Latest & greatest articles for adverse events

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Top results for adverse events

21. [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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. [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

32. 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

33. 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

34. 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

35. Association of Facility Type With Procedural-Related Morbidities and Adverse Events Among Patients Undergoing Induced Abortions. Full Text available with Trip Pro

Association of Facility Type With Procedural-Related Morbidities and Adverse Events Among Patients Undergoing Induced Abortions. Multiple states have laws requiring abortion facilities to meet ambulatory surgery center (ASC) standards. There is limited evidence regarding abortion-related morbidities and adverse events following abortions performed at ASCs vs office-based settings.To compare abortion-related morbidities and adverse events at ASCs vs office-based settings.Retrospective cohort (...) abortion-related morbidity or adverse event (such as retained products of conception, abortion-related infection, hemorrhage, and uterine perforation) within 6 weeks after an abortion. Two secondary outcomes, both subsets of the primary outcome, were major abortion-related morbidities and adverse events (such as hemorrhages treated with a transfusion, missed ectopic pregnancies treated with surgery, and abortion-related infections that resulted in an overnight hospital admission) and abortion-related

2018 JAMA

36. A High-yield Fall Risk and Adverse Events Screening Questions From the Stopping Elderly Accidents, Death, and Injuries (STEADI) Guideline for Older Emergency Department Fall Patients Full Text available with Trip Pro

A High-yield Fall Risk and Adverse Events Screening Questions From the Stopping Elderly Accidents, Death, and Injuries (STEADI) Guideline for Older Emergency Department Fall Patients The objectives were to examine whether responses to the Stopping Elderly Accidents, Death, and Injuries (STEADI) questions responses predicted adverse events after an older adult emergency department (ED) fall visits and to identify factors associated with such recurrent fall.We conducted a prospective study at two (...) urban, teaching hospitals. We included patients aged ≥ 65 years who presented to the ED for an accidental fall. Data were gathered for fall-relevant comorbidities, high-risk medications for falls, and the responses to 12 questions from the STEADI guideline recommendation. Our outcomes were the number of 6-month adverse events that were defined as mortality, ED revisit, subsequent hospitalization, recurrent falls, and a composite outcome.There were 548 (86.3%) patients who completed follow-up and 243

2018 EvidenceUpdates

37. Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database Full Text available with Trip Pro

Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database Voluntary reports on adverse events (AEs) submitted by consumers have been facilitated through the MedWatch program in the United States (US), but few studies have described the characteristics of voluntary reports.The aim of this study was to reveal the characteristics of current voluntary reports on AEs reported by consumers

2018 Drugs - real world outcomes

38. Effect of Systematic Physician Cross-checking on Reducing Adverse Events in the Emergency Department: The CHARMED Cluster Randomized Trial Full Text available with Trip Pro

Effect of Systematic Physician Cross-checking on Reducing Adverse Events in the Emergency Department: The CHARMED Cluster Randomized Trial Emergency departments (ED) are environments that are at high risk for medical errors. Previous studies suggested that the proportion of medical errors may decrease when more than 1 physician is involved.To reduce the proportion of medical errors by implementing systematic cross-checking between emergency physicians.This cluster randomized crossover trial (...) includes a random sample of 14 adult patients (age ≥18 years) per day during two 10-day period in 6 EDs (n = 1680 patients) in France.Systematic cross-checking between emergency physicians, 3 times a day, which included a brief presentation of one physician's case to another, followed by the second physician's feedback to the first.Medical error in the ED, defined as an adverse event (either a near miss or a serious adverse event). The primary end point was identified using a 2-level error detection

2018 EvidenceUpdates

39. Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes Full Text available with Trip Pro

Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes Pencil-beam scanning intensity modulated proton therapy (IMPT) may allow for an improvement in the therapeutic ratio compared with conventional techniques of radiation therapy delivery for pancreatic cancer. The purpose of this study was to describe the clinical (...) implementation of IMPT for intact and clinically localized pancreatic cancer, perform a matched dosimetric comparison with volumetric modulated arc therapy (VMAT), and report acute adverse event (AE) rates and patient-reported outcomes (PROs) of health-related quality of life.Between July 2016 and March 2017, 13 patients with localized pancreatic cancer underwent concurrent capecitabine or 5-fluorouracil-based chemoradiation therapy (CRT) utilizing IMPT to a dose of 50 Gy (radiobiological effectiveness: 1.1

2018 Advances in radiation oncology

40. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Full Text available with Trip Pro

Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline | Journal of Clinical Oncology Search in: Menu Article Tools ASCO SPECIAL ARTICLE Article Tools OPTIONS & TOOLS COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2017.77.6385 Journal of Clinical (...) Oncology - published online before print February 14, 2018 PMID: Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline x Julie R. Brahmer , x Christina Lacchetti , x Bryan J. Schneider , x Michael B. Atkins , x Kelly J. Brassil , x Jeffrey M. Caterino , x Ian Chau , x Marc S. Ernstoff , x Jennifer M. Gardner , x Pamela Ginex , x Sigrun Hallmeyer , x Jennifer Holter Chakrabarty , x

2018 American Society of Clinical Oncology Guidelines