What’s New
MedDRA Version 18.0

MSSO-DI-6001-18.0.0
March 2015

Acknowledgements

ACKNOWLEDGEMENTS®

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What’s New MedDRA Version 18.0
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iiTable of Contents

Table of Contents
1.

DOCUMENT OVERVIEW ....................................................................................... 1

2.

VERSION 18.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 3
2.3 TRANSLATION CHANGES .............................................................................. 5
2.3.1

3.

French Translation Review ................................................................. 5

NEW DEVELOPMENTS IN VERSION 18.0 ........................................................... 6
3.1 UPDATES TO PRODUCT USE CONCEPTS ................................................... 6
3.2 27TH SOC TO BE IMPLEMENTED IN MEDDRA VERSION 19.0 ..................... 6
3.3 SCOPE OF MedDRA: REVISIONS TO INTRODUCTORY GUIDE .................. 7
3.4 NEW WEB-BASED BROWSER........................................................................ 7
3.5 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 8
3.6 PROACTIVITY REQUESTS ............................................................................. 8
3.6.1
3.6.2
3.6.3
3.6.4

4.

Drug Utilization Terms ........................................................................ 9‘Site’ Terms ......................................................................................... 9Classification of spine/spinal and spinal/vertebral column terms ...... 10
Pharmacogenomic Biomarkers in Drug labeling ............................... 10

SUMMARY OF CHANGES ................................................................................... 11
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ....................................... 11
4.2 SUMMARY OF IMPACT ON RECORDS IN MEDDRA FILES ........................ 13
4.3 MedDRA TERM COUNTS .............................................................................. 14
4.4 MODIFIED PT AND LLT NAMES ................................................................... 17
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 18

LIST OF FIGURES
Figure 2-1. Net Changes of Terms per SOC ....................................................... 3
LIST OF TABLES
Table 2-1 New HLGTs ......................................................................................... 4
Table 2-2 New HLTs ........................................................................................... 4
Table 2-3 Merged HLTs....................................................................................... 5
Table 3-1 Renamed SMQs .................................................................................. 8
Table 3-2 Examples of ‘site’ terms added to MedDRA ........................................ 9
Table 3-3 Example of changes to spine/spinal and spinal/vertebral terms ........ 10
Table 3-4 Examples of New Pharmacogenomic Biomarker Terms ................... 10
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs .................................... 11
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Table of Contents

Table 4-2 Summary of Impact on PTs ............................................................... 12
Table 4-3 Summary of Impact on LLTs ............................................................. 12
Table 4-4 Summary of Impact on SMQs ........................................................... 12
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 14
Table 4-6 MedDRA Term Counts ...................................................................... 16
Table 4-7 Modified PT/LLT Names.................................................................... 17
Table 4-8 LLT Currency Changes ..................................................................... 18

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ivDocument Overview

1. DOCUMENT OVERVIEWThis What’s New document contains information on the origins and types of changes
made to the Medical Dictionary for Regulatory Activities (MedDRA) between Versions
17.1 and 18.0.
Section 2, Version 18.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 18.0, highlights changes in Version 18.0
related to change request submissions, new initiatives, and information on Standardised
MedDRA Queries (SMQs).
Section 4, Summary of Changes, contains details on:•

Term history•

The impact of this version on the terminology (in tables)•

Impact on the records in MedDRA files•

MedDRA term and SMQ counts•

Modified Lowest Level Terms (LLT) and Preferred Term (PT) names•

All LLTs in MedDRA that had a currency status change.

All updated documentation associated with this version is located in the distribution filein Adobe® Portable Document Format (PDF) or, for some documents, Microsoft Excel.
Please refer to the !!Readme.txt file for a complete listing.
The Maintenance and Support Services Organization (MSSO) Help Desk can bereached at International AT&T Toll Free at 1-877-258-8280 or mssohelp@meddra.org.

What’s New MedDRA Version 18.0
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1Version 18.0 Change Requests

2. VERSION 18.0 CHANGE REQUESTS
2.1

TERMINOLOGY CHANGES

Changes to MedDRA result from user change requests, from proactivity requests
submitted by MedDRA users, and from internal change requests. Internal change
requests result from MSSO maintenance activities and from special working group
activities in which the MSSO participates.
MedDRA Version 18.0 is a complex change version which means that changes are
made at all levels of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There were a totalof 2,069 change requests processed for this version; 1,758 change requests wereapproved and implemented, and 280 change requests were not approved. There are, in
addition, 31 change requests suspended for further consideration and resolution beyond
this version.
Information on specific changes (e.g., new terms added, LLT promotions, PT
demotions, PT primary SOC changes, etc.) which occurred since the prior MedDRA
release can be obtained via the Version Report included with each respective English
language MedDRA download. In addition, users may wish to use the MedDRA Version
Analysis Tool (MVAT) which is an online tool that compares any two MedDRA versions–
including non-consecutive versions – to identify changes. The output of MVAT is similar
to the Version Report. MVAT is provided free of charge to MedDRA users as part oftheir subscription.
Between MedDRA releases, the MSSO makes available weekly supplemental update
files, which are approved changes that will be implemented for the next MedDRA
version. The supplemental files may be helpful for users to identify changes that will be
implemented in the next release.
An explanation of all changes considered (approved and not approved) for MedDRA
Version 18.0 is accessible as a cumulative Detail Report included in the MedDRA
English version download. Users may review all change requests considered by the
MSSO from MedDRA Version 5.1 to the present in WebCR.
Figure 2-1 (shown below) summarizes all changes made per System Organ Class(SOC) and may be useful to gauge the impact of changes to a specific area of
MedDRA. The data are derived from the difference in counts of primary and secondary
PT/LLTs, HLTs, and HLGTs for Version 18.0 (shown in Table 4-6) and thecorresponding information for Version 17.1. Additionally, term name changes and LLTcurrency status changes are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 18.0.

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2Version 18.0 Change Requests

53
46
71

Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders

1

48
43

Endocrine disorders
Eye disorders

80

Gastrointestinal disorders

642

General disorders and administration site…
Hepatobiliary disorders

17

Immune system disorders
Infections and infestations

71
50
521

Injury, poisoning and procedural complications

208

Investigations

55

Metabolism and nutrition disorders
Musculoskeletal and connective tissue…

71

Neoplasms benign, malignant and…
Nervous system disorders
Pregnancy, puerperium and perinatal…
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders

25
11
22
47
31

170
189

283

Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders

9

76

156

Figure 2-1. Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 18.0 included thosesubmitted by users, special initiatives, and those internally identified by the MSSO
during change request processing.
Complex change proposals were posted on the MedDRA website for feedback from the
MedDRA user community from 7 July 2014 to 1 August 2014. Complex changes were
followed by further internal review and consensus discussions which resulted in the final
approved set of 16 complex changes.
The complex changes implemented in Version 18.0 are summarized below. Please see
the “Related Documents” on the Change Request section of the MedDRA website for
specific details.
At the SOC level: No changes were made to existing SOCs.

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3

Version 18.0 Change Requests

At the HLGT level: One new High Level Grouping Term (HLGT) was added and no
HLGTs were merged as a result of complex changes in Version 18.0. The changes are
as follows:
New HLGTs
New HLGT

To SOC

Product use issues

Injury, poisoning and procedural complications
Table 2-1 New HLGTs

At the HLT level: There were eight new High Level Terms (HLTs) added and seven
HLTs merged as a result of complex changes in Version 18.0. The changes are as
follows:
New HLTs
New HLTTo SOC

Abdominal hernias NEC

Gastrointestinal disorders

Limb fractures

Musculoskeletal and connective tissue disorders

Limb fractures and dislocations

Injury, poisoning and procedural complications

Off label uses

Injury, poisoning and procedural complications

Overdoses NEC

Injury, poisoning and procedural complications

Patient positioning

Surgical and medical procedures

Product use issues NEC

Injury, poisoning and procedural complications

Underdoses NEC

Injury, poisoning and procedural complications
Table 2-2 New HLTs

Merged HLTs
Merged HLT

To HLT

SOC

Abdominal cavity hernias
NEC

Abdominal hernias NEC

Gastrointestinal disorders

Abdominal hernias, site
unspecified

Abdominal hernias NEC

Gastrointestinal disorders

Lower limb fractures

Limb fractures

Musculoskeletal andconnective tissue disorders

Lower limb fractures anddislocations

Limb fractures anddislocations

Injury, poisoning andprocedural complications

Overdoses

Overdoses NEC

Injury, poisoning andprocedural complications

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4Version 18.0 Change Requests

Merged HLT

To HLT

SOC

Upper limb fractures

Limb fractures

Musculoskeletal andconnective tissue disorders

Upper limb fractures anddislocations

Limb fractures anddislocations

Injury, poisoning andprocedural complications

Table 2-3 Merged HLTs

2.3

TRANSLATION CHANGES

2.3.1 French Translation Review
In an effort to review and improve the French translation of MedDRA, the MSSO is
conducting a review of the translation of terms from English into French. This will be an
ongoing effort that is expected to last several MedDRA releases. To assist MedDRA
users to understand changes that have been implemented, the MSSO has included a
spreadsheet in the French MedDRA Version 18.0 download which contains a list of allchanges made. This spreadsheet indicates which translation changes are conceptualchanges (i.e., change in meaning) versus those that are minor corrections such as
spelling or modifications to diacritical marks. This spreadsheet will be included in all
future versions of the French translation of MedDRA until the review is complete.
Please see the Change Request section of the MedDRA website if you wish to request
an improvement in the translation of a term or terms in any non-English version of
MedDRA.

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5New Developments in Version 18.0

3. NEW DEVELOPMENTS IN VERSION 18.0
3.1

UPDATES TO PRODUCT USE CONCEPTS

A number of MedDRA users have requested complex and related changes, including
new terms requests, to better organize the placement of product use concepts including
medication error, overdose, and underdose concepts, as well as misuse concepts andoff label use concepts. The MSSO reviewed the feedback received from these
proposals and, in collaboration with the ICH M1 Points to Consider Working Group,developed a structure to better organize product use concepts. The following points
briefly describe the approach taken. Please see the document “Implemented Complex
Changes for Version 18.0” on the Change Request section of the MedDRA website fordetails.
•

A new HLGT Product use issues has been added to SOC Injury, poisoning andprocedural complications to group related product use concepts (medication errors,
misuse, off label use, overdoses, and underdoses) in one location to facilitate coding
and retrieval, without the need for extensive multi-axial links. New HLGT Productuse issues contains four new HLTs:o HLT Product use issues NEC accommodates a mix of misuse, intentional use,
and other non-specific use concepts. This new HLT will have two new PT
concepts in addition to existing non-specific use PTs:–

PT Product use issue accommodates non-specific product use concepts
that are not specifically identified as medication errors, off label use,
misuse etc.

–

PT Intentional product use issue accommodates use issue concepts thatare known to be intentional but are not specifically identified as being
misuse or off label use.

o HLT Overdoses NEC accommodates overdose concepts that are notnecessarily maladministrations and replaces HLT Overdoses.
o HLT Underdoses NEC accommodates underdose concepts that are notnecessarily maladministrations.
o HLT Off label uses accommodates off label use concepts.
3.2

27TH SOC TO BE IMPLEMENTED IN MedDRA VERSION 19.0

The ICH MedDRA Management Board has endorsed the creation of an additional (27th)
System Organ Class in MedDRA. The 27th SOC (which is yet to be named) is being
created to accommodate non-clinical/non-patient related concepts. These terms coverissues related to medical products and are important from a regulatory perspective as
they may have an indirect effect on patient safety.
Initially, the 27th SOC will include product quality issue terms which are defined asabnormalities that may be introduced during the manufacturing/labeling, packaging,
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6New Developments in Version 18.0

shipping, handling, or storage of medical products. The existing HLGT Product quality
issues will be moved from SOC General disorders and administration site conditions to
the new SOC and will be supplemented by new terms related specifically to the
manufacturing process. The impact on organizations which are not involved withproduct manufacturing or product quality is expected to be minimal.
The 27th SOC is expected to be implemented in March 2016 in MedDRA Version 19.0.
The MSSO will provide more detailed information on the 27th SOC through documents,
webinars, broadcast emails, and other communications well in advance of the planned
implementation date in 2016. For questions on the 27th SOC, please contact the MSSO
Help Desk.
3.3

SCOPE OF MedDRA: REVISIONS TO INTRODUCTORY GUIDE

Revisions will be made to Section 1.5 (Scope of the Terminology) in the Introductory
Guide for MedDRA Version 18.0. The revised wording pertains to the types of medical
products and concepts that MedDRA supports and the potential for expansion of theterminology into new topic areas. These revisions are the result of the Blue Ribbon
Panel recommendations on the scope of MedDRA which were endorsed by the
MedDRA Management Board. The relevant wording is extracted and presented below.
“The MedDRA terminology applies to all phases of development of medical products forhuman use, excluding animal toxicology. The scope of MedDRA encompasses medical,
health-related, and regulatory concepts pertaining to such products. The terminology
also addresses the health effects and malfunction of devices (e.g., PT Device related
infection and PT Device failure). Furthermore, the terminology may also support othertypes of products which are regulated in at least one region such as food or cosmetics.”“In consultation with the MedDRA Management Board, the terminology may be
expanded in scope to accommodate additional medical/health-related and regulatory
concepts that are developed based on collaborative efforts involving relevant experts.
The addition of new topic areas will undergo the usual MSSO change request process.”
3.4

NEW WEB-BASED BROWSERThe MSSO is pleased to announce that the new MedDRA Web-Based Browser (WBB)
is available as of 1 December 2014. A MedDRA User ID and Password are required touse the application. The new WBB has features which are similar to the current
MedDRA Desktop Browser plus a few new ones. Users will be able to:
•
•
•
•
•
•
•
•

Browse the MedDRA hierarchy and SMQs
Search for MedDRA terms or codes and SMQs
View multiple supported languages simultaneously
Use Research Bin to collect terms for analysis and research purposes
View term history
View term detail information
Export search results to a spreadsheet
Access the unique features of the MedDRA Japanese translation

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7New Developments in Version 18.0

The WBB is free to all MedDRA users as part of a MedDRA subscription. Please viewor download a videocast from the Training Materials section of the MedDRA website
located under “Tools” to learn how to log into and use the WBB. Additionally, there is auser guide available.
3.5

STANDARDISED MedDRA QUERIES (SMQs)

Two new level 1 SMQs were released into production in MedDRA Version 18.0: SMQ
Respiratory failure and SMQ Tendinopathies and ligament disorders. There are now 98
level 1 SMQs in production as of this version. Please see the MedDRA Version 18.0
SMQ Introductory Guide for more information about the new SMQs including their
inclusion and exclusion criteria.
In addition to new SMQs, four SMQs related to central nervous system vasculardisorders or conditions were renamed in MedDRA Version 18.0. Terms related to thespinal cord are included in these SMQs in addition to terms related to the brain and,
therefore, renaming these SMQs better reflects the anatomical areas covered. See thetable below for the renamed SMQs.
Previous SMQ NameNew SMQ Name

Cerebrovascular disorders (SMQ)

Central nervous system vascular disorders(SMQ)

Cerebrovascular disorders, not specified as
haemorrhagic or ischaemic (SMQ)

Central nervous system vascular disorders,
not specified as haemorrhagic or ischaemic(SMQ)

Ischaemic cerebrovascular conditions (SMQ)

Ischaemic central nervous system vascularconditions (SMQ)

Haemorrhagic cerebrovascular conditions(SMQ)

Haemorrhagic central nervous system
vascular conditions (SMQ)

Table 3-1 Renamed SMQs

3.6

PROACTIVITY REQUESTS

The proactive maintenance process allows MedDRA users to propose general changes
to MedDRA outside of the established change request process. These proactivity
requests may address inconsistencies, make corrections, or suggest improvements.
During the Version 18.0 change request processing period, the MSSO evaluated fiveproactivity proposals submitted by MedDRA users. Of the five proposals, four were
implemented and one was not approved. See below for details on the implemented

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8New Developments in Version 18.0

requests. The MSSO publishes and updates a list of all proposals received and theirstatus on the Change Request section of the MedDRA website.
The MSSO is interested in learning about any ideas that users may have about“proactive” improvements to MedDRA. Please email your ideas for “proactive” MedDRA
improvements to the MSSO Help Desk. Be as specific as possible in describing yoursuggestion(s), and include a justification which explains why you think your proposal
should be implemented.
3.6.1 Drug Utilization Terms
A MedDRA user requested a review of a set of drug utilization terms for potential
inclusion into MedDRA. Based on a review by the MSSO, most of the requested
concepts were already represented in MedDRA either as direct matches or close
concepts. A total of three new terms were added (PT Clinical trial participant, PT
Planning to become pregnant, and LLT Drug supply chain interruption), and the statusof LLT Out of medication was changed to non-current because this ambiguous concept
could refer to an individual patient running out of medication or a supply chain issue.
3.6.2 ‘Site’ Terms
In two separate requests, the MSSO was asked to consider adding more ‘site’ (e.g.,administration site) concepts to MedDRA to provide more coding options for MedDRA
users. Based on this review, a total of 224 new concepts were added mostly to SOC
General disorders and administration site conditions. The MSSO’s approach was to add
a set of administration site terms similar to existing injection site terms and fill in gaps tomirror injection site terms as appropriate for vaccination site, infusion site, application
site, and medical device site terms. Appropriate secondary links were added for new
terms based on MedDRA rules and conventions described in the MedDRA Introductory
Guide. Please see the table below for examples of terms added.
PT

Primary HLT*

Application site phlebitis

Application and instillation site reactions

Infusion site hyperaesthesia

Infusion site reactions

Medical device site injury

Complications associated with device NEC

Vaccination site eczema

Vaccination site reactions

LLT

PT

Administration site joint redness

Administration site joint erythema

Application site joint redness

Application site joint erythema

Table 3-2 Examples of ‘site’ terms added to MedDRA*SOC General disorders and administration site conditions is the primary SOC

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9New Developments in Version 18.0

3.6.3 Classification of spine/spinal and spinal/vertebral column terms
The MSSO was asked to review the specific choice of term or hierarchical placement ofvarious MedDRA concepts relating to the anatomy of the back which are not always
consistent with respect to bony structures or to nervous/soft tissues. Many of theseterms are derivations of ‘vertebra,’ ‘spine’, and ‘back.’ Of the total 1,366 LLT, PT, HLT,
and HLGT applicable MedDRA terms reviewed, 12 change requests were implemented
to ensure the consistent use of these terms. The changes pertained to consistency ofterm definition, term status, and hierarchical relationships. See below for an example:
LLT Spinal hematoma was made non-current because it is an ambiguous term; ’spinal’
could refer to the spinal cord or to the bony structure/vertebra.(See also Section 4.5).

LLT

MedDRA v17.1

Spinal hematoma

MedDRA v18.0

Status

LLT

StatusCurrent

Spinal hematoma

Non-current

Table 3-3 Example of changes to spine/spinal and spinal/vertebral terms

Section 5.1 of the Introductory Guide to MedDRA will be updated to include a statement
explaining that, for purpose of MedDRA, spine/spinal terms are considered synonymouswith vertebral and spinal column concepts rather than with the spinal cord, unless"spinal” clearly represents a neurological concept such as PT Spinal claudication.
3.6.4 Pharmacogenomic Biomarkers in Drug labeling
A MedDRA user requested the MSSO to consider adding additional medically relevant
pharmacogenomics biomarker terms to MedDRA to provide more options for coding
and analysis. After reviewing the proposal, the MSSO added 72 new medically relevant
pharmacogenomic terms to MedDRA and made changes to four existing terms. Please
see the table below for examples.
New PT

Primary HLTPrimary SOC

HLA-B*5701 assay
positive

Cell marker analyses

Investigations

HER-2 protein
overexpression

Acquired gene mutations andother alterations

General disorders andadministration site conditions

ESR1 positive

Oestrogen receptor assay
positive

Investigations

PgR positive

Progesterone receptor assay
positive

Investigations

New LLTPT

Primary SOC

Table 3-4 Examples of New Pharmacogenomic Biomarker Terms

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10Summary of Changes

4. SUMMARY OF CHANGES
4.1

SUMMARY OF IMPACT ON THE TERMINOLOGY

The tables below (Tables 4-1 through 4-5) summarize the impact on MedDRA in
Version 18.0. These tables are intended only as a reference. For detailed information on
the changes to Version 18.0, please see the MedDRA Version Report included within
the English language download.
SOC, HLGT, HLT Changes
Level Change Request Action Net Change v17.1 v18.0
SOC

HLGT

HLT

Total SOCs

0

26

26

New HLGTs

1

01

Merged HLGTs

0

0

0

Total HLGTs1

1

334

335

New HLTs808Merged HLTs

7

0

7

Total HLTs1

1

1,720

1,721

Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs

1

Total net change of HLGTs or HLTs equals the number of new HLGTs or HLTs minus
the number of respective merged HLGTs or HLTs.
PT Changes
Level Change Request Action
PT

v17.1

v18.0

New PTs

281

557

Promoted LLTs

32

23

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11Summary of Changes

Level Change Request Action

v17.1

v18.0

Demoted PTs

64

43

Net Change1

249

537

Total PTs

20,80821,345

Table 4-2 Summary of Impact on PTs
1

Net change of PTs equals the number of new PTs plus the number of promoted LLTs
minus the number of demoted PTs.
LLT Changes
Level Change Request Action Net Change
LLT

Total LLTs1

1,008

v17.1

v18.0

73,221

74,229

Table 4-3 Summary of Impact on LLTs
1

Total LLTs include PTs as they are also represented as LLTs.
New SMQs
Level Net Change

v17.1

v18.0

1

2

96

98

2

0

82

82

3

0

20

20

4

0

12

12

5

0

2

2

Table 4-4 Summary of Impact on SMQs

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12Summary of Changes

4.2

SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES

The table below summarizes the impact on MedDRA in Version 18.0. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

HLT_PT.ASC

MDHIER.ASC

PT.ASC

LLT.ASC

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Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

1

Removed0Modified

0

Added

1

Removed0Modified

0

Added

8

Removed7

Modified

0

Added

8

Removed7

Modified

0

Added

1,059

Removed189

Modified

0

Added

1,264

Removed228

Modified

0

Added

580

Removed43

Modified

19

Added

1,008

Removed013

Summary of Changes

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Modified

254

Added1

2

Removed0Modified

212

Added

1,657

Removed0Modified

181

Table 4-5 Summary of Impact on Records in MedDRA Files1

The number of SMQs added includes both top level (Level 1) and sub-search SMQs.

4.3

MedDRA TERM COUNTS

The table below shows term counts by SOC for HLGTs, HLTs, primary and secondary
PTs and LLTs, and primary PTs and LLTs.

SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,101

271

4,072

940

87

17

Cardiac disorders

1,367

307

2,245

553

36

10

Congenital,familial andgenetic disorders

3,282

1,227

3,282

1,227

98

19

Ear and labyrinth
disorders

417

81

761

190

17

6

Endocrine
disorders

631

176

1,675

489

38

9

Eye disorders

2,365

563

3,541

940

64

13

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HLTs3 HLGTs3

14

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2Gastrointestinal
disorders

3,680

813

7,206

1,613

108

21

General disordersandadministration site
conditions

2,815

1,065

3,542

1,315

49

9

Hepatobiliary
disorders

617

179

1,377

398

19

4

Immune systemdisorders

414

122

2,398

624

26

4

Infections andinfestations

6,866

1,822

7,177

1,903

149

12

Injury, poisoning
and procedural
complications

6,153

994

8,349

1,974

69

8

Investigations

13,121

5,305

13,121

5,305

106

23

Metabolism andnutrition disorders

925

267

2,489

699

63

14

Musculoskeletaland connective
tissue disorders

2,348

414

6,111

1,161

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,344

1,880

8,995

2,144

201

39

Nervous systemdisorders

3,372

873

6,680

1,757

107

20

What’s New MedDRA Version 18.0
March 2015
MSSO-DI-6001-18.0.0

HLTs3 HLGTs3

15

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

Pregnancy,
puerperium andperinatalconditions

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

1,602

212

2,786

546

48

8

Psychiatricdisorders

2,199

488

2,996

698

78

23

Renal and urinary
disorders

1,166

328

2,482

680

32

8

Reproductive
system andbreast disorders

1,682

459

4,020

1,107

52

16

Respiratory,
thoracic andmediastinal
disorders

1,594

487

3,932

1,054

48

11

Skin andsubcutaneous
tissue disorders

1,949

457

4,458

1,264

56

10

Socialcircumstances

605

256

605

256

20

7

Surgical andmedicalprocedures

4,367

2,015

4,367

2,015

141

19

Vasculardisorders

1,247

284

6,217

1,461

68

11

Total

74,22921,345

HLTs3 HLGTs3

Table 4-6 MedDRA Term Counts

1

Primary count only includes the number of terms that are primarily linked to thedesignated SOC at either the LLT level or the PT level. The sums of primary LLTs andPTs match those in Tables 4-2 and 4-3.
What’s New MedDRA Version 18.0
March 2015
MSSO-DI-6001-18.0.0

16Summary of Changes
2

Total count includes the number of terms that are both primarily and secondarily linked
to the designated SOC at either the LLT level or the PT level. Therefore, the sums of
total LLTs and PTs are greater than those in Tables 4-2 and 4-3.
3

The HLT and HLGT counts are not necessarily unique values given MedDRA’s multiaxiality (see Section 2.2 of the Introductory Guide for a discussion of multi-axiality).
There are some HLTs that are counted in more than one SOC. For example, HLT
Connective tissue disorders congenital and HLGT Musculoskeletal and connective
tissue disorders congenital are counted in both SOC Congenital, familial and genetic
disorders and SOC Musculoskeletal and connective tissue disorders. The sums of HLTs
and HLGTs are greater than those found in Table 4-1.
4.4

MODIFIED PT AND LLT NAMESAs part of ongoing MedDRA maintenance activities, existing PTs and LLTs can be
modified (renamed) to correct for misspelling, double spacing, capitalization, or othererrors that meet the renaming criteria in MedDRA. This rename provision retains theoriginal MedDRA code of the term and preserves its original meaning, and facilitates thereuse of the same MedDRA code for the renamed PT/LLTs.
The table below lists the seven terms renamed in English MedDRA Version18.0.
Code

Level

Term Name in v17.1

Term Name in v18.0

10074231

LLT

Biliocutaneus fistula

Biliocutaneous fistula

10075460

PT

Blastic plasmacytoid denditric cell
neoplasia

Blastic plasmacytoid dendritric cell
neoplasia

10071595PT

C-KIT receptor assay

C-kit receptor assay

10066835

PT

Eagles syndrome

Eagle's syndrome

10074991

LLT

Nipple alveolar complex resection

Nipple areolar complex resection

10059202

LLT

Peter's anomalyPeters anomaly

10053780

LLT

Well's syndrome

Wells syndrome

Table 4-7 Modified PT/LLT Names

What’s New MedDRA Version 18.0
March 2015
MSSO-DI-6001-18.0.0

17Summary of Changes

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the nine terms at the LLT level in MedDRA Version 18.0 thathave a change in their currency status along with the rationale for the change.
Currency
StatusChanged to

Rationale

Current

A change to current status adds this common colloquial
term to enhance coding options in English and otherlanguages.

Nonexudative senile
macular degeneration ofretinaCurrent

Both existing LLTs - LLT Nonexudative senile maculardegeneration of retina and hyphenated LLT Nonexudative senile macular degeneration of retina are
accepted as correct spellings of the expression.

Tummy ache

Current

A change to current status adds this common colloquial
term to enhance coding options in English and otherlanguages.

Adenomegaly

Non-current

Breast excisionNon-current

Open fracture of C5-C7
level with unspecified
spinal cord injury

Non-current

Out of medication

Non-current

Spinal haematoma

Non-current

Spinal hematoma

Non-current

Lowest Level Term

Belly ache

The concept can be represented by one of the multiple
existing LLTs under PT Lymphadenopathy such as LLT
Swollen lymph nodes.
Even though in clinical practice "breast excision" mainlyrefers to excision of a part of the breast, it may be also beinterpreted as a synonym of mastectomy. Therefore, forclarification of the concept, LLT Breast excision will bemade non-current and replaced by a new LLT Breast
lump excision under PT Breast lump removal.
This LLT represents a combination concept which does
not conform to MedDRA conventions. This change wasmade as part of the proactivity request to review theclassification of spinal terms versus conditions ofvertebrae. See Section 3.6.3.
"Out of medication" can be considered ambiguous as it
could refer to an individual patient running out of
medication or a supply chain issue.
Spinal haematoma is ambiguous because "Spinal" canrefer to either spinal cord or the bony structure/vertebra.
This change was made as part of the proactivity request
to review the classification of spinal terms versus
conditions of vertebrae. See Section 3.6.3.
Spinal hematoma is ambiguous because "Spinal" canrefer to either spinal cord or the bony structure/vertebra.
This change was made as part of the proactivity request
to review the classification of spinal terms versus
conditions of vertebrae. See Section 3.6.3.

Table 4-8 LLT Currency Changes
What’s New MedDRA Version 18.0
March 2015
MSSO-DI-6001-18.0.0

18