About: Adverse Event

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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

Attributes	Values
rdf:type	Class
rdfs:label	Adverse Event
rdfs:subClassOf	Finding by Cause
Concept_In_Subset	Individual Case Safety Report Terminology Type of Event ICSR Terminology Clinical Data Interchange Standards Consortium Terminology CDISC SDTM Reason for Non-Completion Terminology CDISC SDTM Terminology
Semantic_Type	Finding
Preferred_Name	Adverse Event
UMLS_CUI	C0877248
Contributing_Source	BRIDG CDISC FDA
ALT_DEFINITION	Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attackBRIDG An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse effects do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe.NCI-GLOSS Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. [Modified from ICH E2A] Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary)CDISC
Legacy_Concept_Name	Adverse_Event
FULL_SYN	ADVERSE EVENTPTFDA Adverse EventPTNCI AEABNCI AdverseEventPTBRIDG ADVERSE EVENTPTCDISC Adverse EventSYNCITCGA adverse eventPTNCI-GLOSSCDR0000444960 Adverse ExperienceSYNCI
DEFINITION	Any unfavorable or unintended symptom, sign, or disease including an abnormal laboratory finding) temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Such events can be intervention related, dose related, route related, patient related, or caused by an interaction with another drug(s) or procedure(s).NCI
code	C41331
is rdfs:subClassOf of	Substance Adverse Event Recurring Adverse Event Persistent Adverse Event Adverse Reaction Expected Adverse Event Unexpected Adverse Event Adverse Event by Outcome and Action Criteria or Severity Adverse Event by Cause Adverse Event by CTCAE Category Post-Study Adverse Event Defined Adverse Event

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