MedDRA 10.0 Review MedDRA Version Changes General Remarks Terminology Files: What you need to know MedDRA Version 10.0 Specific Changes Version 10.0 Changes Overview Changes in a Nutshell Changes Highlights MedDRA Version 10.0 Terminology Frequency Distribution MedDRA Version 10.1 - What's coming ahead?
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MedDRA 10.0 Review
MedDRA Version Changes
General Remarks
Terminology Files: What you need to know
MedDRA Version 10.0 Specific Changes
Version 10.0 Changes Overview
Changes in a Nutshell
Changes Highlights
MedDRA Version 10.0 Terminology Frequency Distribution
MedDRA Version 10.1 - What's coming ahead?
MedDRA Changes - General Remarks There are two possible types of changes to 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 to HLT, HLGT, and SOC terminology. Currently, the initial MedDRA terminology version release in one specific year (5.0, 6.0, 7.0, 8.0, 9.0) includes both simple and complex changes, and the subsequent release in the same year (5.1, 6.1, 7.1, 8.1, 9.1) 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.
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Files Containing MedDRA Terminology,Documentation, and Terminology
Changes Information Directory Folder File Name Description How to use it
MedDRA10 (most recent version
release) _ intguide.pdf
MedDRA Introductory Guide is a language specific
document that describes characteristics of MedDRA
including rules, conventions, and terminology hierarchy
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release) _ smq_intguide.pdf
SMQ Introductory Guide is a document that describes
SMQs basic concepts
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release) _ whatsnew.pdf
The "What's New" document provides a summary of all corresponding MedDRA
version changes, modifications to terminology conventions, and information
on other MedDRA-related activities
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release) _ asciidoc.pdf
MedDRA ASCII Files Documentation contains
MedDRA files' description and fields definitions. In addition, it
contains all the information required to create MedDRA
relational database.
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release) _ conseq.pdf
MedDRA Consecutive File Documentation contains
consecutive files' description and fields definitions.
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release) _ changereq_info.pdf
Change Request Information document provides all information regarding
terminology change requests
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release) _ sub_pot.pdf
Subscriber Portfolio document contains details
about your MedDRA subscription
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release) _ phonecard.pdf
MedDRA MSSO Phone System provides information on how to access the MSSO
by phone
To view requires Adobe Acrobat reader.
MedDRA10 (most recent version
release)
_
!!readme.txt
Readme document contains a list of all documents included in each new MedDRA version
release.
To view requires any reader that supports
*.txt files
Directory Folder File Name Description How to use it
MedDRA10 (most recent version
release) MedAscii llt.asc
Lower Level Term file. Contains ALL LLT in the hierarchy including non-
current 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
MedDRA10 (most recent version
release) MedAscii pt.asc
Prefer Term file. Contains all PT in the
hierarchy.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii hlt.asc
High Level Term file. Contains all HLT in the
hierarchy.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii hlgt.asc
High Level Group Term file.Contains all HLGT in the
hierarchy.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii soc.asc
System Organ Class file. Contains all 26 SOCs in the
hierarchy.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii mdhier.asc
MedDRA Hierarchy file. Contains the MedDRA
hierarchy excluding LLTs.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii hlt_pt.asc
PT & HLT codes file. Contains all PT-HLT
associations.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10(most recent version
release) MedAscii hlgt_hlt.asc
HLT & HLGT codes file.Contains all HLT-HLGT
associations.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii soc_hlgt.asc
HLGT & SOC codes file. Contains all HLGT-SOC
associations.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii spec.asc
Special Search Categories (SSC) file.
Contains a list of all Special Search Categories.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii spec_pt.asc
Special Search Categories & PT file.
Contains a list of all Special Search Categories (SSC) and
the PTs included in each.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii SMQ_List.asc
Standardised MedDRA Query (SMQ) list file.
Contains a complete list of all production (means available
for use) SMQs.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii SMQ_Content.asc
Standardised MedDRA Query (SMQ) content file.
Contains all production SMQs and their respective subordinate terms.
Follow instructions asciidoc.pdf document to use in a relational
database.
MedDRA10 (most recent version
release) MedAscii intl_ord.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)
Follow instructions asciidoc.pdf document to use in a relational
database.
Directory Folder File Name Description How to use it
MedDRA10 (most recent version
release) SeqAscii llt.seq
Lower Level Term sequential file.
Contains all LLT changes since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii pt.seq
Prefer Term file. Contains all PT changes since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii hlt.seq
High Level Term file. Contains all HLT changes
since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii hlgt.seq
High Level Group Term file.Contains all HLGT changes
since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii soc.seq
System Organ Class file. Contains all SOCs changes
since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii mdhier.seq
MedDRA Hierarchy file. Contains the MedDRA
hierarchy changes since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii hlt_pt.seq
PT & HLT codes file. Contains all PT-HLT changes
since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii hlgt_hlt.seq
HLT & HLGT codes file. Contains all HLT-HLGT changes since previous
version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10(most recent version
release) SeqAscii soc_hlgt.seq
HLGT & SOC codes file.Contains all HLGT-SOC
associations.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii spec.seq
Special Search Categories (SSC) file.
Contains a list of all Special Search Categories changes
since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii spec_pt.seq
Special Search Categories & PT file.
Contains a list of all Special Search Categories (SSC) and
the PTs changes since previous version.
Follow instructions conseq.pdf document to
use in a relational database.
MedDRA10 (most recent version
release) SeqAscii intl_ord.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)
Follow instructions conseq.pdf document to
use in a relational database.
Directory Folder File Name Description How to use it
MedDRA MSSO Downloads Page:
http://www.meddrams so.com/translations/
downloads.htm
_ MedDRAVersion Reports.xls
MedDRA Verison 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:
http://www.meddrams so.com/translations/
downloads.htm
_ Detailed_WhatsNewReport.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.
Retirement of SSCs Special Search Categories (SSCs) have been replaced by Standardized MedDRA Queries (SMQs).?SSCs have been a part of the terminology since Version 2.1 (March 1999). From Version 10.0 and on the MSSO will discontinue the maintenance and distribution of SSCs. However, SSCs will be available to MedDRA users as archive files at the MSSO download page.
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17 Complex Changes These 17 complex changes involve HLGTs and HLTs only. Two HLGTs and five HLTs were renamed. Five HLTs were merged under other HLTs. In addition, five new HLTs were added to the hierarchy. Renamed HLGTs
Old Name New Name Infections - pathogen class unspecified Infections - pathogen unspecified
Neurological and special sense investigationsNeurological, special senses and psychiatric investigations
Renamed HLTs
Old Name New Name Cardiac pacemaker therapeutic procedures Cardiac device therapeutic procedures Scalar conditions Scaly conditions Sepsis, bacteraemia and viraemia Sepsis, bacteraemia, viraemia and fungaemia NEC Injuries due to in utero exposure Pregnancy related accidental exposures and injuries Narcolepsy associated symptoms Narcolepsy and associated conditions
Merged HLTs
Merged HLT Merged Under Diabetic eye disorders NEC Ocular disorders NEC Variola viral infections Orthopox viral infections Vaccinia viral infections Orthopox viral infections Australia viral infections Flaviviral infections Congenital cardiac valve disorders Congenital cardiovascular disorders NEC
New HLTs
Merged HLT Merged Under Diabetic eye disorders NEC Ocular disorders NEC Variola viral infections Orthopox viral infections Vaccinia viral infections Orthopox viral infections Australia viral infections Flaviviral infections Congenital cardiac valve disorders Congenital cardiovascular disorders NEC
The following tables present all PTs contained within each new HLT.
PT Mini mental status examination PT Mini mental status examination abnormal PT Mini mental status examination normal PT Neuropsychological test PT Neuropsychological test abnormal PT Psychiatric evaluation PT Psychiatric evaluation abnormal PT Psychiatric evaluation normal PT Psychiatric investigation
HLT Contraceptive Methods Male PT Condom PT Male contraception PT Male sterilisation
Several terms in MedDRA contained spelling errors and/or double spacing sometimes causing data retrieval problems. Following is a complete list of all the corrected terms.
LLT_Name_v91 LLT_Name_v10 Aminorrhea Amniorrhea Ano-rectal stenosis Anorectal stenosis Ano-rectal ulcer Anorectal ulcer Blastomyces pnemonia recurrent Blastomyces pneumonia recurrent Cerebellar or brain stem contu w /o ment of open intcran wound, with prol_ _oss cons and rtrn to pecl
Cerebellar or brain stem contu w /o ment of open intcran wound, with prol_ loss cons and rtrn to pecl
Cerebral revasculariztion synangiosis Cerebral revascularization synangiosis Chronic obstructive asthma (with obstructive pulmonary disease), wlo ment of status asthmaticus
Chronic obstructive asthma (with obstructive pulmonary disease), w/o-ment of status asthmaticus
Cns_ _complications of anesthesia or other sedation in labor and delivery, unspec as to eoc
Cns_complications of anesthesia or other sedation in labor and delivery, unspec as to eoc
Cns_ _comps of anesthesia or other sedat labor and delivered, with men of postpart comp
Cns_comps of anesthesia or other sedat labor and delivery, delivery, delivered, with men of postpart comp
Dyspepsia_ _aggravated Dyspepsia-aggravated Human immunodeficiency virus, type 2_ _infection in conditions classified elsewhere and of unspec sit
Human immunodeficiency virus, type 2_infection in conditions classified elsewhere and of unspec sit
Hypothalamo-pituitary disorders Hypothalamo-pituitary disorder Inappropriate device irritation of tissue Inappropriate device stimulation of tissue Kaschin-Beck disease_ _involving multiple sites
Kaschin-Beck disease_involving multiple sites
Kaschin-Beck disease_ _involving other specified sites
Kaschin-Beck disease_involving other specified sites
Kaschin-Beck disease_ _involving pelvic region and thigh
Kaschin-Beck disease_involving pelvic region and thigh
Mouth ulceration_ _aggravated Mouth ulceration-aggravated Oedema abdomen NOS Oedema abdomen Oth closed skull frac with intcran inj of oth and unspec nature, with prol_ _Icc, w/o rtrn to pecl
Oth closed skull frac with intcran inj of oth and unspec nature, with prol_loc, w /o rtrn to pecl
Oth open skull frac with intcran inj of oth and unspec nature, with prolonged_ _loss of
Oth open skull frac with intcran inj of oth and unspec nature, w ith prolonged_loss of
Other current conditions classifiable elsewhere of mother,_ _antepartum
Other current conditions classifiable elsewhere of mother,_antepartum
Poisoning by mixed viral-ricket and bact vaccines, except combinations with_pertussis component
Port-a-Cath insertion Portacath insertion Progression of non small cell lung cancer Progression of non-small cell lung cancer Proteinuria_ _aggravated Proteinuria-aggravated Quadriplegia and quadriparesis of_ _C1-C4, incomplete
Quadriplegia and quadriparesis of_C1-C4, incomplete
Sterilization NOS Sterilization Subdural hem following inj, with open intcran_ _wound, with moderate loc
Subdural hem following inj, with open intcran_wound, with moderate loc
Promoted LLTs-40 LLTs promoted to PT. Following are
some examples.
PT Name PT Altered state of consciousness PT Angioedema PT Atrioventricular block complete PT Carotid artery bypass PT Elective procedure PT Elective surgery PT Multiple injuries PT Nasal inflammation
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Featured LLT Changes
New LLTs-527 new LLTs. Following are a few examples.
LLT Name PT Name
New LLT Medication after taste Pharmaceutical product complaint New LLT Drug side effect Adverse drug reaction New LLT Pharmacodynamic interaction Drug interaction New LLT Pharmacokinetic interaction Drug interaction New LLT Menoxenia Menstrual disorder New LLT Emmeniopathy Menstrual disorder New LLT Uncontrolled hypertension Hypertension
Demoted PTs - 68 PT were demoted to LLT level in
version 10.0. Following are some examples.
LLT Name (former PTs in version 9.1)
ABO isoimmunisation Herpetic gingivostomatitis Adherent leukoma Herpetic stomatitis Angioneurotic oedema Impingement syndrome Anticonvulsant toxicity Intestinal spasm Arteriopathic disease Intra-nasal antrostomy Atrioventricular block third degree Intranasal numbness Bronchitis acute Intubation complication Bronchitis acute viral Isoimmunisation Buttock pain Latissimus dorsi flap Carotid artery atheroma Low tension glaucoma Catheter site bruise Pneumatic retinopexy Conductive keratoplasty Polytraumatism Corneal epithelium disorder Post procedural dizziness Cryoretinopexy Post procedural headache Dacryocanaliculitis infective Post procedural nausea Dacryocystitis infective Post procedural vomiting Death of child Postoperative infection Death of friend Pulmonary coccidioides Death of parent Rebound hypertension Death of sibling Regurgitation of food Death of spouse Renal papillitis necrotising Descemet's membrane disorder Retinal naevus Detached retina repair Ross river virus infection Difficult to wean from ventilator Sacral pain
3. Cardiac failure (SMQ) - has broad and narrow terms search option. CIOMS working group is requesting input from users regarding the development of an algorithm for this SMQ.
Cardiac Failure (SMQ) PTs=51
LLTs=295
4. Dementia (SMQ)
Dementia (SMQ) PTs=76
LLTs=572
5. Embolic and thrombotic events (SMQ)
Embolic and thrombotic events (SMQ)
Embolic and thrombotic events,
arterial (SMQ) PTs=95
LLTs=403
Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous
(SMQ) PTs=98
LLTs=334
Embolic and thrombotic events,
venous (SMQ) PTs=65
LLTs=243
6. Extrapyramidal syndrome (SMQ)
Extrapyramidal syndrome (SMQ)
Akathisia (SMQ) PTs=8
LLTs=62
Dyskinesia PTs=18
LLTs=113
Dystonia PTs=31
LLTs=203
Parkinson-like events
PTs=30 LLTs=190
7. Malignancies (SMQ)
Malignancies (SMQ)
Malignant or unspecified
tumours (SMQ) PTs=1385
LLTs=6888
Malignancy related conditions
(SMQ) PTs=35
LLTs=72
Malignancy related therapeutic
and diagnostic procedures (SMQ)
PTs=321 LLTs=805
Tumour makers (SMQ) PTs=19
LLTs=55
8. Pre-malignant disorders (SMQ)
Premalignant disorders (SMQ)
Blood premalignant
disorders (SMQ) PTs=32
LLTs=118
Gastrointestinal premalignant
disorders (SMQ)PTs=81
LLTs=262
Reproductive premalignant
disorders (SMQ) PTs=37
Skin premalignant
disorders (SMQ)PTs=18
LLTs=91 LLTs=125
9. Pseudomembranous colitis (SMQ)
Pseudomembranous colitis (SMQ)
PTs=29 LLTs=153
Back to New SMQs
Back to MedDRA Changes Highlights
Back to MedDRA 10.0 Review
MedDRA Version 10.0 Terminology Frequency Distribution