Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx
Background<p>Pralsetinib, a selective oral inhibitor of rearranged during transfection (RET) fusion proteins and oncogenic RET mutants, has shown significant efficacy in treating RET fusion-positive non-small cell lung cancer and thyroid cancer. However, since pralsetinib was approved in the U...
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2024
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| _version_ | 1852025261817593856 |
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| author | Yi Yin (448434) |
| author2 | Fengli Sun (5049689) Youpeng Jin (16852825) |
| author2_role | author author |
| author_facet | Yi Yin (448434) Fengli Sun (5049689) Youpeng Jin (16852825) |
| author_role | author |
| dc.creator.none.fl_str_mv | Yi Yin (448434) Fengli Sun (5049689) Youpeng Jin (16852825) |
| dc.date.none.fl_str_mv | 2024-11-12T06:15:00Z |
| dc.identifier.none.fl_str_mv | 10.3389/fonc.2024.1491167.s003 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/dataset/Table_3_A_real_world_pharmacovigilance_study_of_FDA_Adverse_Event_Reporting_System_events_for_pralsetinib_xlsx/27677364 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Oncology and Carcinogenesis not elsewhere classified FDA Adverse Event Reporting System (FAERS) pralsetinib pharmacovigilance real-world analysis adverse event (AE) |
| dc.title.none.fl_str_mv | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx |
| dc.type.none.fl_str_mv | Dataset info:eu-repo/semantics/publishedVersion dataset |
| description | Background<p>Pralsetinib, a selective oral inhibitor of rearranged during transfection (RET) fusion proteins and oncogenic RET mutants, has shown significant efficacy in treating RET fusion-positive non-small cell lung cancer and thyroid cancer. However, since pralsetinib was approved in the United States in September 2020, there have been limited reports of post-marketing adverse events (AEs). In this study, we aimed to analyze the AE signals with pralsetinib on the basis of the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to provide instructions in clinical practice.</p>Methods<p>All AE reports were obtained from the FAERS database from the first quarter (Q3) of 2020 to the second quarter (Q2) of 2024. Various signal quantification techniques were used for analysis, including reporting odds ratios, proportional reporting ratios, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker (MGPS)-based empirical Bayesian geometric mean.</p>Results<p>Out of 8,341,673 case reports in the FAERS database, 1,064 reports of pralsetinib as the “primary suspected (PS)” AEs were recorded, covering 26 system organ classes and 256 preferred terms. Of the reports, 62.5% were from consumers rather than healthcare professionals. The most common systems were general disorders and administration site conditions (n = 704), investigations (n = 516), and gastrointestinal disorders (n = 405). A total of 95 significant disproportionality preferred terms (PTs) conformed to the four algorithms simultaneously. AEs that ranked the top three at the PT level were hypertension (n = 80), asthenia (n = 79), and anemia (n = 65). Of the 95 PTs with significant disproportionation, unexpected significant AEs such as increased blood calcitonin, increased myocardial necrosis marker, and bacterial cystitis were observed, which were not mentioned in the drug’s instructions. The median onset time of pralsetinib-associated AEs was 41 days [interquartile range (IQR) 14–86 days]. The majority of the AEs occurred in 30 days (42.86%).</p>Conclusion<p>Our pharmacovigilance analysis of real-world data from the FEARS database revealed the safety signals and potential risks of pralsetinib usage. These results can provide valuable evidence for further clinical application of pralsetinib and are important in enhancing clinical medication safety.</p> |
| eu_rights_str_mv | openAccess |
| id | Manara_4e42e33fac0063de2ed7c78a5774bae2 |
| identifier_str_mv | 10.3389/fonc.2024.1491167.s003 |
| network_acronym_str | Manara |
| network_name_str | ManaraRepo |
| oai_identifier_str | oai:figshare.com:article/27677364 |
| publishDate | 2024 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsxYi Yin (448434)Fengli Sun (5049689)Youpeng Jin (16852825)Oncology and Carcinogenesis not elsewhere classifiedFDA Adverse Event Reporting System (FAERS)pralsetinibpharmacovigilancereal-world analysisadverse event (AE)Background<p>Pralsetinib, a selective oral inhibitor of rearranged during transfection (RET) fusion proteins and oncogenic RET mutants, has shown significant efficacy in treating RET fusion-positive non-small cell lung cancer and thyroid cancer. However, since pralsetinib was approved in the United States in September 2020, there have been limited reports of post-marketing adverse events (AEs). In this study, we aimed to analyze the AE signals with pralsetinib on the basis of the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to provide instructions in clinical practice.</p>Methods<p>All AE reports were obtained from the FAERS database from the first quarter (Q3) of 2020 to the second quarter (Q2) of 2024. Various signal quantification techniques were used for analysis, including reporting odds ratios, proportional reporting ratios, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker (MGPS)-based empirical Bayesian geometric mean.</p>Results<p>Out of 8,341,673 case reports in the FAERS database, 1,064 reports of pralsetinib as the “primary suspected (PS)” AEs were recorded, covering 26 system organ classes and 256 preferred terms. Of the reports, 62.5% were from consumers rather than healthcare professionals. The most common systems were general disorders and administration site conditions (n = 704), investigations (n = 516), and gastrointestinal disorders (n = 405). A total of 95 significant disproportionality preferred terms (PTs) conformed to the four algorithms simultaneously. AEs that ranked the top three at the PT level were hypertension (n = 80), asthenia (n = 79), and anemia (n = 65). Of the 95 PTs with significant disproportionation, unexpected significant AEs such as increased blood calcitonin, increased myocardial necrosis marker, and bacterial cystitis were observed, which were not mentioned in the drug’s instructions. The median onset time of pralsetinib-associated AEs was 41 days [interquartile range (IQR) 14–86 days]. The majority of the AEs occurred in 30 days (42.86%).</p>Conclusion<p>Our pharmacovigilance analysis of real-world data from the FEARS database revealed the safety signals and potential risks of pralsetinib usage. These results can provide valuable evidence for further clinical application of pralsetinib and are important in enhancing clinical medication safety.</p>2024-11-12T06:15:00ZDatasetinfo:eu-repo/semantics/publishedVersiondataset10.3389/fonc.2024.1491167.s003https://figshare.com/articles/dataset/Table_3_A_real_world_pharmacovigilance_study_of_FDA_Adverse_Event_Reporting_System_events_for_pralsetinib_xlsx/27677364CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/276773642024-11-12T06:15:00Z |
| spellingShingle | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx Yi Yin (448434) Oncology and Carcinogenesis not elsewhere classified FDA Adverse Event Reporting System (FAERS) pralsetinib pharmacovigilance real-world analysis adverse event (AE) |
| status_str | publishedVersion |
| title | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx |
| title_full | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx |
| title_fullStr | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx |
| title_full_unstemmed | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx |
| title_short | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx |
| title_sort | Table 3_A real−world pharmacovigilance study of FDA Adverse Event Reporting System events for pralsetinib.xlsx |
| topic | Oncology and Carcinogenesis not elsewhere classified FDA Adverse Event Reporting System (FAERS) pralsetinib pharmacovigilance real-world analysis adverse event (AE) |