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Projectional radiography / Pleural effusion / Gene therapy / Chest radiograph / Ovarian cancer / Chest / Thoracentesis / Medicine / Biology / Thorax


SERIOUS, POSSIBLY ASSOCIATED AND UNEXPECTED ADVERSE EVENTS REPORTED FOR HUMAN GENE TRANSFER PROTOCOLS REPORTING PERIOD: [removed]/02 RECOMBINANT DNA ADVISORY COMMITTEE MEETING June 2002 Event #
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Document Date: 2013-12-10 13:06:27


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Company

Rhone-Poulenc Rorer / Genzyme Corporation / MediGene Inc. / Aventis Pharmaceuticals / Berlex Laboratories / Cell Genesys Inc. / /

Event

FDA Phase / /

Facility

Stable Angina / /

IndustryTerm

gene transfer product / Cancer Therapy / transfer product / Therapy for Alzheimer's Disease / telephone contact / cortical bleeding site / /

MedicalCondition

Full cardiac arrest / Intermittent Claudication / nuchal rigidity / ventricular tachycardia / headaches / chest pain / Small pericardial effusion / seizures / strain / Metastatic Solid Tumors / further chest pain / cellulitis / nausea / numbness / hemiparesis / venous congestion / Non-Small Cell Lung Cancer / Advanced Non-Small Cell Lung Cancer / Stable Angina / tachycardia / cardiac arrest / sustained ventricular tachycardia / significant coronary artery disease / sided disease / rectal cancer / Lung Tumor / hypotension / adenocarcinoma / severe dehydration / severe back pain / Tumor / acute delirium / anginal chest pain / cancer / indigestion / disease / respiratory failure / Refractory Squamous Cell Carcinoma / dyspnea / elbow pain / shortness of breath / chills / intra-abdominal carcinomatosis / stroke / fever / Alzheimer's Disease / seizure / subject's extensive underlying atherosclerotic disease / pain / renal insufficiency / Recurrent Malignant Glioma / Metastatic Cancer / joule shock / coughing spell / pleural effusion / peripheral artery disease / thrombus / newly diagnosed diabetes / acute infection / severe global left ventricular dysfunction / /

MedicalTreatment

Radiation Therapy / antibiotics / Vaccination / bed rest / surgery / Cancer Therapy / Gene Therapy / Bypass / cautery / vaccinations / /

Organization

Bi-Weekly Intratumoral Administration of RPR/INGN / 5-FU and 5-FC administration / VP16 Gene Transfer Administration / Gencell Division / RECOMBINANT DNA ADVISORY COMMITTEE / American Cancer Society / /

Person

Error / Critical Limb Ischemia / /

Position

investigator / Principal Investigator / study coordinator / /

Product

Intramyocardial Injection / Intra-Tumoral Injection / T10 / IV / Decadron / Intramuscular Injection / Ceftriaxone / G207 / Genetically Modified Salmonella / GM-CSF ® Secreting Bystander Cell / Ad2/Hypoxia Inducible Factor / /

ProvinceOrState

Michigan / /

Technology

alpha / Radiation / X-Ray / OBA Date Event Date Protocol / MRI / Gene Therapy / treating cancer / RECOMBINANT DNA / /

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