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Latest & greatest articles for adverse events
The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms of evidence. If you wanted the latest trusted evidence on adverse events or other clinical topics then use Trip today.
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Differences in Adverse Drug Events Among Pediatric Patients With and Without Cancer: Sub-Analysis of a Retrospective Cohort Study This study investigated the differences in the incidence and severity of adverse drug events (ADEs) in pediatric patients with and without cancer.We used data from the Japan Adverse Drug Events Study for pediatrics, a cohort study enrolling pediatric inpatients at two tertiary care teaching hospitals in Japan. ADEs were identified by on-site review of all medical
AdverseEvents With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial The goal of our study was to compare the frequency and severity of recovery reactions between ketamine and ketamine-propofol 1:1 admixture ("ketofol").We performed a multicentric, randomized, double-blind trial in which adult patients received emergency procedural sedations with ketamine or ketofol. Our primary outcome was the proportion of unpleasant recovery reactions (...) . Other outcomes were frequency of interventions required by these recovery reactions, rates of respiratory or hemodynamic events, emesis, and satisfaction of patients as well as providers.A total of 152 patients completed the study, 76 in each arm. Compared with ketamine, ketofol determined a 22% reduction in recovery reactions incidence (p < 0.01) and less clinical and pharmacologic interventions required by these reactions. There was no serious adverseevent in both groups. Rates in hemodynamic
Bevacizumab for advanced cervical cancer: final overall survival and adverseevent analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenesis drug bevacizumab for women with advanced cervical cancer on the basis of improved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecologic Oncology Group (GOG) 240 trial. In this study, we (...) until disease progression, unacceptable toxic effects, voluntary withdrawal by the patient, or complete response. We stratified randomisation by GOG performance status (0 vs 1), previous radiosensitising platinum-based chemotherapy, and disease status (recurrent or persistent vs metastatic). We gave treatment open label. Primary outcomes were OS (analysed in the intention-to-treat population) and adverseevents (analysed in all patients who received treatment and submitted adverseevent information
2017LancetControlled trial quality: predicted high
Patient-reported tolerability of adverseevents in phase 1 trials Phase I experts recommend revisiting dose-limiting toxicity (DLT) definition to include chronic and cumulative toxicities induced by new molecularly targeted therapies. Patient's assessment of late toxicities' tolerability is, however, unknown.A prospective survey on adverseevents (AEs) tolerability on 23 National Cancer InstituteCommon Terminology Criteria for AdverseEvent, Version 4 (NCI-CTCAE.v4) items was conducted
Usefulness of Multiple Biomarkers for Predicting Incident Major Adverse Cardiac Events in Patients Who Underwent Diagnostic Coronary Angiography (from the Catheter Sampled Blood Archive in Cardiovascular Diseases [CASABLANCA] Study) We sought to develop a multiple biomarker approach for prediction of incident major adverse cardiac events (MACE; composite of cardiovascular death, myocardial infarction, and stroke) in patients referred for coronary angiography. In a 649-participant training
Beta-blocker subtype and risks of perioperative adverseevents following non-cardiac surgery: a nationwide cohort study Beta-blockers vary in pharmacodynamics and pharmacokinetic properties. It is unknown whether specific types are associated with increased perioperative risks. We evaluated perioperative risks associated with beta-blocker subtypes, overall and in patient subgroups.We performed a Danish Nationwide cohort study, 2005-2011, of patients treated chronically with beta blocker (...) (atenolol, bisoprolol, carvedilol, metoprolol, propranolol, or other) prior to non-cardiac surgery. Risks of 30-day all-cause mortality (ACM) and 30-day major adverse cardiovascular events (MACE) were estimated using adjusted logistic regression models and odds ratios with 95% confidence intervals. We identified 61 660 patients, most frequently treated with metoprolol (67% of patients, mean age 69 years, 49% males), atenolol (10% of patients, mean age 68 years, 36% males), or carvedilol (9% of patients
Self reported outcomes and adverseevents after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland. Objectives To assess self reported outcomes and adverseevents after self sourced medical abortion through online telemedicine.Design Population based study.Setting Republic of Ireland and Northern Ireland, where abortion is unavailable through the formal healthcare system except in a few restricted circumstances.Population 1000 (...) women who underwent self sourced medical abortion through Women on Web (WoW), an online telemedicine service, between 1 January 2010 and 31 December 2012.Main outcome measures Successful medical abortion: the proportion of women who reported ending their pregnancy without surgical intervention. Rates of adverseevents: the proportion who reported treatment for adverseevents, including receipt of antibiotics and blood transfusion, and deaths reported by family members, friends, or the authorities
Hepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus: A Review of Cases Reported to the U.S. Food and Drug Administration AdverseEvent Reporting System. Direct-acting antiviral agents (DAAs) are used increasingly to treat hepatitis C virus (HCV) infection. Reports were published recently on hepatitis B virus (HBV) reactivation (HBV-R) in patients with HBV-HCV co-infection. Hepatitis B virus reactivation, defined as an abrupt increase (...) in HBV replication in patients with inactive or resolved HBV infection, may result in clinically significant hepatitis.To assess whether HBV-R is a safety concern in patients receiving HCV DAAs.Descriptive case series.U.S. Food and Drug Administration (FDA) AdverseEvent Reporting System (FAERS).29 patients with HBV-R receiving HCV DAAs.Clinical and laboratory data.The FDA identified 29 unique reports of HBV-R in patients receiving DAAs from 22 November 2013 to 15 October 2016. Two cases resulted
Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study Mayor S, Baines E, Vincent C, Lankshear A, Edwards A, Aylward M, Hogan H, Harper P, Davies J, Mamtora A, Brockbank E & Gray J Record Status (...) This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Mayor S, Baines E, Vincent C, Lankshear A, Edwards A, Aylward M, Hogan H, Harper P, Davies J, Mamtora A, Brockbank E & Gray J. Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study. Health Services and Delivery Research 2017; 5(9) Authors' objectives Despite
Radial versus femoral access in patients with acute coronary syndromes with or without ST-segment elevation: A pre-specified analysis from the randomized minimizing adverse haemorrhagic events by transradial access site and systemic implementation of angi To assess whether radial compared with femoral access is associated with consistent outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS).In the Minimizing (...) Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) programme patients were randomized to radial or femoral access, stratified by STEMI (2001 radial, 2009 femoral) and NSTE-ACS (2196 radial, 2198 femoral). The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding In the overall study population, radial
Adverseevents in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs. Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverseevents (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal.To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT
Preventing drug-related adverseevents following hospital discharge: the role of the pharmacist Transition of care (ToC) points, and in particular hospital admission and discharge, can be associated with an increased risk of adverse drug events (ADEs) and other drug-related problems (DRPs). The growing recognition of the pharmacist as an expert in medication management, patient education and communication makes them well placed to intervene. There is evidence to indicate that the inclusion
Trends in Perioperative Major Adverse Cardiovascular and Cerebrovascular Events associated with Non-Cardiac Surgery Major adverse cardiovascular and cerebrovascular events (MACCE) are a significant source of perioperative morbidity and mortality following noncardiac surgery.To evaluate national trends in perioperative cardiovascular outcomes and mortality after major noncardiac surgery and to identify surgical subtypes associated with cardiovascular events using a large administrative database (...) occurred in 317 479 hospitalizations (3.0%), corresponding to an annual incidence of approximately 150 000 events after applying sample weights. Major adverse cardiovascular and cerebrovascular events occurred most frequently in patients undergoing vascular (7.7%), thoracic (6.5%), and transplant surgery (6.3%). Between 2004 and 2013, the frequency of MACCE declined from 3.1% to 2.6% (P for trend <.001; adjusted odds ratio [aOR], 0.95; 95% CI, 0.94-0.97) driven by a decline in frequency
The effect of endotracheal tubes versus laryngeal mask airways on perioperative respiratory adverseevents in infants: a randomised controlled trial. Perioperative respiratory adverseevents (PRAE) are the most common critical incidents in paediatric anaesthesia and occur more often in infants. Use of laryngeal mask airways (LMAs) is associated with reduced PRAE compared with endotracheal tubes in older children (>1 year). We aimed to evaluate the effect of these devices on the incidence
2017LancetControlled trial quality: predicted high
In adults with ankle osteoarthritis (OA), is total ankle replacement/fusion/debridement better than no treatment for pain and function, risks and harms and adverseevents? Getting Evidence into Clinical Practice: Musculoskeletal Research Facilitation Group (CAT Group) Date: February 2018 CAT Lead: Jo Pike Date CAT completed: February 2018 email@example.com Date CAT to be reviewed: February 2021 Specific Question: In adults with ankle Osteoarthritis (OA) A is total ankle replacement/fusion (...) /debridement better than no treatment for pain and function, risks and harms and adverseevents? Clinical bottom line At present, there are no studies that compare surgical intervention with no treatment for the management of patients with ankle OA. Due to the lack of evidence of comparing no treatment with surgical intervention for pain and function, risks and harms and adverseevents, then clinical practice should remain unchanged. Within the available evidence, it is apparent that surgical intervention
Adverseevents associated with ERCP GUIDELINE Adverseevents associated with ERCP Prepared by: ASGE STANDARDS OF PRACTICE COMMITTEE Vinay Chandrasekhara, MD, Mouen A. Khashab, MD, V. Raman Muthusamy, MD, FASGE, Ruben D. Acosta, MD, Deepak Agrawal, MD, MPH, David H. Bruining, MD, Mohamad A. Eloubeidi, MD, MHS, FASGE, Robert D. Fanelli, MD, FACS, FASGE, SAGES Representative, Ashley L. Faulx, MD, FASGE, Suryakanth R. Gurudu, MD, FASGE, Shivangi Kothari, MD, Jenifer R. Lightdale, MD, MPH, FASGE (...) consider the clinical appropriateness of ERCP, it is important for them to have a thorough understanding of available alter- natives and of the potential adverseevents associated with the procedure. In addition, they must understand and attempt to follow maneuvers that reduce the risk of adverseevents. Early recognition and appropriate manage- ment of potential adverseevents are critical to reducing morbidity and mortality associated with the procedure. The diagnosis and management of all adverse