Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis
Copyright© Bentham Science Publishers; For any queries, please email at epubbenthamscience.net..
BACKGROUND: Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance.
AIM: The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013).
METHODOLOGY: Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated.
RESULTS: A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib.
CONCLUSION: However, further causality assessment is required to confirm the association of these drugs with identified potential signals.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2023 |
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| Enthalten in: |
Current drug safety - (2023) vom: 21. Nov. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Raghuvanshi, Sourabh [VerfasserIn] |
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| Links: |
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| Themen: |
Disproportionality analysis |
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| Anmerkungen: |
Date Revised 22.11.2023 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.2174/0115748863276447231108092936 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364821841 |
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| 100 | 1 | |a Raghuvanshi, Sourabh |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis |
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| 500 | |a Date Revised 22.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a Copyright© Bentham Science Publishers; For any queries, please email at epubbenthamscience.net. | ||
| 520 | |a BACKGROUND: Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance | ||
| 520 | |a AIM: The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013) | ||
| 520 | |a METHODOLOGY: Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated | ||
| 520 | |a RESULTS: A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib | ||
| 520 | |a CONCLUSION: However, further causality assessment is required to confirm the association of these drugs with identified potential signals | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Disproportionality analysis | |
| 650 | 4 | |a FAERS | |
| 650 | 4 | |a OpenVigil 2.1 | |
| 650 | 4 | |a Sensitivity analysis | |
| 650 | 4 | |a Signal detection | |
| 650 | 4 | |a US-FDA approved drugs | |
| 700 | 1 | |a Rahman, Mohammad Akhlaquer |e verfasserin |4 aut | |
| 700 | 1 | |a Posa, Mahesh Kumar |e verfasserin |4 aut | |
| 700 | 1 | |a Kumar, Anoop |e verfasserin |4 aut | |
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