cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.28058147.v1
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.
DOI: 10.6084/m9.figshare.28159261
title: Hematological toxicities in antibody–drug conjugates related with breast cancer: a pharmacovigilance study using FDA adverse event reporting system database

description: The trastuzumab emtansine, trastuzumab deruxtecan, and sacituzumab govitecan are antibody–drug conjugates (ADCs) that have demonstrated efficacy in the treatment of breast cancer. Nonetheless, these ADCs can also induce severe toxicities in various organ systems, particularly the hematological system. Therefore, this study evaluated the hematological toxicities associated with ADCs in breast cancer based on real-world data. Data were extracted from the FDA Adverse Event Reporting System (FAERS) database, spanning from 2014 Q1 to 2023 Q3. Further analysis was done on the hematological toxicities related with ADCs, including their features, onset time, and fatality proportion. Out of 10,976 adverse event reports, 1895 hematotoxicity reports (17.26%) were analyzed. All ADCs exhibited positive safety signals for hematological toxicities, as indicated by reporting odds ratios and the information component. Unexpected significant adverse events, including splenomegaly, immune thrombocytopenia, hemolytic anemia, and hemolytic anemia, that were discovered in the medication label transpired during our data mining. The median time-to-onset of these toxicities was 13 days (interquartile range [IQR] 7–54.75), and the fatality proportion associated with hematological toxicities and ADCs was 17.41%. The study indicated that hematological toxicities caused by ADCs preferentially emerge early and may have catastrophic consequences. Early detection and management of these hematological toxicities associated with ADC is essential.
DOI: 10.6084/m9.figshare.28159261.v2
title: Hematological toxicities in antibody–drug conjugates related with breast cancer: a pharmacovigilance study using FDA adverse event reporting system database

description: The trastuzumab emtansine, trastuzumab deruxtecan, and sacituzumab govitecan are antibody–drug conjugates (ADCs) that have demonstrated efficacy in the treatment of breast cancer. Nonetheless, these ADCs can also induce severe toxicities in various organ systems, particularly the hematological system. Therefore, this study evaluated the hematological toxicities associated with ADCs in breast cancer based on real-world data. Data were extracted from the FDA Adverse Event Reporting System (FAERS) database, spanning from 2014 Q1 to 2023 Q3. Further analysis was done on the hematological toxicities related with ADCs, including their features, onset time, and fatality proportion. Out of 10,976 adverse event reports, 1895 hematotoxicity reports (17.26%) were analyzed. All ADCs exhibited positive safety signals for hematological toxicities, as indicated by reporting odds ratios and the information component. Unexpected significant adverse events, including splenomegaly, immune thrombocytopenia, hemolytic anemia, and hemolytic anemia, that were discovered in the medication label transpired during our data mining. The median time-to-onset of these toxicities was 13 days (interquartile range [IQR] 7–54.75), and the fatality proportion associated with hematological toxicities and ADCs was 17.41%. The study indicated that hematological toxicities caused by ADCs preferentially emerge early and may have catastrophic consequences. Early detection and management of these hematological toxicities associated with ADC is essential.
DOI: 10.6084/m9.figshare.28090217
title: Adverse events in patients with castration-resistant prostate cancer treated with ra-223: a retrospective pharmacovigilance study

description: Radium-223 (Ra-223) received U.S. Food and Drug Administration (FDA) approval for treating castration-resistant prostate cancer with symptomatic bone metastases, excluding visceral metastases. Despite this, the safety profile of Ra-223 in large-scale, population-based use still needs to be explored. This research assesses the side effects of Ra-223 by analyzing reports of adverse events (AEs) from the FDA’s Adverse Event Reporting System (FAERS) database. Four sequential analysis strategies were employed to assess the significance of these AEs. In total, 4,228 Ra-223-related AE reports were identified in the FAERS database. These Ra-223-induced AEs were observed in 26 target system organ classes (SOCs). 124 Ra-223-induced AEs were detected in 26 SOCs, predominantly affecting the blood and lymphatic systems. Other notable AEs included diarrhea, nausea, asthenia, fatigue, malaise, and decreased appetite, some of which were not previously documented in product specifications. The median time to onset of AEs was 56 days (Interquartile Range 26–103 days), with the majority of AEs occurring within the first three months after Ra-223 administration. Our findings align with clinical observations and suggest potential new and unexpected AEs related to Ra-223, underscoring the need for prospective clinical studies to confirm these results and clarify their relationships. These insights provide valuable evidence for further safety studies and the rational use of Ra-223.
DOI: 10.6084/m9.figshare.28090217.v2
title: Adverse events in patients with castration-resistant prostate cancer treated with ra-223: a retrospective pharmacovigilance study

description: Radium-223 (Ra-223) received U.S. Food and Drug Administration (FDA) approval for treating castration-resistant prostate cancer with symptomatic bone metastases, excluding visceral metastases. Despite this, the safety profile of Ra-223 in large-scale, population-based use still needs to be explored. This research assesses the side effects of Ra-223 by analyzing reports of adverse events (AEs) from the FDA’s Adverse Event Reporting System (FAERS) database. Four sequential analysis strategies were employed to assess the significance of these AEs. In total, 4,228 Ra-223-related AE reports were identified in the FAERS database. These Ra-223-induced AEs were observed in 26 target system organ classes (SOCs). 124 Ra-223-induced AEs were detected in 26 SOCs, predominantly affecting the blood and lymphatic systems. Other notable AEs included diarrhea, nausea, asthenia, fatigue, malaise, and decreased appetite, some of which were not previously documented in product specifications. The median time to onset of AEs was 56 days (Interquartile Range 26–103 days), with the majority of AEs occurring within the first three months after Ra-223 administration. Our findings align with clinical observations and suggest potential new and unexpected AEs related to Ra-223, underscoring the need for prospective clinical studies to confirm these results and clarify their relationships. These insights provide valuable evidence for further safety studies and the rational use of Ra-223.
DOI: 10.6084/m9.figshare.28159261.v1
title: Hematological toxicities in antibody-drug conjugates related with breast cancer: a pharmacovigilance study using FDA adverse event reporting system database

description: The trastuzumab emtansine, trastuzumab deruxtecan, and sacituzumab govitecan are antibody-drug conjugates (ADCs) that have demonstrated efficacy in the treatment of breast cancer. Nonetheless, these ADCs can also induce severe toxicities in various organ systems, particularly the hematological system. Therefore, this study evaluated the hematological toxicities associated with ADCs in breast cancer based on real-world data. Data were extracted from the FDA Adverse Event Reporting System (FAERS) database, spanning from the 2014 Q1 to 2023 Q3. Further analysis was done on the hematological toxicities related with ADCs, including their features, onset time, and fatality proportion. 1895 hematotoxicity reports (17.26%) were analyzed out of 10,976 adverse event reports. All ADCs exhibited positive safety signals for hematological toxicities, as indicated by reporting odds ratios and the information component. Unexpected significant adverse events, including splenomegaly, immune thrombocytopenia, hemolytic anemia, and hemolytic anemia, that were discovered in the medication label transpired during our data mining. The median time-to-onset of these toxicities was 13 days (interquartile range [IQR] 7-54.75), and the fatality proportion associated with hematological toxicities and ADCs was 17.41%. The study indicated that hematological toxicities caused by ADCs preferentially emerge early and may have catastrophic consequences. Early detection and management of these hematological toxicities associated with ADC is essential.
DOI: 10.6084/m9.figshare.28090217.v1
title: Adverse events in patients with castration-resistant prostate cancer treated with radium-223: a retrospective pharmacovigilance study

description: Radium-223 (Ra-223) received U.S. Food and Drug Administration (FDA) approval for treating castration-resistant prostate cancer with symptomatic bone metastases, excluding visceral metastases. Despite this, the safety profile of Ra-223 in large-scale, population-based use still needs to be explored. This research assesses the side effects of Ra-223 by analyzing reports of adverse events (AEs) from the FDA’s Adverse Event Reporting System (FAERS) database. Four sequential analysis strategies were employed to assess the significance of these AEs. In total, 4228 Ra-223-related AE reports were identified in the FAERS database. These Ra-223-induced AEs were observed in 26 target system organ classes (SOCs). 124 Ra-223-induced AEs were detected in 26 SOCs, predominantly affecting the blood and lymphatic systems. Other notable AEs included diarrhea, nausea, asthenia, fatigue, malaise, and decreased appetite, some of which were not previously documented in product specifications. The median time to onset of AEs was 56 days (Interquartile Range 26-103 days), with the majority of AEs occurring within the first three months after Ra-223 administration. Our findings align with clinical observations and suggest potential new and unexpected AEs related to Ra-223, underscoring the need for prospective clinical studies to confirm these results and clarify their relationships. These insights provide valuable evidence for further safety studies and the rational use of Ra-223.
DOI: 10.6084/m9.figshare.28321566
title: Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database

description: The FDA Adverse Event Reporting System (FAERS) was used to evaluate the associations between oral anticoagulants (OACs) and acute kidney injury (AKI). 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. 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. 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.
DOI: 10.6084/m9.figshare.28321566.v2
title: Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database

description: The FDA Adverse Event Reporting System (FAERS) was used to evaluate the associations between oral anticoagulants (OACs) and acute kidney injury (AKI). 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. 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. 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.
DOI: 10.6084/m9.figshare.28491055
title: Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system

description: Amivantamab stands as the pioneering bispecific antibody that targets both EGFR and MET, utilized in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations. Nevertheless, a thorough assessment of its safety characteristics in the real-world remains unknown. The adverse event (AE) reports were collected through a search of the FDA Adverse Event Reporting System (FAERS) database spanning from 2019 Q1 to 2024 Q1, and then disproportionality analysis was utilized. Totally, 9,252,269 AE reports were obtained from the FAERS database, with 893 reports of amivantamab classified as primary suspect AEs. Amivantamab-related AEs were distributed in 23 organ systems, and 87 significant preferred terms (PTs) met the reporting odds ratio criteria. Novel significant AEs were detected, and the median time to onset of amivantamab-associated AEs was 43 days. In subgroup analysis, a higher proportion of patients who were male, over 65 years, and with pneumonitis or pneumonia were reported in the death cases. We also found that AEs may vary between intravenous and subcutaneous administration. This investigation offered novel prospects for monitoring and addressing undesirable medication effects associated with amivantamab, which might improve the clinical medication safety.
DOI: 10.6084/m9.figshare.28491055.v1
title: Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system

description: Amivantamab stands as the pioneering bispecific antibody that targets both EGFR and MET, utilized in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations. Nevertheless, a thorough assessment of its safety characteristics in the real-world remains unknown. The adverse event (AE) reports were collected through a search of the FDA Adverse Event Reporting System (FAERS) database spanning from 2019 Q1 to 2024 Q1, and then disproportionality analysis was utilized. Totally, 9,252,269 AE reports were obtained from the FAERS database, with 893 reports of amivantamab classified as primary suspect AEs. Amivantamab-related AEs were distributed in 23 organ systems, and 87 significant preferred terms (PTs) met the reporting odds ratio criteria. Novel significant AEs were detected, and the median time to onset of amivantamab-associated AEs was 43 days. In subgroup analysis, a higher proportion of patients who were male, over 65 years, and with pneumonitis or pneumonia were reported in the death cases. We also found that AEs may vary between intravenous and subcutaneous administration. This investigation offered novel prospects for monitoring and addressing undesirable medication effects associated with amivantamab, which might improve the clinical medication safety.
DOI: 10.6084/m9.figshare.28321566.v1
title: Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the food and drug administration adverse event reporting system (FAERS) database

description: The FDA Adverse Event Reporting System (FAERS) was used to evaluate the associations between oral anticoagulants (OACs) and acute kidney injury (AKI). Disproportionality analysis were 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. The median age of patients with reported OACs-associated AKI was 76 years (interquartile range = 68–83 years), with 53.82% of the reports being for males. 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. After adjusting for factors confounding the interactions between age, sex and the administered medication, all five OACs had different risk factors for AKI. 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. The study highlights the strong association between AKI and OACs, emphasizing the need for regular renal function monitoring from the initial stages of OACs, especially in elderly male patients. Further in-depth research is needed to confirm these findings.
DOI: 10.6084/m9.figshare.28051048
title: Adverse events of nusinersen: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database

description: Nusinersen, the initial FDA-approved medication, treats Spinal Muscular Atrophy. This study utilized the FDA’s adverse event reporting system (FAERS) database to examine, evaluate, and provide substantiation for the safety of Nusinersen to assist in clinical decision-making. Nusinersen-related adverse reaction signals were mined using the reporting odds ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN), Multi-item Gamma-Poisson Shrinker (MGPS) models with Empirical Bayesian Geometric Mean (EBGM). The rate and frequency of reported adverse reactions were investigated. Nusinersen-induced adverse events were observed in 25 system organ categories (SOCs). A total of 230 disproportionate preferred terms (PTs) were eliminated using four algorithms. Cardiac arrest, autism spectrum disorder, and epilepsy emerged as potential new side effects not previously listed, warranting further attention for drug safety. Analysis of the age distribution of the signals found that younger patients should be watched out for upper respiratory tract infections and increased CSF pressure; senior patients should be extensively checked for symptoms of post-lumbar puncture syndrome and protein urine present. Our investigation discovered potential signals of novel adverse drug events that could support clinical monitoring and risk identification of Nusinersen. However, these results should be interpreted with caution.
DOI: 10.6084/m9.figshare.28051048.v1
title: Adverse events of nusinersen: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database

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