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City Symposium Vernried / Washington / D.C. / New York / Stuttgart / London / / Company Goldman / Baxter International Inc. / Misbah SA / Yuasa / Baxter Healthcare Corporation / IgG / Rowland LP. / M. Dekker Inc. / / Country West Germany / United States / / Event FDA Phase / / Facility Chapel HM / Laboratory Tests / Laboratory Tests If / / IndustryTerm treatment of primary immunodeficiency disorders / solvent/detergent-treated blood products / manufacturing process / applicable manufacturing conditions / manufacturing / drug products / pale yellow solutions / intravenous solutions / treatment for Guillain-Barre syndrome / intravenous gammaglobulin products / healthcare / / MedicalCondition photophobia / Infections Urinary Tract Infection Gastroenteritis Lower Respiratory Tract Infection / hypoxemia / pulmonary edema / Lung Abscess / HBV / neurologic disease / certain current virus infections / measles / primary hypogammaglobulinemia / Anaphylaxis / ORF / Events Validated Infections / vascular collapse Neurological coma / pulmonary / drowsiness / non-validated infections / CreutzfeldtJakob disease / pulmonary edema / bullous dermatitis / infectious agent / anaphylactic reactions / Diarrhea / urinary tract infections / Wiskott-Aldrich syndrome / cardiac arrest / muscle cramps / Otitis Media / tiredness / renal dysfunction / hypotension Neurological seizures / abdominal pain / autoimmune disorders / Fisher M. Hemolytic anemia / Transfusion Related Acute Lung Injury / bacterial infections / agammaglobulinemia / monoclonal gammopathies / nasopharyngitis / upper respiratory infections / congenital X-linked agammaglobulinemia / low-grade fever / shortness of breath / chills / Pneumonia Lower Respiratory Tract Infection / Guillain-Barre syndrome / CJD / autoimmune thrombocytopenia / HCV / fever / vomiting / runny nose / Rubella / Prog Allergy / primary disorders / Infection / dizziness / rash / Other Infections / Empyema / acute renal failure / acute bacterial infections / disorders / chronic sinopulmonary disease / primary immunodeficiency disorders / Hepatitis A / nuchal rigidity / chest pain / mumps / paraproteinemia / headache / pleocytosis / recurrent infections / bronchitis / primary immunodeficiency diseases / neuromuscular diseases / rash and joint pain / nausea / tetanus / hepatitis C / hepatic dysfunction / severe hypersensitivity / fatigue / Encephalopathy / validated infectious complications / erythema multiforme / renal disease / hypersensitivity / sinusitis / consciousness Hematologic pancytopenia / MS / Pruritus / infections / infectious agents / back pain / sepsis / osmotic nephrosis / bronchospasm Cardiovascular thromboembolism / wheezing / Number Percentage Number Percentage Headache / Monogr Allergy / Acute myocardial infarction / aseptic meningitis / acute lung injury / acute serious bacterial infections / Hemolytic anemia / B19V infection / disease / atherosclerosis / commonly observed infections / dyspnea / Validated Infections / poor appetite / severe anaphylactic reaction / Pain / congenital rubella syndrome / diabetes mellitus / urticaria / Respiratory apnea / rigors / chest tightness / hypogammaglobulinemia / Cough / thrombosis / Meningitis / Syndrome / Validated Acute Serious Bacterial Infections / respiratory distress / / MedicalTreatment immunoglobulin therapy / Immunotherapy / oxygen therapy / alternative therapies / immunization / intravenous infusion / / MusicGroup Nausea / / Organization US Department of Health and Human Services / Blood Products Advisory Committee / Advisory Committee on Immunization Practices / DOSAGE AND ADMINISTRATION / FDA / FDA Blood Products Advisory Committee / Committee for Medicinal Products for Human Use / PRECAUTIONS / Committee on Infectious Disease / American Academy of Pediatrics / / Person M. Hemolytic / Wilson JR / Encephalomyocarditis Virus / Pseudorabies Virus / Keith P. Stroke / Arch Neurol / Silver Spring / Prince / Davis J. Hemolysis / Ann Rheum / Ann Intern / Bovine Viral Diarrhea Virus / / / Position immunizing physician / physician / General / MP / Lance LL / investigator / Prince / model / Fisher / / Product dextrose / Epinephrine / Glycine / Hepatitis B Surface / Log10 / pH / IgG / GAMMAGARD LIQUID / / ProvinceOrState ARDS / Maryland / / PublishedMedium Morbidity and Mortality Weekly Report / / RadioStation Prince AM / / Technology antibodies / Pharmacokinetics / / SocialTag 
GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% Table 2: Summary of Validated Acute Serious Bacterial Infections for the Per-Protocol Analysis Number of Events Validated Infections a