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https://www.readbyqxmd.com/read/28333597/when-is-parenteral-nutrition-appropriate
#1
Patricia Worthington, Jane Balint, Matthew Bechtold, Angela Bingham, Lingtak-Neander Chan, Sharon Durfee, Andrea K Jevenn, Ainsley Malone, Maria Mascarenhas, Daniel T Robinson, Beverly Holcombe
Parenteral nutrition (PN) represents one of the most notable achievements of modern medicine, serving as a therapeutic modality for all age groups across the healthcare continuum. PN offers a life-sustaining option when intestinal failure prevents adequate oral or enteral nutrition. However, providing nutrients by vein is an expensive form of nutrition support, and serious adverse events can occur. In an effort to provide clinical guidance regarding PN therapy, the Board of Directors of the American Society for Parenteral and Enteral Nutrition (ASPEN) convened a task force to develop consensus recommendations regarding appropriate PN use...
March 2017: JPEN. Journal of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28332720/efficacy-and-safety-of-luliconazole-5-nail-solution-for-the-treatment-of-onychomycosis-a-multicenter-double-blind-randomized-phase-iii-study
#2
Shinichi Watanabe, Hiroshi Kishida, Akihiro Okubo
Onychomycosis is a highly prevalent and intractable disease. The first-line treatment agents are oral preparations, but an effective topical medication has long been desired. The objective was to investigate the efficacy and safety of luliconazole 5% nail solution, an imidazole antifungal agent, for the treatment of patients with onychomycosis. A multicenter, double-blind, randomized phase III study was conducted in Japanese patients with distal lateral subungual onychomycosis affecting the great toenails, with 20-50% clinical involvement...
March 23, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28331223/therapeutic-efficacy-and-safety-of-pcsk9-monoclonal-antibodies-on-familial-hypercholesterolemia-and-statin-intolerant-patients-a-meta-analysis-of-15-randomized-controlled-trials
#3
Li Jun Qian, Yao Gao, Yan Mei Zhang, Ming Chu, Jing Yao, Di Xu
Proprotein convertase subtilisin/kexin9 monoclonal antibodies (PCSK9-mAb) have been studied intensively to identify their effect in lowering levels of low density lipoprotein cholesterol (LDL-C). However, the applicable target of PCSK9-mAbs remains inconclusive so far. Therefore, this first meta-analysis was carried out to clarify the therapeutic efficacy and safety of PCSK9-mAbs on the potential patients: familial hypercholesterolemia and statin-intolerant patients. All randomized controlled trials that met the search terms were retrieved in multiple databases...
March 22, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28329738/transarterial-chemo-embolization-for-liver-metastases-in-patients-with-neuroendocrine-tumors
#4
Hiroyuki Okuyama, Masafumi Ikeda, Hideaki Takahashi, Izumi Ohno, Yusuke Hashimoto, Shuichi Mitsunaga, Yasunari Sakamoto, Shunsuke Kondo, Chigusa Morizane, Hideki Ueno, Tatsushi Kobayashi, Yasuaki Arai, Takuji Okusaka
OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of transarterial (chemo)embolization [TA(C)E] for the control of liver metastasis in patients with neuroendocrine tumors (NETs). METHODS: In this retrospective study, we enrolled 43 patients with metastatic NETs who had been treated with TA(C)E between December 1999 and June 2013 at the National Cancer Center Hospital, Tokyo or the National Cancer Center Hospital East, Kashiwa. We assessed tumor response, time to treatment failure (TTF), overall survival (OS), and frequency of adverse events in these patients, and attempted to identify predictors of TTF...
March 23, 2017: Oncology
https://www.readbyqxmd.com/read/28329211/therapeutic-vaccine-for-genital-herpes-simplex-virus-2-infection-findings-from-a-randomized-trial
#5
David I Bernstein, Anna Wald, Terri Warren, Kenneth Fife, Stephen Tyring, Patricia Lee, Nick Van Wagoner, Amalia Magaret, Jessica B Flechtner, Sybil Tasker, Jason Chan, Amy Morris, Seth Hetherington
Background.: Genital herpes simplex virus type 2 (HSV-2) infection causes recurrent lesions and frequent viral shedding. GEN-003 is a candidate therapeutic vaccine containing HSV-2 gD2ΔTMR and ICP4.2, and Matrix-M2 adjuvant. Methods.: Persons with genital herpes were randomized into three dose cohorts to receive three intramuscular doses 21 days apart of 10 µg, 30 µg, or 100 µg of GEN-003, antigens without adjuvant, or placebo. Participants obtained genital swabs twice-daily for HSV-2 detection and monitored genital lesions for 28-day periods at baseline and intervals after the last dose...
January 30, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28328847/effect-of-topical-isopropyl-unoprostone-on-macular-atrophy-progression-in-eyes-with-exudative-age-related-macular-degeneration
#6
Chieko Shiragami, Masahiro Miyake, Atsushi Fujiwara, Yuki Morizane, Akitaka Tsujikawa, Ayana Yamashita, Fumio Shiraga
BACKGROUND: To evaluate the efficacy and safety of topical isopropyl unoprostone (IU) in treating macular atrophy in age-related macular degeneration (AMD) patients. METHODS: Fifty-two AMD patients with macular atrophy were included and randomly assigned (1:1) to the treatment (topical 0.15% IU) or placebo group. Subjects used study eye drops 3 times a day for 54 weeks. The macular atrophy was documented on fundus autofluorescence photographs and measured using RegionFinder...
March 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28328159/improved-disease-activity-with-fosdagrocorat-pf-04171327-a-partial-agonist-of-the-glucocorticoid-receptor-in-patients-with-rheumatoid-arthritis-a-phase-2-randomized-study
#7
Thomas Stock, Dona Fleishaker, Xin Wang, Arnab Mukherjee, Charles Mebus
AIM: To assess efficacy and safety of fosdagrocorat (PF-04171327), a potential dissociated agonist of the glucocorticoid receptor, in rheumatoid arthritis (RA) patients. METHODS: This multicenter, double-blind, parallel-group, active- and placebo-controlled Phase 2 study (NCT00938587) randomized 86 patients (1 : 1 : 1 : 1) to receive fosdagrocorat 10 mg, fosdagrocorat 25 mg, prednisone 5 mg or placebo, all with stable background methotrexate therapy. The primary outcome was change from baseline in Disease Activity Score of 28 joints (DAS28-4[C-reactive protein (CRP)]) after 2 weeks of treatment...
March 22, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28327944/a-phase-2-randomized-double-blind-placebo-%C3%A2-controlled-study-of-chemo-immunotherapy-combination-using-motolimod-with-pegylated-liposomal-doxorubicin-in-recurrent-or-persistent-ovarian-cancer-a-gynecologic-oncology-group-partners-study
#8
B J Monk, M F Brady, C Aghajanian, H A Lankes, T Rizack, J Leach, J M Fowler, R Higgins, P Hanjani, M Morgan, R Edwards, W Bradley, T Kolevska, P Foukas, E Swisher, K S Anderson, R Gottardo, J K Bryan, M Newkirk, K L Manjarrez, R S Mannel, R M Hershberg, G Coukos
Background: A phase 2, randomized, placebo-controlled trial was conducted in women with recurrent epithelial ovarian carcinoma to evaluate the efficacy and safety of motolimod-a Toll-like receptor 8 (TLR8) agonist that stimulates robust innate immune responses-combined with pegylated liposomal doxorubicin (PLD), a chemotherapeutic that induces immunogenic cell death. Patients and methods: Women with ovarian, fallopian tube, or primary peritoneal carcinoma were randomized 1 : 1 to receive PLD in combination with blinded motolimod or placebo...
February 21, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28327932/integrated-safety-analysis-of-rolapitant-with-coadministered-drugs-from-phase-ii-iii-trials-an-assessment-of-cyp2d6-or-bcrp-inhibition-by-rolapitant
#9
S Barbour, T Smit, X Wang, D Powers, S Arora, V Kansra, M Aapro, J Herrstedt
Background: Rolapitant, a long-acting neurokinin (NK) 1 receptor antagonist (RA), has demonstrated efficacy in prevention of chemotherapy-induced nausea and vomiting in patients administered moderately or highly emetogenic chemotherapy. Unlike other NK 1 RAs, rolapitant does not inhibit or induce cytochrome P450 (CYP) 3A4, but it does inhibit CYP2D6 and breast cancer resistance protein (BCRP). To analyze potential drug-drug interactions between rolapitant and concomitant medications, this integrated safety analysis of four double-blind, randomized phase II or III studies of rolapitant examined adverse events by use versus non-use of drug substrates of CYP2D6 or BCRP...
February 23, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28327804/efficacy-and-safety-of-amphotericin-b-deoxycholate-versus-n-methylglucamine-antimoniate-in-pediatric-visceral-leishmaniasis-an-open-label-randomized-and-controlled-pilot-trial-in-brazil
#10
Myrlena Mescouto Borges, Maria Cristina da Silva Pranchevicius, Elza Ferreira Noronha, Gustavo Adolfo Sierra Romero, César Omar Carranza-Tamayo
INTRODUCTION: Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. METHODS: This was a randomized, open-label, 2-arm and controlled pilot clinical trial...
January 2017: Revista da Sociedade Brasileira de Medicina Tropical
https://www.readbyqxmd.com/read/28327140/efficacy-and-safety-of-canagliflozin-in-patients-with-type-2-diabetes-based-on-history-of-cardiovascular-disease-or-cardiovascular-risk-factors-a-post-hoc-analysis-of-pooled-data
#11
Michael J Davies, Katherine Merton, Ujjwala Vijapurkar, Jacqueline Yee, Rong Qiu
BACKGROUND: Treatment of patients with type 2 diabetes mellitus (T2DM) and a history of cardiovascular (CV) disease or CV risk factors may present clinical challenges due to the presence of comorbid conditions and the use of concomitant medications. The sodium glucose co-transporter 2 inhibitor, canagliflozin, has been shown to improve glycaemic control and reduce body weight and blood pressure (BP) with a favourable tolerability profile in a broad range of patients with T2DM. This post hoc analysis assessed the efficacy and safety of canagliflozin in patients with T2DM based on CV disease history or CV risk factors...
March 21, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28326906/a-practical-guide-to-the-sublingual-immunotherapy-tablet-adverse-event-profile-implications-for-clinical-practice
#12
David I Bernstein, Jose A Bardelas, Bodil Svanholm Fogh, Amarjot Kaur, Ziliang Li, Hendrik Nolte
OBJECTIVES: Treatment with allergy immunotherapy improves allergic rhinoconjunctivitis, but can also improve comorbidities associated with allergic rhinitis such as asthma. Sublingual immunotherapy (SLIT)-tablets are a convenient and efficacious method of allergy immunotherapy. They are self-administered after the first tablet has been provided under medical supervision. Therapy may elicit local reactions or, rarely, systemic allergic reactions. The objective of this report is to inform healthcare practitioners about the safety and tolerability profile of SLIT-tablets and use this information to provide practical guidance that may inform patients regarding potential adverse reactions and how to manage them...
March 22, 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28326596/systematic-review-with-network-meta-analysis-comparative-efficacy-and-tolerability-of-different-intravenous-iron-formulations-for-the-treatment-of-iron-deficiency-anaemia-in-patients-with-inflammatory-bowel-disease
#13
REVIEW
A Aksan, H Işık, H H Radeke, A Dignass, J Stein
BACKGROUND: Iron deficiency anaemia (IDA) is a common complication of inflammatory bowel disease (IBD) associated with reduced quality of life and increased hospitalisation rates. While the best way of treating IDA in IBD patients is not clearly established, current European guidelines recommend intravenous iron therapy in IBD patients with severe anaemia or intolerance to oral iron compounds. AIM: To compare the efficacy and tolerability of different intravenous iron formulations used to treat IDA in IBD patients in a systematic review and Bayesian network meta-analysis (NMA), PROSPERO registration number: 42016046565...
March 21, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28326559/a-phase-1-study-to-evaluate-the-safety-and-ldl-cholesterol-lowering-effects-of-rg7652-a-fully-human-monoclonal-antibody-against-proprotein-convertase-subtilisin-kexin-type-9
#14
Amos Baruch, Diana Luca, Robert S Kahn, Kyra J Cowan, Maya Leabman, Nageshwar R Budha, Cecilia P C Chiu, Yan Wu, Daniel Kirchhofer, Andrew Peterson, John C Davis, Whittemore G Tingley
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 (PCSK9) downregulates low-density lipoprotein (LDL) receptors, thereby leading to a rise in circulating LDL cholesterol (LDL-C). RG7652 is a fully human monoclonal antibody against PCSK9. This placebo-controlled, phase 1 ascending-dose study in healthy subjects evaluated the safety of RG7652 and its efficacy as a potential LDL-C-lowering drug. HYPOTHESIS: Anti-PCSK9 antibody therapy safely and effectively reduces LDL-C...
March 22, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28323965/long-acting-ctp-modified-hgh-mod-4023-results-of-a-safety-and-dose-finding-study-in-ghd-children
#15
Nataliya Zelinska, Violeta Iotova, Julia Skorodok, Oleg Malievsky, Valentina Peterkova, Lubov Samsonova, Ron G Rosenfeld, Zvi Zadik, Michal Jaron-Mendelson, Ronit Koren, Leanne Amitzi, Dmitri Raduk, Oren Hershkovitz, Gili Hart
Context: Daily injections are required for growth hormone replacement therapy, which may cause low compliance as a result of inconvenience and distress in patients. Objective: CTP-modified human growth hormone (MOD-4023) is developed for once-a-week dosing regimen in GH-deficient (GHD) adults and children. The present trial was a safety and dose-finding study for weekly MOD-4023 in GHD children. Design: a multi-center, open-label, randomized, controlled Phase 2 study in children with GHD, evaluating the safety, tolerability, PK/PD and efficacy of 3 different weekly MOD-4023 doses, compared to daily r-hGH...
January 31, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323917/gh-treatment-in-children-with-prader-willi-syndrome-3-years-longitudinal-data-in-prepubertal-children-and-adult-height-data-from-kigs-database
#16
N E Bakker, A Lindberg, J Heissler, H A Wollmann, C Camacho-Hübner, A C Hokken-Koelega
Context: Longitudinal data of children with Prader-Willi syndrome (PWS) treated with Genotropin were registered in Pfizer-International-Growth-Database (KIGS). Objective: Evaluate efficacy and safety of GH-treatment in a unique large group of children with PWS. Design: Longitudinal data registered in KIGS, from 1987-2012. Setting: Worldwide retrospective cohort study. Patients: 522 prepubertal children treated with GH for 3 years and 173 children who had reached adult height...
February 16, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28321877/pharmacological-interventions-for-acute-hepatitis-b-infection-an-attempted-network-meta-analysis
#17
REVIEW
Konstantinos Mantzoukis, Manuel Rodríguez-Perálvarez, Elena Buzzetti, Douglas Thorburn, Brian R Davidson, Emmanuel Tsochatzis, Kurinchi Selvan Gurusamy
BACKGROUND: Infection with hepatitis B virus (HBV) can be symptomatic or asymptomatic. Apart from chronic HBV infection, the complications related to acute HBV infection are severe acute viral hepatitis and fulminant hepatitis characterised by liver failure. The optimal pharmacological treatment of acute HBV infection remains controversial. OBJECTIVES: To assess the benefits and harms of pharmacological interventions in the treatment of acute HBV infection through a network meta-analysis and to generate rankings of the available treatments according to their safety and efficacy...
March 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28319996/oral-direct-acting-agent-therapy-for-hepatitis-c-virus-infection-a-systematic-review
#18
Oluwaseun Falade-Nwulia, Catalina Suarez-Cuervo, David R Nelson, Michael W Fried, Jodi B Segal, Mark S Sulkowski
Background: Rapid improvements in hepatitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chronic HCV infection. Purpose: To summarize published literature on the efficacy and safety of oral DAAs for treatment of persons with chronic HCV infection. Data Sources: MEDLINE and EMBASE from inception through 1 November 2016. Study Selection: 42 English-language studies from controlled and single-group registered clinical trials of adults with HCV infection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included at least 2 DAAs...
March 21, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28319551/a-contemporary-medicolegal-analysis-of-implanted-devices-for-chronic-pain-management
#19
Christopher R Abrecht, Penny Greenberg, Ellen Song, Richard D Urman, James P Rathmell
BACKGROUND: Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. METHODS: We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service...
April 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28318767/immunogenicity-and-safety-of-concomitant-administration-of-meningococcal-serogroup-b-4cmenb-and-serogroup-c-menc-crm-vaccines-in-infants-a-phase-3b-randomized-controlled-trial
#20
Marco Aurelio P Safadi, Federico Martinon-Torres, Lily Yin Weckx, Edson Duarte Moreira, Eduardo Jorge da Fonseca Lima, Ilhem Mensi, Marco Calabresi, Daniela Toneatto
BACKGROUND: After implementation of routine infant MenC vaccination, MenB remains a serious cause of meningococcal disease, yet to be targeted by vaccination programs in several countries. This study (NCT01339923) investigated the immunogenicity and safety of MenC CRM-conjugated vaccine (MenC-CRM) concomitantly administered with MenB vaccine (4CMenB). METHODS: Infants (N=251) were randomised 1:1 to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM alone (Group 2) at 3 and 5months (M3, M5) and a booster at 12months of age (M12), and pneumococcal vaccine at M3, M5, M7, M12...
March 15, 2017: Vaccine
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