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https://www.readbyqxmd.com/read/29779201/clinical-acceptability-of-trimetazidine-modified-release-80-mg-once-daily-versus-trimetazidine-modified-release-35-mg-twice-daily-in-stable-angina-pectoris
#1
Yuri M Pozdnyakov
INTRODUCTION: Trimetazidine (TMZ) is an anti-ischemic metabolic agent that has been shown to be efficacious in angina treatment, both in monotherapy and in combination. A new formulation of TMZ modified-release (MR) 80 mg was developed, which is to be taken once daily (od), instead of twice daily (bid) for the currently available TMZ MR 35 mg, with the aim of simplifying the medication regimen. METHODS: The present study was an international, multicenter, randomized, double-blind, parallel-group phase III study with a 12-week treatment period...
May 19, 2018: Cardiology and Therapy
https://www.readbyqxmd.com/read/29778515/safety-and-immunogenicity-of-fractional-dose-intradermal-injection-of-two-quadrivalent-conjugated-meningococcal-vaccines
#2
Emile F F Jonker, Mariëtte B van Ravenhorst, Guy A M Berbers, Leo G Visser
BACKGROUND: Vaccination with conjugated meningococcal vaccines is the best way to prevent invasive meningococcal disease. Changes in serogroup epidemiology have led to the inclusion of quadrivalent vaccines in the national immunization programs of several countries, but vaccines are frequently in short supply. Intradermal administration has the potential to increase vaccine availability through dose reduction, without sacrificing efficacy. It has never before been investigated for glycoconjugate meningococcal vaccines...
May 16, 2018: Vaccine
https://www.readbyqxmd.com/read/29777868/comparative-efficacy-and-safety-of-different-antiviral-agents-for-cytomegalovirus-prophylaxis-in-allogeneic-hematopoietic-cell-transplantation-a-systematic-review-and-meta-analysis
#3
Nico Gagelmann, Per Ljungman, Jan Styczynski, Nicolaus Kröger
Over the past 25 years, several randomized controlled trials have investigated the efficacy of different antiviral agents for cytomegalovirus (CMV) prophylaxis in allogeneic hematopoietic-cell transplantation. We performed a systematic literature review, conventional meta-analysis and network meta-analysis using a random-effects model and risk ratios (RR) with corresponding 95% confidence intervals (CI) as effect estimates. Fifteen randomized controlled trials were identified, including seven different antiviral agents: acyclovir, ganciclovir, maribavir, brincidofovir, letermovir, valacyclovir, and vaccine...
May 16, 2018: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29776750/safety-and-immunogenicity-of-a-vi-dt-typhoid-conjugate-vaccine-phase-i-trial-in-healthy-filipino-adults-and-children
#4
Maria Rosario Capeding, Samuel Teshome, Tarun Saluja, Khalid Ali Syed, Deok Ryun Kim, Ju Yeon Park, Jae Seung Yang, Yang Hee Kim, Jiwook Park, Sue-Kyoung Jo, Yun Chon, Sudeep Kothari, Seon-Young Yang, Dong Soo Ham, Ji Hwa Ryu, Hee-Seong Hwang, Ju-Hwan Mun, Julia Lynch, Jerome Kim, Hun Kim, Jean-Louis Excler, Sushant Sahastrabuddhe
BACKGROUND: Typhoid fever remains a major public health problem in low- and middle-income countries where children aged 2-14 years bear the greatest burden. Vi polysaccharide is poorly immunogenic in children <2 years of age, and protection in adults is modest. The limitations of Vi polysaccharide vaccines can be overcome by conjugation of the Vi to a carrier protein. A typhoid conjugate vaccine composed of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) has been developed...
May 15, 2018: Vaccine
https://www.readbyqxmd.com/read/29772565/safety-of-iohexol-administration-to-measure-glomerular-filtration-rate-in-different-patient-populations-a-25-year-experience
#5
Flavio Gaspari, Surabhi Thakar, Fabiola Carrara, Annalisa Perna, Matias Trillini, Maria Carolina Aparicio, Olimpia Diadei, Silvia Ferrari, Antonio Cannata, Nadia Stucchi, Piero Ruggenenti, Giuseppe Remuzzi, Norberto Perico
BACKGROUND/AIM: In clinical research setting, accurate and precise measurement of glomerular filtration rate (GFR) is essential to overcome the limitations of GFR estimation with equations, which are often unreliable. In recent decades, a method for measuring GFR by plasma clearance of iohexol, a non-ionic radiocontrast agent, was developed. To evaluate the safety of the procedure, we aimed to review all immediate adverse reactions that could be related to iohexol administration in our group's 25 years worth of experience...
May 17, 2018: Nephron
https://www.readbyqxmd.com/read/29772402/serious-adverse-events-following-normal-pressure-hydrocephalus-surgery
#6
Vikas Kotagal, Elizabeth Walkowiak, Jason A Heth
OBJECTIVE: Recent Normal Pressure Hydrocephalus (NPH) practice guidelines describe a serious adverse event (SAE) rate following surgery of 11%. PATIENTS & METHODS: We conducted a retrospective review of 162 consecutive patients who have undergone work-up at our center's multidisciplinary NPH clinic over a 47 month time period (2/2014-12/2017). Of these, 22 ultimately underwent neurosurgical ventricular shunt surgery as treatment for NPH. Clinical records were reviewed for SAEs categorized as possibly/probably/definitely related to NPH surgery...
May 14, 2018: Clinical Neurology and Neurosurgery
https://www.readbyqxmd.com/read/29770930/safety-profile-of-the-interleukin-1-inhibitors-anakinra-and-canakinumab-in-real-life-clinical-practice-a-nationwide-multicenter-retrospective-observational-study
#7
Jurgen Sota, Antonio Vitale, Antonella Insalaco, Paolo Sfriso, Giuseppe Lopalco, Giacomo Emmi, Marco Cattalini, Raffaele Manna, Rolando Cimaz, Roberta Priori, Rosaria Talarico, Ginevra de Marchi, Micol Frassi, Romina Gallizzi, Alessandra Soriano, Maria Alessio, Daniele Cammelli, Maria Cristina Maggio, Stefano Gentileschi, Renzo Marcolongo, Francesco La Torre, Claudia Fabiani, Serena Colafrancesco, Francesca Ricci, Paola Galozzi, Ombretta Viapiana, Elena Verrecchia, Manuela Pardeo, Lucia Cerrito, Elena Cavallaro, Alma Nunzia Olivieri, Giuseppe Paolazzi, Gianfranco Vitiello, Armin Maier, Elena Silvestri, Chiara Stagnaro, Guido Valesini, Marta Mosca, Salvatore de Vita, Angela Tincani, Giovanni Lapadula, Bruno Frediani, Fabrizio De Benedetti, Florenzo Iannone, Leonardo Punzi, Carlo Salvarani, Mauro Galeazzi, Rossella Angotti, Mario Messina, Gian Marco Tosi, Donato Rigante, Luca Cantarini
A few studies have reported the safety profile of interleukin (IL)-1 blockers from real life. The aim of this study is to describe anakinra (ANA) and canakinumab (CAN) safety profile in children and adults, based on data from a real-life setting. Demographic, clinical, and therapeutic data from patients treated with ANA and CAN were retrospectively collected and analyzed. Four hundred and seventy five patients were enrolled; ANA and CAN were prescribed in 421 and 105 treatment courses, respectively. During a mean follow-up of 24...
May 17, 2018: Clinical Rheumatology
https://www.readbyqxmd.com/read/29768451/intravitreal-ocriplasmin-for-the-treatment-of-vitreomacular-traction-and-macular-hole-a-study-of-efficacy-and-safety-based-on-nice-guidance
#8
Mahiul M K Muqit, Robin Hamilton, Jason Ho, Sally Tucker, Helen Buck
PURPOSE: To evaluate the real world clinical outcomes of intravitreal ocriplasmin in patients with vitreomacular traction (VMT) with and without full thickness macular holes (FTMH) treated according to NICE guidance. METHODS: Retrospective observational case series of 25 patients treated with a single intravitreal ocriplasmin injection between December 2013 and December 2015. Best corrected visual acuity and optical coherence tomography exams were performed to determine visual outcomes and anatomical VMT release and FTMH closure over time...
2018: PloS One
https://www.readbyqxmd.com/read/29768414/adipose-derived-mesenchymal-stem-cells-admsc-for-the-treatment-of-secondary-progressive-multiple-sclerosis-a-triple-blinded-placebo-controlled-randomized-phase-i-ii-safety-and-feasibility-study
#9
Oscar Fernández, Guillermo Izquierdo, Victoria Fernández, Laura Leyva, Virginia Reyes, Miguel Guerrero, Antonio León, Carlos Arnaiz, Guillermo Navarro, Maria Dolores Páramo, Antonio De la Cuesta, Bernat Soria, Abdelkrim Hmadcha, David Pozo, Rafael Fernandez-Montesinos, Maria Leal, Itziar Ochotorena, Patricia Gálvez, Maria Angeles Geniz, Francisco Javier Barón, Rosario Mata, Cristina Medina, Carlos Caparrós-Escudero, Ana Cardesa, Natividad Cuende
BACKGROUND: Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures. PATIENTS AND METHODS: In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months...
2018: PloS One
https://www.readbyqxmd.com/read/29768412/adverse-events-following-single-dose-treatment-of-lymphatic-filariasis-observations-from-a-review-of-the-literature
#10
Philip J Budge, Carly Herbert, Britt Andersen, Gary J Weil
BACKGROUND: WHO's Global Programme to Eliminate Lymphatic Filariasis (LF) uses mass drug administration (MDA) of anthelmintic medications to interrupt LF transmission in endemic areas. Recently, a single dose combination of ivermectin (IVM), diethylcarbamazine (DEC), and albendazole (ALB) was shown to be markedly more effective than the standard two-drug regimens (DEC or IVM, plus ALB) for achieving long-term clearance of microfilaremia. OBJECTIVE AND METHODS: To provide context for the results of a large-scale, international safety trial of MDA using triple drug therapy, we searched Ovid Medline for studies published from 1985-2017 that reported adverse events (AEs) following treatment of LF with IVM, DEC, ALB, or any combination of these medications...
May 16, 2018: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/29768328/efficacy-and-safety-of-etomidate-midazolam-for-screening-colonoscopy-in-the-elderly-a-prospective-double-blinded-randomized-controlled-study
#11
Jung Min Lee, Geeho Min, Jae Min Lee, Seung Han Kim, Hyuk Soon Choi, Eun Sun Kim, Bora Keum, Yoon Tae Jeen, Hoon Jai Chun, Hong Sik Lee, Chang Duck Kim, Jong-Jae Park, Beom Jae Lee, Seong Ji Choi, Woojung Kim
BACKGROUND AND AIMS: Recent studies have shown that etomidate is associated with fewer serious adverse events than propofol and has a noninferior sedative effect. We investigated whether etomidate-midazolam is associated with fewer cardiopulmonary adverse events and has noninferior efficacy compared to propofol-midazolam for screening colonoscopy in the elderly. METHODS: A prospective, single-center, double-blinded, randomized controlled trial was performed. Patients aged over 65 years who were scheduled to undergo screening colonoscopy were randomized to receive either etomidate or propofol based on midazolam...
May 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29765441/suspected-unexpected-and-other-adverse-reactions-to-antiretroviral-drugs-used-as-post-exposure-prophylaxis-of-hiv-infection-five-year-experience-from-clinical-practice
#12
Justyna D Kowalska, Ewa Pietraszkiewicz, Ewa Firląg-Burkacka, Andrzej Horban
Introduction: With increased use of antiretroviral drugs (ARVs) in HIV uninfected persons, proper reporting on suspected unexpected serious adverse reactions (SUSARs) and continued insight into adverse drug reactions (ADRs) are needed for adequate information on safety of ARVs in such populations. Material and methods: Medical documentation of persons receiving ARVs after non-occupational HIV exposure (non-occupational post-exposure prophylaxis - nPEP) during 5 successive years (2009-2013) was evaluated by two HIV physicians...
April 2018: Archives of Medical Science: AMS
https://www.readbyqxmd.com/read/29764416/safety-of-a-condom-uterine-balloon-tamponade-esm-ubt-device-for-uncontrolled-primary-postpartum-hemorrhage-among-facilities-in-kenya-and-sierra-leone
#13
Aparna Ramanathan, Melody J Eckardt, Brett D Nelson, Moytrayee Guha, Monica Oguttu, Zaid Altawil, Thomas Burke
BACKGROUND: Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. METHODS: Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study...
May 15, 2018: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/29764238/successful-administration-of-bi-695501-an-adalimumab-biosimilar-using-an-autoinjector-ai-results-from-a-phase-ii-open-label-clinical-study-voltaire-%C3%A2-rl
#14
Stanley Cohen, Piotr A Klimiuk, Tillmann Krahnke, Deepak Assudani
BACKGROUND: This study examined the patient handling experience and self-injection success of patients with rheumatoid arthritis (RA) administering BI 695501 using an AI. METHODS: This Phase II, 7-week, open-label, interventional study (NCT02636907) included adult patients with moderately to severely active RA not adequately controlled by DMARDs, with no experience of self-injecting with AI/pen. Patients self-injected BI 695501 via AI every 2 weeks in the AI Assessment Period (AAP)...
May 15, 2018: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29764225/initial-combination-therapy-with-vildagliptin-plus-metformin-in-drug-na%C3%A3-ve-patients-with-t2dm-a-24-week-real-life-study-from-asia
#15
Manoj Chawla, Tae Ho Kim, Roberto C Mirasol, Pathan Faruque, Kathryn Cooke, Peggy Hours-Zesiger, Abhijit Shete
AIMS: To assess the effectiveness and safety of vildagliptin/metformin initial combination therapy in drug-naïve patients with type 2 diabetes mellitus (T2DM). METHODS: INITIAL was a 24-week prospective, observational study in T2DM patients with glycated hemoglobin (HbA1c) ≥7.5%, and prescribed vildagliptin/metformin as initial combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. Key secondary endpoints were HbA1c change from baseline to week 12, proportion of patients achieving HbA1c ≤7...
May 15, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29763632/lack-of-value-of-juvenile-animal-toxicity-studies-for-supporting-the-safety-of-pediatric-oncology-phase-i-trials
#16
REVIEW
Thomas Visalli, Nancy Bower, Tushar Kokate, Paul A Andrews
Toxicity studies in juvenile animals (JAS) are sometimes performed to support clinical trials in pediatric oncology patients, and there are differing conclusions on the value of JAS for pediatric drug development. This manuscript provides a review of the pediatric clinical data for 25 molecularly-targeted and 4 biologic anticancer therapeutics. Other publications that evaluated the value of JAS in pediatric drug development focus on differences in toxicity between juvenile animals and adult animals. The present paper examines pediatric-specific clinical findings to focus on dose setting in pediatric oncology patients and safety monitoring in terms of the potential value of JAS...
May 12, 2018: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29762909/open-label-dose-escalation-phase-1-study-of-safety-and-single-and-multiple-dose-pharmacokinetics-of-dichlorphenamide-in-healthy-volunteers
#17
Fredric Cohen
Single-and multiple-dose pharmacokinetics and safety were investigated in this phase 1 study of dichlorphenamide, a carbonic anhydrase inhibitor approved in the United States for treatment of primary periodic paralysis. Dichlorphenamide was administered to 6 cohorts (n = 6 each) of healthy adults. Cohorts A through E received single doses of 25-400 mg followed by 50-800 mg/day in divided doses for 10 total doses. Cohort F (safety analysis only) received up to 28 titrated doses from 100-800 mg/day. Plasma for pharmacokinetics sampling was obtained predose and up to 48 hours postdose...
May 15, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29762255/ombitasvir-paritaprevir-ritonavir-dasabuvir-ribavirin-for-chronic-hepatitis-c-virus-genotype-1b-infected-cirrhotics-turquoise-iv
#18
Vasily Isakov, Dzmitry Paduta, Rolando M Viani, Jeffrey V Enejosa, Viktor Pasechnikov, Olga Znoyko, Pavel Ogurtsov, Pavel O Bogomolov, Marina V Maevskaya, Xiaotian Chen, Nancy S Shulman
OBJECTIVE: An estimated 336 per 100 000 people in Russia are infected with hepatitis C virus, including up to 75% with genotype (GT) 1b. In the TURQUOISE-II/-III trials, a 12-week regimen of the direct-acting antiviral agents ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) in GT1b-infected patients with compensated cirrhosis resulted in 12-week sustained virologic response (SVR) rates of 100%. PATIENTS AND METHODS: In TURQUOISE-IV, GT1b-infected patients (n=36) from Russia and Belarus with compensated cirrhosis, who were treatment naive or previously treated with pegylated interferon/ribavirin (RBV), received OBV/PTV/ritonavir+DSV+RBV for 12 weeks...
May 14, 2018: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29761915/reduction-of-parenteral-nutrition-and-hydration-support-and-safety-with-long-term-teduglutide-treatment-in-patients-with-short-bowel-syndrome-associated-intestinal-failure-steps-3-study
#19
Douglas L Seidner, Ken Fujioka, Joseph I Boullata, Kishore Iyer, Hak-Myung Lee, Thomas R Ziegler
BACKGROUND: Patients with intestinal failure associated with short bowel syndrome (SBS-IF) require parenteral support (PS) to maintain fluid balance or nutrition. Teduglutide (TED) reduced PS requirements in patients with SBS-IF in the randomized, placebo (PBO)-controlled STEPS study (NCT00798967) and its 2-year, open-label extension, STEPS-2 (NCT00930644). METHODS: STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0...
May 15, 2018: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/29761739/efficacy-safety-and-quality-of-life-in-patients-receiving-subcutaneous-igg-treatment-experience-in-bogot%C3%A3-colombia
#20
María Claudia Ortega-López, Javier Garay, Mónica León Pinilla
AIM: Investigate efficacy, safety and quality of life of gammanorm® 16.5% (subcutaneous immunoglobulin [SCIG]) in patients with primary immunodeficiencies (PIDs) and safety and to lesser extent efficacy in autoimmune diseases. PATIENTS & METHODS: Medical records were extracted from 31 pediatric and 12 adult patients who received SCIG as part of the Personalized Program at University Children's Hospital, Bogotá, Colombia. RESULTS: Mean SCIG dose was 28...
May 15, 2018: Immunotherapy
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