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https://www.readbyqxmd.com/read/28449320/a-randomised-double-blind-trial-of-the-safety-and-efficacy-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-in-subjects-with-type-2-diabetes-and-renal-impairment
#1
Antonio Chacra, Ira Gantz, Geraldine Mendizabal, Lucila Durlach, Edward A O'Neill, Zachary Zimmer, Shailaja Suryawanshi, Samuel S Engel, Eseng Lai
AIMS: To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI). METHODS: Patients with T2DM with moderate RI (estimated glomerular filtration rate [eGFR] ≥30 to <60 mL/min/1.73 m(2) ) (N=114), severe RI (eGFR <30 mL/min/1.73 m(2) ) (N=55) or end-stage renal disease on dialysis (N=44), who were either not on an antihyperglycaemic agent therapy for at least 12 weeks at screening, washed-off of oral antihyperglycaemic agent monotherapy or low-dose dual combination therapy, or on insulin monotherapy, with baseline glycated haemoglobin (HbA1c) of 6...
April 27, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28449273/systematic-review-the-safety-of-vedolizumab-for-the-treatment-of-inflammatory-bowel-disease
#2
REVIEW
W A Bye, V Jairath, S P L Travis
BACKGROUND: Vedolizumab specifically recognises the α4β7 integrin and selectively blocks gut lymphocyte trafficking: potentially, it offers gut-specific immunosuppression. AIM: To review the safety of vedolizumab and summarise post-marketing data to assess if any safety concerns that differ from registration trials have emerged. METHOD: A systematic bibliographic search identified six registration trials and nine cohort studies. RESULTS: Integrated data from registration trials included 2830 vedolizumab-exposed patients (4811 person-years exposure [PYs]) and 513 placebo patients...
April 27, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28449232/safety-pharmacokinetics-and-pharmacologic-effects-of-the-selective-androgen-receptor-modulator-gsk2881078-in-healthy-men-and-postmenopausal-women
#3
Richard V Clark, Ann C Walker, Susan Andrews, Philip Turnbull, Jeffrey A Wald, Mindy H Magee
AIM: Selective androgen receptor modulators (SARMs) induce anabolic effects on muscle without the adverse effects of androgenic steroids. In this first-in-human study, we report safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of the SARM GSK2881078. METHODS: In Part A, healthy young men (n = 10) received a single dose of study drug (0 mg, 0.05 mg, 0.1 mg, 0.2 mg GSK2881078 or matching-placebo). In Part B, repeat-dose cohorts in men (n = 65) were 0...
April 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28449038/real-time-imaging-of-single-neuronal-cell-apoptosis-in-patients-with-glaucoma
#4
Maria F Cordeiro, Eduardo M Normando, M Jorge Cardoso, Serge Miodragovic, Seham Jeylani, Benjamin M Davis, Li Guo, Sebastien Ourselin, Roger A'Hern, Philip A Bloom
Retinal cell apoptosis occurs in many ocular neurodegenerative conditions including glaucoma-the major cause of irreversible blindness worldwide. Using a new imaging technique that we have called DARC (detection of apoptosing retinal cells), which until now has only been demonstrated in animal models, we assessed if annexin 5 labelled with fluorescent dye DY-776 (ANX776) could be used safely in humans to identify retinal cell apoptosis. Eight patients with glaucomatous neurodegeneration and evidence of progressive disease, and eight healthy subjects were randomly assigned to intravenous ANX776 doses of 0...
April 26, 2017: Brain: a Journal of Neurology
https://www.readbyqxmd.com/read/28448193/safety-and-effectiveness-of-etanercept-for-treatment-of-juvenile-idiopathic-arthritis-results-from-a-postmarketing-surveillance
#5
Masaaki Mori, Naonobu Sugiyama, Yosuke Morishima, Noriko Sugiyama, Takeshi Kokubo, Syuji Takei, Shumpei Yokota
OBJECTIVES: The objectives of this surveillance were to determine safety and effectiveness of etanercept in patients with juvenile idiopathic arthritis (JIA). METHODS: In this postmarketing surveillance, patients aged 5-16 years with active polyarthritis JIA were treated with etanercept at the doses approved in the Japanese package insert. The occurrence and seriousness of adverse events (AEs) were assessed using the Japanese Medical Dictionary for Regulatory Activities version 15...
April 27, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28447485/empirical-estimation-of-under-reporting-in-the-u-s-food-and-drug-administration-adverse-event-reporting-system-faers
#6
Yasser M Alatawi, Richard A Hansen
OBJECTIVE: To examine how closely reporting rates in the FDA Adverse Event Reporting System (FAERS) reflect expected rates of known adverse drug events (ADEs). METHODS: We selected three groups of drugs to reflect hypothesized variation in sensitivity to reporting, including statins, biologics, and narrow therapeutics index drugs (NTI). The numbers of ADEs in FAERS were divided by utilization estimates from ambulatory health care data (NAMCS/NHAMCS) to calculate a reported proportion...
April 27, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28446192/prospective-clinical-and-radiographic-evaluation-of-an-allogeneic-bone-matrix-containing-stem-cells-trinity-evolution%C3%A2-viable-cellular-bone-matrix-in-patients-undergoing-two-level-anterior-cervical-discectomy-and-fusion
#7
Timothy A Peppers, Dennis E Bullard, Jed S Vanichkachorn, Scott K Stanley, Paul M Arnold, Erik I Waldorff, Rebekah Hahn, Brent L Atkinson, James T Ryaby, Raymond J Linovitz
BACKGROUND: Trinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures. METHODS: In a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage...
April 26, 2017: Journal of Orthopaedic Surgery and Research
https://www.readbyqxmd.com/read/28445659/adalimumab-plus-methotrexate-for-uveitis-in-juvenile-idiopathic-arthritis
#8
Athimalaipet V Ramanan, Andrew D Dick, Ashley P Jones, Andrew McKay, Paula R Williamson, Sandrine Compeyrot-Lacassagne, Ben Hardwick, Helen Hickey, Dyfrig Hughes, Patricia Woo, Diana Benton, Clive Edelsten, Michael W Beresford
Background Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of juvenile idiopathic arthritis (JIA). We tested the efficacy of adalimumab in the treatment of JIA-associated uveitis. Methods In this multicenter, double-blind, randomized, placebo-controlled trial, we assessed the efficacy and safety of adalimumab in children and adolescents 2 years of age or older who had active JIA-associated uveitis. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either adalimumab (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every 2 weeks...
April 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28445246/single-delivery-of-high-diversity-fecal-microbiota-preparation-by-colonoscopy-is-safe-and-effective-in-increasing-microbial-diversity-in-active-ulcerative-colitis
#9
Vinita Jacob, Carl Crawford, Shirley Cohen-Mekelburg, Monica Viladomiu, Gregory G Putzel, Yecheskel Schneider, Fatiha Chabouni, Sarah OʼNeil, Brian Bosworth, Viola Woo, Nadim J Ajami, Joseph F Petrosino, Ylaine Gerardin, Zain Kassam, Mark Smith, Iliyan D Iliev, Gregory F Sonnenberg, David Artis, Ellen Scherl, Randy S Longman
BACKGROUND: Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high-diversity FMT donors is a promising treatment to induce remission in ulcerative colitis. METHODS: We designed a prospective, open-label pilot study to assess the safety, clinical efficacy, and microbial engraftment of single FMT delivery by colonoscopy for active ulcerative colitis using a 2-donor fecal microbiota preparation (FMP). Safety and clinical endpoints of response, remission, and mucosal healing at week 4 were assessed...
April 25, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28444181/allogeneic-human-mesenchymal-stem-cell-infusions-for-aging-frailty
#10
Samuel Golpanian, Darcy L DiFede, Aisha Khan, Ivonne Hernandez Schulman, Ana Marie Landin, Bryon A Tompkins, Alan W Heldman, Roberto Miki, Bradley J Goldstein, Muzammil Mushtaq, Silvina Levis-Dusseau, John J Byrnes, Maureen Lowery, Makoto Natsumeda, Cindy Delgado, Russell Saltzman, Mayra Vidro-Casiano, Marietsy V Pujol, Moisaniel Da Fonseca, Anthony A Oliva, Geoff Green, Courtney Premer, Audrey Medina, Krystalenia Valasaki, Victoria Florea, Erica Anderson, Jill El-Khorazaty, Adam Mendizabal, Pascal J Goldschmidt-Clermont, Joshua M Hare
Background: Impaired endogenous stem cell repair capacity is hypothesized to be a biologic basis of frailty. Therapies that restore regenerative capacity may therefore be beneficial. This Phase 1 study evaluated the safety and potential efficacy of intravenous, allogeneic, human mesenchymal stem cell (allo-hMSC)-based therapy in patients with aging frailty. Methods: In this nonrandomized, dose-escalation study, patients received a single intravenous infusion of allo-hMSCs: 20-million (n = 5), 100-million (n = 5), or 200-million cells (n = 5)...
April 21, 2017: Journals of Gerontology. Series A, Biological Sciences and Medical Sciences
https://www.readbyqxmd.com/read/28444153/computed-tomography-derived-fractional-flow-reserve-testing-in-stable-patients-with-typical-angina-pectoris-influence-on-downstream-rate-of-invasive-coronary-angiography
#11
Jesper Møller Jensen, Hans Erik Bøtker, Ole Norling Mathiassen, Erik Lerkevang Grove, Kristian Altern Øvrehus, Kamilla Bech Pedersen, Christian Juhl Terkelsen, Evald Høj Christiansen, Michael Maeng, Jonathon Leipsic, Anne Kaltoft, Lars Jakobsen, Jacob Thorsted Sørensen, Troels Thim, Steen Dalby Kristensen, Lars Romer Krusell, Bjarne Linde Nørgaard
Aims: To assess the use of downstream coronary angiography (ICA) and short-term safety of frontline coronary CT angiography (CTA) with selective CT-derived fractional flow reserve (FFRCT) testing in stable patients with typical angina pectoris. Methods and results: Between 1 January 2016 and 30 June 2016 all patients (N = 774) referred to non-emergent ICA or coronary CTA at Aarhus University Hospital on a suspicion of CAD had frontline CTA performed. Downstream testing and treatment within 3 months and adverse events ≥90 days were registered...
April 20, 2017: European Heart Journal Cardiovascular Imaging
https://www.readbyqxmd.com/read/28443695/safety-pharmacology-of-acute-mdma-administration-in-healthy-subjects
#12
Patrick Vizeli, Matthias E Liechti
3,4-Methylenedioxymethamphetamine (MDMA; ecstasy) is being investigated in MDMA-assisted psychotherapy. The present study characterized the safety pharmacology of single-dose administrations of MDMA (75 or 125 mg) using data from nine double-blind, placebo-controlled, crossover studies performed in the same laboratory in a total of 166 healthy subjects. The duration of the subjective effects was 4.2 ± 1.3 h (range: 1.4-8.2 h). The 125 mg dose of MDMA produced greater 'good drug effect' ratings than 75 mg. MDMA produced moderate and transient 'bad drug effect' ratings, which were greater in women than in men...
February 1, 2017: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/28442933/drainage-of-malignant-ascites-patient-selection-and-perspectives
#13
REVIEW
Maciej Stukan
Malignant ascites (MA) is a sign of advanced cancer and poor prognosis. MA can result in impairment in quality of life (QOL) and significant symptoms. As a supportive treatment, ascites can be drained by paracentesis (PC), percutaneously implanted catheters (tunneled, untunneled, central venous catheters), or peritoneal ports, or peritoneovenous shunts. The aim of this study was to evaluate the effectiveness, safety, and patient-reported outcomes (PRO) of different drainage methods for the management of MA...
2017: Cancer Management and Research
https://www.readbyqxmd.com/read/28441904/the-safety-of-ustekinumab-for-the-treatment-of-psoriatic-arthritis
#14
A López-Ferrer, A Laiz, L Puig
The cytokines interleukin (IL)-12 and IL-23 have been involved in the pathogenesis of psoriasis and psoriatic arthritis. Ustekinumab is a fully human monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23. Ustekinumab prevents the interaction of IL-12 and IL-23 binding to its receptor, blocking the T1 and T17 inflammatory pathways. Ustekinumab has been evaluated for the treatment of various chronic immune mediated diseases including psoriasis and psoriatic arthritis (PsA). Most of the data regarding the safety of ustekinumab come from the experience treating patients with psoriasis, but clinical trials have demonstrated its efficacy and safety in the treatment of both diseases...
April 25, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28441266/safety-of-the-inactivated-japanese-encephalitis-virus-vaccine-ixiaro%C3%A2-in-children-an-open-label-randomized-active-controlled-phase-3-study
#15
Katrin L Dubischar, Vera Kadlecek, Benjamin Sablan, Charissa Fay Borja-Tabora, Salvacion Gatchalian, Susanne Eder-Lingelbach, Zsuzsanna Mueller, Kerstin Westritschnig
BACKGROUND: Japanese encephalitis (JE) remains a serious health concern in Asian countries and has sporadically affected pediatric travelers. In the present study we monitored the safety profile of the JE virus (JEV) vaccine IXIARO in a pediatric population. METHODS: We randomized 1869 children between the age of 2 months and 17 years in an age-stratified manner to vaccination with IXIARO or one of the control vaccines, Prevnar and HAVRIX 720. Adverse events (AEs) (unsolicited and solicited local and systemic adverse events), serious AEs and medically-attended AEs were assessed up to Day 56 and Month 7 after the first dose...
April 24, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28441110/effects-of-the-us-food-and-drug-administration-boxed-warning-of-erythropoietin-stimulating-agents-on-utilization-and-adverse-outcome
#16
John Bian, Brian Chen, Dawn L Hershman, Norman Marks, LeAnn Norris, Richard Schulz, Charles Bennett
Purpose In March 2007, a US Food and Drug Administration boxed warning was issued for erythropoietin-stimulating agents (ESAs) regarding serious adverse events, such as venous thromboembolism (VTE). We evaluated the US Food and Drug Administration's boxed warning of ESAs used to treat chemotherapy-induced anemia because evidence on the effectiveness of boxed warnings remains inconclusive. Patients and Methods Using 2004 to 2009 SEER-Medicare data, we exploited a natural experiment to examine the effects of ESA boxed warnings on utilization and risk of VTE...
April 25, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28441094/background-rates-of-disease-in-latin-american-children-from-a-rotavirus-vaccine-study
#17
Marc Baay, Kaatje Bollaerts, Claudio Struchiner, Thomas Verstraeten
BACKGROUND: Knowledge of background rates of adverse events is crucial to assess vaccine safety concerns. We used data from a rotavirus vaccine study (Ruiz-Palacios et al., NEJM, 2006) including 63,225 infants from 11 Latin American countries to investigate reporting rates of serious adverse events (SAEs) among these infants, and describe rates by country, gender, age, and season. METHODS: For this randomized, double-blind, placebo-controlled, phase 3 trial, investigators from Argentina, Brazil, Chile, Colombia, Dominican Republic, Honduras, Mexico, Nicaragua, Panama, Peru, and Venezuela recruited 6-to-13-week-old healthy infants...
April 25, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28440858/treatment-with-disease-modifying-drugs-for-people-with-a-first-clinical-attack-suggestive-of-multiple-sclerosis
#18
REVIEW
Graziella Filippini, Cinzia Del Giovane, Marinella Clerico, Omid Beiki, Miriam Mattoscio, Federico Piazza, Sten Fredrikson, Irene Tramacere, Antonio Scalfari, Georgia Salanti
BACKGROUND: The treatment of multiple sclerosis has changed over the last 20 years. The advent of disease-modifying drugs in the mid-1990s heralded a period of rapid progress in the understanding and management of multiple sclerosis. With the support of magnetic resonance imaging early diagnosis is possible, enabling treatment initiation at the time of the first clinical attack. As most of the disease-modifying drugs are associated with adverse events, patients and clinicians need to weigh the benefit and safety of the various early treatment options before taking informed decisions...
April 25, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28440004/safety-and-effectiveness-of-room-temperature-stable-recombinant-factor-viia-in-patients-with-haemophilia-a-or-b-and-inhibitors-results-of-a-multinational-prospective-observational-study
#19
K Kavakli, F Demartis, M Karimi, P Eshghi, D Neme, H Chambost, L Sommer, M Zak, G Benson
INTRODUCTION: A room temperature stable formulation of recombinant activated factor VII (NovoSeven(®) ), allowing convenient storage and therefore improved treatment access, has been developed. Bioequivalence to the previous NovoSeven(®) was demonstrated in healthy humans, leading to European approval (2008). Although no confirmed cases of neutralising antibodies to rFVIIa in patients with haemophilia A or B have been observed with the original formulation, changes in formulation or storage condition may alter immunogenicity...
April 24, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28438884/safety-evaluation-of-trastuzumab-emtansine-in-japanese-patients-with-her2-positive-advanced-breast-cancer
#20
Junichiro Watanabe, Yoshinori Ito, Toshiaki Saeki, Norikazu Masuda, Toshimi Takano, Shintaro Takao, Kazuhiko Nakagami, Koichiro Tsugawa, Shintaro Nakagawa, Kazumitsu Kanatani, Takahiro Nakayama
BACKGROUND/AIM: Tolerability and safety of trastuzumab emtansine (T-DM1) was investigated in Japanese patients with HER2-positive advanced breast cancer who were previously treated with chemotherapy and trastuzumab. PATIENTS AND METHODS: Patients with inoperable or recurrent breast cancer who were previously treated with chemotherapy and trastuzumab in adjuvant and/or metastatic disease were included. T-DM1 3.6 mg/kg was administered intravenously every 21 days...
May 2017: In Vivo
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