cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.28046503
title: Assessment of distributions and gender difference in adverse events related to faricimab: a real-world study based on FDA adverse event reporting system

description: 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. 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). 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 to 180 days. 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.
DOI: 10.6084/m9.figshare.28046503.v1
title: Assessment of distributions and gender difference in adverse events related to faricimab: a real-world study based on FDA adverse event reporting system

description: 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. 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). 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 to 180 days. 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.
DOI: 10.6084/m9.figshare.28683270
title: Adverse events associated with acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database

description: The precise incidence of immune-related adverse events (irAEs) remains unclear. This pharmacovigilance study investigated acute pancreatitis (AP) associated with immune checkpoint inhibitors (ICIs) using real-world data from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis employing reporting odds ratios (RORs) was conducted to detect AP signals in ICI-treated patients compared to the entire FAERS database. A total of 152,042 individual patients were included in the dataset from which we identified a cohort of 921 acute pancreatitis adverse events (AEs). The severe outcome of acute pancreatitis was death, with a rate of 13.6% (125/921). Immune checkpoint inhibitor (ICI)-related acute pancreatitis AEs were classified into two categories (pancreatitis and immune-mediated pancreatitis) based on the type of adverse event observed. ICI treatments were significantly correlated with the risk of ICIs-induced acute pancreatitis (AP) but varied among different drugs. The median time to AP onset was 57 days, with events occurring throughout the first year post-ICI initiation. Our findings provide an enhanced understanding of potential acute pancreatitis related adverse events and provide actionable insights for the early detection and management of ICI related pancreatic adverse events.
DOI: 10.6084/m9.figshare.28683270.v1
title: Adverse events associated with acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database

description: The precise incidence of immune-related adverse events (irAEs) remains unclear. This pharmacovigilance study investigated acute pancreatitis (AP) associated with immune checkpoint inhibitors (ICIs) using real-world data from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis employing reporting odds ratios (RORs) was conducted to detect AP signals in ICI-treated patients compared to the entire FAERS database. A total of 152,042 individual patients were included in the dataset from which we identified a cohort of 921 acute pancreatitis adverse events (AEs). The severe outcome of acute pancreatitis was death, with a rate of 13.6% (125/921). Immune checkpoint inhibitor (ICI)-related acute pancreatitis AEs were classified into two categories (pancreatitis and immune-mediated pancreatitis) based on the type of adverse event observed. ICI treatments were significantly correlated with the risk of ICIs-induced acute pancreatitis (AP) but varied among different drugs. The median time to AP onset was 57 days, with events occurring throughout the first year post-ICI initiation. Our findings provide an enhanced understanding of potential acute pancreatitis related adverse events and provide actionable insights for the early detection and management of ICI related pancreatic adverse events.
DOI: 10.6084/m9.figshare.28045551
title: Identification of risk factors for gastrointestinal immune–related adverse events associated with immune check point inhibitors

description: Gastrointestinal (GI) toxicities are among the most common and potentially severe immune-related adverse events (irAEs), and data on risk factors remain limited. This study aimed to identify risk factors for GI-irAEs in patients treated with ICIs. We conducted a retrospective analysis of patients with any type of malignant tumor who received ICIs between January 2020 and January 2022. GI-irAEs were defined as the onset of diarrhea during the observation period. Univariate analysis was employed to explore associations between GI-irAEs and patient characteristics. Of the 485 patients screened, 361 were eligible for analysis. GI-irAEs occurred in 29 patients (8.03%). Patients with GI cancer demonstrated shorter event-free survival (EFS) compared to those with non-GI cancer (2.33, 95% CI: 1.03–4.95; <i>p</i> = 0.0275). Additionally, ≥ grade 2 GI-irAEs were observed in 14 patients (3.88%). Patients with GU cancer had a significantly higher incidence of GI-irAEs (odds ratio: 3.26, 95%CI 1.21–8.71, <i>p</i> = 0.0497) and exhibited shorter EFS (hazard ratio: 3.07, 95%CI: 1.05–8.96; <i>p</i> = 0.0273) compared to those with non-GU cancer. Our findings suggest that GI cancer may be a risk factor for developing GI-irAEs, while GU cancer may predispose patients to ≥ grade 2 GI-irAEs.
DOI: 10.6084/m9.figshare.28045551.v2
title: Identification of risk factors for gastrointestinal immune–related adverse events associated with immune check point inhibitors

description: Gastrointestinal (GI) toxicities are among the most common and potentially severe immune-related adverse events (irAEs), and data on risk factors remain limited. This study aimed to identify risk factors for GI-irAEs in patients treated with ICIs. We conducted a retrospective analysis of patients with any type of malignant tumor who received ICIs between January 2020 and January 2022. GI-irAEs were defined as the onset of diarrhea during the observation period. Univariate analysis was employed to explore associations between GI-irAEs and patient characteristics. Of the 485 patients screened, 361 were eligible for analysis. GI-irAEs occurred in 29 patients (8.03%). Patients with GI cancer demonstrated shorter event-free survival (EFS) compared to those with non-GI cancer (2.33, 95% CI: 1.03–4.95; <i>p</i> = 0.0275). Additionally, ≥ grade 2 GI-irAEs were observed in 14 patients (3.88%). Patients with GU cancer had a significantly higher incidence of GI-irAEs (odds ratio: 3.26, 95%CI 1.21–8.71, <i>p</i> = 0.0497) and exhibited shorter EFS (hazard ratio: 3.07, 95%CI: 1.05–8.96; <i>p</i> = 0.0273) compared to those with non-GU cancer. Our findings suggest that GI cancer may be a risk factor for developing GI-irAEs, while GU cancer may predispose patients to ≥ grade 2 GI-irAEs.
DOI: 10.6084/m9.figshare.28693375
title: Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system

description: Metronidazole (MNZ) can be administered for various infections. The impact of comorbidities/concomitant drugs on MNZ-induced central nervous system (CNS) disorders remains unclear. We assessed the risk of metronidazole-related CNS disorders using the Japan Adverse Drug Event Report (JADER, May 2023) and the US Food and Drug Administration Adverse Event Reporting System (FAERS, Q1 2023), excluding comorbidities/concomitant drugs. Clonazepam and diazepam were evaluated as potential prophylactics based on the efficacy of benzodiazepines for MNZ-related CNS disorders. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated. Additionally, sensitivity analysis by sex and age was conducted. The ROR (95% CI) of CNS disorders associated with MNZ in JADER and FAERS were 3.16 (2.69–3.72) and 1.69 (1.64–1.73), respectively. MNZ was significantly related to CNS disorders after excluding comorbidities (brain/spinal cord or liver abscesses) and concomitant drugs (glucocorticoids, antiepileptic, antiparkinson, and schizophrenia drugs). In sensitivity analysis, MNZ was significantly related to CNS disorders, despite sex and age. The ROR in the concomitant with clonazepam (CZP) was 0.70 (0.53–0.92) in FAERS. MNZ may be associated with CNS disorders, even if comorbidities/concomitant drugs that are potential risk factors for CNS disorders are excluded. Additionally, CZP may suppress CNS disorders.
DOI: 10.6084/m9.figshare.28045551.v1
title: Identification of risk factors for gastrointestinal immune–related adverse events associated with immune check point inhibitors

description: Gastrointestinal (GI) toxicities are among the most common and potentially severe immune-related adverse events (irAEs), and data on risk factors remain limited. This study aimed to identify risk factors for GI-irAEs in patients treated with ICIs. We conducted a retrospective analysis of patients with any type of malignant tumor who received ICIs between January 2020 and January 2022. GI-irAEs were defined as the onset of diarrhea during the observation period. Univariate analysis was employed to explore associations between GI-irAEs and patient characteristics. Of the 485 patients screened, 361 were eligible for analysis. GI-irAEs occurred in 29 patients (8.03%). Patients with GI cancer demonstrated shorter event-free survival (EFS) compared to those with non-GI cancer (2.33, 95% CI: 1.03–4.95; <i>p</i> = 0.0275). Additionally, ≥ grade 2 GI-irAEs were observed in 14 patients (3.88%). Patients with GU cancer had a significantly higher incidence of GI-irAEs (odds ratio: 3.26, 95%CI 1.21–8.71, <i>p</i> = 0.0497) and exhibited shorter EFS (hazard ratio: 3.07, 95%CI: 1.05–8.96; <i>p</i> = 0.0273) compared to those with non-GU cancer. Our findings suggest that GI cancer may be a risk factor for developing GI-irAEs, while GU cancer may predispose patients to ≥ grade 2 GI-irAEs.
DOI: 10.6084/m9.figshare.28129845
title: Gabapentinoids related psychiatric disorders: an analysis based on the FAERS database from 2004 to 2023

description: Gabapentinoids, including gabapentin and pregabalin, are commonly used for neuropathic pain but have safety concerns. This study analyzed U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) data to assess risks of psychiatric disorders as adverse effects. Data from 2004 to 2023 were extracted for disproportionality analysis using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-Item Gamma Poisson Shrinker (MGPS) to evaluate the association between gabapentinoids and psychiatric AEs. Kaplan-Meier and log-rank tests assessed the incidence and onset profiles, while chi-square examined mortality and hospitalization rates differences. Of 174,321 AE reports, 22.67% involved psychiatric disorders. Gabapentinoids increased psychiatric disorder incidence at SOC level, with events like anxiety and suicidal ideation. Differences in incidence and health outcomes between gabapentin and pregabalin were significant (<i>p</i> &lt; 0.05). There is a correlation between the use of gabapentinoids and psychiatric disorders. Further research is needed into the mechanisms and prevention strategies for these adverse effects.
DOI: 10.6084/m9.figshare.28129845.v1
title: Gabapentinoids related psychiatric disorders: an analysis based on the FAERS database from 2004 to 2023

description: Gabapentinoids, including gabapentin and pregabalin, are commonly used for neuropathic pain but have safety concerns. This study analyzed U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) data to assess risks of psychiatric disorders as adverse effects. Data from 2004 to 2023 were extracted for disproportionality analysis using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-Item Gamma Poisson Shrinker (MGPS) to evaluate the association between gabapentinoids and psychiatric AEs. Kaplan-Meier and log-rank tests assessed the incidence and onset profiles, while chi-square examined mortality and hospitalization rates differences. Of 174,321 AE reports, 22.67% involved psychiatric disorders. Gabapentinoids increased psychiatric disorder incidence at SOC level, with events like anxiety and suicidal ideation. Differences in incidence and health outcomes between gabapentin and pregabalin were significant (<i>p</i> &lt; 0.05). There is a correlation between the use of gabapentinoids and psychiatric disorders. Further research is needed into the mechanisms and prevention strategies for these adverse effects.
DOI: 10.6084/m9.figshare.27731896
title: Cardiovascular outcomes of urate-lowering therapies in patients with gout or hyperuricemia: a network meta-analysis

description: To evaluate the comparative cardiovascular safety of urate-lowering therapies (ULTs) in patients with gout or hyperuricemia. Randomized controlled trials (RCTs) for ULTs with reported cardiovascular outcomes were included. Pairwise and network random-effect meta-analyses were performed to obtain the odds ratios (ORs) with 95% confidence intervals (CIs). The surface under the cumulative ranking curve (SUCRA) was employed to assess and rank the cardiovascular safety of ULTs. A total of 3,663 literature were retrieved, of which 26 RCTs involving 25,329 patients were finally included. Pairwise and network meta-analyses showed that allopurinol demonstrated a significant reduction in arrhythmia compared with febuxostat (for pairwise meta-analysis, OR = 0.69, 95%CI 0.49 to 0.97; for network meta-analysis, OR = 0.71, 95%CI 0.51 to 0.99). Nevertheless, there was no statistically significant difference observed in other outcomes between different ULTs or between ULTs and placebo (<i>p</i> &gt; 0.05). According to the SUCRA, febuxostat and pegloticase, had the highest probability of mitigating the occurrence of major adverse cardiovascular events (MACEs) and all-cause mortality respectively. Overall, ULTs showed relatively good cardiovascular safety in patients with gout or hyperuricemia. However, febuxostat has a higher risk of arrhythmia compared with allopurinol. Further studies are needed to confirm our findings.
DOI: 10.6084/m9.figshare.27731896.v1
title: Cardiovascular outcomes of urate-lowering therapies in patients with gout or hyperuricemia: a network meta-analysis

description: To evaluate the comparative cardiovascular safety of urate-lowering therapies (ULTs) in patients with gout or hyperuricemia. Randomized controlled trials (RCTs) for ULTs with reported cardiovascular outcomes were included. Pairwise and network random-effect meta-analyses were performed to obtain the odds ratios (ORs) with 95% confidence intervals (CIs). The surface under the cumulative ranking curve (SUCRA) was employed to assess and rank the cardiovascular safety of ULTs. A total of 3,663 literature were retrieved, of which 26 RCTs involving 25,329 patients were finally included. Pairwise and network meta-analyses showed that allopurinol demonstrated a significant reduction in arrhythmia compared with febuxostat (for pairwise meta-analysis, OR = 0.69, 95%CI 0.49 to 0.97; for network meta-analysis, OR = 0.71, 95%CI 0.51 to 0.99). Nevertheless, there was no statistically significant difference observed in other outcomes between different ULTs or between ULTs and placebo (<i>p</i> &gt; 0.05). According to the SUCRA, febuxostat and pegloticase, had the highest probability of mitigating the occurrence of major adverse cardiovascular events (MACEs) and all-cause mortality respectively. Overall, ULTs showed relatively good cardiovascular safety in patients with gout or hyperuricemia. However, febuxostat has a higher risk of arrhythmia compared with allopurinol. Further studies are needed to confirm our findings.
DOI: 10.6084/m9.figshare.28359380
title: A real-world pharmacovigilance study of blinatumomab based on the FDA adverse event reporting system

description: Blinatumomab, the first CD3/CD19 bispecific antibody, is FDA-approved for relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adults and children. This study evaluates its safety profile through pharmacovigilance analysis of adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS). We conducted a disproportionality analysis using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Data from 2014Q1 to 2023Q4 were analyzed to identify safety signals related to blinatumomab, along with a stratification analysis to examine AE onset timing. A total of 17,131 AE reports were retrieved from the FAERS database, with 6,266 indicating blinatumomab as the primary suspect. We identified 277 preferred terms (PTs) demonstrating significant disproportionality across all algorithms. Notably, unexpected AEs included Graft Versus Host Disease, myelosuppression, and hypokalaemia. Common AEs were consistent across gender and age groups, predominantly occurring within one month of treatment. This pharmacovigilance study utilizing the FAERS database identified potential AE signals associated with blinatumomab, providing essential insights for its safe clinical use.
DOI: 10.6084/m9.figshare.28359380.v1
title: A real-world pharmacovigilance study of blinatumomab based on the FDA adverse event reporting system

description: Blinatumomab, the first CD3/CD19 bispecific antibody, is FDA-approved for relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adults and children. This study evaluates its safety profile through pharmacovigilance analysis of adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS). We conducted a disproportionality analysis using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Data from 2014Q1 to 2023Q4 were analyzed to identify safety signals related to blinatumomab, along with a stratification analysis to examine AE onset timing. A total of 17,131 AE reports were retrieved from the FAERS database, with 6,266 indicating blinatumomab as the primary suspect. We identified 277 preferred terms (PTs) demonstrating significant disproportionality across all algorithms. Notably, unexpected AEs included Graft Versus Host Disease, myelosuppression, and hypokalaemia. Common AEs were consistent across gender and age groups, predominantly occurring within one month of treatment. This pharmacovigilance study utilizing the FAERS database identified potential AE signals associated with blinatumomab, providing essential insights for its safe clinical use.
DOI: 10.6084/m9.figshare.28747547
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.28747547.v2
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.