Advanced searches left 3/3

Adverse Event - Europe PMC

Summarized by Plex Scholar
Last Updated: 28 July 2022

* If you want to update the article please login/register

Hematological toxicities in PARP inhibitors: A real-world study using FDA adverse event reporting system (FAERS) database.

Objective Poly ADP-ribose polymerase inhibitors have dramatically improved clinical outcomes in gynecological oncology. However, PARPis can cause acute organ system abnormalities, including the hematological system. Based on the real-world results, our research sought to extensively characterize the hematological toxicities of PARPis. Methods Disproportionality analysis was used to determine the correlation between PARPis and hematotoxicity adverse events. Results Out of 24,045 adverse events reports, 4088 hematotoxicity reports were analyzed, with a median age of 64. 95 years. In four detection methods, All PARPis were found with positive safety warnings of hematological harm in four detection techniques. Unexpected adverse events such as lymphadenopathy, lymphoedema, and lymphoedema could also occur, as well as metastases to lymph nodes. With PARPis, the median time-to-onset was 28 days, and the fatality ratio of hematological toxicities was 8. 76 percent, with a statistical discretion between different PARPis. Conclusion Hematological disorders caused by PARPis preferred to develop early and may result in serious outcomes.

Source link: https://europepmc.org/article/MED/35871395


Hepatic Failure Associated with Immune Checkpoint Inhibitors: A Real-world Study from the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Background: Although immunological checkpoint inhibitors linked liver disease commonly as mild elevations of liver enzymes, hepatic dysfunction caused by ICIs has only been reported in a small case series and case series. In the real-world database, we set out to investigate the connection between ICIs and hepatic dysfunction, as well as identify the clinical characteristics of ICI-associated hepatic failure. The overall median time from ICIs beginning to hepatic failure onset was 38 days, with 73% of the adverse events occurring within the first three months. Compared to nivolumab or ipilimumab alone, the combination of nivolumab and ipilimumab produced more signs of hepatic failure. Conclusion ICIs had potential urinary dysfunction, the majority of cases of hepatic failure occurred within the first three months and had poor results, and should have prompted clinical interest.

Source link: https://europepmc.org/article/PPR/PPR522096


A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Niraparib

Background: Niraparib has been approved for the treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube, and primary peritoneal cancer. The authors retrospectively investigated niraparib-related adverse events in the U. S. Food and Drug Administration's Adverse Event Reporting System, which was based on data mining. Results According to the FAERS website, there are 738157 reports, out of which 11701 reported niraparib as the 'u2018 prime minister's suspected u2019 drug. ' The average onset time of niraparib-related AEs was 18 days, and the majority of the cases occurred within the first months after niraparib's implementation.

Source link: https://europepmc.org/article/PPR/PPR520421


A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS).

Introduction Tizanidine is primarily metabolized by cytochrome P450 1A2, and therefore drugs that inhibit the enzyme clearance of tizanidine will have a dramatic effect on the clearance of tizanidine, leading to increased plasma tizanidine concentrations and potentially fatal adverse events. Objects Our aim was to investigate the occurrence of adverse events reported in the FDA Adverse Event Reporting System, which includes a combination of tizanidine and drugs that inhibit the metabolic activity of CYP1A2. Methods utilized Anxiology of FAERS Reports from 2004-to-2020 Quarter 1 The following adverse events: hypotension, bradycardia, syncope, heart arrest, fall or fracture were determined by a disproportionality analysis of FAERS reports mentioning tizanidine as a suspect or intervening role, or having any involvement, a CYP1A2 inhibitor, and fall or fracture were all calculated from an observational case. The combination of tizanidine with CYP1A2 inhibitors, according to this review, could result in serious health problems related to low blood pressure, such as falls and fractures.

Source link: https://europepmc.org/article/MED/35834155


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

Background: The neural integrity monitor electromyogram endotracheal tube is a common device used to track neural responses based on muscle activity. Case description We are presenting a case where a patient undergoing hemithyroidectomy had an adverse reaction while using the Medtronic NIM 2122 EMG endotracheal tube. Conclusions These endotracheal tubes causing obstruction have appeared in a variety of studies, including those in which overinflation of the cuff caused cuff herniation and blockage of the Murphy eye and the bevel. The patient's brief body habitus may also be a small contributing factor. In this type of ET tube, the electrodes must lie inside the vocal cords to the tip of the bevel is longer than in a standard ET tube. In this version of NIM EMG tube, the distance from the true vocal cords to where the cuff sits in the trachea is also increased.

Source link: https://europepmc.org/article/MED/35831790


Case Report of a Malignant Melanoma Patient With Longitudinally Extensive Transverse Myelitis: Immune-related Adverse Event or Human Herpes Virus 7 Infection?

'Immune checkpoint inhibitors' are used in patients with metastatic malignant melanoma. On the surface of T cells, programmed cell death-1 and cytotoxic lymphocyte-associated protein 4 are found and are used as indicators for immune response against the tumor formation. Case Ipilimumab and nivolumab combination therapy was administered in a 60-year-old male patient with malignant melanoma after finding metastasis after pegylimab, another immune checkpoint inhibitor, later on. All upper extremity muscle groups were found to have 5-/5 muscle strength, 1/5 muscle endurance in the lower limbs, and a lack of sensation in the lower extremities that did not have a clear measure, according to a neurological examination. Human herpes Virus-7 DNA isolated in cerebrospinal fluid could not be confirmed in serum but not in serum. Conclusion: Patients treated with immune checkpoint inhibitors should be monitored for signs and symptoms of irAE, as shown in this article.

Source link: https://europepmc.org/article/PPR/PPR517741


Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database.

Introduction As chimeric antigen receptor T-cell therapies become more widely available in the armamentarium of the hematologist, there is a growing need to monitor post-marketing safety. Methods We investigated the U. S. Food and Drug Administration Adverse Event Reporting System to look at potential adverse drug reactions to tisagenlecleucel and axicabtagene ciloleucel, as well as axicabtagene ciloleucel. Disproportionality analyses were conducted by comparing chimeric antigen receptor T-cell therapy with all other drugs and other oncohematological agents in a similar manner, whether restricted to adults or restricted to adults. The development of adverse drug reaction time to onset and cytokine release syndrome signs were investigated. Conclusions: Our analysis supports the well-known adverse drug reactions and detections that might be emerging safety issues specific for each chimeric antigen receptor T-cell therapy, as well as providing insight into the role of tisa-cel in inducing certain immunodeficiency-related events and coagulopathies, as well as axi-cel in neurotoxicity.

Source link: https://europepmc.org/article/MED/35829913


Exploratory study of seed spots analysis to characterize dose and linear-energy-transfer effect in adverse event initialization of pencil-beam-scanning proton therapy.

Background The initialization of cancer patients treated with pencil-beam proton therapy may have a significant effect on adverse event initialization of cancer patients treated with pencil-beam proton therapy. Only include a subset of voxels that are dosimetrically significant, so it is important to investigate the synergistic effects of dose and LET in AE initialization. Purpose: The aim of this paper was to perform an exploratory investigation into the dose and LET effects on PBS' AE initialization using seed spots analysis. Methods The inclusion of 113 head-and-neck cancer patients receiving curative PBS was included in this study. The AE patients were included in the seed spot analysis to derive the descriptive characteristics of AE initialization, and the remaining 7 mandible osteoradionecrosis patients and 93 control patients were used to determine the feature-based volume constraint of mandible osteoradionecrosis. For all patients in the AE group, the AE regions were contoured and the appropriate dose-LET volume histograms of AE regions were produced. As important voxels, we selected high LET voxels in a range of moderate to high doses. In this preliminary research, the use of dose and LET was discovered to be a descriptive characteristic of seed spots leading to AE initialization. The derived xBD volume constraint for mandible osteoradionecrosis revealed promising results, with a region under curve of 0. 87 for the very limited patient samples included in this analysis. In the very limited H&N cancer patient data treated with PBS included in this research, the derived xBD volume constraint may predict mandible osteoradionecrosis reasonably well.

Source link: https://europepmc.org/article/MED/35820062


Adverse event profiles of PCSK9 inhibitors alirocumab and evolocumab: Data mining of the FDA adverse event reporting system.

Proprotein convertase subtilisin/kexin type inhibitor is a new drug class approved for treating dyslipidemias. Using the Food and Drug Administration Adverse Event Reporting System, we set out to investigate the safety characteristics of PCSK9 inhibitors. Methods We featured adverse event reports regarding alirocumab and evolocumab submitted to the FAERs from 2015-Q3 to 2021Q1. When the lower limit of the 95% confidence interval of ROR exceeded 1 and u22653 AEs was reported, A signal was considered. PCSK9 inhibitors were distributed from July 1, 2015 to March 31, 2021, according to FAERS' database. Although some differences were noted, alirocumab and evolocumab both had similar safety profiles. Conclusion The FAERs' data mining is particularly useful for investigating PCSK9 inhibitor-induced AEs. Our findings were generally consistent with clinical experience, and may have aided clinicians in enhancing the safety of PCSK9 inhibitors in clinical use.

Source link: https://europepmc.org/article/MED/35818959


Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study.

The goal of the Micronutrients for ADHD study, an eight-week multi-site randomized clinical trial of a broad-spectrum multinutrient therapy, was measured in adverse events of children aged 6-12 years with ADHD and emotional dysregulation. The PAERS' treatment sensitivity was assessed by determining the difference in change of the item scores from baseline to end of the RCT. Study Findings The 126 children in the ITT sample had a mean age of 9. 8 with the majority male and 72% diagnosed with ADHD prior to the study screening. Baseline presence of PAERS symptoms was similar across treatment groups: the most common condition was ADHD symptoms followed by Irritable signs; following this were asthmatic disorders. With an ITT result in decline of -0. 36 with ITT results and -0. 48 with per-protocol results, the micronutrient group saw a larger decline in the mean anxiety composite score than the placebo group, with a larger decrease in the mean anxiety combined score in comparison to the placebo group.

Source link: https://europepmc.org/article/MED/35770861

* 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