cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.28015201
title: A real-world disproportionality analysis of colchicine: data mining of the public version of FDA Adverse Event Reporting System

description: Colchicine is widely used for gout and familial Mediterranean fever (FMF) and has cardiovascular benefits. However, it is linked to various adverse drug reactions (ADRs). This study aimed to analyze colchicine-related ADRs using FAERS data for safer clinical use. FAERS data from April 2005 to March 2024 were analyzed using ROR, PRR, BCPNN, and EBGM algorithms. ADRs were categorized by System Organ Classes (SOCs) and Preferred Terms (PTs). A total of 2,435 colchicine-related ADRs were identified. The most significant SOCs were Injury, poisoning, and procedural complications (<i>n</i> = 1,197, EBGM05 = 6.59) and Gastrointestinal disorders (<i>n</i> = 817, EBGM05 = 7.34). At the PT level, notable ADRs included Neuromyopathy (<i>n</i> = 27, EBGM05 = 153.12), Toxic cardiomyopathy (<i>n</i> = 8, EBGM05 = 138.58), and Spur cell anemia (<i>n</i> = 3, EBGM05 = 88.06). New signals at the PT level, including Necrotizing myositis (<i>n</i> = 6, EBGM05 = 31.22) and Septic arthritis staphylococcal (<i>n</i> = 3, EBGM05 = 28.94), were detected. Continuous monitoring is essential to detect established and emerging ADRs. These findings enhance understanding of colchicine’s safety profile, with further research needed to validate these signals.
DOI: 10.6084/m9.figshare.28015201.v2
title: A real-world disproportionality analysis of colchicine: data mining of the public version of FDA Adverse Event Reporting System

description: Colchicine is widely used for gout and familial Mediterranean fever (FMF) and has cardiovascular benefits. However, it is linked to various adverse drug reactions (ADRs). This study aimed to analyze colchicine-related ADRs using FAERS data for safer clinical use. FAERS data from April 2005 to March 2024 were analyzed using ROR, PRR, BCPNN, and EBGM algorithms. ADRs were categorized by System Organ Classes (SOCs) and Preferred Terms (PTs). A total of 2,435 colchicine-related ADRs were identified. The most significant SOCs were Injury, poisoning, and procedural complications (<i>n</i> = 1,197, EBGM05 = 6.59) and Gastrointestinal disorders (<i>n</i> = 817, EBGM05 = 7.34). At the PT level, notable ADRs included Neuromyopathy (<i>n</i> = 27, EBGM05 = 153.12), Toxic cardiomyopathy (<i>n</i> = 8, EBGM05 = 138.58), and Spur cell anemia (<i>n</i> = 3, EBGM05 = 88.06). New signals at the PT level, including Necrotizing myositis (<i>n</i> = 6, EBGM05 = 31.22) and Septic arthritis staphylococcal (<i>n</i> = 3, EBGM05 = 28.94), were detected. Continuous monitoring is essential to detect established and emerging ADRs. These findings enhance understanding of colchicine’s safety profile, with further research needed to validate these signals.
DOI: 10.6084/m9.figshare.28015201.v1
title: A real-world disproportionality analysis of colchicine: data mining of the public version of FDA adverse event reporting system

description: Colchicine is widely used for gout and familial Mediterranean fever (FMF) and has cardiovascular benefits. However, it is linked to various adverse drug reactions (ADRs). This study aimed to analyze colchicine-related ADRs using FAERS data for safer clinical use. FAERS data from April 2005 to March 2024 were analyzed using ROR, PRR, BCPNN, and EBGM algorithms. ADRs were categorized by System Organ Classes (SOCs) and Preferred Terms (PTs). A total of 2,435 colchicine-related ADRs were identified. The most significant SOCs were Injury, poisoning, and procedural complications (<i>n</i> = 1,197, EBGM05 = 6.59) and Gastrointestinal disorders (<i>n</i> = 817, EBGM05 = 7.34). At the PT level, notable ADRs included Neuromyopathy (<i>n</i> = 27, EBGM05 = 153.12), Toxic cardiomyopathy (<i>n</i> = 8, EBGM05 = 138.58), and Spur cell anemia (<i>n</i> = 3, EBGM05 = 88.06). New signals at the PT level, including Necrotizing myositis (<i>n</i> = 6, EBGM05 = 31.22) and Septic arthritis staphylococcal (<i>n</i> = 3, EBGM05 = 28.94), were detected. Continuous monitoring is essential to detect established and emerging ADRs. These findings enhance understanding of colchicine’s safety profile, with further research needed to validate these signals.
DOI: 10.6084/m9.figshare.28747547.v1
title: Cardiovascular adverse events associated with EGFR and HER2 dual TKIs: a pharmacovigilance study based on the FAERS database

description: EGFR and HER2 dual TKIs have been approved for the treatment of advanced breast cancer in patients who are HER2-positive for second and/or third-line treatment. However, there is a lack of attention to the cardiovascular adverse events (AEs) caused by EGFR and HER2 dual TKIs. We analyzed data spanning between March 2007 and June 2024 using the FAERS database and the reporting odds ratio, proportional reporting ratio, and Bayesian confidence propagation neural network to perform disproportionality analysis. Compared with non-cardiovascular AEs, cardiovascular AEs were associated with more severe clinical outcomes, such as higher rates of hospitalization, life-threatening events, disability, and death. Our analysis revealed that lapatinib had a higher-than-expected reporting rate for three SMQs, including cardiac failure, embolic and thrombotic events, and cardiomyopathy. No significant cardiovascular signals were observed for neratinib. Disproportionality analysis results revealed a positive signal for cardiac failure, embolic and thrombotic events, and cardiomyopathy of lapatinib, and no positive signal for neratinib. We should pay attention to high-risk signals in clinical practice and monitor them appropriately.
DOI: 10.6084/m9.figshare.28468284
title: Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database

description: Cell-cycle protein-dependent kinase 4 and 6 inhibitors (CDK4/6is) in combination with endocrine therapy (ET) are widely used in patients with early and advanced breast cancer (BC). CDK4/6is also lead to numerous side effects. This study aims to elucidate the relationship between CDK4/6is and hepatotoxicities. As of 31 March 2024, we conducted a systematic search of PubMed, Embase, and the Cochrane Library databases, as well as several oncology conference proceedings. We included 20 randomized controlled trials (RCTs) with 24,342 breast cancer (BC) patients and 400 cases from the FDA Adverse Event Reporting System (FAERS). Fixed-effect and random-effect models were used to calculate odds ratios (ORs) of hepatotoxicity in the RCTs, while Reporting Odds Ratios (RORs) were calculated for the FAERS data. Overall, CDK4/6 inhibitors (CDK4/6is) were associated with significant hepatotoxicities compared to controls (OR = 1.76, 95%CI 1.40–2.22, I<sup>2</sup> = 75%). Palbociclib, ribociclib, and abemaciclib exhibited significant hepatotoxicities, while dalpiciclib did not. FAERS data showed significant liver enzyme and organ toxicity signals for ribociclib and abemaciclib but not for palbociclib. CDK4/6is increase the risk of hepatotoxicities in patients with BC. Palbociclib, ribociclib, and abemaciclib caused liver damage, while dalpiciclib did not. The most common manifestations were elevated ALT and AST levels.
DOI: 10.6084/m9.figshare.28468284.v1
title: Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database

description: Cell-cycle protein-dependent kinase 4 and 6 inhibitors (CDK4/6is) in combination with endocrine therapy (ET) are widely used in patients with early and advanced breast cancer (BC). CDK4/6is also lead to numerous side effects. This study aims to elucidate the relationship between CDK4/6is and hepatotoxicities. As of 31 March 2024, we conducted a systematic search of PubMed, Embase, and the Cochrane Library databases, as well as several oncology conference proceedings. We included 20 randomized controlled trials (RCTs) with 24,342 breast cancer (BC) patients and 400 cases from the FDA Adverse Event Reporting System (FAERS). Fixed-effect and random-effect models were used to calculate odds ratios (ORs) of hepatotoxicity in the RCTs, while Reporting Odds Ratios (RORs) were calculated for the FAERS data. Overall, CDK4/6 inhibitors (CDK4/6is) were associated with significant hepatotoxicities compared to controls (OR = 1.76, 95%CI 1.40–2.22, I<sup>2</sup> = 75%). Palbociclib, ribociclib, and abemaciclib exhibited significant hepatotoxicities, while dalpiciclib did not. FAERS data showed significant liver enzyme and organ toxicity signals for ribociclib and abemaciclib but not for palbociclib. CDK4/6is increase the risk of hepatotoxicities in patients with BC. Palbociclib, ribociclib, and abemaciclib caused liver damage, while dalpiciclib did not. The most common manifestations were elevated ALT and AST levels.
DOI: 10.6084/m9.figshare.28464151
title: Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database

description: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Event Reporting System (FAERS) database to guide clinical use. We evaluated retrospectively extracted reports of AEs from the FAERS database between the first quarter of 2009 and the second quarter of 2024. The presence of a significant association between Ilaris and AEs was assessed by using disproportionality analyses including ROR,PRR,BCPNN,MGPS. After evaluating 14,691,170 data, 7968 ILaris-associated AEs were obtained after removing duplicates and unspecified sex items. A number of AEs were finalized through the study, including Common Pyrexia, Condition Aggravated, Influenza, and unexpected signals not listed in the drug insert, such as Pulmonary Thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis. Ilaris induced AEs involving 27 system organ classes (SOCs). There were gender differences in AEs signaling associated with Ilaris. It is critical for healthcare professionals to closely monitor patients for symptoms (such as pulmonary thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis) and other adverse events during treatment.
DOI: 10.6084/m9.figshare.28464151.v2
title: Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database

description: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Event Reporting System (FAERS) database to guide clinical use. We evaluated retrospectively extracted reports of AEs from the FAERS database between the first quarter of 2009 and the second quarter of 2024. The presence of a significant association between Ilaris and AEs was assessed by using disproportionality analyses including ROR,PRR,BCPNN,MGPS. After evaluating 14,691,170 data, 7968 ILaris-associated AEs were obtained after removing duplicates and unspecified sex items. A number of AEs were finalized through the study, including Common Pyrexia, Condition Aggravated, Influenza, and unexpected signals not listed in the drug insert, such as Pulmonary Thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis. Ilaris induced AEs involving 27 system organ classes (SOCs). There were gender differences in AEs signaling associated with Ilaris. It is critical for healthcare professionals to closely monitor patients for symptoms (such as pulmonary thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis) and other adverse events during treatment.
DOI: 10.6084/m9.figshare.28464151.v1
title: Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS Database

description: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Event Reporting System (FAERS) database to guide clinical use. We evaluated retrospectively extracted reports of AEs from the FAERS database between the first quarter of 2009 and the second quarter of 2024. The presence of a significant association between Ilaris and AEs was assessed by using disproportionality analyses including ROR,PRR,BCPNN,MGPS. After evaluating 14,691,170 data, 7968 ILaris-associated AEs were obtained after removing duplicates and unspecified sex items. A number of AEs were finalized through the study, including Common Pyrexia、Condition Aggravated、Influenza, and unexpected signals not listed in the drug insert, such as Pulmonary Thrombosis、Hepatomegaly、Blood Lactate Dehydrogenase Increased、Splenomegaly、Appendicitis. Ilaris induced AEs involving 27 system organ classes (SOCs). There were gender differences in AEs signaling associated with Ilaris. It is critical for healthcare professionals to closely monitor patients for symptoms (such as pulmonary thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis) and other adverse events during treatment.
DOI: 10.6084/m9.figshare.28448059
title: What does real-world data reveal about cangrelor’s safety? An analysis of FDA adverse event reporting system (FAERS) database

description: Cangrelor is used to reduce thrombotic events in adults undergoing percutaneous coronary intervention, but real-world safety data is limited. This study analyzes adverse events (AEs) related to cangrelor using the FDA adverse event reporting system (FAERS) database. We employed statistical techniques such as the reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker to analyze the data from the FAERS database. Out of a total of 15,011,506 case reports, 209 events were related to cangrelor. Thirty-one preferred term (PT) describing AEs were identified, affecting eight organ systems. The most reported PT was off-label use (<i>n</i> = 163). Several unexpected AEs not listed in the drug labeling emerged, including cardiac arrest, and cardiac failure. Although percutaneous coronary intervention was the most common indication (35.4%), numerous events were associated with off-label use, particularly for conditions such as acute myocardial infarction, antiplatelet therapy, and anticoagulant therapy. Our research reveals both anticipated and unexpected AEs, providing important new information on the safety profile of cangrelor. Furthermore, we have discovered certain problems pertaining to product applications. It is recommended that manufacturers clearly highlight indications and usage instructions, and medical personnel closely follow drug administration protocols.
DOI: 10.6084/m9.figshare.28448059.v1
title: What does real-world data reveal about cangrelor’s safety? An analysis of FDA adverse event reporting system (FAERS) database

description: Cangrelor is used to reduce thrombotic events in adults undergoing percutaneous coronary intervention, but real-world safety data is limited. This study analyzes adverse events (AEs) related to cangrelor using the FDA adverse event reporting system (FAERS) database. We employed statistical techniques such as the reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker to analyze the data from the FAERS database. Out of a total of 15,011,506 case reports, 209 events were related to cangrelor. Thirty-one preferred term (PT) describing AEs were identified, affecting eight organ systems. The most reported PT was off-label use (<i>n</i> = 163). Several unexpected AEs not listed in the drug labeling emerged, including cardiac arrest, and cardiac failure. Although percutaneous coronary intervention was the most common indication (35.4%), numerous events were associated with off-label use, particularly for conditions such as acute myocardial infarction, antiplatelet therapy, and anticoagulant therapy. Our research reveals both anticipated and unexpected AEs, providing important new information on the safety profile of cangrelor. Furthermore, we have discovered certain problems pertaining to product applications. It is recommended that manufacturers clearly highlight indications and usage instructions, and medical personnel closely follow drug administration protocols.
DOI: 10.6084/m9.figshare.28077866
title: A real-world pharmacovigilance analysis for agalsidase beta: findings from the FDA adverse event reporting database

description: Fabry disease (FD), an X-linked lysosomal disorder, is marked by a lack of alpha-galactosidase A (α-Gal A). Agalsidase beta, a recombinant form of α-Gal A, is fundamental to enzyme replacement therapy for FD but requires close monitoring for adverse events (AEs). This study retrospectively analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) database for agalsidase beta-related AEs. Disproportionality analysis was used for data analysis. A total of 7,611 AE reports for agalsidase beta were analyzed. The most common AEs included pyrexia, pain, chills, malaise, and nausea. Several system organ classes including Cardiac Disorders, General Disorders and Administration Site Conditions, and Vascular Disorders, showed positive signals. Subgroup analysis by gender revealed differences in AE reporting, with males exhibiting a higher reporting odds ratio for certain preferred terms such as Renal Transplant and Drug Specific Antibody Present. The FAERS database analysis of agalsidase beta AEs identified a significant number of cardiovascular, renal, and cerebrovascular system-related reports. While agalsidase beta is generally well-tolerated, the study underscores the necessity for gender-specific treatment approaches due to the higher incidence of certain AEs in males.
DOI: 10.6084/m9.figshare.28077866.v1
title: A real-world pharmacovigilance analysis for agalsidase beta: findings from the FDA adverse event reporting database

description: Fabry disease (FD), an X-linked lysosomal disorder, is marked by a lack of alpha-galactosidase A (α-Gal A). Agalsidase beta, a recombinant form of α-Gal A, is fundamental to enzyme replacement therapy for FD but requires close monitoring for adverse events (AEs). This study retrospectively analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) database for agalsidase beta-related AEs. Disproportionality analysis was used for data analysis. A total of 7,611 AE reports for agalsidase beta were analyzed. The most common AEs included pyrexia, pain, chills, malaise, and nausea. Several system organ classes including Cardiac Disorders, General Disorders and Administration Site Conditions, and Vascular Disorders, showed positive signals. Subgroup analysis by gender revealed differences in AE reporting, with males exhibiting a higher reporting odds ratio for certain preferred terms such as Renal Transplant and Drug Specific Antibody Present. The FAERS database analysis of agalsidase beta AEs identified a significant number of cardiovascular, renal, and cerebrovascular system-related reports. While agalsidase beta is generally well-tolerated, the study underscores the necessity for gender-specific treatment approaches due to the higher incidence of certain AEs in males.
DOI: 10.6084/m9.figshare.28695720
title: Adverse events associated with obeticholic acid: a real-world, pharmacovigilance study

description: Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease predominantly affecting middle-aged women. While ursodeoxycholic acid (UDCA) is the first-line treatment, 30–40% of patients do not respond adequately, necessitating alternative therapies like Obeticholic Acid (OCA), an FXR agonist. The long-term safety of OCA remains insufficiently studied. This study utilized the US FDA Adverse Event Reporting System (FAERS) to evaluate OCA safety through large-scale data mining, using disproportionality analyses (ROR, PRR, BCPNN, and MGPS) to identify adverse event signals. From Q2 2016 to Q1 2024, 5,864 reports linked to OCA usage were identified among 13,245,871 AE reports. Significant signals across 27 System Organ Classes were found, with pruritus (12.54%), fatigue (4.16%), and nausea (1.64%) being the most prevalent adverse events. Severe hepatic events like liver failure were rare (0.6%). Median time to onset of AEs was 178 days. The most common outcomes reported were important medical events (18.6%), hospitalization (17.8%), and death (6.5%). This study provides key insights into the safety profile of OCA, highlighting the importance of monitoring for pruritus and hepatic complications, particularly within the first six months of treatment.
DOI: 10.6084/m9.figshare.28695720.v1
title: Adverse events associated with obeticholic acid: a real-world, pharmacovigilance study

description: Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease predominantly affecting middle-aged women. While ursodeoxycholic acid (UDCA) is the first-line treatment, 30–40% of patients do not respond adequately, necessitating alternative therapies like Obeticholic Acid (OCA), an FXR agonist. The long-term safety of OCA remains insufficiently studied. This study utilized the US FDA Adverse Event Reporting System (FAERS) to evaluate OCA safety through large-scale data mining, using disproportionality analyses (ROR, PRR, BCPNN, and MGPS) to identify adverse event signals. From Q2 2016 to Q1 2024, 5,864 reports linked to OCA usage were identified among 13,245,871 AE reports. Significant signals across 27 System Organ Classes were found, with pruritus (12.54%), fatigue (4.16%), and nausea (1.64%) being the most prevalent adverse events. Severe hepatic events like liver failure were rare (0.6%). Median time to onset of AEs was 178 days. The most common outcomes reported were important medical events (18.6%), hospitalization (17.8%), and death (6.5%). This study provides key insights into the safety profile of OCA, highlighting the importance of monitoring for pruritus and hepatic complications, particularly within the first six months of treatment.
DOI: 10.6084/m9.figshare.28058147
title: Adverse drug events associated with metreleptin administration: a real-world pharmacovigilance study from 2014 to 2024 using the FAERS database

description: This study analyzed adverse drug event (ADE) signals associated with metreleptin using the FDA Adverse Event Reporting System (FAERS) to provide insights for safe clinical use. Data from 1 January 2014, to 31 March 2024, were extracted. Signal intensity for adverse events was assessed using reporting odds ratio (ROR), Medicines and Healthcare Products Regulatory Agency (MHRA), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods. Time-to-onset (TTO) correlations were evaluated using the Weibull shape parameter (WSP). Logistic regression identified potential hospitalization risk factors. 4,000 ADE reports were identified, with 1,025 significant events mainly involving females (66.73%) and reported by healthcare professionals (67.80%), primarily from the United States (84.10%). 101 preferred term (PT) signals were confirmed by all methods, with 57 PTs not listed on the drug label. Overall TTO was 547 days (IQR: 113–1325), with gastrointestinal disorders and investigations as hospitalization risk factors. This study provides critical insights into the TTO of ADEs related to metreleptin, informing safe clinical application and emphasizing the importance of monitoring potential side effects.