serious adverse event

  • 1Serious adverse event — A serious adverse event (SAE) in human drug trials are defined as any untowardmedical occurrence that at any dose results in #death, #is life threatening #requires inpatient hospitalization or prolongation of existing hospitalization #results in… …

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  • 2Serious Adverse Event — Ein schwerwiegendes unerwünschtes Ereignis (SUE) (von engl. serious adverse event, SAE) ist ein schwerwiegendes Vorkommnis oder eine schwerwiegende Nebenwirkung, das oder die im Rahmen einer klinischen Studie mit Arzneimitteln bei einem Patienten …

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  • 3Adverse event — An adverse event (AE) is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a… …

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  • 4Adverse drug reaction — Classification and external resources Adverse drug reaction leading to hepatitis (drug induced hepatitis) with granulomata. Other causes were excluded with extensive investigations. Liver biopsy …

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  • 5Vaccine Adverse Event Reporting System — The Vaccine Adverse Event Reporting System is a United States program for vaccine safety, co sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post marketing safety… …

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  • 6Adverse effect — Classification and external resources ICD 10 T78 ICD 9 995.89 In medicine, an …

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  • 7Adverse effect (medicine) — In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as chemotherapy or surgery. An adverse effect may be termed a side effect (when judged to be secondary to a main or… …

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  • 8Research on Adverse Drug events And Reports — (RADAR) is a pharmacovigilance team of 25 doctors who receive calls about possible adverse drug reactions and investigate. RADAR is based out of Northwestern s Feinberg School of Medicine and the VA Center for Management of Complex Chronic Care… …

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  • 9Radar (Research on Adverse Drug events And Reports) — The aims of the Research on Adverse Drug events And Reports (RADAR) Project are to disseminate safety reports for serious adverse drug reactions (sADRs) and to identify barriers to identification and reporting of these clinical events.… …

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  • 10Sentinel event — A sentinel event is defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) as any unanticipated event in a healthcare setting resulting in death or serious physical or psychological injury to a person or persons, not …

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