MedDRA 11.1 Review. Terminology Files: What you need to know. MedDRA Version 11.1 Terminology Frequency Distribution

Transcription

1 MedDRA 11.1 Review MedDRA Version Changes General Remarks Terminology Files: What you need to know MedDRA Version 11.1 Specific Changes Version 11.1 Changes Overview Changes in a Nutshell Changes Highlights MedDRA Version 11.1 Terminology Frequency Distribution MedDRA Version What's coming ahead?

2 MedDRA Changes - General Remarks There are two possible types of changes in the MedDRA terminology: simple changes and complex changes. Simple changes are changes to the existing terminology that involve terms at the PT and LLT levels. There are two types of Simple changes: (1) changes introduced by subscribers request and (2) Maintenance changes (also referred to as Associate changes). Maintenance changes are generated as a by-product of other changes requested by subscribers, or changes introduced by the MedDRA Management Board to preserve consistency within the dictionary. Complex changes involve modifications within the entire hierarchy, including the HLT, HLGT, and SOC terminology. Currently, the initial MedDRA terminology version release in one specific year (10.0, 11.0) includes both simple and complex changes, and the subsequent release in the same year (10.1, 11.1) represents a simple change of terminology. These changes are based on MedDRA subscribers' terminology change requests and on MedDRA terminology maintenance needs identified by MedDRA's maintenance organization reviewers. Please note that as a consequence of implementing some of these changes (e.g. demoting a multiaxial PT, adding a new HLT, etc.) it may be necessary to break the multiaxial links, to re-link the replacement terms, and/or to enable additional terms to be included within a particular SOC. All these changes may require modifications to your existing MedDRA coding, guideline development, and data retrieval practices. Keep in mind that changes involve both MedDRA terminology updates as well as Standardized MedDRA Queries (SMQ). Back to MedDRA 11.1 Review

3 Files Containing MedDRA Terminology, Documentation, and Terminology Changes Information Directory Folder File Name Description How to use it intguide.pdf smqintguide.pdf MedDRA Introductory Guide is a language specific document that describes characteristics of MedDRA including rules, conventions, and terminology hierarchy SMQ Introductory Guide is a document that describes SMQs basic concepts The "What's New" document provides a summary of all corresponding MedDRA whatsnew.pdf version changes, modifications to terminology conventions, and information on other MedDRA-related activities MedDRA ASCII and Consecutive Files Documentation contain MedDRA files' description and fields definitions. In ASCIIseqdatafiles.pdf addition, this document contains all the information required to create MedDRA relational Change Request Information document changereqinfo.pdf provides all information regarding terminology change requests Subscriber Portfolio document contains details subport.pdf about your MedDRA subscription Readme document contains a list of all!!readme.txt documents included in each new MedDRA version release. To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader. To view requires any reader that supports *.txt files

4 Directory Folder File Name Description How to use it llt.asc Lower Level Term file. Contains all LLTs in the hierarchy including noncurrent terms Refer to PDF document ascii.pdf for a complete description of this file's content and how to format it to create a table in a relational database pt.asc Prefer Term file. Contains all PTs in the hierarchy. relational hlt.asc High Level Term file. Contains all HLTs in the hierarchy. relational hlgt.asc High Level Group Term file. Contains all HLGTs in the hierarchy. relational soc.asc System Organ Class file. Contains all 26 SOCs in the hierarchy. relational mdhier.asc MedDRA Hierarchy file. Contains the MedDRA hierarchy excluding LLTs. relational hltpt.asc PT & HLT codes file. Contains all PT-HLT associations. relational

5 HLT & HLGT codes (most recent version hlgthlt.asc file.contains all HLT-HLGT associations. relational sochlgt.asc HLGT & SOC codes file. Contains all HLGT-SOC associations. relational SMQList.asc Standardised MedDRA Query (SMQ) list file. Contains a complete list of all production (means available for use) SMQs. relational SMQContent.asc Standardised MedDRA Query (SMQ) content file. Contains all production SMQs and their respective subordinate terms. relational intlord.asc International System Organ Class order file. Contains the serial code for international System Organ Class sort order (based on relative importance of each SOC) relational Directory Folder File Name Description How to use it llt.seq Lower Level Term sequential file. Contains all LLT changes since previous version. pt.seq Prefer Term file. Contains all PT changes since previous version.

6 hlt.seq High Level Term file. Contains all HLT changes since previous version. hlgt.seq High Level Group Term file. Contains all HLGT changes since previous version. soc.seq System Organ Class file. Contains all SOC changes since previous version. mdhier.seq MedDRA Hierarchy file. Contains the MedDRA hierarchy changes since previous version. hltpt.seq PT & HLT codes file. Contains all PT-HLT changes since previous version. hlgthlt.seq HLT & HLGT codes file. Contains all HLT-HLGT changes since previous version. sochlgt.seq HLGT & SOC codes file.contains all HLGT- SOC associations. intlord.seq International System Organ Class order file. Contains all changes to the serial code for international System Organ Class sort order (based on relative importance of each SOC)

7 Directory Folder File Name Description How to use it MedDRA MSSO Downloads Page: so.com/translations/ downloadsenglish.htm MedDRAVersion Reports.xls MedDRA Version Report file. Contains all MedDRA terminology changes since previous version release in a spreadsheet format. Microsoft Excel format. Very useful file for MedDRA version upgrade reviews. MedDRA MSSO Downloads Page: so.com/translations/ downloadsenglish.htm DetailedWhatsNew Report.pdf Detailed What's New Report file. Contains all version changes in full detail. To view requires Adobe Acrobat reader. Very useful file for MedDRA version upgrade reviews. Back to MedDRA 11.1 Review

8 MedDRA 11.1 Changes: Overview Changes In a Nutshell Maintenance Changes New Terms New SMQs Back to MedDRA 11.1 Review Changes Highlights Featured PT Changes s Promoted LLTs Featured LLT Changes New LLTs Demoted PTs Currency changes

9 MedDRA Version 11.1 Specific Changes Changes In a Nutshell Maintenance Changes An issue with the ICD-9 data field in the MedDRA term record has been corrected in this release to remove any leading blanks. There were ninety nine such terms in which the ICD-9 code had leading blanks. New Terms There were no visible trends observed in the change requests submitted and implemented in this MedDRA release. New SMQs Nine new SMQs were added in MedDRA Version There are now 67 SMQs in production as of this version. Breast neoplasms, malignant and unspecified (SMQ) Cardiomyopathy (SMQ) Demyelination (SMQ) Hypertension (SMQ) Lens disorders (SMQ) Optic nerve disorders (SMQ) Ovarian neoplasms, malignant and unspecified (SMQ) Prostate neoplasms, malignant and unspecified (SMQ) Uterine and fallopian tube neoplasms, malignant and unspecified (SMQ) New SMQs in version 11.1 Back to MedDRA 11.1 Review

10 MedDRA Version 11.1 Specific Changes Changes Highlights Featured PT Changes PT Changes: new PTs - 28 Promoted LLTs - 94 demoted PTs - Net new 134 PTs Following are several examples: Version 11.1 PT Venous insufficiency Encephalomyelitis Abnormal loss of weight Chronotropic incompetence Congenital inguinal hernia Umbilical haematoma Pneumoretroperitoneum Application site haematoma Drug effect delayed Injection site exfoliation Bone abscess Device intolerance Nephroscopy Histamine intolerance Exertional headache Promoted LLT Promoted LLT Promoted LLT

11 Back Featured LLT Changes New LLTs 452 new LLTs Demoted PTs 94 PTs were demoted to LLT level in version 11.1 Currency changes 6 LLTs had a currency change in version non-current LLTs became current, 3 current LLTs became non-current (examples below) 7 LLTs were modified in version 11.1 (text modification) LLT Version 11.1 Currency Mixed conductive and sensorineural deafness Current Mixed conductive and sensorineural hearing loss Current Paternal drugs affecting foetus Current Drug exposure prior and during pregnancy via father Non-current VAIN vaginal intraepithelial neoplasm Non-current Vulval intraepithelial neoplasm Non-current LLT Currency Changes

12 LLT Code Version 11.0 Version Parathyrn Parathyrin Parathyrn decreased decreased Parathyrin Parathyrn high Parathyrin high Modified LLT Names Back Back to MedDRA 11.1 Review

13 MedDRA Version 11.1 Terminology Frequency Distribution by MedDRA Version Level Version Version Version Version Version Version Version Version SOC HLGT HLT 1,683 1,683 1,682 1,682 1,682 1,682 1,688 1,688 PT 16,751 16,976 17,320 17,505 17,719 17,867 18,075 18,209 LLT Current LLT's Non-current LLT's 62,348 53,370 8,978 62,950 53,967 8,983 63,817 54,834 8,983 64,620 55,621 8,999 65,147 56,125 9,022 65,605 56,580 9,025 66,135 57,104 9,031 66,587 57,556 9,031 Back to MedDRA 11.1 Review

14 MedDRA Version What's Coming Ahead? The next MedDRA terminology release, version 12.0, is scheduled for March Back to MedDRA 11.1 Review