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Epidemiology / Health / Chemistry / Cefepime / Pyrrolidines / Thiazoles / Clinical trial / Febrile neutropenia / Randomized controlled trial / Clinical research / Medicine / Design of experiments


U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Translational Sciences Office of Biostatistics
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Company

Pharmacoepidemiology Group / Bristol-Myers Squibb / ITT / /

Country

United States / /

Event

FDA Phase / /

MedicalCondition

Pseudomonas / Skin Structure Infection / pneumonia / Intra-abdominal Infection / cancer / complicated intra-abdominal infections / pathogen infections / Urinary Tract Infection / solid tumor / solid tumors / febrile neutropenia subgroup / baseline infection / Renal insufficiency / skin structure infections / febrile neutropenia / skin infections / Active cancer / pyelonephritis / complicated intraabdominal infections / uncomplicated and complicated urinary tract infections / concurrent bacteremia / /

MedicalTreatment

adjunctive therapy / antibiotics / bone marrow transplant / /

Organization

U.S. Department of Health and Human Services / Division of Anti-infective and Ophthalmology Products Clinical Team / Translational Sciences Office / Food and Drug Administration / Division of Anti-infective / FDA / Biometrics Division / Food and Drug Administration Center for Drug Evaluation / Research Office / /

Person

Peter Kim / Sumathi Nambiar / Charles Cooper / George Rochester / Kyong Hyon / /

Position

Team Leader Project Manager / Statistical Team Leader / /

Product

ceftazidime / piperacillin / cefepime hydrochloride / cefotaxime / Maxipime / Ceftriaxone / Ophthalmology Drug / United States / /

PublishedMedium

Baseline / /

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