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AttributesValues
rdf:type
rdfs:label
  • Phase IV Trial
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Research Activity
Preferred_Name
  • Phase IV Trial
UMLS_CUI
  • C0282462
Contributing_Source
  • CDISC
ALT_DEFINITION
  • After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.NCI-GLOSS
  • Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)CDISC
Legacy_Concept_Name
  • Phase_IV_Trial
FULL_SYN
  • 4SYCDISC
  • Phase IV Clinical TrialsSYNCI
  • Phase 4 StudySYNCI
  • Clinical Trials, Phase IVSYNCI
  • Phase IV TrialPTNCI
  • Phase IV StudySYNCI
  • Trial Phase 4SYCDISC
  • Phase IV TrialPTCDISC
  • phase IV trialPTNCI-GLOSSCDR0000045835
DEFINITION
  • A randomized, controlled trial that is designed to evaluate the long-term safety and efficacy of a drug for a given indication. Often they are designed to study side effects that may have become apparent after the phase III study was completed.NCI
code
  • C15603
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