Adverse event classification dictionary---MedDRA ? SOC ? PT ?

 

A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation.

 it is the adverse event classification dictionary

The MedDRA dictionary is organized with a five-level hierarchy. The highest or broadest level is System Organ Class (SOC), further divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT), and finally into the most granular Lowest Level Terms (LLT).[6] In addition, the MedDRA dictionary includes Standardized MedDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest.[7]

SMQs are developed to facilitate retrieval of MedDRA-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development.


According to MedDRA 23.0 (March 2020):

  • SOC – 27
    • The 27 SOCs are: Blood and lymphatic system disorders; Cardiac disorders; Congenital, familial and genetic disorders; Ear and labyrinth disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General disorders and administration site conditions; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Injury, poisoning and procedural complications; Investigations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified (including cysts and polyps); Nervous system disorders; Pregnancy, puerperium, and perinatal conditions; Psychiatric disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Social circumstances; Surgical and medical procedures; Vascular disorders; Product issues
  1. HLGT – 337
  2. HLT – 1737
  3. PT – 24289
  4. LLT – 81812

ATC V.S. MedDRA



ATC classification of drugs and MedDRA classification of adverse reactions in the original FAERS data and in 163 identified clusters.

 Left: The number of drugs was counted for each category of the ATC anatomical level (first level of the ATC hierarchy). 

Right: The number of ADRs was counted for each of the MedDRA “System organ class” (SOC) (first level of the MedDRA hierarchy). The numbers are compared between the original 1317×1374 matrix (blue) and the 163 identified balusters (red). Although blustering only covered a small number of drugs and ADRs, it conserved their diversity in the ATC and MedDRA classifications. (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.)




Reference :

https://en.wikipedia.org/wiki/MedDRA

https://www.researchgate.net/figure/ATC-classification-of-drugs-and-MedDRA-classification-of-adverse-reactions-in-the_fig1_259994300

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