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- Adverse_event abstract "An adverse event (AE) is 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 unfavourable and 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.AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to local ethics committee . Adverse events categorized as \"serious\" ( results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect or medical important condition ) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented in the annual summary sent to the regulatory authority.The sponsor collects AE reports from the local researchers, and notifies all participating sites of the AEs at the other sites, as well as both the local investigators' and the sponsors' judgment of the seriousness of the AEs. This process allows the sponsor and all the local investigators access to a set of data that might suggest potential problems with the study treatment while the study is still ongoing.".
- Adverse_event wikiPageExternalLink www.clinicaltrials.gov.
- Adverse_event wikiPageExternalLink www.fda.gov.
- Adverse_event wikiPageExternalLink www.ich.org.
- Adverse_event wikiPageID "2234553".
- Adverse_event wikiPageLength "5660".
- Adverse_event wikiPageOutDegree "15".
- Adverse_event wikiPageRevisionID "703066369".
- Adverse_event wikiPageWikiLink Adverse_drug_reaction.
- Adverse_event wikiPageWikiLink Adverse_effect.
- Adverse_event wikiPageWikiLink Category:Clinical_research.
- Adverse_event wikiPageWikiLink Category:Pharmaceutical_industry.
- Adverse_event wikiPageWikiLink Clinical_Trials_Directive.
- Adverse_event wikiPageWikiLink Clinical_trial.
- Adverse_event wikiPageWikiLink Data_monitoring_committee.
- Adverse_event wikiPageWikiLink EudraVigilance.
- Adverse_event wikiPageWikiLink European_Union.
- Adverse_event wikiPageWikiLink Good_clinical_practice.
- Adverse_event wikiPageWikiLink Pharmacovigilance.
- Adverse_event wikiPageWikiLink Serious_adverse_event.
- Adverse_event wikiPageWikiLink United_States_National_Library_of_Medicine.
- Adverse_event wikiPageWikiLinkText "Adverse event".
- Adverse_event wikiPageWikiLinkText "adverse event".
- Adverse_event wikiPageWikiLinkText "adverse reactions".
- Adverse_event wikiPageWikiLinkText "adverse".
- Adverse_event wikiPageUsesTemplate Template:Colbegin.
- Adverse_event wikiPageUsesTemplate Template:Colend.
- Adverse_event wikiPageUsesTemplate Template:For.
- Adverse_event wikiPageUsesTemplate Template:Refimprove.
- Adverse_event wikiPageUsesTemplate Template:Reflist.
- Adverse_event wikiPageUsesTemplate Template:Research_help.
- Adverse_event subject Category:Clinical_research.
- Adverse_event subject Category:Pharmaceutical_industry.
- Adverse_event type Industry.
- Adverse_event type Pharmaceutic.
- Adverse_event comment "An adverse event (AE) is 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.".
- Adverse_event label "Adverse event".
- Adverse_event sameAs Q19903190.
- Adverse_event sameAs Zdarzenie_niepożądane.
- Adverse_event sameAs m.01311jrp.
- Adverse_event sameAs Q19903190.
- Adverse_event wasDerivedFrom Adverse_event?oldid=703066369.
- Adverse_event isPrimaryTopicOf Adverse_event.