cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.28682880
title: Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system

description: Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adverse events (AEs) associated with SZC using the FDA Adverse Event Reporting System (FAERS). Relevant data regarding SZC were extracted from FAERS, and signal detection was conducted using four distinct algorithms. The Weibull shape parameter characterized the AE onset time. Kaplan-Meier analysis was used to evaluate the cumulative incidence of AEs associated with SZC. Among 8,846,085 case reports recorded in the FAERS database, 1,160 SZC-related AEs were identified. Beyond AEs, such as hypokalemia, edema, constipation, and ileus, listed on the SZC label, 26 additional positive risk signals were not stated, including X-ray gastrointestinal tract abnormal, cardiac failure, and aspiration pneumonia. The median onset time of SZC-related AEs was 42 days. Furthermore, AEs differed between male and female patients. This study confirmed SZC label safety warnings and identified new AEs, offering insights for clinical monitoring of SZC. We studied a medicine called Sodium Zirconium Cyclosilicate (SZC). It helps lower high potassium levels in the blood, which is a common problem for people with diabetes, heart failure, or kidney disease. Even though many people use SZC, we don’t know much about its side effects. Sometimes, medicines have side effects that we only discover after lots of people have taken them. To find out more about SZC, we used a big database from the U.S. Food and Drug Administration (FDA) that collects reports of side effects. We used special methods to check for any hidden side effects. We found that SZC can cause some side effects that we already knew about, like low potassium, swelling, constipation, and bowel problems. But we also found some new ones, like unusual X-ray results in the gut, heart problems, and a type of lung infection called aspiration pneumonia. We also discovered that side effects usually started around 42 days after people began taking SZC. There were also differences in the side effects between men and women. Our study helps bring attention to side effects that might have been missed before. Knowing more about these side effects can help doctors and patients use SZC more safely. This way, we can make sure the medicine helps more than it hurts.
DOI: 10.6084/m9.figshare.28682880.v1
title: Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system

description: Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adverse events (AEs) associated with SZC using the FDA Adverse Event Reporting System (FAERS). Relevant data regarding SZC were extracted from FAERS, and signal detection was conducted using four distinct algorithms. The Weibull shape parameter characterized the AE onset time. Kaplan-Meier analysis was used to evaluate the cumulative incidence of AEs associated with SZC. Among 8,846,085 case reports recorded in the FAERS database, 1,160 SZC-related AEs were identified. Beyond AEs, such as hypokalemia, edema, constipation, and ileus, listed on the SZC label, 26 additional positive risk signals were not stated, including X-ray gastrointestinal tract abnormal, cardiac failure, and aspiration pneumonia. The median onset time of SZC-related AEs was 42 days. Furthermore, AEs differed between male and female patients. This study confirmed SZC label safety warnings and identified new AEs, offering insights for clinical monitoring of SZC. We studied a medicine called Sodium Zirconium Cyclosilicate (SZC). It helps lower high potassium levels in the blood, which is a common problem for people with diabetes, heart failure, or kidney disease. Even though many people use SZC, we don’t know much about its side effects. Sometimes, medicines have side effects that we only discover after lots of people have taken them. To find out more about SZC, we used a big database from the U.S. Food and Drug Administration (FDA) that collects reports of side effects. We used special methods to check for any hidden side effects. We found that SZC can cause some side effects that we already knew about, like low potassium, swelling, constipation, and bowel problems. But we also found some new ones, like unusual X-ray results in the gut, heart problems, and a type of lung infection called aspiration pneumonia. We also discovered that side effects usually started around 42 days after people began taking SZC. There were also differences in the side effects between men and women. Our study helps bring attention to side effects that might have been missed before. Knowing more about these side effects can help doctors and patients use SZC more safely. This way, we can make sure the medicine helps more than it hurts.
DOI: 10.6084/m9.figshare.28429618
title: Toxicity spectrum of taxanes: a safety analysis from pre-marketing to post-marketing

description: As fundamental chemotherapy drugs, paclitaxel and its derivatives are essential for cancer treatment. This analysis comprehensively evalutaed the toxicity spectrum of taxanes from the perspective of clinical trials and the real-world. Pooled-analyses were performed to estimate incidences of adverse events (AEs) with random-effect models after searching databases. Reports of AEs were retrospectively obtained from the US Food and Drug Administration’s (FDA’s) Adverse Event Reporting System (FAERS) database, and positive signals were quantified by employing three algorithms. A total of 36 studies involving 10,828 patients were analyzed in pooled-analysis, and 58,835 case reports were retrieved. Leukopenia (59.69, 95% confidence interval 41.34–75.69) and neutropenia (29.69, 23.31–36.99) ranked first among all grades and severe AEs, respectively. Alopecia, regardless of grades, had the highest estimated incidence of non-hematological AEs. The estimated incidences of AEs of Nab-paclitaxel tended to be higher than other formulations, especially neutropenia (46.53, 35.01–58.42). Docetaxel had the least signals but alopecia and depression have quantified several signals. The safety of nab-paclitaxel was beyond expectation, and unusual signals of alopecia and depression of docetaxel need to be paid attention to. Results of clinical trials and FAERS indicated consistency between premarket and postmarket studies.
DOI: 10.6084/m9.figshare.28429618.v2
title: Toxicity spectrum of taxanes: a safety analysis from pre-marketing to post-marketing

description: As fundamental chemotherapy drugs, paclitaxel and its derivatives are essential for cancer treatment. This analysis comprehensively evalutaed the toxicity spectrum of taxanes from the perspective of clinical trials and the real-world. Pooled-analyses were performed to estimate incidences of adverse events (AEs) with random-effect models after searching databases. Reports of AEs were retrospectively obtained from the US Food and Drug Administration’s (FDA’s) Adverse Event Reporting System (FAERS) database, and positive signals were quantified by employing three algorithms. A total of 36 studies involving 10,828 patients were analyzed in pooled-analysis, and 58,835 case reports were retrieved. Leukopenia (59.69, 95% confidence interval 41.34–75.69) and neutropenia (29.69, 23.31–36.99) ranked first among all grades and severe AEs, respectively. Alopecia, regardless of grades, had the highest estimated incidence of non-hematological AEs. The estimated incidences of AEs of Nab-paclitaxel tended to be higher than other formulations, especially neutropenia (46.53, 35.01–58.42). Docetaxel had the least signals but alopecia and depression have quantified several signals. The safety of nab-paclitaxel was beyond expectation, and unusual signals of alopecia and depression of docetaxel need to be paid attention to. Results of clinical trials and FAERS indicated consistency between premarket and postmarket studies.
DOI: 10.6084/m9.figshare.28429618.v1
title: Toxicity spectrum of taxanes: A safety analysis from pre-marketing to post-marketing

description: As fundamental chemotherapy drugs, paclitaxel and its derivatives are essential for cancer treatment. This analysis comprehensively evalutaed the toxicity spectrum of taxanes from the perspective of clinical trials and the real-world. Pooled-analyses were performed to estimate incidences of adverse events (AEs) with random-effect models after searching databases. Reports of AEs were retrospectively obtained from the US Food and Drug Administration’s (FDA’s) Adverse Event Reporting System (FAERS) database and positive signals were quantified by employing three algorithms. A total of 36 studies involving 10,828 patients were analyzed in pooled-analysis and 58,835 case reports were retrieved. Leukopenia (59.69, 95% confidence interval 41.34-75.69) and neutropenia (29.69, 23.31-36.99) ranked first among all grades and severe AEs, respectively. Alopecia, regardless of grades, had the highest estimated incidence of non-hematological AEs. The estimated incidences of AEs of Nab-paclitaxel tended to be higher than other formulations, especially neutropenia (46.53, 35.01-58.42). Docetaxel had the least signals but alopecia and depression have quantified several signals. The safety of nab-paclitaxel was beyond expectation and unusual signals of alopecia and depression of docetaxel need to be paid attention to. Results of clinical trials and FAERS indicated consistency between premarket and postmarket studies.
DOI: 10.6084/m9.figshare.29039904
title: Pancreatic adverse events induced by immune checkpoint inhibitors: a real-world observational study

description: Immune checkpoint inhibitor (ICI)-induced pancreatic adverse events (AEs) are rare occurrences that are poorly documented in the literature. We conducted a retrospective review of patients who had ICI up to June 2023. Patient follow-up was extended until death or to May 2024. The primary outcome was the incidence of severe ICI-related pancreatic AEs. Logistic regression was used to investigate the associations between clinical characteristics and severe ICI-related pancreatic AEs. The study included 7,840 participants who received ICI. The study population was predominantly male (74.50%), with a median age of 59.20 years [IQR 51.90–67.70 years]. Among them, 49 patients (0.63%) developed severe ICI-related pancreatic AEs. Logistic regression revealed that pancreatic cancer (OR 5.47; [95% CI, 1.12–26.82], <i>p</i> = 0.036), lung cancer (OR 2.62; [95% CI, 1.09–6.34], <i>p</i> = 0.032), younger patients (OR 0.97; [95% CI, 0.94–0.99], <i>p</i> = 0.015), and using PD-L1 inhibitor (OR 3.09, [95% CI 1.46 to 6.52], <i>p</i> = 0.003) were associated with a higher risk of severe ICI-related pancreatic AEs. This study demonstrated that most ICI-related pancreatic AEs were asymptomatic. Primary tumor type, age, and ICI type may be predictive factors for severe ICI-related pancreatic AEs. https://www.chictr.org.cn identifier is ChiCTR2300075974.
DOI: 10.6084/m9.figshare.29039904.v1
title: Pancreatic adverse events induced by immune checkpoint inhibitors: a real-world observational study

description: Immune checkpoint inhibitor (ICI)-induced pancreatic adverse events (AEs) are rare occurrences that are poorly documented in the literature. We conducted a retrospective review of patients who had ICI up to June 2023. Patient follow-up was extended until death or to May 2024. The primary outcome was the incidence of severe ICI-related pancreatic AEs. Logistic regression was used to investigate the associations between clinical characteristics and severe ICI-related pancreatic AEs. The study included 7,840 participants who received ICI. The study population was predominantly male (74.50%), with a median age of 59.20 years [IQR 51.90–67.70 years]. Among them, 49 patients (0.63%) developed severe ICI-related pancreatic AEs. Logistic regression revealed that pancreatic cancer (OR 5.47; [95% CI, 1.12–26.82], <i>p</i> = 0.036), lung cancer (OR 2.62; [95% CI, 1.09–6.34], <i>p</i> = 0.032), younger patients (OR 0.97; [95% CI, 0.94–0.99], <i>p</i> = 0.015), and using PD-L1 inhibitor (OR 3.09, [95% CI 1.46 to 6.52], <i>p</i> = 0.003) were associated with a higher risk of severe ICI-related pancreatic AEs. This study demonstrated that most ICI-related pancreatic AEs were asymptomatic. Primary tumor type, age, and ICI type may be predictive factors for severe ICI-related pancreatic AEs. https://www.chictr.org.cn identifier is ChiCTR2300075974.
DOI: 10.6084/m9.figshare.28380996.v1
title: The impact of the COVID-19 pandemic on adverse events associated with ACEIs and ARBs: a real-world analysis using the FDA adverse event reporting system

description: During the 2019 coronavirus disease (COVID-19) pandemic, although patients were advised to continue using angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), it remains unclear whether the pandemic influenced the occurrence of adverse reactions to these drugs. This study aims to analyze and compare changes in ACEIs and ARBs adverse events before and during the COVID-19 pandemic, exploring its potential impact on the safety of these medications. We used real-world data to explore the impact of the COVID-19 pandemic on adverse events related to ACEIs and ARBs. During the pandemic, ACEI-related adverse events (70 cases) and ARB-related adverse events (7 cases) showed increased reporting rates and RORs, with a notable rise in ACEI-related ear and labyrinth disorders. Additionally, 170 new adverse event signals were detected for ACEIs (8 with significantly increased risk) and 191 signals for ARBs (2 with significantly increased risk). This study, based on real-world data, revealed significant signals indicating that ACEI use during the COVID-19 pandemic may have increased the risk of renal adverse events and ear labyrinth diseases. The study emphasized the need for increased caution when using ACEIs and ARBs during the pandemic.
DOI: 10.6084/m9.figshare.28106685
title: Influence of rapidly increased numbers of reports on adverse events of the COVID-19 vaccine in the Japanese pharmacovigilance database on disproportionality analysis of antineoplastic drug-associated adverse cardiovascular events

description: Antineoplastic drug-associated adverse cardiovascular events (ACEs) are a concern; however, information on new antineoplastic drugs is limited. In this situation, signal detection and hypothesis building by analyzing the pharmacovigilance database are useful. However, increased numbers of reports on COVID-19 vaccine-related ACEs in the pharmacovigilance database have affected the results of the disproportionality analysis. Therefore, examining the effect of increased reports on COVID-19 vaccine-related ACEs on detecting anticancer drug-related ACEs is critical. Disproportionality analysis was performed using the Japanese Adverse Drug Event Report (JADER) database. Reporting odds ratio and information components were used as indicators to detect potential associations between drugs and adverse events. The analysis was performed in two situations: using all data in the JADER database and excluding cases with the COVID-19 vaccine. Various antineoplastic drugs were associated with diverse ACEs. Additionally, safety signals for ACEs of some antineoplastic drugs were masked by reports on COVID-19 vaccine-related ACEs. The rapid increased reports on COVID-19 vaccine-related ACEs in the JADER database had an impact on signal detection activities for antineoplastic drug-associated ACEs. Therefore, the impact of reporting COVID-19 vaccine-related ACEs on current signal detection activities should be evaluated over time.
DOI: 10.6084/m9.figshare.28000089
title: Drug-induced megacolon in schizophrenia: a pharmacovigilance study of antipsychotic medications from the Japanese Adverse Drug Event database: a disproportionality analysis

description: Megacolon, characterized by colon dilation due to a nerve plexus disorder, can be fatal if untreated. Antipsychotic drugs for schizophrenia have anticholinergic effects that may cause chronic constipation and impaired gastrointestinal motility, potentially leading to megacolon. However, the megacolon risk associated with each antipsychotic drug has not been thoroughly evaluated. This study characterized the drug-induced megacolon using the Japanese adverse drug event database A retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report from April 2004 to April 2024. The study included 10,884 schizophrenia patients with, with 72 reports of antipsychotic-induced megacolon. Antipsychotic-induced megacolon was reported with 13 different antipsychotic drugs. Analysis of the reporting odds ratio for drug-induced megacolon for each antipsychotic revealed three drugs with statistically significant positive signals: zotepine = 7.25; sulpiride = 4.53; and quetiapine = 4.34. In addition, logistic regression analysis revealed that antipsychotic-induced megacolon is characterized by female sex. Zotepine, sulpiride, and quetiapine are associated with antipsychotic-induced megacolon in schizophrenia patients, and it is suggested that there is a gender difference. This study provides novel evidence for evaluating adverse drug events related to schizophrenia pharmacotherapy, contributing to improved quality of life for these patients.
DOI: 10.6084/m9.figshare.28000089.v2
title: Drug-induced megacolon in schizophrenia: a pharmacovigilance study of antipsychotic medications from the Japanese Adverse Drug Event database: a disproportionality analysis

description: Megacolon, characterized by colon dilation due to a nerve plexus disorder, can be fatal if untreated. Antipsychotic drugs for schizophrenia have anticholinergic effects that may cause chronic constipation and impaired gastrointestinal motility, potentially leading to megacolon. However, the megacolon risk associated with each antipsychotic drug has not been thoroughly evaluated. This study characterized the drug-induced megacolon using the Japanese adverse drug event database A retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report from April 2004 to April 2024. The study included 10,884 schizophrenia patients with, with 72 reports of antipsychotic-induced megacolon. Antipsychotic-induced megacolon was reported with 13 different antipsychotic drugs. Analysis of the reporting odds ratio for drug-induced megacolon for each antipsychotic revealed three drugs with statistically significant positive signals: zotepine = 7.25; sulpiride = 4.53; and quetiapine = 4.34. In addition, logistic regression analysis revealed that antipsychotic-induced megacolon is characterized by female sex. Zotepine, sulpiride, and quetiapine are associated with antipsychotic-induced megacolon in schizophrenia patients, and it is suggested that there is a gender difference. This study provides novel evidence for evaluating adverse drug events related to schizophrenia pharmacotherapy, contributing to improved quality of life for these patients.
DOI: 10.6084/m9.figshare.28106685.v1
title: Influence of rapidly increased numbers of reports on adverse events of the COVID-19 vaccine in the Japanese pharmacovigilance database on disproportionality analysis of antineoplastic drug-associated adverse cardiovascular events

description: Antineoplastic drug-associated adverse cardiovascular events (ACEs) are a concern; however, information on new antineoplastic drugs is limited. In this situation, signal detection and hypothesis building by analyzing the pharmacovigilance database are useful. However, increased numbers of reports on COVID-19 vaccine-related ACEs in the pharmacovigilance database have affected the results of the disproportionality analysis. Therefore, examining the effect of increased reports on COVID-19 vaccine-related ACEs on detecting anticancer drug-related ACEs is critical. Disproportionality analysis was performed using the Japanese Adverse Drug Event Report (JADER) database. Reporting odds ratio and information components were used as indicators to detect potential associations between drugs and adverse events. The analysis was performed in two situations: using all data in the JADER database and excluding cases with the COVID-19 vaccine. Various antineoplastic drugs were associated with diverse ACEs. Additionally, safety signals for ACEs of some antineoplastic drugs were masked by reports on COVID-19 vaccine-related ACEs. The rapid increased reports on COVID-19 vaccine-related ACEs in the JADER database had an impact on signal detection activities for antineoplastic drug-associated ACEs. Therefore, the impact of reporting COVID-19 vaccine-related ACEs on current signal detection activities should be evaluated over time.
DOI: 10.6084/m9.figshare.28000089.v1
title: Drug-induced megacolon in schizophrenia: a pharmacovigilance study of antipsychotic medications from the Japanese Adverse drug Event Database: a disproportionality analysis

description: Megacolon, characterized by colon dilation due to a nerve plexus disorder, can be fatal if untreated. Antipsychotic drugs for schizophrenia have anticholinergic effects that may cause chronic constipation and impaired gastrointestinal motility, potentially leading to megacolon. However, the megacolon risk associated with each antipsychotic drug has not been thoroughly evaluated. This study characterized the drug-induced megacolon using the Japanese adverse drug event database A retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report from April 2004 to April 2024. The study included 10,884 schizophrenia patients with, with 72 reports of antipsychotic-induced megacolon. Antipsychotic-induced megacolon was reported with 13 different antipsychotic drugs. Analysis of the reporting odds ratio for drug-induced megacolon for each antipsychotic revealed three drugs with statistically significant positive signals: zotepine = 7.25; sulpiride = 4.53; and quetiapine = 4.34. In addition, logistic regression analysis revealed that antipsychotic-induced megacolon is characterized by female sex. Zotepine, sulpiride, and quetiapine are associated with antipsychotic-induced megacolon in schizophrenia patients, and it is suggested that there is a gender difference. This study provides novel evidence for evaluating adverse drug events related to schizophrenia pharmacotherapy, contributing to improved quality of life for these patients.
DOI: 10.15468/dl.e2bnrh
title: Occurrence Download

description: A dataset containing 1440 species occurrences available in GBIF matching the query:
{
 "DatasetKey" : [
 "is EMBRAPA FLORESTAS | Soil macrofauna communities in a long-term soil tillage experiment at Embrapa Soybean, Londrina, Paraná, Brazil"
 ]
}

 The dataset includes 1440 records from 1 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0029573-250426092105405/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.15468/dl.dczpp9
title: Occurrence Download

description: A dataset containing 1485 species occurrences available in GBIF matching the query:
{
 "TaxonKey" : [
 "is Eucalyptus rudis Endl."
 ]
}

 The dataset includes 1485 records from 129 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0029572-250426092105405/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.