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Serious and Other Selected Adverse Events Reported for Human Gene Transfer Protocols Recombinant DNA Advisory Commitee Meeting September 2004 Protocol Number: Protocol Title:
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Document Date: 2013-12-16 10:30:38

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File Size: 345,56 KB

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City

Miami / /

Country

Germany / United States / /

Facility

Stable Angina / University of Miami / /

IndustryTerm

Treatment of Unresectable Locally Advanced Pancreatic Cancer / gene transfer product / Treatment of Rectal Cancer / Treatment of Cystic Fibrosis / study product / study device / Therapy of Malignant Pleural Disease / /

MedicalCondition

congestive heart failure / comatose / subject's wound infection / tumors / disease / subject's congestive heart failure / Peripheral Arterial Disease / central line infection / subject developed nausea / Locally Advanced Esophageal Cancer / Transit Melanoma / chills / bronchopneumonia / cellulitis / erythema / fever / hemoptysis / Malignant Pleural Disease Using E1 / Hodgkins disease / vomiting / pain / Progressive Glioblastoma Multiforme / Diabetes Mellitus / heart failure / right empyema / pancreatitis / lymphopenia / Infectious Diseases / Metastatic Colorectal Adenocarcinoma / Stable Angina / Permacath infection / transient fever / infection / bronchopneumonia and possible sepsis / end-stage Renal Disease / Cystic Fibrosis / acute pancreatitis / thrombosis / breast cancer / Severe Peripheral Artery Occlusive Disease / Rectal Cancer / Severe underlying cardiac disease / Pancreatic Cancer / sepsis / Late Infantile Neuronal Ceroid Lipofuscinosis / /

MedicalTreatment

antibiotics / vaccinations / Chemotherapy / antibiotic therapy / surgery / Dialysis / /

Organization

University of Miami / Administration of a Replication Deficient Adeno-Associated Virus Gene Transfer Vector Expressing / Administration of NV1FGF / /

Position

Investigator / consulting cardiologist / IBC Chair / /

Product

IV / albuterol / IntraMuscular Injection / /

Technology

Gene Therapy / Radiation / 07/2004 Protocol / 28/2004 Protocol / 24/2004 Protocol / Chemotherapy / 13/2004 Protocol / Recombinant DNA / 25/2004 Protocol / Dialysis / /

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