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Adverse Event - DOAJ

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Last Updated: 28 July 2022

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Detecting drug-drug interactions between therapies for COVID-19 and concomitant medications through the FDA adverse event reporting system

Background: Patients with underlying medical conditions are prone to opioid-drug interactions as a result of the use of multiple drugs. Methods and Methods: We investigated 18,589 COVID-19 AEs from the FDA Adverse Event Reporting System, a source of post-market drug safety, between 2020 and 2021, and determined potential DDIs and related adverse events in COVID-19 patients. Results: Our analysis combined our results with the Liverpool database and performed a Monte Carlo simulation to confirm the identified DDIs. We compared our results with the Liverpool database and generated a Monte Carlo simulation to confirm the identified DDIs. Remdesivir was discovered to interact with the largest number of concomitant drugs in the world. Hydroxychloroquine was found to be a trigger of the majority of AEs.

Source link: https://doi.org/10.3389/fphar.2022.938552


Thrombocytopenia as an Immune-Related Adverse Event in Malignant Pleural Mesothelioma: A Case Report

At a regular medical check-up, a 69-year-old man was detected with a pulmonary opacity. Fluorodeoxyglucose deposits along the right pleura in areas of multiple nodules and irregular pleural thickening emerged in the aftermath of positron emission tomography with computed tomography. Multiple tumors in the pleural cavity recurred after 6 months of malignant pleural mesothelioma. Nivolumab was used for emergency immunotherapy as salvage immunotherapy. Both the platelet count increased and the platelet count increased, so a steady cycle of nivolumab was restarted. This case revealed that nivolumab could be readministered for recurrent antitumor results, as well as careful monitoring of immune-related adverse events.

Source link: https://doi.org/10.1016/j.jtocrr.2022.100351


Urbanization level and medical adverse event deaths among US hospital inpatients over the period 2010–2019

Urban-rural inequity is also a significant source of health inequity in high-income countries. This report was designed to compare deaths due to medical adverse events among U. S. hospital inpatients in different urbanization zones. All certified deaths of U. S. inpatients during the period 2010-2013 were compiled by the National Center for Health Statistics in an open database. Each decedent's urbanization level was determined in accordance with the 2013 NCHS Urban-Rural Classification Plan. Of the 8 071 907 recorded inpatient deaths during the study period, 21 444 were mainly due to medical adverse events. When compared to decedents who lived in large metropolitan areas or nonmetropolitans, decedents who lived in medium or small metropolitan areas and nonmetropolitans had an approximately 0. 5 percent higher incidence of adverse events per 1000 deaths. There were no statistically significant differences between decedents from medium or small metropolitans and nonmetropolitans, according to the authors.

Source link: https://doi.org/10.1016/j.pmedr.2022.101888


Multi-organ Immune-Related Adverse Event Is a Risk Factor of Immune Checkpoint Inhibitor-Associated Myocarditis in Cancer Patients: A Multi-center Study

paraphrasedoutput:MethodsThis was a retrospective review. We wanted to find the effect of multi-organ irAEs on ICI myocarditis in terms of clinical appearance, diagnosis, and prognosis. From 6 hospitals in China, ICI myocarditis patients' clinical records were obtained. In 32 patients, the severe myocarditis was present. Patients with multi-organ irAEs and need early corticosteroid therapy were more severe in patients with heart disease and myocarditis. paraphrasedoutput:ConclusionMyocarditis is a disease associated with ICI-associated myocarditis' Chronic myocarditis, suicide, and poor prognosis among patients with multi-organ irAEs. Thymoma was linked to patients with multiple organ involvement in the hospital. Patients could profit from early corticosteroid therapy. After myocarditis, heart arrest was an independent risk factor for OS.

Source link: https://doi.org/10.3389/fimmu.2022.879900


Adverse event using Medtronic NIM™ EMG endotracheal tube on a patient receiving anesthesia for hemithyroidectomy: a case report

Abstract Background The neural integrity monitor electromyogram endotracheal tube is a common tool to measure neural response in muscle activity. Case report Themedtronic NIM2122 EMG endotracheal tube used in a patient undergoing hemithyroidectomy had an adverse reaction while using the Medtronic NIM2022 EMG endotracheal tube. Conclusions Numerous reports indicate that these endotracheal tubes are blocking obstruction, particularly those in which overinflation of the cuff caused cuff herniation and blockage of the Murphy eye and bevel. The patient's short body habitus may have also been a small contributing factor. In this model of ET tube, the electrodes must extend from the vocal cords to the tip of the bevel is longer than those in a standard ET tube. In this version NIM EMG tube, the distance from the genuine vocal cords to where the cuff sits in the trachea is also longer.

Source link: https://doi.org/10.1186/s12871-022-01762-x


Adverse Event Reporting Quality in Cancer Clinical Trials Evaluating Immune Checkpoint Inhibitor Therapy: A Systematic Review

BackgroundImmunotherapy has emerged as one of the most important cancer treatments in recent years. paraphrasedoutput:MethodsWe investigated the harm reporting quality of IO trials, particularly immune-related AE. All relevant phase II and III clinical trials evaluating cancer immunotherapy published between January 1, 2010, and December 31, 2021, were retrieved by PubMed, Embase, Cochrane Library, and Web of Science databases to find all head-to-head phase II and III clinical trials investigating cancer immunotherapy published between January 1, 2010, and December 31, 2021. A 16-point harm reporting quality score derived from the 2004 Consolidated Standards of Reporting Trials extension was used to evaluate publications. ConclusionsThe multivariable regression model revealed that the higher impact factor and a phase III clinical trial were independent predictors of higher quality scores in IO randomized trials, according to the authors. Efforts could be made to enhance harm reporting and standardize reporting methods.

Source link: https://doi.org/10.3389/fimmu.2022.874829


A Real-World Disproportionality Analysis of Olaparib: Data Mining of the Public Version of FDA Adverse Event Reporting System

paragraph: Government of China; 3Department of Pharmacy, Pengzhou, People's Republic of China; 4Department of Pharmacy, Pengzhou Medical College, Tongji Hospital, Pengzhou, People's Republic of China, People's Republic of China; Peopleu2019s Republic of China; 4Department of Pharmacy, Pengzhou, People's Republic of China; 5Department of Pharmacy, Huazhong University of Science and Technology, Pengzhou, People's Republic of China; 3Department of Pharmacy, Tongji Hospital, Tongji University of China; 3Department of China; 2Department of Pharmacy, Tongji University of China; 3Department of China; 3Department of China; 2Department of China; 4Department of China; 4Department of China; 3Department of China; 4Department of China; 4Department of China; 3Department of China; 4Department of China; 4Department of China; 1Department of China; 4Department of China; Peopleu2019 Results: Out of 8,450,009 reports based on the FAERS' Adverse Event Reporting System, 6302 reports of olaparib-associated adverse events of real life were found. Methods: The new study was designed to examine the signals of olaparib-related adverse events of real-world using data mining of the U. S. Food and Drug Administration's Adverse Event Reporting System. Methods: The latest report sought to determine the effects of olapa AEs: Conclusion: The median onset time of olaparib-related AEs was 61 days, and the majority of the cases occurred within the first 1 month after olaparib's establishment, and we also found potential new and unexpected AEs signals for olaparib, suggesting that prospective clinical studies were required to confirm these findings and show their relationship.

Source link: https://doaj.org/article/7b4c6fc17a7e47f6817c4e030b8e5acf


Risk adjusted 30‐day mortality and serious adverse event rates among a large, multi‐center cohort of emergency department patients with acute heart failure

Abstract Background The incidence of emergency department patients with acute heart failure remained elevated, but admission rates for acute heart failure in the emergency department remained stable. Identifying low-risk patients who can be suitable for outpatient care with the use of a risk stratification device could lead to improved disposition decision making. We used a 30 day risk calculator we previously designed and divided patients into four categories of potential 30u2010day risk of a major adverse event in a planned 30u2010day risk scenario. According to ED disposition: immediate discharge, discharge after investigation, and hospital admission, we determined the 30u2010day mortality and composite SAE rates among patients by risk category: direct discharge, discharge after investigation, and hospital admission. Conclusions The observed 30th and total SAE mortality and mortality rates in the low and moderate risk groups were less than 1% and 2%, respectively, among 25 percent of patients in the low and moderate risk groups. Conclusion The use of a risk stratification device may help identify lower risk AHF patients who may be suitable for ED discharge.

Source link: https://doi.org/10.1002/emp2.12742


Ocular Complications after COVID-19 Vaccination, Vaccine Adverse Event Reporting System

The U. S. Food and Drug Administration approved COVID-19 vaccines for emergency use authorization in December 2020. Following vaccination against COVID-19, we investigated the ocular adverse event reports in patients reported to the Vaccine Adverse Event Reporting System. We searched the VAERS website for U. S. results among people who received COVID-19 vaccines between December 2020 and December 2021. Our aim was to analyze and quantify the ocular adverse events submitted to VAERS in order to provide clinicians and researchers with a more comprehensive view of these ocular side effects. Females accounted for 78% of adverse event reports, and the age group between 40 and 59 years had the most frequent adverse events. According to a review of these results, there may be a potential connection between COVID-19 vaccines and ocular adverse events. Healthy subjects would help clarify the vaccineu2019s safety profile, according to Future COVID-19 vaccine safety studies, which may help clarify the vaccine'u2019s safety profile.

Source link: https://doi.org/10.3390/vaccines10060941


Cost comparison of adverse event management among breast and ovarian cancer patients treated with poly (ADP-ribose) polymerase inhibitors: analysis based on phase 3 clinical trials

The AE unit costs per patient per treatment course were calculated by multiplying the AE unit costs by the number of AEs for each arm of each trial. CONclusions Hematological disorders were the key movers of AE management costs for PARPis. Hematological disorders were the primary causes of AE management costs for PARPis.

Source link: https://doi.org/10.1080/20016689.2022.2078474

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions