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APPENDIX A. ACRONYMS AND ABBREVIATIONS

 

Terminology Acronym

Thesaurus Name

COSTART ©

Coding Symbols for a Thesaurus of Adverse Reaction Terms

J-ART

Japanese Adverse Reaction Terminology

MedDRA

Medical Dictionary for Regulatory Activities

WHO-ART ©

World Health Organization Adverse Reaction Terminology



MedDRA Terminology Acronym

Definition

SOC

System Organ Class. The highest level in the hierarchy.

HLGT

High Level Group Term. Groups together HLTs that are related by anatomy, pathology, physiology, aetiology, or function.

HLT

High Level Term. Groups together PTs that are related by anatomy, pathology, physiology, aetiology, or function.

PT

Preferred Term. A single medical concept.

LLT

Lowest Level Term. A synonym, quasi-synonym, or sub-element of a PT.

SMQ

Standardised MedDRA Query. A grouping of MedDRA terms that relate to a defined medical condition or area of interest.


Please refer to the MedDRA Introductory Guide and the SMQ Introductory Guide for a more detailed description of MedDRA terminology definitions.