Adverse event profiles of solvent-based and nanoparticle albumin-bound paclitaxel formulations using the Food and Drug Administration Adverse Event Reporting System.
Misa NaganumaKohei TaharaShiori HasegawaAkiho FukudaSayaka SasaokaHaruna HatahiraYumi MotookaSatoshi NakaoRirika MukaiKouseki HiradeTomoaki YoshimuraTakeshi KatoHirofumi TakeuchiMitsuhiro NakamuraPublished in: SAGE open medicine (2019)
This is the first study to evaluate the adverse event profile of nanoparticle albumin-bound paclitaxel using US Food and Drug Administration Adverse Event Reporting System data. Considering that the US Food and Drug Administration Adverse Event Reporting System database does not allow to infer causality or risk ranking, the different reporting frequencies of anaphylactic reaction and acute renal failure between solvent-based paclitaxel and nanoparticle albumin-bound paclitaxel must be further investigated via analytical observational research.
Keyphrases
- adverse drug
- drug administration
- electronic health record
- drug induced
- emergency department
- human health
- liver failure
- intensive care unit
- chemotherapy induced
- risk assessment
- respiratory failure
- mass spectrometry
- extracorporeal membrane oxygenation
- artificial intelligence
- climate change
- liquid chromatography
- acute respiratory distress syndrome