MedDRA 12.0 Review MedDRA Version Changes General Remarks Terminology Files: What you need to know MedDRA Version 12.0 Specific Changes Version 12.0 Changes Overview Changes in a Nutshell Changes Highlights MedDRA Version 12.0 Terminology Frequency Distribution MedDRA Version 12.1 - What's coming ahead?
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 (11.0, 12.0) includes both simple and complex changes, and the subsequent release in the same year (11.1, 12.1) 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).
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Files Containing MedDRA Terminology, Documentation, and Terminology Changes Information
Directory
Folder
MedDRA12.0 (most recent version release)
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MedDRA12.0 (most recent version release)
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MedDRA12.0 (most recent version release)
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MedDRA12.0 (most recent version release)
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MedDRA12.0 (most recent version release)
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MedDRA12.0 (most recent version release)
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MedDRA12.0 (most recent version release)
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File Name
Description
How to use it
MedDRA Introductory Guide is a language specific document that To view requires intguide.pdf describes characteristics of Adobe Acrobat reader. MedDRA including rules, conventions, and terminology hierarchy SMQ Introductory Guide is To view requires smq_intguide.pdf a document that describes Adobe Acrobat SMQs basic concepts reader. The "What's New" document provides a summary of all corresponding MedDRA To view requires whatsnew.pdf version changes, Adobe Acrobat modifications to reader. terminology conventions, and information on other MedDRA-related activities MedDRA ASCII and Consecutive Files Documentation contain MedDRA files' description To view requires and fields’ definitions. In ASCII_seq_datafiles.pdf Adobe Acrobat addition, this document reader. contains all the information required to create MedDRA relational database. Change Request Information document To view requires Adobe Acrobat changereq_info.pdf provides all information reader. regarding terminology change requests Subscriber Portfolio To view requires document contains details Adobe Acrobat sub_port.pdf about your MedDRA reader. subscription Readme document To view requires any contains a list of all !!readme.txt reader that supports documents included in each new MedDRA *.txt files version release.
Directory
Folder
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
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.
Follow instructions asciidoc.pdf document to use in a relational database.
hlt.asc
High Level Term file. Contains all HLTs in the hierarchy.
Follow instructions asciidoc.pdf document to use in a relational database.
hlgt.asc
High Level Group Term Follow instructions file. asciidoc.pdf Contains all HLGTs in the document to use in a hierarchy. relational database.
soc.asc
Follow instructions System Organ Class file. asciidoc.pdf Contains all 26 SOCs in document to use in a the hierarchy. relational database.
mdhier.asc
Follow instructions MedDRA Hierarchy file. asciidoc.pdf Contains the MedDRA document to use in a hierarchy excluding LLTs. relational database.
hlt_pt.asc
PT & HLT codes file. Contains all PT-HLT associations.
Follow instructions asciidoc.pdf document to use in a relational database.
MedDRA12.0 (most MedAscii recent version release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
MedDRA12.0 (most recent version MedAscii release)
Directory
Folder
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
hlgt_hlt.asc
Follow instructions HLT & HLGT codes asciidoc.pdf file.Contains all HLT-HLGT document to use in a associations. relational database.
soc_hlgt.asc
Follow instructions HLGT & SOC codes file. asciidoc.pdf Contains all HLGT-SOC document to use in a associations. relational database.
SMQ_List.asc
Standardised MedDRA Follow instructions Query (SMQ) list file. asciidoc.pdf Contains a complete list of document to use in a all production (means relational database. available for use) SMQs.
SMQ_Content.asc
Standardised MedDRA Follow instructions Query (SMQ) content file. asciidoc.pdf Contains all production document to use in a SMQs and their respective relational database. subordinate terms.
intl_ord.asc
International System Organ Class order file. Follow instructions Contains the serial code asciidoc.pdf for international System document to use in a Organ Class sort order relational database. (based on relative importance of each SOC)
File Name
Description
How to use it
llt.seq
Lower Level Term Follow instructions sequential file. conseq.pdf document Contains all LLT changes to use in a relational since previous version. database.
pt.seq
Follow instructions Prefer Term file. conseq.pdf document Contains all PT changes to use in a relational since previous version. database.
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
MedDRA12.0 (most recent version SeqAscii release)
hlt.seq
Follow instructions High Level Term file. conseq.pdf document Contains all HLT changes to use in a relational since previous version. database.
hlgt.seq
High Level Group Term Follow instructions file. conseq.pdf document Contains all HLGT to use in a relational changes since previous database. version.
soc.seq
Follow instructions System Organ Class file. conseq.pdf document Contains all SOC changes to use in a relational since previous version. database.
mdhier.seq
MedDRA Hierarchy file. Follow instructions Contains the MedDRA conseq.pdf document hierarchy changes since to use in a relational previous version. database.
hlt_pt.seq
PT & HLT codes file. Follow instructions Contains all PT-HLT conseq.pdf document changes since previous to use in a relational version. database.
hlgt_hlt.seq
HLT & HLGT codes file. Follow instructions Contains all HLT-HLGT conseq.pdf document changes since previous to use in a relational version. database.
soc_hlgt.seq
HLGT & SOC codes file.Contains all HLGTSOC associations.
intl_ord.seq
Follow instructions conseq.pdf document to use in a relational database.
International System Organ Class order file. Follow instructions Contains all changes to the conseq.pdf document serial code for international to use in a relational System Organ Class sort database. order (based on relative importance of each SOC)
Directory MedDRA MSSO Downloads Page: http://www.meddrams so.com/translations/ downloads_English.htm
MedDRA MSSO Downloads Page: http://www.meddrams so.com/translations/ downloads_English.htm
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File Name
Description
How to use it
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.
Detailed_WhatsNew 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.
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MedDRA 12.0 Changes: Overview Changes In a Nutshell
Complex Changes
New Terms and Product Quality Terms
Standardized MedDRA Queries (SMQs)
Changes Highlights Featured PT Changes
New PTs
Promoted LLTs
Featured LLT Changes
New LLTs
Demoted PTs
Currency changes
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Changes In a Nutshell Complex Changes The complex changes implemented in Version 12.0 are summarized below. At the SOC level: No changes were made to existing SOC terms and no new SOCs were added in Version 12.0. At the HLGT level: Two HLGTs were added and 1 HLGT merged as a result of the complex changes in Version 12.0. They are as follows: • New HLGTs Neoplasm related morbidities to SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) Product quality issues to SOC General disorders and administration site conditions • Modified HLGT Names There were no modified HLGTs in Version 12.0. • Merged HLGTs Cancer-related morbidities to HLGT Neoplasm related morbidities At the HLT level: There were 14 new High Level Terms (HLTs) added, 1 HLT renamed and 3 HLTs merged as a result of the complex changes in Version 12.0. They are as follows: • New HLTs Anxiety disorders NEC to HLGT Anxiety disorders and symptoms Feelings and sensations NEC to HLGT General system disorders NEC Infusion site reactions to HLGT Administration site reactions Musculoskeletal and connective tissue pain and discomfort to HLGT Musculoskeletal and connective tissue disorders NEC Obsessive-compulsive disorders and symptoms to HLGT Anxiety disorders and symptoms Product contamination and sterility issues to HLGT Product quality issues Product label issues to HLGT Product quality issues Product packaging issues to HLGT Product quality issues Product physical issues to HLGT Product quality issues Product quality issues NEC to HLGT Product quality issues Ulcers NEC to HLGT Tissue disorders NEC Vaccination related complications to HLGT Procedural and device related injuries and complications NEC Vaccination site reactions to HLGT Administration site reactions Withdrawal and rebound effects to HLGT Therapeutic and nontherapeutic effects (excl toxicity) • Renamed HLTs v11.1 Injection and infusion site reactions to Injection site reactions in v12.0 • Merged HLTs Anxiety disorders NEC (incl obsessive compulsive disorder) to HLT Anxiety disorders NEC Body temperature perception to HLT Feelings and sensations NEC
Change in physical activity level NEC to HLT Stereotypies and automatisms
Back New Terms and Product Quality terms As a result of adding the new HLTs, new PTs were added and existing PTs were moved or secondary links established. The following actions occurred: Infusion site PTs were moved from newly renamed HLT Injection site reactions to HLT Infusion site reactions. New PTs such as Vaccination site inflammation and Vaccination site pain were added to HLT Vaccination site reactions LLT vaccination site terms such as LLT Vaccination site erythema and LLT Vaccination site induration were promoted as PTs to HLT Vaccination site reactions. Vaccination related complication terms such as PT Hypotonic-hyporesponsive episode and PT Measles post vaccine were either moved to HLT Vaccination site complications or secondary links were established to this HLT. The majority of PTs added to HLT Withdrawal and rebound effects were added as secondary links. Only PT Drug withdrawal syndrome, PT Drug withdrawal syndrome neonatal, and PT Rebound effect are primarily linked to HLT Withdrawal and rebound effects. A number of pain, injury, discomfort, and syndrome terms (e.g., PT Neck pain, PT Whiplash injury, PT Limb discomfort, and PT Piriformis syndrome) were moved to new HLT Musculoskeletal and connective tissue pain and discomfort from HLT Musculoskeletal and connective tissue signs and symptoms NEC. Feeling and sensations related terms (e.g., PT Hunger, PT Thirst, and PT Sensation of pressure) moved to HLT Feelings and Sensations NEC from HLT General signs and symptoms NEC. Ulcer related terms such as PT Ulcer hemorrhage and PT Tumor ulceration were either moved to HLT Ulcers NEC or a secondary link established for this HLT.
PRODUCT QUALITY TERMS The United States Food and Drug Administration (FDA) proposed a set of product quality terms for inclusion into MedDRA so they can use a single coding system for both adverse events and product quality issues. The MedDRA Management Board approved the proposal to include the product quality terms for MedDRA Version 12.0. With the input from MedDRA Expert Panel, the MSSO medical team reviewed and processed the change requests of
product quality terms. As a result, a number of product quality terms were added to MedDRA Version 12.0. A new HLGT Product quality issues was added to SOC General disorders and administration site conditions. Under HLGT Product quality issues are five new HLTs. The new HLTs are: HLT Product contamination and sterility issues HLT Product label issues HLT Product packaging issues HLT Product physical issues HLT Product quality issues NEC
There were a total of 139 new PT and LLT terms added and 24 existing PT/LLT terms moved under the product quality HLTs for a total of 163 terms.
Back Standardized MedDRA Queries (SMQs) A total of 7 new level 1 SMQs were released into production in MedDRA Version 12.0.There are now 74 level 1 SMQs in production as of this version. For MedDRA Version 12.0 there were three types of changes made to SMQs. New subSMQs were added to group previously ungrouped PTs in a few hierarchical SMQs. The following new sub-search SMQs were added in relation to this change. SMQ Bradyarrhythmia terms, nonspecific SMQ Cardiac arrhythmia terms, nonspecific SMQ Cerebrovascular disorders, not specified as haemorrhagic or ischaemic SMQ Conditions associated with central nervous system haemorrhages and cerebrovascular accidents SMQ Depression (excl suicide and self injury) SMQ Other ischaemic heart disease SMQ Premalignant disorders, general conditions and other specific site disorders SMQ Tachyarrhythmia terms, nonspecific The second change that occurred to SMQs in Version 12.0 was to the scope of PTs in the haemorrhage sub-SMQs after a review by the MSSO and CIOMS. Specifically, SMQ Haemorrhage terms (excl laboratory terms) which comprise all clinical terms describing haemorrhages changed from broad to narrow. Terms in SMQ Haemorrhage laboratory terms remain broad with four exceptions: PT Blood urine, PT Blood urine present, PT Occult blood positive, and PT Gastric occult blood positive. These four terms describe findings that cannot occur without an underlying haemorrhage, even if it's only a microhaemorrhage. The third change to the SMQs was to reduce the number of characters used in the description information field for five SMQs in SMQ ASCII files. This was done to accommodate space constraints of the description field that were exceeded when translating the descriptions from English into other languages. To correct this problem, the English descriptions were shortened. The five SMQs affected by this change are:
• SMQ Acute central respiratory depression • SMQ Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) • SMQ Dementia • SMQ Hyperglycaemia/new onset diabetes mellitus • SMQ Hyponatraemia/SIADH
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MedDRA Version 12.0 Specific Changes
Changes Highlights Featured PT Changes PT Changes: - 285 new PTs - 38 Promoted LLTs - 49 demoted PTs - Net new 274 PTs Following are several examples:
Version 12.0 PT Vaccination site reaction
Promoted LLT
Vaccination error
Promoted LLT
Withdrawal hypertension
Promoted LLT
Multiple hereditary exostosis
New PT
Sticky platelet syndrome
New PT
Injection site dysaesthesia
New PT
Needle issue
New PT
Syringe issue
New PT
Catheter culture
New PT
Surgical preconditioning
New PT
Radiation neuropathy
New PT
Product name confusion
New PT
Product shape issue
New PT
Product taste abnormal
New PT
Tobacco poisoning
New PT
Back
Featured LLT Changes
New LLTs – 572 new LLTs
Demoted PTs – 49 PTs were demoted to LLT level in version 12.0
Currency changes –10 LLTs had a currency change in version 12.0 -3 non-current LLTs became current, -7 current LLTs became non-current (examples below)
1 LLT and 1 PT were modified in version 12.0 (text modification)
LLT
Version 12.0 Currency
Acute on chronic respiratory failure
Current
Corrected transposition of great vessels
Current
Neurologic disorder NOS
Current
Cervix cerlage procedure
Non-current
Cyclic citrullinated peptide A increased
Non-current
Drug misuse
Non-current
Extensive limb swelling
Non-current
MAC
Non-current
Other and unspecified superficial injury to foot and toes, infected
Non-current
Vaginal and intraepithelial neoplasm
Non-current
LLT Currency Changes
Level
LLT Code
Version 11.1
Version 12.0
LLT
10068529
Corneal microcycstic
Corneal
microcystic edema PT
10064963
Weill-marchesani Marchesani syndrome syndrome
Modified LLT Names
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edema Weill-
MedDRA Version 12.0 Terminology Frequency Distribution by MedDRA Version
Level
Version Version Version Version Version Version Version Version Version 8.0
8.1
9.0
9.1
10.0
10.1
11.0
11.1
12.0
SOC
26
26
26
26
26
26
26
26
26
HLGT
332
332
332
332
332
332
332
332
333
HLT
1,683
1,683
1,682
1,682
1,682
1,682
1,688
1,688
1,699
PT
16,751
16,976
17,320
17,505
17,719
17,867
18,075
18,209
18,483
LLT
62,348
62,950
63,817
64,620
65,147
65,605
66,135
66,587
67,159
Current LLT's
53,370
53,967
54,834
55,621
56,125
56,580
57,104
57,556
58,124
Non-current LLT's 8,978
8,983
8,983
8,999
9,022
9,025
9,031
9,031
9,035
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MedDRA Version 12.0 - What's Coming Ahead? •
The next MedDRA terminology release, version 12.1, is scheduled for September 2009.
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