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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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Risk Factors for AdverseEvents in Emergency Department Procedural Sedation for Children Procedural sedation for children undergoing painful procedures is standard practice in emergency departments worldwide. Previous studies of emergency department sedation are limited by their single-center design and are underpowered to identify risk factors for serious adverseevents (SAEs), thereby limiting their influence on sedation practice and patient outcomes.To examine the incidence and risk factors (...) medication. The secondary risk factors were demographic characteristics, preprocedural medications and fasting status, current or underlying health risks, and procedure type.Four outcomes were examined: SAEs, significant interventions performed in response to an adverseevent, oxygen desaturation, and vomiting.Of the 6295 children included in this study, 4190 (66.6%) were male and the mean (SD) age was 8.0 (4.6) years. Adverseevents occurred in 736 patients (11.7%; 95% CI, 6.4%-16.9%). Oxygen
Effect of Transfusion on Mortality and Other AdverseEvents Among Critically Ill Septic Patients: An Observational Study Using a Marginal Structural Cox Model RBC transfusion is often required in patients with sepsis. However, adverseevents have been associated with RBC transfusion, raising safety concerns. A randomized controlled trial validated the 7 g/dL threshold, but previously transfused patients were excluded. Cohort studies led to conflicting results and did not handle time-dependent
Postmarketing AdverseEvents Related to the CardioMEMS HF System 28975249 2018 11 13 2380-6591 2 11 2017 Nov 01 JAMA cardiology JAMA Cardiol Postmarketing AdverseEvents Related to the CardioMEMS HF System. 1277-1279 10.1001/jamacardio.2017.3791 Vaduganathan Muthiah M Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. DeFilippis Ersilia M EM Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts
Association of Guideline Adherence for Serial Evaluations With Survival and Adverse Clinical Events in Patients With Asymptomatic Severe Aortic Stenosis For patients with asymptomatic severe aortic stenosis and normal left ventricular function, current practice guidelines empirically recommend serial evaluations every 6 to 12 months. The benefit of this clinical monitoring is unknown.To determine the association of guideline adherence with clinical outcomes in patients with asymptomatic severe (...) aortic stenosis.This retrospective cohort study involved 300 patients with asymptomatic severe aortic stenosis who were seen in the ambulatory Minneapolis Heart Institute at Abbott Northwestern Hospital. Rates of survival and adverse clinical events, including myocardial infarction, stroke, and heart failure hospitalization, were compared between patients who adhered to serial evaluation guidance and those who did not. Medical records were reviewed from July 25, 2007, to December 6, 2012. Data
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