Database System Research Articles

Assessment of distributions and gender difference in adverse events related to faricimab: a real-world study based on FDA adverse event reporting system

ABSTRACT Background Faricimab is a novel bispecific antibody drug for treating retinal disease. We aim to study the adverse events of faricimab based on the FDA Adverse Event Reporting System (FAERS) database. Research design and methods The FAERS data from 2020 to 2024 was extracted to conduct disproportionality analysis. The risk signals were mined by using reporting odds ratio (ROR) and proportional reporting ratio (PRR). Results A total of 1401 cases with adverse events were reported. Eye disorders were the most frequent AEs. New ocular AEs were identified, such as diplopia, metamorphopsia, blindness transient, visual field defect, subretinal fibrosis. New non-ocular AEs were also found such as cellulitis, acute respiratory failure, end stage renal disease, proteinuria, nephropathy, VIth nerve paralysis, and deafness. It was found that there is a difference between men and women on the ocular adverse events. Adverse events happened in the initial month of the treatment, but mostly happened between the 91 to180 days. Conclusions Faricimab have ocular and non-ocular adverse events, in which some ocular adverse events differ across genders. Important potential adverse events should be considered in the clinical practice to provide better individualized treatment.

Adverse events of nusinersen: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database

ABSTRACT Introduction Nusinersen, the initial FDA-approved medication, treats Spinal Muscular Atrophy. This study utilized the FDA’s adverse event reporting system (FAERS) database to examine, evaluate, and provide substantiation for the safety of Nusinersen to assist in clinical decision-making. Methods Nusinersen-related adverse reaction signals were mined using the reporting odds ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN), Multi-item Gamma-Poisson Shrinker (MGPS) models with Empirical Bayesian Geometric Mean (EBGM). The rate and frequency of reported adverse reactions were investigated. Results Nusinersen-induced adverse events were observed in 25 system organ categories (SOCs). A total of 230 disproportionate preferred terms (PTs) were eliminated using four algorithms. Cardiac arrest, autism spectrum disorder, and epilepsy emerged as potential new side effects not previously listed, warranting further attention for drug safety. Analysis of the age distribution of the signals found that younger patients should be watched out for upper respiratory tract infections and increased CSF pressure; senior patients should be extensively checked for symptoms of post-lumbar puncture syndrome and protein urine present. Conclusions Our investigation discovered potential signals of novel adverse drug events that could support clinical monitoring and risk identification of Nusinersen. However, these results should be interpreted with caution.

Outpatient visits and treatment methods of patients with hand and wrist injuries in Vreden National Medical Research Center of Traumatology and Orthopedics

Background. Number of injuries of the hand and wrist is constantly growing from year to year. Inpatient treatment of these patients increases both time and financial costs for healthcare organizations. Thus, analysing the structure of patients who applied to the emergency department would make it possible to take more objective decisions on the organization of healthcare delivery. The aim — to analyse outpatient visits and treatment methods of patients with hand and wrist injuries who applied to the emergency department of the Vreden National Medical Research Center of Traumatology and Orthopedics. Methods. A sample of 18.848 patients who applied to the emergency department with hand and wrist injury in the period from 2020 to 2023 was drawn in the database of the Medialog medical information system of the Center. Results. The most common types of hand and wrist injuries were: metacarpal and phalangeal fractures, damage to the skin and subcutaneous tissue, damage to the finger flexor tendons and nerves. Of the operations performed, K-wire osteosynthesis and primary suture of the extensor or flexor tendons of the fingers were most often used. Significantly less common were the following operations: primary surgical debridement, suture of nerves and blood vessels, replantation and revascularization. About 20% of patients with hand injuries can receive emergency medical care in emergency rooms of Saint Petersburg, thereby reducing the queue for surgical service in the Center’s emergency department. Conclusion. Treatment of patients with hand and wrist injuries requires comprehensive approach involving doctors of various specialties at each stage of the treatment. Proper organization of such patients’ treatment will significantly improve the quality of medical care and the treatment outcomes.

Safety of talimogene laherparepvec: a real‐world retrospective pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS)

BackgroundOncolytic virus therapy is a rapidly evolving emerging approach for the medical management of cancer. Talimogene laherparepvec (T-VEC) is the first and only Food and Drug Administration (FDA)-approved oncolytic virus therapy. Considering that exactly how T-VEC works is not known, there is a strong need for a comprehensive pharmacovigilance study to identify safety signals of potential risks with T-VEC.ObjectiveThe objective of this study was to assess the risk of adverse events (AEs) related to T-VEC.MethodsWe implemented a pharmacovigilance study utilizing individual case safety reports (ICSRs) reported to the FDA Adverse Event Reporting System (FAERS) database dated from 2004 quarter 1 to 2023 quarter 3. In this study, we used two algorithms, reporting odds ratio (ROR) and information component (IC), to assess the risk of AEs related to T-VEC.ResultsA total of 1138 ICSRs of patients who received the T-VEC and reported to the FDA dated from 2004 quarter 1 to 2023 quarter 3 were available. A total of seven system organ classes (SOCs) demonstrated statistically significant signals, i.e. General disorders and administration site conditions, Injury, poisoning and procedural complication, Infections and infestations, Neoplasms benign, malignant and unspecified, Skin and subcutaneous tissue disorders, Hepatobiliary disorders, and Endocrine disorders. From the preferred term level perspective, the most reported AEs in T-VEC-treated patients were pyrexia, illness, influenza, influenza-like illness, and chills. Unexpected significant AEs were detected, such as sepsis, encephalitis, syncope, and lymphadenopathy.ConclusionsMost AEs in T-VEC-treated patients have been previously mentioned in the prescriptive information or documented in other clinical trials. But safety signals were also be detected in 4 unexpected AEs (sepsis, encephalitis, syncope, and lymphadenopathy). Further clinical trials need to be undertaken to facilitate a more comprehensive comprehension of the safety profile of T-VEC.

A real‑world pharmacovigilance study of raloxifene based on the FDA adverse event reporting system (FAERS)

ABSTRACT Background Raloxifene was approved for the treatment of postmenopausal osteoporosis; however, its safety profile remains inadequately understood. This study aimed to evaluate the safety signals associated with raloxifene. Research design and methods Adverse events (AEs) related to raloxifene, spanning from the first quarter of 2004 to the fourth quarter of 2023, were extracted from the FDA Adverse Event Reporting System (FAERS) database. A disproportionality analysis was conducted using several methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM). Results The analysis yielded 7 229 reports related to raloxifene across 19 277 AEs. A total of 217 significantly disproportionate signals were identified, including muscle spasms and hot flashes. Notably, the study also uncovered novel AEs, including eye conditions like cataracts and macular degeneration, as well as gynecological issues like uterine polyps and hemorrhage. Additionally, the analysis confirmed that pulmonary embolism and deep vein thrombosis were the two most prevalent thromboembolic AEs. Conclusion Our study reaffirmed some existing safety information regarding raloxifene while also unveiling novel risk signals. The findings provided crucial insights to enhance the rational use of the drug and inform safety regulatory strategies.

Trends in Pediatric Neck Injuries During Sporting Activities

Background: Although neck injuries secondary to sporting activities in the pediatric demographic presenting to the emergency department (ED) are common, predictors of needing higher-level care (HLC) outside immediate treatment and release are not clear. The aim of this study was to describe how these neck injuries present in the United States (US) and identify predictors of HLC. Methods: We interrogated the US National Electronic Injury Surveillance System (NEISS) database for presentations to the ED of pediatric patients (aged 6–18 years old) whose primary complaint was neck injury in the setting of sport between 2014 and 2023. Statistical analysis utilized weighted estimates to evaluate incidence and then univariate and multivariate regression analyses were carried out to identify parameters associated with HLC for these patients. Results: Overall, a national weighted total of 360,885 ED presentations were estimated to have occurred in the last decade without any statistical change over the years. The mean age was 12.7 years, with more males (60.0%) than females (40.0%). The most common race observed was Black (50.6%), and these injuries most commonly occurred at a sporting complex (62.9%). Neck strains (59.9%) were the most common diagnosis seen across all presentations, followed by neck pain (29.1%), neck contusions (including abrasion) (6.4%), neck fractures (1.7%) and neck lacerations (0.8%). Ultimately, the majority of presentations were treated and released from the ED (95.5%). There were 4.5% of presentations, however, that did require HLC. Older age (OR 1.07, p = 0.004), male gender (OR 1.51, p = 0.002), involvement of other body part(s) (OR 1.45, p = 0.007) and non-strain neck injuries (OR 11.8, p < 0.001) were all independent, statistically significant predictors of HLC. Football (18.6%) was the most common sport associated with these presentations overall, but this was driven mostly by male cases. For females, the most common sport associated with these presentations was cheerleading (12.3%). Conclusions: In the last decade, neck injuries secondary to sporting activities in the pediatric demographic presenting to the ED have remained consistent. We have identified a unique set of predictors for presentations requiring HLC. These findings can be used in tandem with the findings that there are a number of gender-specific sports that drive these presentations to develop more sensitive and specific protocols for both primary prevention and ED triaging.

Cardiovascular Events Associated with CDK4/6 Inhibitors: A Safety Meta-Analysis of Randomized Controlled Trials and a Pharmacovigilance Study of the FAERS Database.

CDK4/6 inhibitors are highly valued, but the incidence of cardiovascular adverse events (CVAEs) associated with CDK4/6 inhibitors is not clear. Our aim was therefore to assess the risk of developing CVAEs associated with CDK4/6 inhibitors, by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs), along with a pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS) database. Eligible CVAEs were extracted from the ClinicalTrials.gov registry. A systematic search of electronic databases (PubMed, Embase, Cochrane Library, and important meetings) until 3 September 2023 was conducted. A disproportionality analysis was performed from the first quarter (Q1) of 2013 to Q1 of 2023 using data from the FAERS database. Study heterogeneity was assessed using the I2 statistic. Using Peto odds ratio (Peto OR) and inverse variance methods to calculate the risk and incidence of CVAEs associated with CDK4/6 inhibitors. In total, 17 RCTs with 23,437 patients were included in our meta-analysis. During the follow-up period of 8.4-34.0 months, CDK4/6 inhibitors significantly increased the risk of CVAEs (Peto OR, 1.86, 95% confidence interval, 1.30-2.68, P < 0.01). The rates of hypertension and QT prolongation were 68.07 (62.87-73.27) and 57.15 (50.83-63.48) per 1000 patients, respectively. Moreover, we identified nine CVAEs that were not reported in RCTs. These included acute coronary syndrome, arrhythmia, lymphoedema, hot flush, vein rupture, thrombophlebitis migrans, embolism venous, angiopathy and intracardiac thrombus, which were found to be strongly correlated with CDK4/6 inhibitors. Furthermore, the risk of CVAEs varied depending on the specific CDK4/6 inhibitors used, its combination with different endocrine therapies, and the patient's treatment stage. CDK4/6 inhibitors increase the risk of CVAEs, some of which may lead to serious consequences. Early recognition and management of CVAEs is of great importance in clinical practice. PROSPERO registration number CRD42023462059.

Development and Evaluation of Pakistan Explorer: A Recommender Web Platform for Navigating Pakistani Culture

The study seeks to bridge the gap in existing cultural exploration resources by offering a personalized, technology-driven understanding of Pakistan’s diverse cultural heritage, which answers the significant void in tailored cultural exploration, particularly for Pakistani heritage. This project not only showcases the rich traditions, cuisine, and arts of Pakistan but also addresses the lack of tailored cultural information available for this region. The platform's advanced recommendation algorithms promote personalized user experiences, thus fostering cross-cultural understanding and appreciation. The backbone of this platform is a hybrid- recommendation system which combines both content-based filtering with collaborative-filtering through the innovative use of the 'Surprise' library's Singular Value Decomposition (SVD) algorithm, a method not typically applied in cultural context platforms. Additionally, the system integrates real-time data processing for dynamic content updates, including weather and local events, which are crucial for real-time travel and cultural recommendations. The platform has demonstrated a capability to offer personalized and dynamic cultural insights, substantially improving user engagement and satisfaction. The application of the SVD algorithm in a new domain—cultural recommendations—is a novel adaptation, showing promising results in enhancing the relevancy of content delivered to users. For future scalability, transitioning from embedded data within the Flask app to a more robust database system, such as SQL or NoSQL, is recommended. This would facilitate easier data management and richer feature implementation. The research could also benefit from focusing on integrating more AI-driven capabilities, such as natural language processing (NLP) to parse and categorize user reviews and feedback, which could further refine and personalize recommendations. The innovative use of SVD in cultural context platforms presents a new avenue for academic exploration and can be expanded to other cultural recommendation systems.

Postmarketing Safety Surveillance of Topiramate: A Signal Detection and Analysis Study Based on the FDA Adverse Event Reporting System Database.

This study aims to investigate the occurrence of adverse events associated with topiramate by analyzing data from the FDA Adverse Event Reporting System. The goal is to provide a basis for the safe clinical use of topiramate. Adverse event data from the FDA Adverse Event Reporting System, from its inception through the first quarter of 2024, were extracted. Signal detection was conducted using three methods: the reporting odds ratio, the medicines and healthcare products regulatory agency method, and the Bayesian confidence propagation neural network. Adverse events were statistically analyzed according to the preferred term and system organ class classifications from the Medical Dictionary for Regulatory Activities version 27.0. Positive signals were then compared against the drug label and the Important Medical Event list. A total of 12,168 adverse event reports involving topiramate as the primary suspect were analyzed, resulting in the extraction of 244 positive signals across 15 system organ classes. Among these, 21 signals were identified as serious adverse reactions not included in the drug label, encompassing 5 system organ classes. Notable signals included hypospadias, spina bifida, abortion spontaneous, renal tubular dysfunction, uveitis, retinal detachment, and choroidal effusion. Additionally, signals such as osmotic demyelination syndrome and Arnold-Chiari malformation were identified as requiring further monitoring. This study identified several unexpected and serious adverse reaction signals that align with previously reported cases. These findings underscore the need for ongoing study, focused attention, and vigilant monitoring during the clinical use of topiramate.

Development of a Decision Support System for University Administration: Integrating Business Process Management and Multidimensional Data Analysis

The paper provides an overview of decision support systems to demonstrate their role in supporting decision-making in university administration. Enhancing university performance and modernizing university administration must be top priorities for university leaders and decision-makers since quality is the foundation that supports innovation. Good decision-making is the first step towards efficiency and quality in the academic setting. The article’s main topic is developing IT solutions to support decision-making business processes of student admission. By utilizing models of university business processes and applying business intelligence principles, with the support of multidimensional data analysis, it can be effectively introduced and integrated. The study attempts to provide selection criteria for selecting a development environment for creating a support system focused on university management based on data from the student information system database and the author’s personal experience. The contributions include creating OLAP analytical models and a data warehouse model to support university managerial decisions.

A real-world pharmacovigilance study of Sorafenib based on the FDA Adverse Event Reporting System

AimsThe primary objective of this study was to closely monitor and identify adverse events (AEs) associated with Sorafenib, a pharmacological therapeutic agent used to treat hepatocellular carcinoma, renal cell carcinoma, and thyroid cancer. The ultimate goal was to optimize patient safety and provide evidence-based guidance for the appropriate use of this drug.MethodsReports from the FDA Adverse Event Reporting System (FAERS) database were comprehensively collected and analyzed, covering the first quarter of 2004 to the first quarter of 2024. Disproportionality analysis was performed using robust algorithms for effective data mining to quantify the signals associated with Sorafenib-related AEs.ResultsIn total, we identifued 18,624 patients (82,857 AEs in the Sorafenib population) from the collected reports and examined, the occurrence of Sorafenib-induced AEs in 26 organ systems. The study results revealed the presence of the expected AEs, including Diarrhoea, Palmar-plantar erythrodysaesthesia syndrome, Hepatocellular carcinoma, Fatigue, and Rash, which was consistent with the information provided in the drug insert. In addition, unexpected significant AEs, such as Gait inability, Palmoplantar keratoderma and Hyperkeratosis were observed at the preferred term (PT) level. These findings suggest the potential occurrence of adverse reactions not currently documented in drug descriptions.ConclusionThis study successfully detected new and unforeseen signals associated with Sorafenib-related AEs related to Sorafenib administration, providing important insights into the complex correlations between AEs and Sorafenib use. The results of this study emphasize the critical importance of continuous and vigilant surveillance for the timely identification and effective management of AEs to improve the overall patient safety and wellbeing in the context of Sorafenib therapy.

Patterns of Use of β-2 Agonists, Steroids, and Mucoactive Medications to Treat Bronchiolitis in the PICU: U.S. Pediatric Health Information System 2009-2022 Database Study.

Describe β2-agonists, steroids, hypertonic saline (HTS), n-acetylcysteine (NAC), and dornase alfa (DA) use to treat bronchiolitis, factors associated with use, and associations between use and PICU length of stay (LOS). Retrospective, multicenter cohort study. PICUs in the Pediatric Health Information System database. PICU admitted children 24 months young or younger with bronchiolitis. None. We analyzed 47,520 hospitalizations between July 1, 2018, and June 30, 2022. We calculated the rate of medication use overall and the median (range) rate for each hospital: β2-agonist (24,984/47,520 [52.6%]; median hospital, 51.7% [21.4-81.7%]), steroid (15,878/47,520 [33.4%]; median hospital, 33.4% [6.0-54.8%]), HTS (7,041/47,520 [14.8%]; median hospital, 10.5% [0-66.1%]), NAC (1,571/47,520 [3.3%]; median hospital, 0.8% [0-22.0%], and DA (840/47,520 [1.8%]; median hospital, 1.4% [0-13.6%]). Logistic regression using generalized estimating equations (GEEs) identified associations between concurrent asthma and β2-agonist (adjusted odds ratio [aOR], 8.68; 95% CI, 7.08-10.65; p < 0.001) and steroid (aOR, 10.10; 95% CI, 8.84-11.53; p < 0.001) use. Mechanical ventilation was associated with all medications: β2-agonists (aOR, 1.79; 95% CI, 1.57-2.04; p < 0.001), steroids (aOR, 2.33; 95% CI, 1.69-3.21; p < 0.001), HTS (aOR, 1.82; 95% CI, 1.47-2.25; p < 0.001), NAC (aOR, 3.29; 95% CI, 2.15-5.03; p < 0.001), and DA (aOR, 7.65; 95% CI, 4.30-13.61; p < 0.001). No medication was associated with decreased PICU LOS. To assess changes in medication use over time and associations with the 2014 American Academy of Pediatrics bronchiolitis guidelines, we expanded our analysis to 83,820 hospitalizations between July 1, 2009, and June 30, 2022. Logistic regression with GEEs found no change in β2-agonist use; steroid use increased after guideline publication (aOR, 1.05; 95% CI, 1.01-1.10; p = 0.02), HTS use changed from increasing prior to the guidelines (aOR, 1.32; 95% CI, 1.11-1.56; p = 0.001) to stable since guideline publication (aOR, 0.93; 95% CI, 0.81-1.07; p = 0.33). β2-agonists, steroids, and HTS are commonly, but variably used for PICU bronchiolitis treatment. Medication use appears relatively stable over the last decade.

System of Monitoring the Financial Activity of the Enterprise

Monitoring of financial activity is one of the key functions of enterprise management, because it, in particular, ensures control of current costs and income; contributes to the analysis of the financial state of the enterprise; supports planning of future financial flows. The purpose of the article is the research of information systems for monitoring the financial activity of enterprises, the identification of problems of financial activity, the analysis of the ways of using the appropriate software and the development of the system for monitoring the financial activity of enterprises. The research methods are the main methodological approaches and technological tools for the development of financial monitoring systems. Such methods, in particular, are: systematic and comparative analyzes – to identify the peculiarities of the creation of systems for monitoring the financial activity of enterprises; the method of expert assessments, which involves the analysis of literary sources and information resources, conducting interviews and surveys of experts, as well as the processes of development and testing of scalable and high-performance financial monitoring systems. The novelty of the research is the creation of a complex system for monitoring financial activity, which includes an intuitive interface, a flexible database and the ability to generate various reports, giving users the opportunity to effectively manage their financial data, simplifying the process of entering, editing and analyzing information through the use of a stack of modern technologies. The conclusion of the research carried out in the article is that the work was: identified the main problems of monitoring the financial activity of enterprises, which are solved with the help of modern financial monitoring systems; an analysis of existing software solutions was carried out; the advantages and disadvantages of the existing software for monitoring the financial activities of enterprises were analyzed; the main so-called «bottlenecks» of the automation of financial monitoring, which need to be solved, have been identified. On the basis of the conducted analysis, an author’s system for monitoring the company’s financial activity was developed, focused on ease of use and efficiency of financial data management. The development of the software of the author’s system included: the selection of the appropriate technological stack; system architecture development; implementation of basic functional modules (for example, such as transaction management, categories and reports); system database development; system interface development. The results of the conducted research open up new opportunities for improving financial management and making informed decisions based on the received data.

Red blood cell transfusion and the use of intravenous iron in iron‐deficient patients presenting to the emergency department

AbstractBackground and aimsRed blood cell transfusions are often used to treat iron‐deficient patients in the emergency department (ED), while treatment with intravenous (IV) iron is preferred, as it increases hemoglobin concentration rapidly and durably. We aim to evaluate the incidence of iron deficiency anemia, frequency of blood transfusion and iron supplementation, and factors associated with blood transfusion in the ED.MethodsWe conducted a retrospective cohort study of adult patients presenting to the St. Boniface Hospital (Winnipeg, Canada) ED from 2014 to 2018. Electronic data obtained from the Emergency Department Information System and Laboratory Information Services databases identified patients presenting with iron deficiency anemia, defined as microcytic (mean corpuscular volume &lt; 75 fL) anemia (hemoglobin &lt; 120 g/L) with either a transferrin saturation &lt;20% or ferritin &lt; 30 µmol/L. Ferritin &gt; 100 µmol excluded iron deficiency anemia. The use of blood transfusions or iron supplementation was determined for each patient. Factors associated with blood transfusion were determined using logistic regression analyses.ResultsOf 39,222 patients, 17,945 (45%) were anemic. In anemic patients, iron parameters were ordered in 1848 (10.3%) and iron deficiency anemia was diagnosed in 910 (5.1%). Ninety‐five patients (10.4%) received one red blood cell unit, and 197 patients (21.6%) received ≥2 units. Oral iron and IV iron were prescribed for 64 (7.0%) and 14 (1.5%) patients, respectively. Hemoglobin concentration was the main determinant for treatment with blood transfusion.ConclusionsIron deficiency is underinvestigated among anemic patients presenting to the ED. The only clinical factor associated with red blood cell transfusion in the ED was hemoglobin level, irrespective of symptoms or clinical stability.

Investigation on Phytochemicals and Nutritional Values of Three Passion Fruit Species Planted in Lam Dong Plateau

This study comprehensively evaluated and compared the nutrient contents, total phenolic content, total flavonoid content, antioxidant activity, and anti-nutritional factors of three passion fruit species, namely purple passion fruit (Passiflora edulis f. edulis), yellow passion fruit (&lt;i&gt;Passiflora edulis&lt;/i&gt; var. flavicarpa), and sweet granadilla fruit (&lt;i&gt;Passiflora ligularis&lt;/i&gt;). The passion fruit samples were collected from various gardens throughout the Lam Dong plateau - Vietnam. The analyses were performed as per standard test methods. &lt;i&gt;Passiflora edulis&lt;/i&gt; f. edulis had high contents of carbohydrates, fat, vitamin K1, potassium, phosphorus, and iodine whereas &lt;i&gt;Passiflora edulis&lt;/i&gt; var. flavicarpa was rich in carbohydrates and vitamins group B including B3, B6, and B9. &lt;i&gt;Passiflora ligularis&lt;/i&gt;, on the contrary, primarily provided essential nutrients of protein, vitamins A, and C, and minerals including sodium, potassium, calcium, magnesium, and iron. All three studied passion fruit species generally possessed moderate values of phenolics, flavonoids, and antioxidants; the same pattern was also observed with antinutrients as all three studied passion fruit species were found to contain low concentrations of phytate, tannin, and oxalate. These findings scientifically contribute to the food database system and can be exploited for diet planning.

Mining and analysis of adverse event signals of trastuzumab deruxtecan via real-world data of FDA adverse event reporting system database from 2019 to 2023

ABSTRACT Background Trastuzumab deruxtecan (T-DXd) is a novel generation antibody-drug conjugate. However, current evidence for the safety of T-DXd is mostly limited to clinical trials. It resulted in inability to timely update the adverse event (AE) for drug. Therefore, we mine and analyze AE signals caused by T-DXd based on the FAERS database, and to provide reference for the safe use of drug in clinical practice and reduce the occurrence of AE. Research design and methods This study analyzed real-world data on AEs associated with T-DXd reported in the FAERS database from December 2019 to December 2023, and the reporting odds ratio, proportional report ratio, bayesian confidence propagation neural network and multi-item gamma Poisson shrinker methods were combined to identify and evaluate reports, which can reduce the number of false positive and false negative signals with good sensitivity. Results A total of 4651 AE reports of T-DXd as the ‘primary suspect’ were collected. The median time to onset of T-DXd -related AEs was 25 days. The proportion of serious AEs was 69.40%. Hospitalization (25.67%) and death (24.19%) accounted for the highest occurrence frequency of clinical serious outcomes. The top three AE in both occurrence frequency and signal intensity were interstitial lung disease. We also found twelve kinds of potential novel danger signals not recorded in the drug lable, such as ascites, sepsis, pneumocystis jirovecii pneumonia, and gastroenteritis listeria, which need further attention and verification in clinical practice. Conclusion The results of this study indicate the importance of timely mining and updating information of adverse drug reactions. Drug evaluation should be performed well before using T-DXd, and during treatment, the indexes of pulmonary, bone marrow hematopoietic and cardiac function should be closely monitored, timely intervention measures should be taken to avoid related injury caused by AEs.

Thromboembolic events associated with combined oral contraceptives: a real-world study based on the FDA adverse event reporting system (FAERS) database

ABSTRACT Background The clinical characteristics and time-to-onset of thromboembolic events (TEEs) associated with combined oral contraceptives (COCs) remain unclear, our current study was committed to providing more data for risk evaluation and management of COCs treatment. Research design and methods This pharmacovigilance study was conducted in the FAERS database. We evaluated significant pharmacovigilance signals by using disproportionality analysis. The Weibull shape parameter test was used to analyze the time-to-onset of TEEs. Results A total of 25,080 adverse events were involved in this study. Overall COCs were significantly related to venous thromboembolism (VTE) events. Levonorgestrel, desogestrel, and drospirenone containing COCs were significantly associated with arterial thromboembolism (ATE) besides norethisterone containing COCs. Drospirenone containing COCs associated with TEEs had the highest reporting frequencies (n = 22868, 91.18%). The most-mentioned PT was pulmonary embolism (n = 9244, 36.86%). The median time-to-onset of all TEEs was 264 days, the median time-to-onset of VTE was 258.0 days, shorter than ATE (344.0 days). The Weibull shape parameter test results showed that all of the disproportionality signals had early failure-type features. Conclusions This study found an increased risk of TEEs treated with COCs, particularly with drospirenone. We should pay close attention to risk monitor on the treatment of early stages.

Safety assessment of tafamidis: a real-world adverse event analysis from the FAERS database

ABSTRACT Background Tafamidis emerged as the first FDA-approved drug for treating termed amyloid fibrils. This study aims to analyze adverse events (AEs) related to tafamidis from the second quarter (Q2) of 2019 to the fourth quarter (Q4) of 2023 from the FDA adverse event reporting system (FAERS) database. Research design and methods The AE data related to tafamidis from 2019 Q2 to 2023 Q4 were collected and standardized. Various signal quantification techniques, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker, were employed for analysis. Results Among the 8742 AE reports with tafamidis as the primary suspected drug, 180 preferred terms of AEs spanning 27 different system organ classes were identified. Unique adverse events to tafamidis included renal and urinary disorders and ear and labyrinth disorders, with not mentioned in the official drug label. Additionally, uncommon but significantly strong AE signals, such as blood culture positive and acquired hemophilia, were observed. Common AEs with relatively high occurrence rates included death, off-label use, fall, hypoacusis, and dysphagia. Conclusion These findings offer valuable insights for optimizing the use of tafamidis and reducing potential side effects, thereby facilitating its safe use in clinical settings.

Clarifying the Actual Situation of Old-Old Adults with Unknown Health Conditions and Those Indifferent to Health Using the National Health Insurance Database (KDB) System

Background/Objectives: This study aimed to investigate the actual situation of individuals with unknown health conditions (UHCs) and those indifferent to health (IH) among old-old adults (OOAs) aged 75 years and above using the National Health Insurance Database (KDB) system. Methods: A total of 102 individuals with no history of medical examinations were selected from the KDB system in a city in Japan. Data were collected through home visit interviews and blood pressure monitors distributed by public health nurses (PHNs) from Community Comprehensive Support Centers (CCSCs). The collected data included personal attributes, health concern levels, and responses to a 15-item OOA questionnaire. Semi-structured interviews were conducted with seven PHNs. The control group consisted of 76 users of the “Kayoinoba” service (Kayoinoba users: KUs). Results: Of the 83 individuals who could be interviewed, 50 (49.0%) were classified as UHCs and 11 (10.8%) were classified as IH, including 5 from the low health concern group and 6 who refused to participate. In the word cloud generated from the PHNs’ interviews, the words and phrases “community welfare commissioner”, “community development”, “blood pressure monitor”, “troublesome”, “suspicious”, and “young” were highlighted. In the comparison of health assessments between UHCs and KUs, “body weight loss” and “cognitive function” were more prevalent among KUs, and “smoking” and “social participation” were more prevalent among UHCs. Conclusions: The home visit activities of CCSCs utilizing the KDB system may contribute to an understanding of the actual situation of UHCs, including IHs, among OOAs. UHCs (including patients with IH status) had a higher proportion of risk factors related to smoking and lower social participation than KUs.

Failed/difficult Intubation comparing between pre-COVID-19 and COVID-19 pandemic period using a national insurance claims database and information system of a university hospital

IntroductionEndotracheal intubation can be difficult or even fail under certain patient and anaesthesiologist conditions. During the COVID-19 pandemic a country-wide lockdown policy was enforced in Thailand which stipulated that anaesthesiologists wear personal protective equipment, powered air purifying respirator, or goggles and surgical/N95 mask during the intubation procedure. Thus, an anaesthesiologist’s vision is restricted and grip on the equipment less sure. Under these conditions, the incidence of difficult intubation was expected to increase.MethodsThis time-series study was based on the aggregated age- and sex-standardized monthly incidence of difficult intubation among all intubated patients whose data were recorded in the national insurance claims database and among patients recorded in the records of a university hospital from January 2018 to September 2022. Changes in incidence of difficult intubation following the implementation of a lockdown policy from 26 March 2020 during the COVID-19 pandemic were explored using negative binomial regression and interrupted linear regression time-series analysis.ResultsData of 922,274 individuals in the national database and 95,457 individuals in the university database were retrieved. The overall incidence of difficult intubation in both settings dropped by 25% following lockdown, significantly so in the national database (p < 0.001). At the point of interruption, a significant drop in level was evident in the national data (of 1.682 per thousand per month, P = 0.003) and a non-significant drop at the university level (of 1.118 per thousand per month, P = 0.304).DiscussionThe decreased incidence of difficult intubation during the lockdown period was contrary to expectation but might be related to the deployment solely of anaesthesiologists and more experienced anaesthetic staff using videolaryngoscopes during lockdown following the recommendation for intubation during respiratory disease pandemics.