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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.


release) _ smq_intguide.pdf

SMQ Introductory Guide is a document that describes

SMQs basic concepts



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



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.



release) _ conseq.pdf

MedDRA Consecutive File Documentation contains

consecutive files' description and fields definitions.



release) _ changereq_info.pdf

Change Request Information document provides all information regarding

terminology change requests



release) _ sub_pot.pdf

Subscriber Portfolio document contains details

about your MedDRA subscription



release) _ phonecard.pdf

MedDRA MSSO Phone System provides information on how to access the MSSO

by phone



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


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


release) MedAscii pt.asc

Prefer Term file. Contains all PT in the

hierarchy.

Follow instructions asciidoc.pdf document to use in a relational

database.


release) MedAscii hlt.asc

High Level Term file. Contains all HLT in the

hierarchy.


database.


release) MedAscii hlgt.asc

High Level Group Term file.Contains all HLGT in the

hierarchy.


database.


release) MedAscii soc.asc

System Organ Class file. Contains all 26 SOCs in the

hierarchy.


database.


release) MedAscii mdhier.asc

MedDRA Hierarchy file. Contains the MedDRA

hierarchy excluding LLTs.


database.


release) MedAscii hlt_pt.asc

PT & HLT codes file. Contains all PT-HLT

associations.


database.

MedDRA10(most recent version

release) MedAscii hlgt_hlt.asc

HLT & HLGT codes file.Contains all HLT-HLGT

associations.


database.


release) MedAscii soc_hlgt.asc

HLGT & SOC codes file. Contains all HLGT-SOC

associations.


database.


release) MedAscii spec.asc

Special Search Categories (SSC) file.

Contains a list of all Special Search Categories.


database.


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.


database.


release) MedAscii SMQ_List.asc

Standardised MedDRA Query (SMQ) list file.

Contains a complete list of all production (means available

for use) SMQs.


database.


release) MedAscii SMQ_Content.asc

Standardised MedDRA Query (SMQ) content file.

Contains all production SMQs and their respective subordinate terms.


database.


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)


database.



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.


release) SeqAscii pt.seq

Prefer Term file. Contains all PT changes since previous version.




release) SeqAscii hlt.seq

High Level Term file. Contains all HLT changes

since previous version.




release) SeqAscii hlgt.seq

High Level Group Term file.Contains all HLGT changes





release) SeqAscii soc.seq

System Organ Class file. Contains all SOCs changes





release) SeqAscii mdhier.seq

MedDRA Hierarchy file. Contains the MedDRA

hierarchy changes since previous version.




release) SeqAscii hlt_pt.seq

PT & HLT codes file. Contains all PT-HLT changes





release) SeqAscii hlgt_hlt.seq

HLT & HLGT codes file. Contains all HLT-HLGT changes since previous

version.



MedDRA10(most recent version

release) SeqAscii soc_hlgt.seq

HLGT & SOC codes file.Contains all HLGT-SOC

associations.




release) SeqAscii spec.seq

Special Search Categories (SSC) file.

Contains a list of all Special Search Categories changes





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.




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)




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.


Very useful file for MedDRA version upgrade reviews.

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http://www.meddramsso.com/translations/downloads.htm










MedDRA 10.0 Changes: Overview

MedDRA® Terminology Version 10.0 released in March 1, 2007 contains both

simple and complex changes. Following is a summary of the changes and several

examples. To view a complete list of all terminology changes in version 10.0 go

to:

Version Report - http://www.meddramsso.com/Translations/downloads.htm

(subscriber login required).

Changes In a Nutshell

Retirement of SSCs

17 Complex Changes

Double Spaced Terms and Other Existing Errors

New SMQs


Changes Highlights

Featured HLGT Changes

Featured HLT Changes

Featured PT Changes New PTs

Promoted LLTs

http://www.meddramsso.com/Translations/downloads.htm

Featured LLT Changes New LLTs

Demoted PTs

Currency changes

Featured SMQ Changes New SMQs

MedDRA Version 10.1 - What's coming ahead?



Changes In a Nutshell

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.

HLT Biochemical markers of bone metabolismPT C-telopeptide PT Deoxypyridinoline urine increased PT Deoxypyridinoline/creatinine ratio PT N-telopeptide PT N-telopeptide urine PT N-telopeptide urine abnormal PT N-telopeptide urine decreased PT N-telopeptide urine increased PT N-telopeptide urine normal PT Osteocalcin PT Osteocalcin decreased PT Osteocalcin increased PT Osteoprotegerin PT Osteoprotegerin decreased PT Osteoprotegerin increased PT Osteoprotegerin ligand PT Osteoprotegerin ligand decreased PT Pyridinoline urine PT Pyridinoline urine decreased PT Pyridinoline urine increased

HLT Psychiatric Investigations

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

HLT Orthopox viral infections PT Cow pox PT Smallpox PT Eczema vaccinatum PT Post vaccination autoinoculation PT Vaccinia

Paraneoplastic syndromes NEC PT Eaton-Lambert syndrome PT Hypercalcaemia of malignancy PT Polyneuropathy in malignant disease PT Paraneoplastic cerebellar degenerationPT Paraneoplastic pemphigus PT Paraneoplastic syndrome PT Acrokeratosis paraneoplastica PT Paraneoplastic retinopathy PT Paraneoplastic dermatomyositis

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Double Spaced Terms and Other Existing Errors

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

Pancreatic_ _secretion decreased Pancreatic-secretion decreased Pancreatic_ _secretion increased Pancreatic-secretion increased PDA_ _Repair patent ductus arteriosus PDA_Repair patent ductus arteriosus Poisoning by mixed viral-ricket and bact vaccines, except combinations with_ _pertussis component

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

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New SMQs

1. Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) (SMQ) 2. Convulsions (SMQ) 3. Cardiac failure (SMQ) 4. Dementia (SMQ) 5. Embolic and thrombotic events (SMQ) 6. Extrapyramidal syndrome (SMQ) 7. Malignancies (SMQ) 8. Pre-malignant disorders (SMQ) 9. Pseudomembranous colitis (SMQ)

For more details about these new SMQs, go to Changes Highlights, Featured SMQ Changes.

Back to Changes in a Nutshell

Or


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Changes Highlights

Featured HLGT Changes

See previous section: 17 Complex Changes

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Featured HLT Changes

See previous section: 17 Complex Changes

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Featured PT Changes

New PTs - 242 new PTs. Following are some examples.

Promoted LLTs-40 LLTs promoted to

http://www.meddrahelp.com/4_6_07_MedDRA_10_0_Review-overview.htm#_Featured_SMQ_changes

http://www.meddrahelp.com/4_6_07_MedDRA_10_0_Review-overview.htm#_Featured_SMQ_changes

http://www.meddrahelp.com/4_6_07_MedDRA_10_0_Review-overview.htm#_Featured_PT_Changes

PT Name

PT Inner ear inflammation PT Ocular surface disease PT Localised intraabdominal fluid collection PT Regurgitation PT Stomach mass PT Catheter thrombosis PT Surgical failure PT Disuse syndrome PT Treatment failure PT Vaccine positive rechallenge PT Post procedural infection PT Superinfection fungal PT Superinfection viral PT Superinfection bacterial PT Weaning failure PT Procedural nausea PT Deep vein thrombosis postoperative PT Procedural vomiting PT Procedural headache PT Procedural dizziness PT Device misuse PT Tumour related complication PT Hemisensory neglect PT Visual midline shift syndrome PT Progressive relapsing multiple sclerosis PT Taciturnity PT Violent ideation PT Polymedication

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

Dry socket Single vessel bypass graft Epithelioma Streptococcal serology Extrinsic iliac vein compression Streptococcal serology negative Familiar hemiplegic migraine Streptococcal serology positive Genital pain female Superinfection lung Genital pain male Superinfection oral Genital pruritus female Therapy non-responder Genital pruritus male Uterine cervix hypertrophy Genitalia external painful Vascular ultrasound Hepatic trauma Vessel puncture site bruise

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Currency changes - the following 22 LLTs were made

Non-Current (inactive) in version 10.0 LLT Name

AML progressionAsthenia legsBlood gases abnormCollapsed semi conscious & shockedCongenital musculoskeletal abnormFamiliar hemiplegic migraineFear, focusGases blood abnormHaemangioma-thrombocytopaenia syndromeHesitancy/poor urinary streamLiver function tests multiple abnormMental disorders of motherNeck muscle torsion ofNo drug reactionNon-toxic multinodular goitreNon-toxic nodular goitreNon-toxic uninodular goitrePseudothrombocytopaeniaSpinal fluid abnormSynovitis wrists & feetThrombocytopaeniaVisual evoked potentials abnorm.

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Featured SMQ Changes New SMQs

1. 1. Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) (SMQ)

Adverse pregnancy outcome/reproductive Toxicity (incl

neonatal disorders (SMQ)

Reproductive toxicity (SMQ)

PTs=115 LLTs=529

Pregnancy complications

PTs=200 LLTs=1443

Congenital, familial and

genetic disorders PTs=1010

LLTs=2847

Disorders of the offspring PTs=245

LLTs=954

2. 2. Convulsions (SMQ) Convulsions (SMQ)

PTs=52 LLTs=233

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


MedDRA Version 10.0 Terminology Frequency Distribution

by MedDRA Version

Level Version

7.0 Version

7.1 Version

8.0 Version

8.1 Version

9.0 Version

9.1 Version

10.0 SOC 26 26 26 26 26 26 26 HLGT 332 332 332 332 332 332 332 HLT 1,681 1,681 1,683 1,683 1,682 1,682 1,682 PT 16,449 16,559 16,751 16,976 17,320 17,505 17,719 LLT

Current LLT's Non-current

LLT's

61,204 52,253 8,951

61,704 52,740 8,964

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

Total 79,692 80,302 81,140 81,967 83,177 84,165 84,906


MedDRAVersion 10.1 - What's Coming Ahead?

• MedDRA terminology next release, version 10.1, is September 2007.

• SMQs in development/testing that will most likely be released in

version 10.1

Acute central respiratory depression

Gastrointestinal perforation, ulceration, haemorrhage or

obstruction

Oropharyngeal lesions

Psychosis and psychotic disorders

Thrombophlebitis

Back to MedDRA Changes Highlights or


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