About: Phase II Trial

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Attributes	Values
rdf:type	Class
rdfs:label	Phase II Trial
rdfs:subClassOf	Clinical Study by Phase
Concept_In_Subset	Clinical Data Interchange Standards Consortium Terminology CDISC SDTM Trial Phase Terminology CDISC SDTM Terminology
Semantic_Type	Research Activity
Preferred_Name	Phase II Trial
UMLS_CUI	C0282460
Contributing_Source	CDISC
ALT_DEFINITION	A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.NCI-GLOSS Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)CDISC
Legacy_Concept_Name	Phase_II_Trial
FULL_SYN	2SYCDISC Phase II Clinical TrialSYNCI Phase 2 StudySYNCI Clinical Trials, Phase IISYNCI Phase II TrialPTNCI Phase II StudySYNCI Trial Phase 2SYCDISC Phase II TrialPTCDISC Phase II ProtocolSYNCI phase II trialPTNCI-GLOSSCDR0000045831
DEFINITION	A clinical research protocol designed to study a biomedical or behavioral intervention in a larger group of people (several hundred), to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the intervention.NCI
code	C15601
is rdfs:subClassOf of	Phase IIa Trial Phase IIb Trial

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