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Post marketing surveillance

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https://www.readbyqxmd.com/read/28335691/cases-of-drug-induced-torsade-de-pointes-a-review-of-belgian-cases-in-the-eudravigilance-database
#1
Eline Vandael, Bert Vandenberk, Joris Vandenberghe, Rik Willems, Veerle Foulon
OBJECTIVES: Post-marketing surveillance is very important, especially for rare adverse drug reactions like QTc-prolongation and Torsade de Pointes (TdP). The objective of this study was to investigate the characteristics of Belgian cases of drug-related TdP reported in the EudraVigilance database. METHODS: The EudraVigilance database was searched for Belgian post-marketing cases of TdP reported between December 2001-April 2015. These cases were identified with MedDRA preferred terms...
March 24, 2017: Acta Clinica Belgica
https://www.readbyqxmd.com/read/28293797/comparative-risk-of-major-bleeding-with-new-oral-anticoagulants-noacs-and-phenprocoumon-in-patients-with-atrial-fibrillation-a-post-marketing-surveillance-study
#2
Stefan H Hohnloser, Edin Basic, Michael Nabauer
BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are at least as effective and safe as vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF). All pivotal trials have compared NOACs to warfarin. However, other VKAs are commonly used, for instance phenprocoumon. PATIENTS AND METHODS: A retrospective cohort study using a German claims database assessed the comparative risks of bleeding leading to hospitalization during therapy with NOACs and phenprocoumon in AF patients...
March 14, 2017: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/28277870/safety-and-effectiveness-of-tadalafil-in-patients-with-pulmonary-arterial-hypertension-japan-post-marketing-surveillance-data
#3
Hiroyoshi Yamazaki, Noriko Kobayashi, Masanori Taketsuna, Koyuki Tajima, Masahiro Murakami
OBJECTIVE: To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. METHODS: This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs)...
February 21, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28268822/using-constrained-information-entropy-to-detect-rare-adverse-drug-reactions-from-medical-forums
#4
Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li
Adverse drug reactions (ADRs) detection is critical to avoid malpractices yet challenging due to its uncertainty in pre-marketing review and the underreporting in post-marketing surveillance. To conquer this predicament, social media based ADRs detection methods have been proposed recently. However, existing researches are mostly co-occurrence based methods and face several issues, in particularly, leaving out the rare ADRs and unable to distinguish irrelevant ADRs. In this work, we introduce a constrained information entropy (CIE) method to solve these problems...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28266092/six-year-multi-centre-observational-post-marketing-surveillance-of-the-safety-of-the-hpv-16-18-as04-adjuvanted-vaccine-in-women-aged-10-25%C3%A2-years-in-korea
#5
Chul-Jung Kim, Rok Song, Jing Chen, Fernanda Taveres Da Silva, Kusuma B Gopala, Joon Hyung Kim, Dan Bi, Jong Sup Park
PURPOSE: To evaluate the safety of HPV-16/18 AS04-adjuvanted vaccine when administered as per the PI in Korea. METHODS: A total of 3084 women aged 10-25 years were enrolled in this post-marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose...
March 7, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28248987/why-do-people-use-electronic-nicotine-delivery-systems-electronic-cigarettes-a-content-analysis-of-twitter-2012-2015
#6
John W Ayers, Eric C Leas, Jon-Patrick Allem, Adrian Benton, Mark Dredze, Benjamin M Althouse, Tess B Cruz, Jennifer B Unger
The reasons for using electronic nicotine delivery systems (ENDS) are poorly understood and are primarily documented by expensive cross-sectional surveys that use preconceived close-ended response options rather than allowing respondents to use their own words. We passively identify the reasons for using ENDS longitudinally from a content analysis of public postings on Twitter. All English language public tweets including several ENDS terms (e.g., "e-cigarette" or "vape") were captured from the Twitter data stream during 2012 and 2015...
2017: PloS One
https://www.readbyqxmd.com/read/28231676/-post-marketing-surveillance-of-tanreqing-injection-in-children-a-real-world-study
#7
X X Li, L Zhuo, Y H Yang, S Y Zhan, S D Zhai
Objective: To evaluate the safety of Tanreqing injection among children in the real world. Methods: A multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection...
February 10, 2017: Zhonghua Liu Xing Bing Xue za Zhi, Zhonghua Liuxingbingxue Zazhi
https://www.readbyqxmd.com/read/28227018/using-constrained-information-entropy-to-detect-rare-adverse-drug-reactions-from-medical-forums
#8
Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li, Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li, Jinyan Li, Hui Peng, Chaowang Lan, Yi Zheng
Adverse drug reactions (ADRs) detection is critical to avoid malpractices yet challenging due to its uncertainty in pre-marketing review and the underreporting in post-marketing surveillance. To conquer this predicament, social media based ADRs detection methods have been proposed recently. However, existing researches are mostly co-occurrence based methods and face several issues, in particularly, leaving out the rare ADRs and unable to distinguish irrelevant ADRs. In this work, we introduce a constrained information entropy (CIE) method to solve these problems...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28223094/a-decade-of-the-catalonian-arthroplasty-register-racat-variability-exhaustivity-and-survival-of-prostheses-between-2005-and-2014
#9
J Arias-de la Torre, A Capdevila, O Martínez, L Domingo, M Marinelli, N Robles, J Nardi, L Puig-Verdié, F Pallisó, M Espallargues
BACKGROUND AND AIM: The Catalonian Arthroplasty Register (RACat) is a public health-based population register used to analyse and evaluate hip and knee replacements in Catalonia. The aim of this study is to present the outcomes after 10 years in operation (January 2005-December 2014). METHODOLOGY: Using the information from the RACat and the minimum basic data set at hospital discharge, an analysis was made of the quality and exhaustivity of the data, as well as a descriptive analysis of the patients, prostheses, and care process...
February 17, 2017: Revista Española de Cirugía Ortopédica y Traumatología
https://www.readbyqxmd.com/read/28216355/innovative-postmarket-device-evaluation-using-a-quality-registry-to-monitor-thoracic-endovascular-aortic-repair-in-the-treatment-of-aortic-dissection
#10
Adam W Beck, Joseph V Lombardi, Dorothy B Abel, J Pablo Morales, Danica Marinac-Dabic, Grace Wang, Ali Azizzadeh, John Kern, Mark Fillinger, Rodney White, Jack L Cronenwett, Richard P Cambria
OBJECTIVE: United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals...
February 16, 2017: Journal of Vascular Surgery
https://www.readbyqxmd.com/read/28192490/safety-of-measles-containing-vaccines-in-post-marketing-surveillance-in-anhui-china
#11
Fan-Ya Meng, Yong Sun, Yong-Gang Shen, Hai-Feng Pan, Ji-Hai Tang, Bin-Bing Wang, Chang-Hao Wu, Dong-Qing Ye
The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191...
2017: PloS One
https://www.readbyqxmd.com/read/28190666/design-of-a-framework-for-the-deployment-of-collaborative-independent-rare-disease-centric-registries-gaucher-disease-registry-model
#12
Matthew I Bellgard, Kathryn R Napier, Alan H Bittles, Jeffrey Szer, Sue Fletcher, Nikolajs Zeps, Adam A Hunter, Jack Goldblatt
Orphan drug clinical trials often are adversely affected by a lack of high quality treatment efficacy data that can be reliably compared across large patient cohorts derived from multiple governmental and country jurisdictions. It is critical that these patient data be captured with limited corporate involvement. For some time, there have been calls to develop collaborative, non-proprietary, patient-centric registries for post-market surveillance of aspects related to orphan drug efficacy. There is an urgent need for the development and sustainable deployment of these 'independent' registries that can capture comprehensive clinical, genetic and therapeutic information on patients with rare diseases...
January 27, 2017: Blood Cells, Molecules & Diseases
https://www.readbyqxmd.com/read/28174182/contribution-of-industry-funded-post-marketing-studies-to-drug-safety-survey-of-notifications-submitted-to-regulatory-agencies
#13
Angela Spelsberg, Christof Prugger, Peter Doshi, Kerstin Ostrowski, Thomas Witte, Dieter Hüsgen, Ulrich Keil
OBJECTIVES:  To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. DESIGN:  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. SETTING:  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany...
February 7, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28161880/long-term-safety-and-efficacy-of-omnitrope-%C3%A2-in-adults-with-growth-hormone-deficiency-italian-interim-analysis-of-the-patro-adults-study
#14
D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz
PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope(®), a somatropin biosimilar to Genotropin(®), in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope(®), which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels...
February 4, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28158568/pemetrexed-related-interstitial-lung-disease-reported-from-post-marketing-surveillance-malignant-pleural-mesothelioma-non-small-cell-lung-cancer
#15
Keisuke Tomii, Terufumi Kato, Masashi Takahashi, Satoshi Noma, Yoichiro Kobashi, Sotaro Enatsu, Sumiko Okubo, Noriko Kobayashi, Shoji Kudoh
No abstract text is available yet for this article.
February 2, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28155198/validation-of-new-signal-detection-methods-for-web-query-log-data-compared-to-signal-detection-algorithms-used-with-faers
#16
Susan Colilla, Elad Yom Tov, Ling Zhang, Marie-Laure Kurzinger, Stephanie Tcherny-Lessenot, Catherine Penfornis, Shang Jen, Danny S Gonzalez, Patrick Caubel, Susan Welsh, Juhaeri Juhaeri
INTRODUCTION: Post-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions. METHODS: Recently, a web-based search query method called a query log reaction score (QLRS) was developed to detect whether AEs associated with certain drugs could be found from search engine query data...
February 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28134628/when-is-a-fracture-not-fresh-aligning-reimbursement-with-patient-outcome
#17
Robert Zura, Zekun Jack Xu, Gregory J Della Rocca, Samir Mehta, R Grant Steen
OBJECTIVE: The clinical value of low-intensity pulsed ultrasound (LIPUS) for fresh fracture is known. Yet in the absence of a definition of what "fresh" is, payers have adopted study inclusion criteria drawn from randomized clinical trials as de facto definitions of which patients should be treated, with "fresh" defined as <1 week old. Fracture patients may thus be ineligible for LIPUS treatment after week 1, which potentially denies access to patients who could benefit from LIPUS...
February 15, 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28130774/pre-exposure-prophylaxis-for-hiv-prevention-safety-concerns
#18
REVIEW
Raymond A Tetteh, Barbara A Yankey, Edmund T Nartey, Margaret Lartey, Hubert G M Leufkens, Alexander N O Dodoo
Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28130659/pitavastatin-a-review-in-hypercholesterolemia
#19
REVIEW
Sheridan M Hoy
Oral pitavastatin (Livalo(®); Livazo(®)) is a competitive HMG-CoA reductase inhibitor that is available in the EU for the reduction of elevated total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels in adults with primary hypercholesterolemia and combined (mixed) dyslipidemia. In short-term, phase III or IV studies in this patient population, pitavastatin 1-4 mg once daily was generally no less effective than presumed equipotent dosages of atorvastatin and simvastatin (including in patients with type 2 diabetes or ≥2 cardiovascular risk factors) and was superior to pravastatin (including in patients aged ≥65 years) in lowering LDL-C levels...
April 2017: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/28125608/post-marketing-safety-surveillance-of-the-salvia-miltiorrhiza-depside-salt-for-infusion-a-real-world-study
#20
Ying-Ying Yan, Yi-Heng Yang, Wei-Wei Wang, Yu-Ting Pan, Si-Yan Zhan, Ming-Yang Sun, Hong Zhang, Suo-Di Zhai
BACKGROUND: Salvia Miltiorrhiza Depside Salt for Infusion (SMDS) is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed. OBJECTIVE: To investigate the safety issues, including adverse events (AEs), adverse events related to SMDS (ADEs), and adverse drug reactions (ADRs) of the SMDS in the real world clinical practice. METHODS: This is a prospective, multicenter, pharmacist-led, cohort study in the real world setting...
2017: PloS One
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