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- NCIT_C15603 IAO_0000115 "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." @default.
- NCIT_C15603 NCIT_NHC0 "C15603" @default.
- NCIT_C15603 NCIT_P106 "Research Activity" @default.
- NCIT_C15603 NCIT_P108 "Phase IV Trial" @default.
- NCIT_C15603 NCIT_P207 "C0282462" @default.
- NCIT_C15603 NCIT_P322 "CDISC" @default.
- NCIT_C15603 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C15603 NCIT_P325 "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." @default.
- NCIT_C15603 NCIT_P325 "Post-approval 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: Phase 4 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] See also phase. (CDISC Glossary)" @default.
- NCIT_C15603 NCIT_P325 "Post-approval 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: Phase 4 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] See also phase." @default.
- NCIT_C15603 NCIT_P366 "Phase_IV_Trial" @default.
- NCIT_C15603 normalizedInformationContent "100" @default.
- NCIT_C15603 referenceCount "1" @default.
- NCIT_C15603 hasExactSynonym "4" @default.
- NCIT_C15603 hasExactSynonym "Clinical Trials, Phase IV" @default.
- NCIT_C15603 hasExactSynonym "PHASE IV TRIAL" @default.
- NCIT_C15603 hasExactSynonym "Phase 4 Study" @default.
- NCIT_C15603 hasExactSynonym "Phase IV Clinical Trials" @default.
- NCIT_C15603 hasExactSynonym "Phase IV Study" @default.
- NCIT_C15603 hasExactSynonym "Phase IV Trial" @default.
- NCIT_C15603 hasExactSynonym "Trial Phase 4" @default.
- NCIT_C15603 hasExactSynonym "phase 4" @default.
- NCIT_C15603 hasExactSynonym "phase IV trial" @default.
- NCIT_C15603 inSubset NCIT_C132298 @default.
- NCIT_C15603 inSubset NCIT_C188693 @default.
- NCIT_C15603 inSubset NCIT_C61410 @default.
- NCIT_C15603 inSubset NCIT_C66737 @default.
- NCIT_C15603 inSubset NCIT_C66830 @default.
- NCIT_C15603 inSubset NCIT_C67497 @default.
- NCIT_C15603 type Class @default.
- NCIT_C15603 isDefinedBy ncit.owl @default.
- NCIT_C15603 label "Phase IV Trial" @default.
- NCIT_C15603 subClassOf NCIT_C15206 @default.
- NCIT_C15603 subClassOf NCIT_C15429 @default.
- NCIT_C15603 subClassOf NCIT_C15603 @default.
- NCIT_C15603 subClassOf NCIT_C16203 @default.
- NCIT_C15603 subClassOf NCIT_C43431 @default.
- NCIT_C15603 subClassOf NCIT_C63536 @default.
- NCIT_C15603 subClassOf NCIT_C70820 @default.