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Biology / Pharmacology / Erythropoietin / Darbepoetin alfa / Amgen / Clinical trial / Anemia / Epoetin alfa / Crossover study / Erythropoiesis-stimulating agents / Medicine / Growth factors


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City

London / /

Company

Johnson & Johnson / AEs / Amgen Inc. / EPO / STN103951 Amgen Inc. / Weeks Preceding AE / CBC / Ortho Biotech / not previously receiving EPO / /

Country

United States / United Kingdom / /

Event

Product Issues / M&A / FDA Phase / Business Partnership / Product Recall / /

Facility

King’s College Hospital / /

IndustryTerm

study protocol / treatment of anemia associated with chronic kidney disease / treatment of anemia associated with chronic renal failure / Treatment of Anemia of Chronic Renal Failure / /

MedicalCondition

chronic renal failure Material Reviewed / HIV / chronic renal failure / CAPD chronic ambulatory peritoneal dialysis IVRS / Anaphylaxis / apparent allergic reactions / peritonitis / chronic kidney disease / CIN / end-stage renal disease / chronic renal failure Clinical Studies Management Team / iron deficiency / cervical intraepithelial neoplasia clearance Clinical Logistics Assay System maximum / hypertension / cancer / TVA URR V0 Vss VS thrombosis / ESRD / Stroke / diabetes / MI myocardial infarction MRT / normochromic / normocytic anemia / Seizure / Allergic Reactions / TIA transient ischemic attack TIW / renal failure / anemia / /

MedicalTreatment

red blood cell transfusions / peritoneal dialysis / chemotherapy / CAPD / hemodialysis / vascular surgery / Dialysis / renal transplant / /

Organization

King’s College Hospital / Harmonisation Independent Ethics Committee / Study Administration / /

Person

Karen Weiss / Marc Walton / CIN CL CLAS / Ellis F. Unger / /

Position

Hb / Director / DCTDA To / red Medical Officer / Chief / General / research associate / Medical Officer / /

Product

zidovudine / SC / ARANESP / EPO-Naïve Subjects / Pre-Dialysis / STN103951 / /

ProvinceOrState

Indiana / Hgb. / South Carolina / /

PublishedMedium

the Medical Officer Clinical Review / /

Technology

7 7 7 7 8 8 Protocol / interactive voice response system / 12 Protocol / Pharmacokinetics / 18 18 18 19 Protocol / 14 15 Protocol / chemotherapy / 17 Protocol / This study protocol / 7 Protocol / Dialysis / /

SocialTag