Expert Opinion on Drug Safety最新文献_第9页

Drug-Induced Thrombocytopenia Severity and Toxicity (DITPst): binary classification of drugs by human thrombocytopenia toxicity.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-02 DOI: 10.1080/14740338.2025.2460439

Xiaolu Nie, Fang Hu, Xiaoling Cheng, Jingyao Ma, Xiaoxia Peng, Feng Sun, Xin Ni, Siyan Zhan

{"title":"Drug-Induced Thrombocytopenia Severity and Toxicity (DITPst): binary classification of drugs by human thrombocytopenia toxicity.","authors":"Xiaolu Nie, Fang Hu, Xiaoling Cheng, Jingyao Ma, Xiaoxia Peng, Feng Sun, Xin Ni, Siyan Zhan","doi":"10.1080/14740338.2025.2460439","DOIUrl":"10.1080/14740338.2025.2460439","url":null,"abstract":"Background: Drug-induced thrombocytopenia (DITP) often occurs in patients during clinical treatment. However, clinicians usually fail to distinguish which drugs can be plausible culprits accurately. We aimed to develop a large comprehensive drug benchmark database with DITP toxicity using the recommended method by FDA.Research design and methods: We collected information from six databases that involved drug labeling information, literature, safety signal mining and laboratory testing to generate the annotated drug list with DITP toxicity. Then, we descripted the DITP positive-negative distribution based on the Anatomical Therapeutic Chemical (ATC) coding system; hotspot analysis was conducted to identify therapeutic categories of drugs within each organ system that warrant attention regarding DITP.Results: The DITPst database comprised 1,765 drugs, of which 858 were DITP-positives, whereas 907 were negatives. The investigation of distribution across various therapeutic categories revealed the most frequent DITP-positive categories were immunostimulants (10/11), anti-inflammatory, and antirheumatic products (28/32), and antibacterials for systemic use (102/121). On the contrary, the least frequent DITP-positive therapeutic categories were diagnostic radiopharmaceuticals (12/12), pituitary and hypothalamic hormones and analogues (17/18), and drugs for constipation (16/17).Conclusions: We consider the DITPst benchmark database to be an invaluable resource for the community to improve DITP safety research and drug development.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2025-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143058462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Drug-induced nasal septum perforation: a disproportionality analysis of the FDA adverse event reporting system database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-02 DOI: 10.1080/14740338.2025.2460448

Chubo Xie, Yi Cui, Suizi Zhou, Fang Sun, Zhilin Jiang, Keshuang Wang, Yitong Liu, Yuewu Wang, Qianhui Qiu

{"title":"Drug-induced nasal septum perforation: a disproportionality analysis of the FDA adverse event reporting system database.","authors":"Chubo Xie, Yi Cui, Suizi Zhou, Fang Sun, Zhilin Jiang, Keshuang Wang, Yitong Liu, Yuewu Wang, Qianhui Qiu","doi":"10.1080/14740338.2025.2460448","DOIUrl":"10.1080/14740338.2025.2460448","url":null,"abstract":"Background: Nasal septum perforation represents a significant clinical concern, with limited investigations into the role of medications in its etiology. This study utilizes the FDA Adverse Event Reporting System (FAERS) database to identify the drugs associated with nasal septum perforation and assess their risk.Research design and methods: This retrospective pharmacovigilance study analyzed drug-induced nasal septum perforation data from January 2004 to December 2023. Disproportionality analysis using reporting odds ratio (ROR) assessed drug associations with nasal septum perforation.Results: For 552 identified cases, the most commonly reported drugs were bevacizumab (n = 56), fluticasone propionate (n = 50), methotrexate (n = 34), hydrocodone and acetaminophen (n = 22), and paclitaxel (n = 17). Twenty-six drugs showed positive risk signals, with the top five being azelastine hydrochloride and fluticasone propionate (ROR = 173.82), beclomethasone dipropionate (ROR = 90.91), oxymetazoline (ROR = 53.77), desmopressin (ROR = 51.43), and leucovorin (ROR = 42.83). Intriguingly, 18 of these drugs did not list nasal septum perforation as a known side effect.Conclusion: This study provides a comprehensive overview of drug-induced nasal septum perforation from a pharmacovigilance perspective, highlighting the need for further research to clarify these associations and update drug safety information to reduce patient risk.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-02 DOI: 10.1080/14740338.2025.2461203

Hehe Bai, Jinping Wang, Xiaojing Nie, Huan Li, Li Ma, Xiaonian Han, Lirong Peng

{"title":"Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database.","authors":"Hehe Bai, Jinping Wang, Xiaojing Nie, Huan Li, Li Ma, Xiaonian Han, Lirong Peng","doi":"10.1080/14740338.2025.2461203","DOIUrl":"10.1080/14740338.2025.2461203","url":null,"abstract":"Objective: The FDA Adverse Event Reporting System (FAERS) was used to evaluate the associations between oral anticoagulants (OACs) and acute kidney injury (AKI).Methods: Disproportionality analysis was applied to data in the FAERS database from January 2004 to December 2023 to detect adverse events (AEs) for various OACs. The adjusted reporting odds ratios (RORs) calculated using multiple logistic regression were used to explore the risk factors for OACs-associated AKI.Results: The crude RORs for the associations of AKI with warfarin, rivaroxaban, dabigatran, apixaban, and edoxaban were 1.35, 2.14, 2.98, 1.33, and 3.56, respectively. The risk of OACs-associated AKI was affected by age and sex, being higher in those aged 65 years and males. The adjusted RORs for rivaroxaban, dabigatran, apixaban, and edoxaban were 1.26, 1.67, 0.65, and 2.06, respectively.Nearly 50% of AKI cases occurred within the first 2 months, and each OAC was of the early-failure type. Hospitalization and mortality rates for AKI patients after OACs were 45.53% and 22.98%, respectively.Conclusions: The study revealed a strong association between AKI and OACs, emphasizing the need for regular renal function monitoring , especially in elderly male patients. Further in-depth research is needed to confirm these exploratory findings.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Congenital anomalies associated with the use of cardiovascular drugs during pregnancy: a large-scale data analysis from the FAERS database. 与妊娠期间使用心血管药物相关的先天性异常：来自FAERS数据库的大规模数据分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-01 Epub Date: 2024-12-18 DOI: 10.1080/14740338.2024.2442519

Jingping Zheng, Lin Ma, Zhenpo Zhang, Yankun Liang, Chufeng Din, Qimin Wu, Yuting Wang, Jian Tan, Ling Su

{"title":"Congenital anomalies associated with the use of cardiovascular drugs during pregnancy: a large-scale data analysis from the FAERS database.","authors":"Jingping Zheng, Lin Ma, Zhenpo Zhang, Yankun Liang, Chufeng Din, Qimin Wu, Yuting Wang, Jian Tan, Ling Su","doi":"10.1080/14740338.2024.2442519","DOIUrl":"10.1080/14740338.2024.2442519","url":null,"abstract":"Background: Cardiovascular drugs can cross the placenta during pregnancy, potentially exposing the fetus to teratogenic effects. However, ethical constraints on clinical trials with pregnant women limit safety data and result in inadequate drug labeling.Research design and methods: Using the FAERS database (2004-2023), we conducted a retrospective pharmacovigilance study analyzing adverse event reports involving congenital anomalies in newborns (<28 days). Signal detection methods included Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Our analysis concentrated on the systems or organs involved in the signals, particularly those with higher report counts or signal values, to explore the association between drugs and congenital abnormalities.Results: Among 6,208 cases of congenital anomalies in newborns, 387 were linked to cardiovascular drugs, generating 97 signals for 16 drugs. Strong signals included sartans (renal failure, skeletal deformity), metoprolol (hypospadias, large-for-dates baby), amlodipine (gastrointestinal malformations), and statins, furosemide, and spironolactone (dysmorphism).Conclusions: Enhanced monitoring is recommended for fetal malformations in women exposed to these drugs before or during pregnancy. While our findings suggest associations, they do not establish causality, highlighting the need for further research to ensure medication safety during pregnancy.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"193-199"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Abrocitinib-associated adverse events: a real-world pharmacovigilance study using the FAERS database. 阿罗西替尼相关不良事件：使用 FAERS 数据库进行的真实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-01 Epub Date: 2024-05-16 DOI: 10.1080/14740338.2024.2355336

Yu Sun, Tao Xu, Suyan Zhu, Hongbin Xu

{"title":"Abrocitinib-associated adverse events: a real-world pharmacovigilance study using the FAERS database.","authors":"Yu Sun, Tao Xu, Suyan Zhu, Hongbin Xu","doi":"10.1080/14740338.2024.2355336","DOIUrl":"10.1080/14740338.2024.2355336","url":null,"abstract":"Background: Atopic dermatitis (AD) is a common chronic inflammatory skin disease. Janus kinase (JAK) modulates cytokines involved in AD pathophysiology, and JAK inhibitors have emerged as effective pharmacotherapeutic remedies for AD. Abrocitinib, an oral selective inhibitor of JAK1, is indicated for the management of moderate-to-severe AD. The current study evaluated the adverse events (AEs) associated with abrocitinib in a real-world setting.Methods: To quantify the signals of abrocitinib-associated AEs, we used the US Food and Drug Administration Adverse Event Reporting System (FAERS) for this pharmacovigilance study with two established pharmacovigilance methods.Results: A total of 1071 AEs of abrocitinib were investigated as the primary suspected from the FAERS to detect and characterize relevant safety signals. The analysis revealed 85 signals for abrocitinib. The most common AE for abrocitinib was drug ineffective. The signal strength of eczema herpeticum was 515.87 (277.80-957.98) and 510.59 (5148.65) and exhibited the highest strength for abrocitinib. Rare AEs such as aggravated condition, pruritus, and hypersensitivity were not listed on the label, and attention to these AEs is required.Conclusion: The analysis of the AE signals may provide support for clinical monitoring and risk identification of abrocitinib.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"233-239"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140916066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Serious adverse effects of selected antiseizure medications used for treatment of focal onset seizures. 用于治疗局灶性癫痫发作的抗癫痫药物的严重不良反应。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-01 Epub Date: 2024-12-25 DOI: 10.1080/14740338.2024.2446416

Miloš Milosavljević, Slobodan M Janković

{"title":"Serious adverse effects of selected antiseizure medications used for treatment of focal onset seizures.","authors":"Miloš Milosavljević, Slobodan M Janković","doi":"10.1080/14740338.2024.2446416","DOIUrl":"10.1080/14740338.2024.2446416","url":null,"abstract":"Introduction: The third-generation antiseizure medications used for the treatment of focal seizures, lacosamide, eslicarbazepine acetate, perampanel, brivaracetam, and cenobamate, may elicit serious adverse reactions which could be preventable if a prescriber is acquainted with the risk factors.Areas covered: The literature search was conducted in MEDLINE, SCOPUS, and EBSCO databases, without time and language restrictions. Only clinical studies, observational human studies, case reports, and case series that reported serious adverse drug reactions and risk factors were considered.Expert opinion: In order to prevent psychiatric side effects, the use of these drugs in patients with psychiatric disorders in the past should be avoided, or intensive monitoring of patients should be undertaken in order to detect psychosis or depression as early as possible. When prescribed eslicarbazepine and perampanel, serum sodium and ammonia levels should be periodically monitored. Lacosamide is associated with rhythm and conduction disturbances in the myocardium, so caution and ECG monitoring are required in people with cardiac diseases. Eslicarbazepine, cenobamate, and lacosamide can cause Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome and other allergic manifestations, so they should be used with caution in people with allergies in medical history.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"129-143"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effect of chloroquine pre-treatment on the metoclopramide's pharmacokinetics after their co-administration. 氯喹预处理对联合用药后甲氧氯普胺药代动力学的影响

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-01 Epub Date: 2024-08-08 DOI: 10.1080/14740338.2024.2387312

Badriyah Shadid Alotaibi, Iram Kaukab, Syed Nisar Hussain Shah, Zelal Kharaba, Abdul Rafay Naeem, Haya Yasin, Muhammad Ihtisham Umar, Ghulam Murtaza

{"title":"Effect of chloroquine pre-treatment on the metoclopramide's pharmacokinetics after their co-administration.","authors":"Badriyah Shadid Alotaibi, Iram Kaukab, Syed Nisar Hussain Shah, Zelal Kharaba, Abdul Rafay Naeem, Haya Yasin, Muhammad Ihtisham Umar, Ghulam Murtaza","doi":"10.1080/14740338.2024.2387312","DOIUrl":"10.1080/14740338.2024.2387312","url":null,"abstract":"Background: This study evaluated the pharmacokinetic interactions of orally administered chloroquine and metoclopramide.Methods: The study employed a randomized and two-phase cross-over design with 4-week washout plan. Twelve healthy male volunteers were shortlisted according to the set criteria and were administered with metoclopramide 10 mg PO and chloroquine (a total of 1500 mg) at different intervals which were (500 mg at 0, 6, and 24 h). The concentration of chloroquine and metoclopramide in the blood samples was estimated using a validated HPLC-UV technique to affirm the maximum concentration (Cmax), time to reach Cmax (Tmax), and area under the curve (AUC).Results: Cmax, T1/2, and AUC of metoclopramide were increased up to 20, 10, and 47.8%, respectively, by the concomitantly administering Chloroquine. Chloroquine-treated phase showed increased values of Cmax (ng/ml), AUC (ng.h/ml), and T½ (h), i.e. 41.35 ± 1.61, 504.12 ± 66.25, and 5.72 ± 2.63, as compared to that reference phase i.e. 34.52 ± 4.92, 341.14 ± 112.8, and 5.19 ± 1.14, respectively.Conclusions: Chloroquine was found to attenuate CYP2D6 activity in healthy Pakistani male volunteers. Hence, patients that are prescribed with metoclopramide or other CYP2D6-substrate drugs require a dose adjustment when administered with chloroquine.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"213-219"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-01 DOI: 10.1080/14740338.2025.2460435

Zenan Meng, Xinzhi Li, Yue Liao, Feng Feng, Tingting Wang

{"title":"Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System.","authors":"Zenan Meng, Xinzhi Li, Yue Liao, Feng Feng, Tingting Wang","doi":"10.1080/14740338.2025.2460435","DOIUrl":"10.1080/14740338.2025.2460435","url":null,"abstract":"Background: Brivaracetam (BRV) is a novel drug for the treatment of epilepsy. This study aimed to detect and characterize adverse events (AEs) associated with BRV from the first quarter of 2016 to the second quarter of 2024 using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.Research design and methods: We utilized disproportionality analysis methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), to assess the associations between reported AEs and BRV usage in the FAERS data.Results: A total of 1,781 adverse event reports were analyzed, with Brivaracetam as the primary suspected drug. We identified 13 positive system organ classes (SOCs) and 78 positive preferred term signals (PTs), with a particular focus on nervous system disorders, psychiatric disorders, and injury, poisoning, and procedural complications. Exposures related to injury, poisoning, and procedural complications during pregnancy and lactation showed positive signals, including exposure before pregnancy, during breastfeeding, and during pregnancy. These exposures warrant significant attention.Conclusions: Based on the FAERS database, we conducted a comprehensive analysis of AEs associated with BRV. This study aims to provide guidance for the clinical application of BRV in epilepsy treatment, thereby improving its safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Unraveling the safety and efficacy of semaglutide for people living with HIV and metabolic co-morbidities. 揭示西马鲁肽对艾滋病毒和代谢合并症患者的安全性和有效性。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-01 Epub Date: 2024-11-28 DOI: 10.1080/14740338.2024.2435426

Dimitrios Patoulias, Paschalis Karakasis, Ieva Ruža, Mohamed El-Tanani, Manfredi Rizzo

引用次数: 0

Post-marketing safety of pimavanserin: a real-world pharmacovigilance study based on the FDA adverse event reporting system (FAERS).

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-01 DOI: 10.1080/14740338.2025.2460444

Dong Liu, Xueni Zhang, Haiyan Xu

{"title":"Post-marketing safety of pimavanserin: a real-world pharmacovigilance study based on the FDA adverse event reporting system (FAERS).","authors":"Dong Liu, Xueni Zhang, Haiyan Xu","doi":"10.1080/14740338.2025.2460444","DOIUrl":"10.1080/14740338.2025.2460444","url":null,"abstract":"Background: Pimavanserin is a new non-dopamine neurotransmitter antipsychotic drug. This study aimed to conduct a post-marketing pharmacovigilance study of pimavanserin, through data mining technology using the FDA Adverse Event Reporting System (FAERS) database.Research design and methods: We analyzed adverse event reports for patients using pimavanserin. Data were classified using systematic organ classification (SOC) and preferred term (PT) of the Medical Dictionary for Regular Activities (MedDRA). Four signal algorithms [reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma poisson shrinker (MGPS), and bayesian confidence propagation neural network (BCPNN)] were used to detect positive signals, and the median time-to-onset was determined.Results: Adverse drug events (ADEs) related to pimavanserin (n = 31,852) were analyzed, exhibiting an annual linear upward trend (p = 0.027). The ADEs involved 27 SOCs, but only 'Psychiatric disorders' simultaneously satisfied four algorithms. Overall, 153 PTs simultaneously satisfied four algorithms. Subgroup analysis of differences in the top 30 signal intensity PTs according to sex yielded significant results for seven PTs (p < 0.05). The median time-to-onset was 97 days, the highest proportion occurred within the first 30 days (31.79%).Conclusions: Some new PT signals not listed in the label were identified, and some PT signals showed differences according to sex.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0