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U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. This content has not been altered or updated since it was archived
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Company

EISAI INC. / AEs / Ames / Pediatric Cancers Eisai Inc. / /

Country

Japan / /

Event

FDA Phase / /

Facility

National Cancer Institute / Institute Common Toxicity Criteria / /

IndustryTerm

natural product / cardiovascular systems / /

MedicalCondition

et al. Nat Rev Cancer / Cancers / tumor / ovarian cancer / cancer / histiocytic lymphoma / NSCLC / hypospermia/aspermia / adult cancer / human tumor / prostate cancers / advanced solid tumors / refractory tumors / soft tissue sarcoma / solid tumors / human cancer / neutropenia / Leukopenia Thrombocytopenia Pancytopenia CTC / bladder cancer / pancreatic cancers / melanoma / fatigue / metastatic breast cancer / rat chronic study / pediatric tumor / non-small cell lung cancer / Stable disease / pediatric cancers / promyelocytic leukemia / hypersensitivity / neutropenia / febrile neutropenia / heavily pretreated breast cancer / head and neck cancer / prostate cancer / human breast cancer / established human cancer / breast cancer / mouse lymphoma mutagenesis assay / pancreatic cancer / /

MedicalTreatment

Premedication / chemotherapies / /

Organization

National Cancer Institute / FDA Pediatric ODAC Subcommittee / Oncology Drugs Advisory Committee / European Medicines Agency / Pharmaceuticals and Medical Devices Agency / Medical Devices Agency / U.S. Food and Drug Administration / Japanese NDA / Pediatric Oncology Subcommittee / /

Position

physician / /

Product

paclitaxel / ketoconazole / CYP3A4 / /

Technology

pharmacokinetics / pharmacodynamics / drug development / apoptosis / /

SocialTag