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Evaluation of gemtuzumab ozogamycin associated sinusoidal obstructive syndrome: Findings from an academic pharmacovigilance program review and a pharmaceutical sponsored registry

BACKGROUND: In 2000, the Food and Drug Administration (FDA) approved gemtuzumab ozogamycin for monotherapy for older patients with relapsed AML. A 0.9% rate of hepatic sinusoidal obstructive syndrome (SOS) was noted in licensing trials. In 2001, FDA received reports of 14 GO-associated SOS cases fro...

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Detalhes bibliográficos
Publicado no:Leuk Res
Main Authors: Magwood-Golston, Jametta S., Kessler, Samuel, Bennett, Charles L.
Formato: Artigo
Idioma:Inglês
Publicado em: 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4842309/
https://ncbi.nlm.nih.gov/pubmed/27030962
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.leukres.2016.03.004
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