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Specific Instructions for the Use of Protocol Templates for Organ Dysfunction Studies The goal of an organ dysfunction study is to define the dose of an agent associated with an acceptable toxicity profile and measurabl
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Document Date: 2014-12-01 20:14:01

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City

Philadelphia / /

Company

Integral Laboratory / Investigators and Associates / CTEP / Dana / Medidata / /

Country

Laos / /

Currency

pence / /

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Event

FDA Phase / Product Issues / /

Facility

Duke University / Cancer Institute / Rutgers University / University of Texas / Cancer Institute LAO LAO-TX035 / National Cancer Institute / /

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IndustryTerm

Cancer Therapy / food / dysfunction / metabolic products / Cancer Treatment / chemical / /

MedicalCondition

severe dysfunction / comparable liver dysfunction / neoplasms / Severe liver dysfunction / HIV / dysfunction / Second Malignancy / cardiac arrhythmia / unstable angina / diarrhea / hepatitis / illness / Renal dysfunction / leukemia / tumor / cholangitis / increased hepatic dysfunction / cancer / hepatocellular carcinoma / neutropenic fever / liver diseases / chronic / neoplastic diseases / neutropenia / vomiting / allergic reactions / each hepatic dysfunction / infection / Mild liver dysfunction / different dysfunction / SDC disease / metastases / moderate dysfunction / patient’s primary renal failure / hematologic malignancy / lymphoma / liver dysfunction / nausea / alopecia / gliomas / Hepatic dysfunction / study disease / neurologic dysfunction / renal disease / hypersensitivity / organ dysfunction / MS / infections / sepsis / mild dysfunction / given hepatic dysfunction / congestive heart failure / progressive disease / hematologic malignancies / Moderate liver dysfunction / /

MedicalTreatment

radiotherapy / surgery / contraception / immunosuppression / liver transplants / renal dialysis / dialysis / birth control / premedications / antiretroviral therapy / Retreatment / liver transplant / chemotherapy / /

MusicGroup

A Group / /

Organization

University of California / Mayo Clinic Cancer Center / Rutgers University / Lead Academic Organization / Duke University / Health Products and Food Branch / University of Pittsburgh / University of Chicago / Ohio State University / FDA / University of Texas / National Institute of Health / Food and Drug Administration / Harvard / Corresponding Organization / IDF / Study Agent administration / Yale University / CTEP Protocol and Information Office / NCI Division of Cancer Treatment and Diagnosis / Information Office / Cancer Institute / /

Person

Lee Moffitt / Davis Comprehensive / Capture Investigators / /

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Position

Name Telephone Fax E-mail address Investigator / Responsible Data Manager / physician / General / Guidance The investigator / Organ Dysfunction Working Group Coordinator / Major / Name Address Investigator / Address Address Telephone Telephone Fax Fax e-mail address e-mail address Responsible Research Nurse / investigator / Statistician / Principal Investigator / Investigator and Research Associate / Princess / Governor / Supplemental Investigator Data Form / Coordinator / Director / Registrar / The Principal Investigator / Protocol Chair / /

Product

carboplatin / mitomycin / pharmacokinetic / IND Agent / Other / Please / IND / administration / Name / organ function / study / Pharmacokinetic Single Agent / CYP450 / P2C / /

ProgrammingLanguage

php / /

ProvinceOrState

Ohio / Indiana / Texas / New Jersey / Pennsylvania / /

Technology

in vitro diagnostics / ETCTN protocol / chemotherapy / treating cancer / PDF protocol / dialysis / PDF / pharmacokinetics / local protocol / pharmacodynamics / /

URL

http /

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