Latest & greatest articles for adverse events

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Top results for adverse events

21. Association of Initial and Serial C-Reactive Protein Levels With Adverse Cardiovascular Events and Death After Acute Coronary Syndrome: A Secondary Analysis of the VISTA-16 Trial. Full Text available with Trip Pro

Association of Initial and Serial C-Reactive Protein Levels With Adverse Cardiovascular Events and Death After Acute Coronary Syndrome: A Secondary Analysis of the VISTA-16 Trial. Higher baseline high-sensitivity C-reactive protein (hsCRP) levels after an acute coronary syndrome (ACS) are associated with adverse cardiovascular outcomes. The usefulness of serial hsCRP measurements for risk stratifying patients after ACS is not well characterized.To assess whether longitudinal increases in hsCRP (...) measurements during the 16 weeks after ACS are independently associated with a greater risk of a major adverse cardiac event (MACE), all-cause death, and cardiovascular death.Secondary analysis of the double-blind, multicenter, randomized clinical Vascular Inflammation Suppression to Treat Acute Coronary Syndromes for 16 Weeks (VISTA-16) trial conducted between June 1, 2010, and March 7, 2012 (study termination on March 9, 2012), which included 5145 patients from 362 academic and community hospitals

2019 JAMA cardiology Controlled trial quality: predicted high

22. Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. (Abstract)

Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been (...) if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015.According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred.The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal

2019 JAMA cardiology Controlled trial quality: predicted high

23. Management of anlotinib-related adverse events in patients with advanced non-small cell lung cancer: Experiences in ALTER-0303. Full Text available with Trip Pro

Management of anlotinib-related adverse events in patients with advanced non-small cell lung cancer: Experiences in ALTER-0303. Anlotinib is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor, fibroblast growth factor receptor, platelet-derived growth factor receptor, and stem cell factor receptor (c-Kit). In the phase III ALTER-0303 trial (Clinical Trial Registry ID: NCT 02388919), anlotinib significantly improved overall survival versus placebo in advanced (...) non-small cell lung cancer patients who had received at least two previous chemotherapy and epidermal growth factor receptor/anaplastic lymphoma kinase targeted therapy regimens. This study summarized adverse event management in this trial.Patients were randomized (2:1) to anlotinib or placebo up to progression or intolerable toxicity. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 and managed by investigators. Key

2019 Thoracic cancer Controlled trial quality: uncertain

24. Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association | Arteriosclerosis, Thrombosis, and Vascular Biology Search Hello Guest! Login to your account Email Password Keep me logged in Search March 2019 February 2019 January 2019 This site uses cookies. By continuing to browse this site you are agreeing to our use of cookies. Free Access article (...) ), rosuvastatin (2003), and pitavastatin (2009). These statins are also approved and available in many countries worldwide. All except pitavastatin can be obtained in generic form. The objective of this scientific statement is to provide a rigorous examination of statin safety and tolerability. We generally discuss statins as a class but highlight differences among them as appropriate. This report covers adverse effects of statins, adverse events associated with but not necessarily caused by statins, and drug

2019 American Gastroenterological Association Institute

25. Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial. Full Text available with Trip Pro

Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial. Despite guideline recommendations, many patients discontinue P2Y12 inhibitor therapy earlier than the recommended 1 year after myocardial infarction (MI), and higher-potency P2Y12 inhibitors are underutilized. Cost is frequently cited as an explanation for both of these observations.To determine whether removing (...) co-payment barriers increases P2Y12 inhibitor persistence and lowers risk of major adverse cardiovascular events (MACE).Cluster randomized clinical trial among 301 hospitals enrolling adult patients with acute MI (June 5, 2015, through September 30, 2016); patients were followed up for 1 year after discharge (final date of follow-up was October 23, 2017), with blinded adjudication of MACE; choice of P2Y12 inhibitor was per clinician discretion.Hospitals randomized to the intervention (n = 131

2019 JAMA Controlled trial quality: predicted high

26. Sodium bicarb vs sodium chloride, and acetylcysteine vs placebo, did not differ for adverse events after angiography. (Abstract)

Sodium bicarb vs sodium chloride, and acetylcysteine vs placebo, did not differ for adverse events after angiography. 29459959 2018 12 24 2018 12 24 1539-3704 168 4 2018 02 20 Annals of internal medicine Ann. Intern. Med. Sodium bicarb vs sodium chloride, and acetylcysteine vs placebo, did not differ for adverse events after angiography. JC22 10.7326/ACPJC-2018-168-4-022 Carnicelli Anthony P AP Granger Christopher B CB eng Journal Article Comment United States Ann Intern Med 0372351 0003-4819 0

2018 Annals of Internal Medicine Controlled trial quality: predicted high

27. [Hydroxychloroquine to obtain pregnancy without adverse obstetrical events in primary antiphospholipid syndrome: French phase II multicenter randomized trial, HYDROSAPL]. (Abstract)

[Hydroxychloroquine to obtain pregnancy without adverse obstetrical events in primary antiphospholipid syndrome: French phase II multicenter randomized trial, HYDROSAPL]. Antiphospholipid syndrome is defined by the presence of thrombosis and/or obstetrical adverse events (≥3 recurrent early miscarriage or fetal death or a prematurity<34 weeks of gestation) associated with persistent antiphospholipid antibodies. The pregnancy outcome has been improved by the conventional treatment (aspirin 100mg (...) /day with low molecular weight heparin [LMWH] from 30 to 75% of uncomplicated pregnancies. In PROMISSE study, 19% of pregnancies had at least one obstetrical adverse event despite treatment (maternal, fetal or neonatal complications) in relation with APS. In the European registry of babies born from APS mothers, maternal and foetal adverse events were observed in 13% of cases, with prematurity in 14% despite treatment. The presence of lupus erythematosus, a history of thrombosis, presence of lupus

2018 Gynecologie, obstetrique, fertilite & senologie Controlled trial quality: uncertain

28. In-hospital versus postdischarge major adverse events within 30 days following lower extremity revascularization Full Text available with Trip Pro

In-hospital versus postdischarge major adverse events within 30 days following lower extremity revascularization Studies using hospital discharge data likely underestimate postoperative morbidity and mortality after lower extremity revascularization because they fail to capture postdischarge events. However, the degree of underestimation and the timing of postdischarge complications are not well-characterized.We used the American College of Surgeons National Surgical Quality Improvement Program (...) procedure-targeted vascular databases from 2011 to 2015 to tabulate 30-day adverse events (in hospital and after discharge) for lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) performed for claudication and chronic limb-threatening ischemia (CLTI).A total of 14,125 patients underwent lower extremity revascularization, 8909 patients (63%) with LEB and 5216 (37%) with PVI. For CLTI, total 30-day mortality was similar between PVI and LEB (2.3% vs 2.1%; P = .61), but in-hospital

2018 EvidenceUpdates

29. Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. Full Text available with Trip Pro

Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverse events of current concern.Register based cohort study.Sweden and Denmark from July 2013 to December 2016.A propensity score matched cohort of 17 213 new users of SGLT2 inhibitors (dapagliflozin, 61%; empagliflozin, 38%; canagliflozin, 1%) and 17 213 new users (...) of nationwide registers from two countries, use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation and diabetic ketoacidosis, but not with other serious adverse events of current concern.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

2018 BMJ

30. Combination of the CYP2C19 metabolizer and the GRACE risk score better predicts the long-term major adverse cardiac events in acute coronary syndrome undergoing percutaneous coronary intervention (Abstract)

Combination of the CYP2C19 metabolizer and the GRACE risk score better predicts the long-term major adverse cardiac events in acute coronary syndrome undergoing percutaneous coronary intervention Both Global Registry of Acute Coronary Events (GRACE) risk score and CYP2C19 metabolizer status can independently predict major adverse cardiac events (MACEs) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). We investigated whether their combination

2018 EvidenceUpdates

31. What Is the Diagnostic Accuracy of Cardiac Biomarkers for the Prediction of Adverse Cardiac Events in Patients Presenting With Acute Syncope? Full Text available with Trip Pro

What Is the Diagnostic Accuracy of Cardiac Biomarkers for the Prediction of Adverse Cardiac Events in Patients Presenting With Acute Syncope? What Is the Diagnostic Accuracy of Cardiac Biomarkers for the Prediction of Adverse Cardiac Events in Patients Presenting With Acute Syncope? - Annals of Emergency Medicine Email/Username: Password: Remember me Search Terms Search within Search Share this page To read this article in full, please review your options for gaining access at the bottom (...) of the page. Article in Press What Is the Diagnostic Accuracy of Cardiac Biomarkers for the Prediction of Adverse Cardiac Events in Patients Presenting With Acute Syncope? x Jason R. West , MD (EBEM Commentator) , x James Russell , MD (EBEM Commentator) Department of Emergency Medicine, Lincoln Medical and Mental Health Center, Bronx, NY DOI: Publication History Published online: August 27, 2018 To view the full text, please login as a subscribed user or . Click to view the full text on ScienceDirect

2018 Annals of Emergency Medicine Systematic Review Snapshots

32. New Oncologic Therapies Mean New Oncologic Emergencies: An Approach to Immunotherapy-Related Adverse Events

New Oncologic Therapies Mean New Oncologic Emergencies: An Approach to Immunotherapy-Related Adverse Events New Oncologic Therapies Mean New Oncologic Emergencies: An Approach to Immunotherapy-Related Adverse Events - CanadiEM New Oncologic Therapies Mean New Oncologic Emergencies: An Approach to Immunotherapy-Related Adverse Events In , by Arden Azim October 30, 2018 A 63-year-old man, Andrew, presents to the emergency department with a several-day history of worsening diarrhea. He has (...) pathways promotes anti-tumour immunity, it also removes some of the normal checks and balances on immune activity, and can lead to uncontrolled and aberrant immune activity. Therefore, complications of ICIs are due to auto-immune toxicity caused by over-activation of the immune system , and are referred to as immune-related adverse events (irAEs) . 1,4 It is crucial to differentiate immune-related adverse events from adverse events seen with chemotherapy. Chemotherapy works by killing rapidly dividing

2018 CandiEM

33. Prospective Validation of Clinical Criteria to Identify Emergency Department Patients at High Risk for Adverse Drug Events Full Text available with Trip Pro

Prospective Validation of Clinical Criteria to Identify Emergency Department Patients at High Risk for Adverse Drug Events Adverse drug events (ADEs) cause or contribute to one in nine emergency department (ED) presentations in North America and are often misdiagnosed. EDs have insufficient clinical pharmacists to complete medication reviews in all incoming patients, even though pharmacist-led medications reviews have been associated with improved health outcomes. Our objective was to validate (...) results. The primary outcome was a moderate or severe ADE, defined as an unintended and harmful event related to medication use or misuse, which required a change in medical therapy, diagnostic testing, consultation, or admission. An independent committee adjudicated uncertain and discordant cases. We calculated the diagnostic accuracy of both rules.Among 1,529 patients, 184 (12.0%) were diagnosed with an ADE. Rule 1 contained the variables 1) having a preexisting medical condition or having taken

2018 EvidenceUpdates

34. Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial. Full Text available with Trip Pro

Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial. The appropriate duration of antibiotics for staphylococcal bacteremia is unknown.To test whether an algorithm that defines treatment duration for staphylococcal bacteremia vs standard of care provides noninferior efficacy without increasing severe adverse events.A randomized trial involving adults with staphylococcal bacteremia (...) within a 15% margin; and (2) serious adverse event rates in the intention-to-treat population, tested for superiority. The prespecified secondary outcome measure, tested for superiority, was antibiotic days among per-protocol patients with simple or uncomplicated bacteremia.Among the 509 patients randomized (mean age, 56.6 [SD, 16.8] years; 226 [44.4%] women), 480 (94.3%) completed the trial. Clinical success was documented in 209 of 255 patients assigned to algorithm-based therapy and 207 of 254

2018 JAMA Controlled trial quality: predicted high

35. Pleural or pericardial metastasis: A significant factor affecting efficacy and adverse events in lung cancer patients treated with PD‐1/PD‐L1 inhibitors Full Text available with Trip Pro

Pleural or pericardial metastasis: A significant factor affecting efficacy and adverse events in lung cancer patients treated with PD‐1/PD‐L1 inhibitors Immunotherapy is a new paradigm for the treatment of non-small-cell lung cancer (NSCLC), and targeting the PD-1 or PD-L1 pathway is a promising therapeutic option. Although PD-1/PD-L1 inhibitors are more effective than standard chemotherapy in lung cancer, clinicians are afraid to actively use them because of hyperprogression (...) with pleural or pericardial metastasis than in patients without pleural or pericardial metastasis (4.3% vs. 35.7%; P = 0.007). Patients with pleural or pericardial metastasis had a significantly higher rate of adverse events of any grade (91.3% vs. 50.0%; P = 0.002) and grade 3-5 adverse events (52.2% vs. 25.0%; P = 0.046).Pleural or pericardial metastasis is a significant factor affecting the efficacy and rate of adverse events in advanced NSCLC patients treated with PD-1/PD-L1 inhibitors. Clinicians

2018 Thoracic cancer

36. Individual and Joint Effects of Pulse Pressure and Blood Pressure Treatment Intensity on Serious Adverse Events in the SPRINT Trial (Abstract)

Individual and Joint Effects of Pulse Pressure and Blood Pressure Treatment Intensity on Serious Adverse Events in the SPRINT Trial The objective of this study was to determine individual and joint effects of pulse pressure and blood pressure treatment intensity on serious adverse events in the Systolic Blood Pressure Intervention Trial.Pulse pressure was calculated by subtracting diastolic blood pressure from systolic blood pressure. Blood pressure treatment intensity goal was ≤140mm Hg (...) 10mm Hg] 1.23; 95% confidence interval [CI], 1.18-1.28). The intensive treatment arm had a higher incidence rate of serious adverse events than the control arm (34.2, 95% CI, 31.2-37.3, vs 26.0, 95% CI, 23.4-28.8, P = .0001; HR 1.32; 95% CI, 1.15-1.51). The combined effect was not significant in the relative risk scale (HR 0.97, Pinteraction = .48) but was significant in the risk difference scale (P = .027), contributing 2.5 additional serious adverse events per 1000 person-years for every 10mm Hg

2018 EvidenceUpdates

37. [ANZEN]PMDA Alert for Proper Use of Medical Devices: Adverse Events involving the Use of Bioprostheses for Transcatheter Aortic Valve Implantation, posted

[ANZEN]PMDA Alert for Proper Use of Medical Devices: Adverse Events involving the Use of Bioprostheses for Transcatheter Aortic Valve Implantation, posted PMDA Alert for Proper Use of Medical Devices | Pharmaceuticals and Medical Devices Agency Please make JavaScript on and see this site. Navigation of each product type Our recommended contents Navigation of each product type Our recommended contents PMDA Alert for Proper Use of Medical Devices Here begins the text. PMDA Alert for Proper Use (...) ." In the event of inconsistency, the text in Japanese shall prevail. Pmda - Pharmaceuticals and Medical Devices Agency JCN 3010005007409 Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved. 000044876 0 PMDA Alert for Proper Use of Medical Devices /english/safety/info-services/devices/0005.html en

2018 Pharmaceuticals and Medical Devices Agency, Japan

38. Adverse events

Adverse events Top results for adverse events - Trip Database or use your Google+ account Find evidence fast ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2) and (#3 (...) or #4) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: 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

2018 Trip Latest and Greatest

39. Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia Full Text available with Trip Pro

Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia In the phase 3 TOWER study, blinatumomab demonstrated an overall survival benefit over standard-of-care chemotherapy (SOC) in adults with relapsed or refractory (r/r) Philadelphia chromosome-negative (Ph-) B-precursor acute lymphoblastic leukemia (ALL). Nearly all patients in both treatment arms experienced an adverse event (AE), and the incidence rate of serious AEs was higher (...) for blinatumomab. However, as treatment exposure differed between the 2 arms, we conducted an exploratory safety analysis comparing exposure-adjusted event rates (EAERs) of blinatumomab vs SOC. Analyses were conducted for all patients who received therapy (safety population). Patients received a median (range) of 2 cycles (1-9) of blinatumomab (N = 267) vs 1 cycle (1-4) of SOC (N = 109). Grade ≥3 AE rates were generally higher in cycle 1 of blinatumomab than in cycle 2 (76% vs 37%). After adjusting for time

2018 Blood advances Controlled trial quality: uncertain

40. Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset Full Text available with Trip Pro

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized.The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient (...) of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.©David Peddie, Serena S Small, Katherin Badke, Chantelle Bailey, Ellen Balka, Corinne M Hohl. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 28.06.2018.

2018 JMIR medical informatics