wellbeing, Päijät-Häme Central Hospital, Lahti Finland and University of Eastern Finland, Kuopio, Finland 17 IQVIA Solutions Denmark A/S, Copenhagen, Denmark 18 IQVIA, Espoo, Finland 19 IQVIA, Tartu, Estonia 20 Boehringer Ingelheim International GmbH, Ingelheim, Germany 21 Boehringer Ingelheim International GmbH, US 22 Lilly Deutschland GmbH, Bad Homburg, Germany 23 Steno Diabetes Center Copenhagen, Herlev, Denmark 24 Department of Public Health, University of Copenhagen, Copenhagen, Denmark 25 Department of Cardiology, Oslo University Hospital Ullevål, and University of Oslo, Oslo, Norway 26 Lipid Clinic, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway 27 Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA 28 Department of Cardiology, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBER Cardiovascular, Valencia, Spain" | ||||
| "Diabetes & Metabolism. 2023 Jan; 101418; ISSN 1262-3636 Virtual Conference: American Diabetes Association, 25-29 June 2021 and EASD 27 September -01 October" |
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| , Article | ||||
| , Denmark, Finland, Germany, Norway, Spain, Sweden, UK | ||||
| Abstract: https://doi.org/10.1016/j.diabet.2022.101418 (https://www.sciencedirect.com/science/article/pii/S1262363622000994) | ||||
| Condition | Year | Language | Analysis type | |
| , Cardiovascular disease, Diabetes, Drug safety, Drug Utlization Study | 2023 | English | , Clinical setting: hospital, Clinical setting: Primary care | |
| Empagliflozin is Associated with Lower Risk of Cardiovascular Events and All-Cause Mortality in Routine Care in East Asia: Results from the EMPRISE Study | ||||
| Dae Jung Kim (1), Wayne H-H Sheu (2), Wook-Jin Chung (3), Daisuke Yabe (4-7), Kyoung Hwa Ha (1), Masaomi Nangaku (8), Elise Chia-Hui Tan (9), Koichi Node (10), Atsutaka Yasui (11), Weiyu Lei (12), Sunwoo Lee (13), Laura Saarelainen (14), Anouk Deruaz-Luyet (15), Moe H. Kyaw (16) and Yutaka Seino (4,17), EMPRISE East Asia Study Group | ||||
| "1 Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea 2 Division of Endocrinology and Metabolism, Taipei Veterans General Hospital, Taipei, Taiwan 3 Department of Cardiovascular Medicine, Gachon University Gil Medical Center, Incheon, South Korea 4 Kansai Electric Power Medical Research Institute, Kobe, Japan 5 Department of Diabetes, Metabolism and Endocrinology/Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan 6 Center for Healthcare Information Technology, Tokai National Higher Education and Research System, Nagoya, Japan 7 Division of Metabolism and Molecular Medicine, Kobe University Graduate School of Medicine, Kobe, Japan 8 Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan 9 National Research Institute of Chinese Medicine, Ministry of Health and Welfare, Taipei, Taiwan, and Institute of Hospital and Healthcare Administration, National Yang-Ming University, Taipei, Taiwan 10 Department of Cardiovascular Medicine, Saga University, Saga, Japan 11 Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan 12 Boehringer Ingelheim Taiwan Ltd., Taipei, Taiwan 13 Boehringer Ingelheim Korea Ltd, Seoul, Korea 14 IQVIA, Espoo, Finland 15 Boehringer Ingelheim International GmbH, Ingelheim, Germany 16 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA 17 Kansai Electric Power Hospital, Osaka, Japan " | ||||
| "JDI journal Virtual Conference: ACC, May 2021" |
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| , Article | ||||
| , Japan, Korea, Taiwan | ||||
| Abstract: https://doi.org/10.1111/jdi.13959 | ||||
| Condition | Year | Language | Analysis type | |
| , Cardiovascular disease, Diabetes, Drug safety, Drug Utlization Study | 2023 | English | , Clinical setting: hospital, Clinical setting: Primary care, Retrospective cohort analysis | |
| The CLARION study: first report on safety findings in patients newly initiating treatment with cladribine tablets or fingolimod for multiple sclerosis | ||||
| Helmut Butzkueven, Jan Hillert, Merja Soilu-Hänninen, Tjalf Ziemssen, Jens Kuhle, Stig Wergeland, Melinda Magyari, Joseph R. Berger, Nicholas Moore, Aida Aydemir, Irene Bezemer & Meritxell Sabidó | ||||
| "a Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia; b The Alfred Hospital, Melbourne, VIC, Australia; c Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; d Turku University Hospital Neurocenter and Division of Clinical Neurosciences, University of Turku, Turku, Finland; e Center of Clinical Neuroscience, Department of Neurology, Dresden University of Technology, Dresden, Germany; f Multiple Sclerosis Center and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), Departments of Biomedicine and Clinical Research, University Hospital and University of Basel, Basel, Switzerland; g Department of Neurology, University Hospital and University of Basel, Basel, Switzerland; h Norwegian MS Registry and Biobank, Department of Neurology, Haukeland University Hospital, Bergen, Norway; i Department of Clinical Medicine, University of Bergen, Bergen, Norway; j Danish Multiple Sclerosis Center and the Danish Multiple Sclerosis Registry, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; k Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; l Bordeaux PharmacoEpi (BPE), Universit�e de Bordeaux, Bordeaux, France; m EMD Serono Research & Development Institute, Inc, Billerica, MA, USA, an affiliate of Merck KGaA; n Global Epidemiology, IQVIA, Amsterdam, The Netherlands; o Merck Healthcare KGaA, Darmstadt, Germany" | ||||
| , Article | ||||
| , Australia, Denmark, Finland, Germany, Norway, Sweden, Switzerland, Turkey | ||||
| Abstract: https://www.tandfonline.com/doi/full/10.1080/03007995.2023.2256220 | ||||
| Condition | Year | Language | Analysis type | |
| , Comparative Effectiveness & Health Technology Assessment, Drug safety, Neurological disorders | 2023 | English | , clinical setting: Secondary care, Epidemiological study, Population Based Study | |
| The emerging role of real-world data in advanced breast cancer therapy: Recommendations for collaborative decision-making | ||||
| Paul Cottu 1, Scott David Ramsey 2, Oriol Solà-Morales 3, Patricia A Spears 4, Lockwood Taylor 5 | ||||
| 1Department of Medical Oncology, Institut Curie, 26 Rue D'Ulm, 75005, Paris, France. Electronic address: paul.cottu@curie.fr. 2Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, M2-B232, Seattle, WA, 98155, USA. Electronic address: sramsey@fredhutch.org. 3Health Innovation Technology Transfer Foundation, Aragó 60, E-08015, Barcelona, Spain. Electronic address: osola@fhitt.org. 48605 Carolingian Court, Raleigh, NC, 27615, USA. Electronic address: paspears88@gmail.com. 5Epidemiology, Real World Solutions at IQVIA, 4820 Emperor Boulevard, Durham, NC, 27703, USA. Electronic address: lockwood.taylor@iqvia.com. | ||||
| Breast. 2021 Dec 22;61:118-122. doi: 10.1016/j.breast.2021.12.015. |
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| , Article | ||||
| , France, Italy, USA | ||||
| Abstract: https://pubmed.ncbi.nlm.nih.gov/34959093/ | ||||
| Condition | Year | Language | Analysis type | |
| , Comparative Effectiveness & Health Technology Assessment, Drug safety, Oncology, Regulatory | 2022 | English | , Review | |
| The CLARION study design and status update: a long-term, registry-based study evaluating adverse events of special interest in patients with relapsing multiple sclerosis newly started on cladribine tablets | ||||
| Helmut Butzkueven 1 2, Nicholas Moore 3, Aida Aydemir 4, Jaak Sõnajalg 5, Irene Bezemer 6, Pasi Korhonen 7, Meritxell Sabidó 8, CLARION Study Group | ||||
| 1Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Australia. 2The Alfred Hospital, Melbourne, Australia. 3Bordeaux PharmacoEpi (BPE), Université de Bordeaux, Bordeaux, France. 4Global Biostatistics, EMD Serono Research & Development Institute, Inc, Billerica, MA, USA (an affiliate of Merck KGaA). 5Global Database Studies, IQVIA, Tartu, Estonia. 6Global Epidemiology and Outcomes Research, IQVIA, Amsterdam, The Netherlands. 7IQVIA (former EPID Research), Espoo, Finland. 8Global Epidemiology, Merck Healthcare KGaA, Darmstadt, Germany. | ||||
| Current Medical Research and Opinion, DOI: 10.1080/03007995.2022.2059977 |
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| , Article | ||||
| , Australia, Denmark, Finland, Germany, Norway, Sweden, Switzerland, Turkey | ||||
| Abstract: https://pubmed.ncbi.nlm.nih.gov/35357268/ | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Neurological disorders | 2022 | English | , clinical setting: Secondary care, Epidemiological study, Observational study, Population Based Study, Retrospective database analysis | |
| The longitudinal relationship between fatigue, depression, anxiety, disability, and adherence with cognitive status in patients with early multiple sclerosis treated with interferon beta-1a | ||||
| Hanne van Ballegooijen, Karin van der Hiele, Christian Enzinger, Gert de Voer, Leo H. Visser, on behalf of the CONFIDENCE Study Group | ||||
| IQVIA Netherlands, Real World Evidence, Netherlands b Department of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, Netherlands c Medical University of Graz, Graz, Austria d Merck BV, Schiphol-Rijk, The Netherlands, an affiliate of Merck KGaA, Germany e St Elisabeth Tweesteden Hospital, Tilburg, the Netherlands | ||||
| eNeurologicalSci, Volume 28, 2022, 100409, ISSN 2405-6502, https://doi.org/10.1016/j.ensci.2022.100409. (https://www.sciencedirect.com/science/article/pii/S2405650222000181) |
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| , Article | ||||
| , Austria, Belgium, Netherlands , Slovakia | ||||
| Abstract: https://www.sciencedirect.com/science/article/pii/S2405650222000181 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Drug Utlization Study, Neurological disorders | 2022 | English | , Clinical setting: hospital, clinical setting: Secondary care, Epidemiological study, Population Based Study, Prospective study | |
| Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018 | ||||
| Janet Sultana 1 2, Salvatore Crisafulli 3, Mariana Almas 4, Ippazio Cosimo Antonazzo 5 6, Esme Baan 7, Claudia Bartolini 6, Maria Paola Bertuccio 3, Fedele Bonifazi 8 9, Annalisa Capuano 10 11, Antonella Didio 8 9, Vera Ehrenstein 12, Mariagrazia Felisi 8 13, Carmen Ferrajolo 10 11, Andrea Fontana 14, Remy Francisca 7, Annie Fourrier-Reglat 15, Joan Fortuny 16, Rosa Gini 6, Giulia Hyeraci 6, Christel Hoeve 7, Christos Kontogiorgis 17, Valentina Isgrò 18, Panagiotis-Nikolaos Lalagkas 17, Luca L'Abbate 18, Deborah Layton 19, Annalisa Landi 8 9, Silvia Narduzzi 19, Leonardo Roque Pereira 20, Georgios Poulentzas 17, Concetta Rafaniello 10 11, Giuseppe Roberto 6, Giulia Scondotto 3, Liberata Sportiello 10 11, Maddalena Toma 8 9, Massoud Toussi 19, Katia Verhamme 7, Elisabetta Volpe 8 9, Gianluca Trifirò 18, | ||||
| Pharmacy Department, Mater Dei Hospital, Msida, Malta. 2Exeter College of Medicine and Health, Exeter, UK. 3Department of Medicine, University of Verona, Verona, Italy. 4Real World Solutions Department, IQVIA, Lisbon, Portugal. 5Research Centre on Public Health (CESP), University of Milan-Bicocca, Milan, Italy. 6Agenzia Regionale di Sanità della Toscana, Florence, Italy. 7Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The Netherlands. 8TEDDY European Network of Excellence for Paediatric Clinical Research, Pavia, Italy. 9Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, Italy. 10Department of Experimental Medicine, University of Campania "Vanvitelli", Naples, Italy. 11Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Naples, Italy. 12Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. 13CVBF Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy. 14Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 15Univ. Bordeaux, INSERM, Bordeaux Population Health Research Center, Team of Pharmacoepidemiology, UMR 1219, Bordeaux, France. 16RTI Health Solutions, Barcelona, Spain. 17Democritus University of Thrace, Alexandroupolis, Greece. 18Department of Diagnostics and Public Health, University of Verona, Verona, Italy. 19Data Science Hub, Real World Solutions, IQVIA, London, UK. 20Department of Datascience & Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands. | ||||
| Pharmacoepidemiol Drug Saf . 2022 Jun;31(6):689-705. doi: 10.1002/pds.5413. Epub 2022 Feb 11. |
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| , Article | ||||
| , Denmark, France, Italy, Netherlands, Portugal, Spain, UK | ||||
| Abstract: https://pubmed.ncbi.nlm.nih.gov/35092329/ | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Drug Utlization Study | 2022 | English | , Database Study, Review | |
| Insights from a review of publicly available information on Post Authorisation Safety Studies (PASS) | ||||
| Almas MF, Hoogendoorn WE, Sayeed S, Blackburn S, Bosco J, Parmenter L | ||||
| IQVIA | ||||
| , Poster | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Risk Management & REMS | 2022 | English | , Review | |
| Validation of safety outcomes in routinely collected data: lessons learned from a multinational post-approval safety study | ||||
| Arena PJ, Huang K, Löfling L, Bahmanyar S, Mo J, Schachterle SE, Nunes AP, Smits E, Juuti R, Hoti F, Korhonen P, Adelborg K, Sundbøll J, Rasmussen TR, Løkke A, Ehrenstein V. | ||||
| "Pfizer Inc., New York, New York, United States of America. Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, California, United States of America. EPID Research (an IQVIA company), Espoo, Finland." | ||||
| Pharmacoepidemiol Drug Saf. 2022 Dec 10. doi: 10.1002/pds.5582 |
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| , Article | ||||
| , Denmark, Finland, Netherlands , Sweden, USA | ||||
| Abstract: https://onlinelibrary.wiley.com/doi/10.1002/pds.5582 | ||||
| Condition | Year | Language | Analysis type | |
| , Database Validity and methodology, Drug safety, Oncology | 2022 | English | , Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Retrospective database analysis | |
| Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee | ||||
| Robert Flynn1,2,*, Karin Hedenmalm1, Tarita Murray-Thomas3, Alexandra Pacurariu1, Peter Arlett1, Hilary Shepherd3, Puja Myles3, Xavier Kurz1 | ||||
| 1 Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands 2 Medicines Monitoring Unit (MEMO), Division of Molecular and Clinical Medicine, University of Dundee, Dundee, United Kingdom 3 Clinical Practice Research Datalink (CPRD), MHRA, London, United Kingdom | ||||
| First published: 18 January 2020 https://doi.org/10.1002/cpt.1775 |
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| , Abstract, Article | ||||
| , France, Germany, UK | ||||
| Abstract: https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1775 | ||||
| Condition | Year | Language | Analysis type | |
| , Database Validity and methodology, Drug safety, Health policy | 2020 | English | , Retrospective database analysis | |
| Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions | ||||
| Kristin M Sheffield , Nancy A Dreyer , James F Murray, Douglas E Faries & Megan N Klopchin | ||||
| 1Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA 2IQVIA Real-World & Analytic Solutions, Cambridge, MA 02139, USA 3Real World Analytics, Eli Lilly & Company, Indianapolis, IN 46225, USA | ||||
| Published Online:11 Sep 2020https://doi.org/10.2217/cer-2020-0161 |
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| , Article | ||||
| , USA | ||||
| Abstract: https://www.futuremedicine.com/doi/10.2217/cer-2020-0161 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Drug Utlization Study, Guidelines, Methodology, Public Health | 2020 | English | , Methodology, Observational study, Population Based Study | |
| Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms | ||||
| Mehmet Burcu 1, Nancy A Dreyer 2, Jessica M Franklin 3, Michael D Blum 4, Cathy W Critchlow 5, Eleanor M Perfetto 6, Wei Zhou 1 | ||||
| 1Center for Observational and Real-World Evidence, Merck & Co., Inc., West Point, Pennsylvania, United States. 2Real-World Solutions, IQVIA, Cambridge, Massachusetts. 3Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. 4Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, White Oak, Maryland. 5Center for Observational Research, Amgen Inc., Thousand Oaks, California. 6National Health Council, Washington, District of Columbia, and University of Maryland Baltimore (UMB), Baltimore, Maryland. | ||||
| Pharmacoepidemiol Drug Saf . 2020 Oct;29(10):1228-1235. doi: 10.1002/pds.4975. Epub 2020 Mar 11. |
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| , Article | ||||
| , USA | ||||
| Abstract: https://pubmed.ncbi.nlm.nih.gov/32162381/ | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2020 | English | , Epidemiological study, Real World Data, Real World Evidence | |
| A quantitative bias analysis of the confounding effects due to smoking on the association between fluoroquinolones and risk of aortic aneurysm. | ||||
| Zhang M, Falconer M, Taylor LG | ||||
| "1Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. 2Real World Solutions, IQVIA™, Durham, North California, USA." | ||||
| Pharmacoepidemiol Drug Saf. 2020 Aug;29(8):958-961. doi: 10.1002/pds.5019. Epub 2020 May 13.PMID: 32406104 |
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| , Article | ||||
| , USA | ||||
| Abstract: https://pubmed.ncbi.nlm.nih.gov/32406104/ | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Methodology | 2020 | English | , Observational study | |
| Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe | ||||
| Fife D, Waller J, Kaplan S, Hu P, Phillips S, Oliveria SA, Richarz U | ||||
| Fife: Janssen Research and Development, LLC Waller: Adephi Real World Kaplan: Teva Pharmaceutical Indusries Ltd. Hu: Janssen Global Services Phillips: IQVIA Oliveria, IQVIA Richarz: Janssen Research and Development, LLC | ||||
| Clin Drug Investig (2019). https://doi.org/10.1007/s40261-019-00831-3 |
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| , Article | ||||
| , Belgium, France, Germany, Spain, UK | ||||
| Abstract: https://link.springer.com/article/10.1007/s40261-019-00831-3 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Drug Utlization Study | 2019 | English | , Population Based Study, Retrospective database analysis | |
| European Multi-Country Drug Utilization Study of Dulaglutide | ||||
| Ayad K. Ali1, Karen E. Wells2, Mathieu Ros3, Massoud Toussi3 | ||||
| 1Eli Lilly and Company, Indianapolis, IN, USA 2IQVIA, Oakland, MI, USA 3IQVIA, Courbevoie, France | ||||
| ICPE, Philadelphia, USA, 24-28 August 2019 |
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| , Abstract | ||||
| , France, Germany, Spain, Sweden, UK | ||||
| Condition | Year | Language | Analysis type | |
| , Diabetes, Drug safety | 2019 | English | , Epidemiological study, Observational study, Retrospective cohort analysis, Retrospective database analysis | |
| Methods, Results, and Lessons Learned from Two Postmarketing Drug Safety Surveillance Studies Linking State Cancer Registry Data to Large Pharmacy Databases | ||||
| Harris D1; Casso D2; Midkiff K1; Anderson A2; Gilsenan A1; Oliveria SA2; Andrews E1; KellierSteele N3 | ||||
| 1RTI Health Solutions, Research Triangle Park, NC, United States 2IQVIA, Plymouth Meeting, PA, United States 3Eli Lilly and Company, Indianapolis, IN, United States | ||||
| NAACCR / IACR Combined Annual Conference, Vancouver, Canada, 9-13 June 2019 |
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| , Abstract | ||||
| , USA | ||||
| Abstract: https://www.naaccr.org/wp-content/uploads/2019/06/NAACCR_IACR_Abstract_Program_Final_.pdf | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2019 | English | , Epidemiological study, Observational study, Retrospective cohort analysis, Retrospective database analysis | |
| Osteosarcoma Surveillance Program Estimating the Incidence of Osteosarcoma Among Teriparatide (Forteo) Users by Linking State Cancer Registry Data to Pharmacy Database Data (United States) | ||||
| Kellier-Steele N1, Anderson A2, Casso D2, Oliveria SA2, Gilsenan A3, Midkiff K3, Harris D3, Andrews E3 | ||||
| 1Eli Lilly and Company, Indianapolis, USA, 2IQVIA, Durham, USA, 3RTI-HS, Raleigh, USA | ||||
| WCO, Paris France, 4-7 April 2019 |
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| , Abstract | ||||
| , USA | ||||
| Abstract: https://www.wco-iof-esceo.org/sites/wco19/pdf/WCO19-AbstractBook.pdf | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2019 | English | , Epidemiological study, Observational study, Retrospective cohort analysis, Retrospective database analysis | |
| PRS72 DRUG TREATMENT PATTERNS FOR PULMONARY ARTERIAL HYPERTENSION PATIENTS IN ENGLAND: A RETROSPECTIVE ANALYSIS USING HOSPITAL TREATMENT INSIGHTS DATABASE | ||||
| A. Beaudet A. Yesufu-Udechuku E.W. Davies L.H. Taylor S. Sikander-Rehman R. Ogley F. Exposto | ||||
| Actelion Pharmaceuticals Ltd., Allschwill, BL, Switzerland Actelion Pharmaceuticals UK Ltd, London, UK Actelion Pharmaceuticals Ltd., Allschwill, BL, Switzerland IQVIA, London, UK | ||||
| Open ArchiveDOI:https://doi.org/10.1016/j.jval.2019.09.2561 |
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| , Poster | ||||
| , England | ||||
| Abstract: https://www.valueinhealthjournal.com/article/S1098-3015(19)34939-3/fulltext | ||||
| Condition | Year | Language | Analysis type | |
| , Cardiovascular disease, Drug safety, Drug Utlization Study, Health status & patient reported outcomes | 2019 | English | , Public Health, Real World Data, Retrospective cohort analysis, Retrospective Field Study | |
| Dose increase beyond labelled dose of biologics is associated with incremental pharmacy costs: results from a real-world study in the UK | ||||
| Anthony Bewley 1, Cristiana Miglio 2, Haijun Tian 3, Isabelle Gilloteau 4, Joannah Whitehead 5, Ruben Hermans 2 | ||||
| 1a Whipps Cross University Hospital , London , UK. 2b IQVIA , London , UK. 3c Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA. 4d Novartis Pharma AG , Novartis Campus , Basel , Switzerland. 5e Novartis UK Pharmaceuticals Ltd , Frimley, Camberley , UK. | ||||
| PMID: 30256686 DOI: 10.1080/09546634.2018.1524820 |
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| , Article | ||||
| , UK | ||||
| Abstract: https://pubmed.ncbi.nlm.nih.gov/30256686/ | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Drug Utlization Study, Guidelines, Health status & patient reported outcomes | 2019 | English | , direct-to-patient research, Methodology, Survey research | |
| Unspecified intestinal malabsorption in patients treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers: a retrospective analysis in primary care settings | ||||
| De Bortoli N1, Ripellino C2, Cataldo N3, Marchi S1 | ||||
| 1 Gastroenterology Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy 2 Department of Real World Evidence, HEOR Consultant Freelance, Milan, Italy 3 Department of Real World Evidence, QuintilesIMS, Milan, Italy | ||||
| Expert Opinion on Drug Safety. doi: 10.1080/14740338.2017.1376647. [Epub ahead of print] |
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| , Article | ||||
| , Germany, Italy | ||||
| Abstract: https://www.ncbi.nlm.nih.gov/pubmed/28871813 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Gastrointestinal disorders, Rare Diseases | 2017 | English | , Clinical setting: Primary care, Database Study, Real World Data, Real World Evidence, Retrospective cohort analysis, Retrospective database analysis | |
| Angiotensin II receptor blockers and intestinal malabsorption: an observational cohort study in Germany and Italy | ||||
| Malfertheiner P1, Heiman F2, Ripellino C3, Cataldo N2 | ||||
| 1 Otto-von-Guericke Universität, Klinik für Gastroenterologie, Hepatologie und Infektiologie 2 QuintilesIMS, Milan, Italy 3 HEOR Consultant, Freelance, Milan, Italy | ||||
| ISPOR 20th Annual European Congress, 4-8 November 2017, Glasgow, Scotland |
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| , Poster | ||||
| , Germany, Italy | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Gastrointestinal disorders, Rare disease | 2017 | English | , Database Study, Epidemiological study, Longitudinal study, Observational study, Population Based Study, Real World Data, Real World Evidence, Retrospective cohort analysis, Retrospective database analysis | |
| Evaluation of the effectiveness of risk minimisation measures: a survey among health care professionals to assess their knowledge and attitudes on prescribing conditions of Instanyl® in France and the Netherlands. | ||||
| Toussi M1, Garofano A1, Jouaville L1, Bardoulat I1, Mitrofan L1 | ||||
| 1 QuintilesIMS, La Défense, France | ||||
| 33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management, 2017, August 26-30, Montreal, Canada |
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| , Poster | ||||
| , France, Netherlands | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Pain, Risk Management & REMS | 2017 | English | , Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Public Health, Survey research | |
| Observational safety study of specific outcomes after trivalent cell culture seasonal influenza vaccination (Optaflu®) among adults in THIN database of electronic UK primary healthcare records | ||||
| Gillian C. Hall1 | Paul T.G. Davies2 | M. Yousuf Karim3 | Mendel D.M. Haag4 | Caroline O'Leary5 | ||||
| Grimsdyke House, London, UK 2 Northampton General Hospital NHS Trust, Northampton, UK 3 Frimley Park, Royal Surrey County, St Peter's Hospitals, Surrey, UK 4 Seqirus, Amsterdam, The Netherlands 5QuinitilesIMS Ltd, London, UK | ||||
| Pharmacoepidemiol Drug Saf. 2017;1–7. |
||||
| , Article | ||||
| , UK | ||||
| Abstract: https://doi.org/10.1002/pds.4347 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Immunology and Vaccination | 2017 | English | , Retrospective database analysis | |
| A Database Cohort Study to Assess the Risk of Angioedema Among Patients with Heart Failure Initiating Angiotensin-Converting Enzyme Inhibitors in the USA | ||||
| Thy P. Do, Arpamas Seetasith, Rossella Belleli, Raymond G. Schlienger, Stefano Corda, Chakkarin Burudpakdee, Hendrik J. Streefkerk, Sigrid Behr | ||||
| Novartis Pharma AG (at the time of study) AND Medical and Scientific Services, Real-World Evidence Solutions, IQVIA | ||||
| Am J Cardiovasc Drugs |
||||
| , Article | ||||
| , USA | ||||
| Abstract: http://rdcu.be/znUq | ||||
| Condition | Year | Language | Analysis type | |
| , Cardiovascular disease, Drug safety | 2017 | English | , Epidemiological study, Population Based Study, Retrospective cohort analysis | |
| Developing a Multi-Phase Claims-Based Algorithm to Facilitate the Study of Drug Exposure During Pregnancy | ||||
| Phillips S, Johnson KJ, Shen SW, Woodcroft KJ, Oliveria SA, Simon TA | ||||
| Phillips S: IQVIA; Johnson KJ: IQVIA (formerly); Shen SW: Bristol-Meyers Squibb; Woodcroft KJ: Henry Ford Health System; Oliveria SA: IQVIA; Simon TA: Bristol Meyers Squibb | ||||
| American College of Rheumatology Annual Meeting, 3-8 November 2017 |
||||
| , Abstract | ||||
| , USA | ||||
| Condition | Year | Language | Analysis type | |
| , Database Validity and methodology, Drug safety, Patient Registries & Real-World Study Methods, Pregnancy | 2017 | English | , Database Study, Epidemiological study, Retrospective database analysis | |
| An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy. | ||||
| Richardson JL1, Stephens S1, Thomas SH1, Jamry-Dziurla A2, de Jong-van den Berg L3, Zetstra-van der Woude P3, Laursen M4, Hliva V5, Mt-Isa S6, Bourke A7, Dreyer NA8, Blackburn SC9. | ||||
| 1The UK Teratology Information ServiceNewcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon TyneUnited Kingdom; Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom. 2Department of Medical Genetics Poznan University of Medical Sciences Poznan Poland. 3Unit of PharmacoEpidemiology and PharmacoEconomics Department of Pharmacy University of Groningen Groningen Netherlands. 4Department of Data Delivery and Medicinal Product Statistics The Danish Health Data Authority Copenhagen Denmark. 5Quintiles Real-World and Late Phase Research St. Prex Switzerland. 6Imperial Clinical Trials Unit School of Public Health Imperial College London London United Kingdom. 7Real World Evidence Solutions IMS Health London United Kingdom. 8Quintiles Real-World & Late Phase Research Cambridge, MA United States. 9Quintiles Real-World and Late Phase Research Reading United Kingdom. | ||||
| , Article | ||||
| , Denmark, Netherlands, Poland, UK | ||||
| Abstract: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4869218/pdf/publichealth_v2i1e13.pdf | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Womens Health | 2016 | English | , direct-to-patient research | |
| Validity of ankylosing spondylitis diagnoses in The Health Improvement Network | ||||
| Dubreuil M, Peloquin C, Zhang Y, Choi HK, Inman RD, Neogi T | ||||
| Boston University School of Medicine, Section of Rheumatology; VA Boston Healthcare System; Massachusetts General Hospital, Section of Rheumatology; University of Toronto, Toronto Western Hospital | ||||
| , Article | ||||
| , UK | ||||
| Condition | Year | Language | Analysis type | |
| , Database Validity and methodology, Drug safety, Rheumatology | 2016 | English | , Retrospective database analysis | |
| Backdating of events in electronic primary health care data: should one censor at the date of last data collection | ||||
| Sammon CJ, Petersen | ||||
| Department of Primary Care and Population Health, University College London; Department of Clinical Epidemiology, Aarhus University | ||||
| , Article | ||||
| , UK | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2016 | English | , Retrospective database analysis | |
| Validation of a coding algorithm for intra-abdominal surgeries and adhesion-related complications in an electronic medical records database | ||||
| Scott FI, Mamtani R, Haynes K, Goldberg DS, Mahmoud NN, Lewis JD | ||||
| Division of Gastroenterology, Department of Medicine, University of Pennsylvania; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania; Abramson Cancer Centre, Department of Medicine, University of Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania | ||||
| , Article | ||||
| , UK | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2016 | English | , Retrospective database analysis | |
| The Effect of Safety Warnings on Antipsychotic Drug Prescribing in Elderly Persons with Dementia in the United Kingdom and Italy: A Population-Based Study. | ||||
| Sultana J, Fontana A, Giorgianni F, Pasqua A, Cricelli C, Spina E, Gambassi G, Ivanovic J, Ferrajolo C, Molokhia M, Ballard C, Sharp S, Sturkenboom M, Trifirò G | ||||
| Department of Clinical and Experimental Medicine, University of Messina; Department of Epidemiology, Erasmus Medical Centre; Unit of Biostatistics, IRCCS Casa Sollievo della Sofferenza; Health Search, Italian College of General Practitioners; Department of Internal Medicine; Italian Drug Agency (AIFA); Department of Experimental Medicine, Pharmacology section; Department of Primary Care and Public Health Sciences; Biomedical Research Unit for Dementia; IRCCS Centro Neurolesi Bonino Pulejo | ||||
| , Article | ||||
| , UK | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Neurological disorders | 2016 | English | , Retrospective database analysis | |
| Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice. | ||||
| Beyer-Westendorf J, Camm AJ, Coleman CI, Tamayo S. | ||||
| Thromb Haemost. 2016 Sep 28;116(Suppl. 2):S13-S23. |
||||
| , Article | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2016 | English | ||
| Drug safety assessment using Dubai Real World Claims Database (DRWD) | ||||
| Mahagaonkar SB | ||||
| IMS Health, Dubai, UAE | ||||
| Joint International Conference and Expo on Industrial Pharmacy & 5th Global Pharmacovigilance Summit April 28-29, 2016 Dubai, UAE |
||||
| , Abstract | ||||
| , Dubai | ||||
| Abstract: https://www.omicsonline.org/proceedings/drug-safety-assessment-using-dubai-real-world-claims-database-drwd-43060.html | ||||
| Condition | Year | Language | Analysis type | |
| , Database Validity and methodology, Drug safety | 2016 | English | , Retrospective database analysis | |
| Impacto presupuestario del uso de un contraste isoosmolar frente a contrastes de baja osmolaridad en pacientes con alto riesgo de nefropatía inducida por contraste en el entorno hospitalario español | ||||
| Eduardo Pinar1, José María Hernández2, Josepa Mauri3, Francisco Picó4, Rafael Ruiz5, Ángel Luis de Francisco6, Carmen Barrull7, Emilio Moreno8, Alexis Sampedro8, Felipe Hernández9 | ||||
| 1 Servicio de Hemodinámica, Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, España; 2 Unidad de Hemodinámica, Hospital Virgen de la Victoria, Málaga, España; 3 Unitat d’Hemodinàmica i Cardiologia Intervencionista, Hospital Universitari Germans Trias i Pujol, Barcelona, España; 4 Unidad de Cardiología y Hemodinámica, Hospital Quirón, Murcia, España; 5 Servicio de Hemodinámica e Intervención Endovascular, Hospital Virgen Macarena, Sevilla, España; 6 Servicio de Nefrología, Hospital Universitario Marqués de Valdecilla, Santander, España; 7 Health Economics & Outcomes Research, IMS Health, Barcelona, España; 8 Departamento Médico, GE Healthcare, Madrid, España; 9 Servicio de Cardiología, Hospital Universitario Doce de Octubre, Madrid, España | ||||
| PharmacoEcon Span Res Artic (2016) 13(1):17-24. |
||||
| , Article | ||||
| , Spain | ||||
| Abstract: https://link.springer.com/article/10.1007%2Fs40277-015-0049-z | ||||
| Condition | Year | Language | Analysis type | |
| , Cardiovascular disease, Drug safety, Drug Utlization Study, Health economics | 2016 | Spanish | , Budget impact, Clinical setting: hospital | |
| Between Risk Management and Pharmacoepidemiology: Where Do Post-Authorisation Safety Studies Stand Today? | ||||
| Mariana F. Almas1, Pierre Engel2, Marieke L. De Bruin3, Kathryn Starzyk4, Blackburn Stella1 and Dreyer A. Nancy5 | ||||
| 1Real-World & Late Phase Research, Reading, Berkshirek, United Kingdom; 2Real-World & Late Phase Research, France; 3Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, Netherlands; 4Real-World & Late Phase Research, Cambridge, United States; 5University of North Carolina, Chapel Hill, United States | ||||
| , Abstract | ||||
| Abstract: https://onlinelibrary.wiley.com/doi/full/10.1002/pds.4070 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Regulatory, Risk Management & REMS | 2016 | English | , Review | |
| Liver transplant associated with paracetamol overdose: results from the seven-country SALT study | ||||
| Sinem Ezgi Gulmez,1 Dominique Larrey,2 Georges- Philippe Pageaux,2 Jacques Bernuau,3 Franco Bissoli,4 Yves Horsmans,5 Douglas Thorburn,6 P. Aiden McCormick,7 Bruno Stricker,8 Massoud Toussi,9 Séverine Lignot-Maleyran,1 Sophie Micon,1 Fatima Hamoud,1 Régis Lassalle,1 Jérémy Jové,1 Patrick Blin1 & Nicholas Moore1 | ||||
| 1CIC Bordeaux CIC1401 Pharmaco-épidémiologie, Université de Bordeaux, F-33076 Bordeaux, France, 2CHU St Eloi Hospital, Liver Unit, Montpellier, France, 3Beaujon Hospital, Liver Unit, Clichy, France, 4Department of Internal Medicine, Clinica San Gaudenzio, Novara, Italy, 5Department of Gastroenterology, Louvain Catholic University, Louvain, Belgium, 6Liver Unit, Royal Free NHS Trust, London, UK, 7Liver Unit, St Vincent’s University Hospital and University College Dublin, Dublin, Ireland, 8Department of Epidemiology, Erasmus University, Rotterdam, Netherlands and 9IMSHealth, Real World Evidence Solutions, France | ||||
| British Journal of Clinical Pharmacology 2015 |
||||
| , Article | ||||
| , France, Greece, Ireland, Italy, Netherlands, Portugal, UK | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Public Health | 2015 | English | , Epidemiological study | |
| The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study | ||||
| de Bie S1,2, Coloma PM1, Ferrajolo C1,3, Verhamme KM1, Trifirò G1,4, Schuemie MJ1, Straus SM1,2, Gini R5, Herings R1,6, Mazzaglia G7, Picelli G8,Ghirardi A9, Pedersen L10, Stricker BH1,11,12, van der Lei J1, Sturkenboom MC1; EU-ADR consortium. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.2Dutch Medicines Evaluation Board, Utrecht, the Netherlands. 3Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Pharmacology Section, Second University of Naples, Naples, Italy.4Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy.5Agenzia Regionale di Sanità della Toscana, Florence, Italy.6PHARMO Institute, Utrecht, the Netherlands.Società Italiana di Medicina Generale, Florence, Italy.8Pedianet-Società Servizi Telematici SRL, Padova, Italy. 9Department of Statistics, Universita di Milano-Bicocca, Milan, Italy. • 10Department of Clinical Epidemiology, Aarhus University Hospital Aarhus, Denmark.11Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.12Inspectorate of Health Care, The Hague, the Netherlands. | ||||
| Br J Clin Pharmacol. 2015 Aug;80(2):304-14 |
||||
| , Abstract | ||||
| , Italy | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2015 | English | , Retrospective database analysis | |
| Using real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project | ||||
| Patadia VK1, Coloma P, Schuemie MJ, Herings R, Gini R, Mazzaglia G, Picelli G, Fornari C, Pedersen L, van der Lei J, Sturkenboom M, Trifirò G; EU-ADR consortium | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands. | ||||
| Expert Rev Clin Pharmacol. 2015 Jan;8(1):95-102 |
||||
| , Abstract | ||||
| , Italy | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2015 | English | , Retrospective database analysis | |
| Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection. | ||||
| Pacurariu AC1,2, Straus SM1,2, Trifirò G1,3, Schuemie MJ1, Gini R4, Herings R5, Mazzaglia G6, Picelli G7, Scotti L8, Pedersen L9, Arlett P10, van der Lei J1, Sturkenboom MC1, Coloma PM11. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.2Dutch Medicines Evaluation Board, Utrecht, The Netherlands. • 3Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.4Agenzia Regionale di Sanità della Toscana, Florence, Italy.5PHARMO Institute, Utrecht, The Netherlands.6Società Italiana di Medicina Generale, Florence, Italy.7Pedianet-Società Servizi Telematici SRL, Padua, Italy. • 8Department of Statistics, Università di Milano-Bicocca, Milan, Italy.9Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.10European Medicines Agency, London, UK.11Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands | ||||
| Drug Saf. 2015 Sep 14 |
||||
| , Abstract, Article | ||||
| , Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/26370104 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2015 | English | , Retrospective database analysis, Survey research | |
| REDUCTION IN C-REACTIVE PROTEIN WITH BIOLOGIC DRUGS IN RHEUMATOID ARTHRITIS AND SPONDYLITIS PATIENTS IN GERMAN RHEUMATOLOGIST PRACTICES | ||||
| Gossen N, Kostev K | ||||
| IMS Health, Frankfurt am Main, Germany | ||||
| ISPOR 18th Annual European Congress Milan, Italy November, 2015 |
||||
| , Poster | ||||
| , Germany | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Rheumatology | 2015 | English | ||
| Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy | ||||
| Nancy A Dreyer1, MPH, PhD ;Stella CF Blackburn2, MBBS, MA, MSc ; Shahrul Mt-Isa3, BSc, PhD ; Jonathan L Richardson4,5, BBSc (Hons) ; Simon Thomas4,5, BSc, MD, FRCP ; Maja Laursen6, MSc, PhD ; • Priscilla Zetstra-van der Woude7, MSc ; Anna Jamry-Dziurla8, MSc ; Valerie Hliva9, PhD ; Alison Bourke10, BSc, MSc ; Lolkje de Jong-van den Berg7, PharmD, PhD | ||||
| 1Quintiles Real-World & Late Phase Research, Cambridge, MA, United States | ||||
| , Article | ||||
| , Denmark, Netherlands, Poland, UK | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Pregnancy | 2015 | English | , direct-to-patient research, Internet or Interactive voice response system, Prospective study | |
| Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy. | ||||
| Dreyer NA1, Blackburn SC2, Mt-Isa S3, Richardson JL4, Thomas S4, Laursen M5, Zetstra-van der Woude P6, Jamry-Dziurla A7, Hliva V8, Bourke A9, de Jong-van den Berg L6. | ||||
| 1Quintiles Real-World & Late Phase Research Cambridge, MA United States. 2Quintiles Real-World & Late Phase Research Reading United Kingdom. 3Imperial College London United Kingdom. 4Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom; UK Teratology Information ServiceNewcastle HospitalsNHS Foundation TrustNewcastle upon TyneUnited Kingdom. 5Statens Serum Institut Copenhagen Denmark. 6University of Groningen Groningen Netherlands. 7Poznan University of Medical Sciences Poznan Poland. 8Quintiles Real-World & Late-Phase Research St. Prex Switzerland. 9IMS London United Kingdom. | ||||
| JMIR Public Health Surveill. 2015 Dec 22;1(2):e22. |
||||
| , Article | ||||
| , Denmark, Netherlands, Poland, UK | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Womens Health | 2015 | English | , direct-to-patient research | |
| Direct-To-Patient Research: The Future of Pharmacovigilance | ||||
| Dreyer NA, Mt. Isa S, Richardson JL, Laursen M, Zetstravan der Woude PA, Jamry-Dziurla A, Hliva V, Bourke A | ||||
| , Poster | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2015 | English | , RWLPR (Real-World Late Phase Research-quintiles | |
| Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection | ||||
| Pacurariu AC1,2, Straus SM1,2, Trifirò G1,3, Schuemie MJ1, Gini R4, Herings R5, Mazzaglia G6, Picelli G7, Scotti L8, Pedersen L9, Arlett P10, van der Lei J1, Sturkenboom MC1, Coloma PM11. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.2Dutch Medicines Evaluation Board, Utrecht, The Netherlands. 3Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.4Agenzia Regionale di Sanità della Toscana, Florence, Italy.5PHARMO Institute, Utrecht, The Netherlands.6Società Italiana di Medicina Generale, Florence, Italy.7Pedianet-Società Servizi Telematici SRL, Padua, Italy.8Department of Statistics, Università di Milano-Bicocca, Milan, Italy.9Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.10European Medicines Agency, London, UK.11Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands | ||||
| Drug Saf. 2015 Sep 14 |
||||
| , Abstract | ||||
| , Italy | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2014 | English | , Retrospective database analysis | |
| Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network. | ||||
| Ferrajolo C, Coloma PM, Verhamme KM, Schuemie MJ, De Bie S, Gini R, Herings R, Mazzaglia G, Picelli G, Giaquinto C, Scotti L, Avillach P, Pedersen L, Rossi F, Capuano A, Van der Lei J, Trifiro G, Sturkenboom MC, EU-ADR consortium. | ||||
| C. Ferrajolo (&) P. M. Coloma K. M. C. Verhamme M. J. Schuemie S. de Bie J. van der Lei G. Trifiro´ M. C. J. M. Sturkenboom :Department of Medical Informatics, Erasmus University Medical Center, Dr. Molewaterplein 50, 3015 GE Rotterdam, The Netherlands C. Ferrajolo F. Rossi A. Capuano :Pharmacology Section, Department of Experimental Medicine,Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Second University of Naples, Via L. De Crecchio, 7, 80138 Naples, Italy R. Gini :Regional Health Agency of Tuscany, Florence, Italy R. Herings: PHARMO Institute, Utrecht, The Netherlands G. Mazzaglia :Italian College of General Practitioners, Florence, Italy G. Picelli :Pedianet-Societa` Servizi Telematici SRL, Padua, Italy C. Giaquinto: Department of Paediatrics, University Hospital of Padua, Padua, Italy L. Scotti :Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy P. Avillach: LESIM, ISPED, University of Bordeaux 2, Bordeaux, France L. Pedersen: Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark G. Trifiro´: Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy M. C. J. M. Sturkenboom: Epidemiology, Erasmus University Medical Center, Rotterdam,The Netherlands | ||||
| Drug Saf. 2014 Feb;37(2):99-108 |
||||
| , Article | ||||
| , Italy | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24446276 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Miscellaneous | 2014 | English | , Retrospective database analysis | |
| Validation study in four health-care databases: upper gastrointestinal bleeding misclassification affects precision but not magnitude of drug-related upper gastrointestinal bleeding risk. | ||||
| Valkhoff VE1, Coloma PM2, Masclee GM1, Gini R3, Innocenti F4, Lapi F5, Molokhia M6, Mosseveld M2, Nielsson MS7, Schuemie M2, Thiessard F8, van der Lei J2, Sturkenboom MC9, Trifirò G10; EU-ADR Consortium. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam The Netherlands.2Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.3Agenzi Regionali di Sanità della Toscana, Via Pietro Dazzi 1 - 50141, Firenze, Italy.4Health Search, Italian College of General Practitioners, Via del Pignoncino, 9-11,50142, Florence, Italy.5Centre for Clinical Epidemiology, Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montréal, QC H3T 1E2, Canada; Department of Preclinical and Clinical Pharmacology, University of Florence, Piazza di San Marco, 4, 50121 Firenze, Italy.6Department of Primary Care and Public Health Sciences, Kings College London, Division of Health and Social Care Research, 7th Floor, Capital House, 42 Weston Street, London SE1 3QD, United Kingdom.7Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45 DK-8200 Aarhus N, Denmark.8LESIM, ISPED, Universite Bordeaux 2', 146 Rue Léo Saignat, 33076 Bordeaux, France.9Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Epidemiology, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.10Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Clinical and Experimental Medicine and Pharmacology, Via Consolare Pompea, 1, Messina, University of Messina, Italy. | ||||
| J Clin Epidemiol. 2014 Aug;67(8):921-31. doi: 10.1016/j.jclinepi.2014.02.020. Epub 2014 May 1. |
||||
| , Article | ||||
| , Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24794575 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Gastrointestinal disorders | 2014 | English | , Retrospective database analysis | |
| The risk of metabolic disorders in patients treated with asenapine or olanzapine: a study conducted on real-world data in Italy and Spain. | ||||
| Maina G, Ripellino C, Pegoraro V, Caresano C. | ||||
| ISPOR Annual European Congress. 2014, Amsterdam Value in health |
||||
| , Poster | ||||
| , Italy, Spain | ||||
| Abstract: http://www.valueinhealthjournal.com/article/S1098-3015(14)03164-7/abstract | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Neurological disorders | 2014 | English | , Real World Data | |
| Emergency hospitalizations for unsupervised prescription medication ingestions by young children | ||||
| Lovegrove MC, Mathew J, Hampp C, Governale L, Wysowski DK, Budnitz DS | ||||
| Food and Drug Administration | ||||
| Pediatrics 2014;134(4):e1009-1016. |
||||
| , Article | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/?term=Emergency+hospitalizations+for+unsupervised+prescription+medication+ingestions+by+young+children. | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2014 | English | , Real World Evidence | |
| Prescription Opioid and Heroin Abuse, April 29, 2014 | ||||
| Volkow ND, | ||||
| House Committee on Energy and Commerce Subcommittee on Oversight and Investigations | ||||
| Testimony to congress.House Committee on Energy and Commerce Subcommittee on Oversight and Investigations |
||||
| , Abstract | ||||
| Abstract: https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2015/prescription-opioid-heroin-abuse | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2014 | English | ||
| Replication of the OMOP experiment in Europe: evaluating methods for risk identification in electronic health record databases. | ||||
| Schuemie MJ, Gini R, Coloma PM, Straatman H, Herings RM, Pedersen L, Innocenti F, Mazzaglia G, Picelli G, Van Der Lai J, Sturkenboom MC. | ||||
| Drug Saf. 2013 Oct;36 Suppl 1:S159-69. doi: 10.1007/s40264-013-0109-8. |
||||
| , Article | ||||
| , Europe, Italy | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24166232 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Methodology | 2013 | English | , Methodology, Retrospective database analysis | |
| Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two European countries. | ||||
| Ferrajolo C1, Verhamme KM, Trifirò G, 't Jong GW, Giaquinto C, Picelli G, Oteri A, de Bie S, Valkhoff VE, Schuemie MJ, Mazzaglia G, Cricelli C, Rossi F, Capuano A, Sturkenboom MC.Capuano A, Sturkenboom MC. | ||||
| 1Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Pharmacology Section, Second University of Naples, Via L. De Crecchio, 7, 80138, Naples, Italy | ||||
| Drug Saf. 2013 Oct;36(10):1007-16. doi: 10.1007/s40264-013-0045-7. |
||||
| , Article | ||||
| , Italy, Netherlands | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23591830 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Pediatrics | 2013 | English | , Retrospective database analysis | |
| A reference standard for evaluation of methods for drug safety signal detection using electronic healthcare record databases. | ||||
| Coloma PM, Avillach P, Salvo F, Schuemie MJ, Ferrajolo C, Pariente A, Fourrier-Reglat A, Molokhia M, Patadia V, Van Der Lei J, Sturkenboom M, Trifiro G. | ||||
| Department of Medical Informatics, Erasmus Medical Center, Postbus 2040, 3000, CA, Rotterdam, The Netherlands. | ||||
| Drug Saf. 2013 Jan;36(1):13-23. doi: 10.1007/s40264-012-0002-x |
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| , Article | ||||
| , Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23315292 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Methodology | 2013 | English | , Retrospective database analysis | |
| Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues? | ||||
| Valkhoff VE1, Schade R, 't Jong GW, Romio S, Schuemie MJ, Arfe A, Garbe E, Herings R, Lucchi S, Picelli G, Schink T, Straatman H, Villa M, Kuipers EJ, Sturkenboom MC; Safety of Non-steroidal Anti-inflammatory Drugs (SOS) project. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Dr, Molewaterplein, Rotterdam, The Netherlands | ||||
| BMC Pediatr. 2013 Nov 19;13:192. doi: 10.1186/1471-2431-13-192. |
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| , Article | ||||
| , Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24252465 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Miscellaneous, Pediatrics | 2013 | English | , Retrospective database analysis | |
| An inventory of European data sources for the long-term safety evaluation of methylphenidate. | ||||
| Murray ML, Insuk S, Banaschewski T, Neubert AC, McCarthy S, Buitelaar JK, Coghill D, Dittmann RW, Konrad K, Panei P, Rosenthal E, Sonuga-Barke EJ & Wong IC. | ||||
| Centre for Paediatric Pharmacy Research, University College London School of Pharmacy, London, UK | ||||
| Eur Child Adolesc Psychiatry. 2013 Oct;22(10):605-18. doi: 10.1007/s00787-013-0386-x. Epub 2013 Mar 19. |
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| , Article | ||||
| , Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23508655 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Mental health, Pediatrics | 2013 | English | , Database Study, Methodology, Retrospective database analysis | |
| Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project. | ||||
| Avillach P1, Coloma PM, Gini R, Schuemie M, Mougin F, Dufour JC, Mazzaglia G, Giaquinto C, Fornari C, Herings R, Molokhia M, Pedersen L, Fourrier-Réglat A, Fieschi M, Sturkenboom M, van der Lei J, Pariente A, Trifirò G; EU-ADR consortium.Fieschi M, Sturkenboom M, van der Lei J, Pariente A, Trifirò G; EU-ADR consortium. | ||||
| 1, LESIM, ISPED, University Bordeaux Segalen, Bordeaux,France 2,LERTIM, EA 3283, Faculté de Médecine, Université AixMarseille 2, Marseille, France 3,Department of Medical Informatics, Erasmus University Medical Center, Rotterdam,The Netherlands 4,Regional Health Agency of ARS, Florence, Italy 5,Health Search—Italian College of General Practitioners,Florence, Italy 6,Pedianet—Societa’ Servizi Telematici SRL, Padova, Italy 7,Centre on Public Health,University of Milano-Bicocca,Milano, Italy 8, PHARMO Coöperation UA,Utrecht, The Netherlands 9,Department of Primary Care and Public Health Sciences, Kings College, London,UK 10 Aarhus University Hospital,Århus Sygehus, Denmark 11 INSERM U 657, University Bordeaux Segalen, Bordeaux,France 12Department of Epidemiology,Erasmus University Medical Center, Rotterdam, The Netherlands 13, Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy | ||||
| J Am Med Inform Assoc. 2013 Jan 1;20(1):184-92. doi: 10.1136/amiajnl-2012-000933. Epub 2012 Sep 6. |
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| , Article | ||||
| , Europe, Italy | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22955495 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Methodology | 2013 | English | , Retrospective database analysis | |
| Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two European countries. | ||||
| Ferrajolo C1, Verhamme KM, Trifirò G, 't Jong GW, Giaquinto C, Picelli G, Oteri A, de Bie S, Valkhoff VE, Schuemie MJ, Mazzaglia G, Cricelli C, Rossi F, Capuano A, Sturkenboom MC | ||||
| 1Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Pharmacology Section, Second University of Naples, Via L. De Crecchio, 7, 80138, Naples, Ital | ||||
| Drug Saf. 2013 Oct;36(10):1007-16 |
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| , Abstract | ||||
| , Italy | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2013 | English | , Retrospective database analysis | |
| US-based emergency department visits for fluoroquinolone-associated hypersensitivity reactions | ||||
| Jones SC, Budnitz DS, Sorbello A, Mehta H | ||||
| Food and Drug Administration | ||||
| Pharmacoepidemiol Drug Saf 2013;22(10):1099-1106. |
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| , Article | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/?term=US-based+emergency+department+visits+for+fluoroquinolone-associated+hypersensitivity+reactions. | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2013 | English | , Real World Evidence | |
| Using electronic health care records for drug safety signal detection: a comparative evaluation of statistical methods. | ||||
| Schuemie MJ1, Coloma PM, Straatman H, Herings RM, Trifirò G, Matthews JN, Prieto-Merino D, Molokhia M, Pedersen L, Gini R, Innocenti F, Mazzaglia G, Picelli G, Scotti L, van der Lei J, Sturkenboom MC. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands | ||||
| Med Care. 2012 Oct;50(10):890-7. |
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| , Article | ||||
| , Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22929992 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Methodology | 2012 | English | , Retrospective database analysis | |
| Electronic healthcare databases for active drug safety surveillance: is there enough leverage. | ||||
| Coloma PM1, Trifirò G, Schuemie MJ, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Picelli G, Corrao G, Pedersen L, van der Lei J, Sturkenboom M; EU-ADR Consortium. | ||||
| 1Department of Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands | ||||
| Pharmacoepidemiol Drug Saf. 2012 Jun;21(6):611-21. doi: 10.1002/pds.3197. Epub 2012 Feb 8. |
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| , Article | ||||
| , Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22315152 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Miscellaneous | 2012 | English | , Retrospective database analysis | |
| Risk of cardiac valve regurgitation with dopamine agonist use in Parkinson's disease and hyperprolactinaemia: a multi-country, nested case-control study. | ||||
| Trifirò G1, Mokhles MM, Dieleman JP, van Soest EM, Verhamme K, Mazzaglia G, Herings R, de Luise C, Ross D, Brusselle G, Colao A, Haverkamp W, Schade R, van Camp G, Zanettini R & Sturkenboom MC. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands. g.trifiro@erasmusmc.nl | ||||
| Drug Saf. 2012 Feb 1;35(2):159-71. doi: 10.2165/11594940-000000000-00000. |
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| , Article | ||||
| , Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22204718 | ||||
| Condition | Year | Language | Analysis type | |
| , Cardiovascular disease, Drug safety, Neurological disorders | 2012 | English | , Retrospective database analysis | |
| The risk of new onset heart failure associated with dopamine agonist use in Parkinson's disease. | ||||
| Mokhles MM1, Trifirò G, Dieleman JP, Haag MD, van Soest EM, Verhamme KM, Mazzaglia G, Herings R, Luise Cd, Ross D, Brusselle G, Colao A, Haverkamp W, Schade R, Camp Gv, Zanettini R, Sturkenboom MC | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands. | ||||
| Pharmacol Res. 2012 Mar;65(3):358-64. doi: 10.1016/j.phrs.2011.11.009. Epub 2011 Nov 23. |
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| , Article | ||||
| , Italy, Netherlands, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22123498 | ||||
| Condition | Year | Language | Analysis type | |
| , Cardiovascular disease, Drug safety, Neurological disorders | 2012 | English | , Retrospective database analysis | |
| Validation of a common data model for active safety surveillance research. | ||||
| J Marc Overhage,1,2 Patrick B Ryan,2,3,4 Christian G Reich,2 Abraham G Hartzema,2,5 Paul E Stang2,3 | ||||
| 1Regenstrief Institute, Indiana University, School of Medicine, Indianapolis, Indiana, USA 2Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, Maryland, USA 3Johnson & Johnson Institute, Department of Pharmaceutical Research and Development LLC, Titusville, New Jersey, USA 4UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA 5College of Pharmacy, University of Florida, Gainesville, Florida, USA | ||||
| J Am Med Inform Assoc |
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| , Article | ||||
| , USA | ||||
| Abstract: doi:10.1136/amiajnl-2011-000376 | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety, Methodology | 2011 | English | , Database Study, Real World Data | |
| DIA J 2008 | ||||
| Dreyer NA, Sheth N, Trontell A, Gliklich RE | ||||
| Good practices for handling adverse events detected through patient registries |
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| , Abstract | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2008 | English | , RWLPR (Real-World Late Phase Research-quintiles | |
| The Monitor Association of Clinical Trial Professionals | ||||
| Dreyer NA, Bertagna M, and Gliklich RE | ||||
| , Article | ||||
| Condition | Year | Language | Analysis type | |
| , Drug safety | 2007 | English | , RWLPR (Real-World Late Phase Research-quintiles | |