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Latest & greatest articles for adverse events
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Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious AdverseEvents 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 adverseevent 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
Pleural or pericardial metastasis: A significant factor affecting efficacy and adverseevents in lung cancer patients treated with PDâ€1/PDâ€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 adverseevents of any grade (91.3% vs. 50.0%; P = 0.002) and grade 3-5 adverseevents (52.2% vs. 25.0%; P = 0.046).Pleural or pericardial metastasis is a significant factor affecting the efficacy and rate of adverseevents in advanced NSCLC patients treated with PD-1/PD-L1 inhibitors. Clinicians
Individual and Joint Effects of Pulse Pressure and Blood Pressure Treatment Intensity on Serious AdverseEvents 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 adverseevents 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 adverseevents 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 adverseevents per 1000 person-years for every 10mm Hg
Adverseevents Top results for adverseevents - 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 adverseevents 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
Exposure-adjusted adverseevents 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 adverseevent (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
Association of Facility Type With Procedural-Related Morbidities and AdverseEvents 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 adverseevents following abortions performed at ASCs vs office-based settings.To compare abortion-related morbidities and adverseevents at ASCs vs office-based settings.Retrospective cohort (...) abortion-related morbidity or adverseevent (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 adverseevents (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
A High-yield Fall Risk and AdverseEvents 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 adverseevents 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 adverseevents 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
Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverseevents in non-randomised studies. Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in childhood. The psychostimulant methylphenidate is the most frequently used medication to treat it. Several studies have investigated the benefits of methylphenidate, showing possible favourable effects on ADHD symptoms, but the true magnitude (...) of the effect is unknown. Concerning adverseevents associated with the treatment, our systematic review of randomised clinical trials (RCTs) demonstrated no increase in serious adverseevents, but a high proportion of participants suffered a range of non-serious adverse events.To assess the adverseevents associated with methylphenidate treatment for children and adolescents with ADHD in non-randomised studies.In January 2016, we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, 12 other databases
Spontaneous Reporting on AdverseEvents by Consumers in the United States: An Analysis of the Food and Drug Administration AdverseEvent Reporting System Database Voluntary reports on adverseevents (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
Effect of Systematic Physician Cross-checking on Reducing AdverseEvents 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 adverseevent (either a near miss or a serious adverseevent). The primary end point was identified using a 2-level error detection
Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverseevents, 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 adverseevent (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
Benchmarking study helps hospitals improve measurement of adverseevents Benchmarking study helps hospitals improve measurement of adverseevents Discover Portal Discover Portal Benchmarking study helps hospitals improve measurement of adverseevents Published on 20 June 2017 doi: One in ten inpatients in Welsh hospitals experienced an adverseevent of some sort, about half of which were potentially preventable. This is very similar to the rate in other countries. The figures come from a review (...) of 4,388 patient records between October 2010 and March 2013. Welsh hospitals were using a screening tool at the time called the Global Trigger Tool to estimate rates of adverse effects. The tool surveys case notes of 20 inpatient records each month. Alongside the trigger tool process, researchers reviewed case notes using a more comprehensive two-step process – nurse screening followed by physician review – to compare how different the estimates were and to better understand how many events were
Infants anaesthetised without placing a tube in the trachea have fewer adverse breathing events Infants anaesthetised without placing a tube in the trachea have fewer adverse breathing events Discover Portal Discover Portal Infants anaesthetised without placing a tube in the trachea have fewer adverse breathing events Published on 11 July 2017 doi: Adverse breathing events are about three times more common when using endotracheal tubes than laryngeal mask airways for infants under 12 months (...) complications than tubes. This Australian randomised controlled trial supported this, finding an adverseevent rate of 53% with endotracheal tubes compared with only 18% with laryngeal mask airways. Conventional anaesthesia teaching advises the use of endotracheal tubes in infants even for relatively minor surgery, to provide a secure airway, but incidents may be more common when placing or removing the tube than a laryngeal mask. Share your views on the research. Why was this study needed? Over 8,000
Management of Immune-Related AdverseEvents in Patients Treated With Immune Checkpoint Inhibitor Therapy Management of Immune-Related AdverseEvents 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 AdverseEvents 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
Inhalational versus IV Induction of Anesthesia in Children with a High Risk of Perioperative Respiratory AdverseEvents: A Randomized Controlled Trial Limited evidence suggests that children have a lower incidence of perioperative respiratory adverseevents when intravenous propofol is used compared with inhalational sevoflurane for the anesthesia induction. Limiting these events can improve recovery time as well as decreasing surgery waitlists and healthcare costs. This single center open (...) -label randomized controlled trial assessed the impact of the anesthesia induction technique on the occurrence of perioperative respiratory adverseevents in children at high risk of those events.Children (N = 300; 0 to 8 yr) with at least two clinically relevant risk factors for perioperative respiratory adverseevents and deemed suitable for either technique of anesthesia induction were recruited and randomized to either intravenous propofol or inhalational sevoflurane. The primary outcome
Immune-related adverseevents for anti-PD-1 and anti-PD-L1 drugs: systematic review and meta-analysis. To evaluate rates of serious organ specific immune-related adverseevents, general adverseevents related to immune activation, and adverseevents consistent with musculoskeletal problems for anti-programmed cell death 1 (PD-1) drugs overall and compared with control treatments.Systematic review and meta-analysis.Medline, Embase, Cochrane Library, Web of Science, and Scopus searched to 16 (...) March 2017 and combined with data from ClinicalTrials.gov.Eligible studies included primary clinical trial data on patients with cancer with recurrent or metastatic disease.Three independent investigators extracted data on adverseevents from ClinicalTrials.gov and the published studies. Risk of bias was assessed using the Cochrane tool by three independent investigators.13 relevant studies were included; adverseevent data were available on ClinicalTrials.gov for eight. Studies compared nivolumab
Management of gastrointestinal adverseevents induced by immune-checkpoint inhibitors 29756118 2018 11 14 2589-0514 4 1 2018 Mar Chronic diseases and translational medicine Chronic Dis Transl Med Management of gastrointestinal adverseevents induced by immune-checkpoint inhibitors. 1-7 10.1016/j.cdtm.2017.12.001 Wang Zheng-Hang ZH Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital (...) & Institute, Beijing 100142, China. Shen Lin L Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing 100142, China. eng Journal Article Review 2018 03 13 China Chronic Dis Transl Med 101679934 2095-882X Gastrointestinal tract Immune-checkpoint inhibitors Management Risk factor Treatment-related adverseevent 2017 10 03 2018 5 15 6 0 2018 5 15 6 0 2018 5 15 6 1 epublish 29756118
Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial. The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain.To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS