C

What’s New
MedDRA Version 23.0

March 2020
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Acknowledgements

ACKNOWLEDGEMENTS
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Table of Contents

Table of Contents
1.

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

2.

VERSION 23.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 33.

NEW DEVELOPMENTS IN VERSION 23.0 ........................................................... 6
3.1 BRAZILIAN PORTUGUESE MedDRA .............................................................. 6
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 6
3.3 DEVICE PROBLEM TERMS............................................................................. 6
3.4 RARE AND ORPHAN DISEASES .................................................................... 7
3.5 UPDATES TO THE PLACEMENT OF GENE CONCEPTS .............................. 7
3.6 PROACTIVITY REQUESTS ............................................................................. 8
3.6.1
Review of “disseminated” or “systemic” concepts ............................... 9
3.6.2
Placement of “abrasion” terms ............................................................ 9
3.7 MedDRA MOBILE BROWSER MULTI-LINGUAL INTERFACE ...................... 10

4.

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
Figure 3-1 Mobile MedDRA Browser Multi-lingual interface ............................... 10
LIST OF TABLES
Table 2-1 New HLGTs ......................................................................................... 4
Table 2-2 Merged HLGTs .................................................................................... 4
Table 2-3 New HLTs ........................................................................................... 4
Table 2-4 Merged HLTs....................................................................................... 5
Table 2-5 Moved HLTs ........................................................................................ 5
Table 3-1 Device Problem Terms ........................................................................ 7
Table 3-2 Examples of Rare and Orphan Disease Terms ................................... 7
Table 3-3 Gene concept placement updates ....................................................... 8
Table 3-4 Examples of updates to “disseminated” and “systemic” concepts ....... 9
Table 3-5 Changes to “abrasion” terms ............................................................... 9
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs .................................... 11
Table 4-2 Summary of Impact on PTs ............................................................... 12
Table 4-3 Summary of Impact on LLTs ............................................................. 12
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Table of Contents

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 .................................................................... 18
Table 4-8 LLT Currency Changes ..................................................................... 18

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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
22.1 and 23.0.
Section 2, Version 23.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 23.0, highlights changes in Version 23.0
related to change request submissions, new initiatives, information on Standardised
MedDRA Queries (SMQs), and any recent updates to software tools provided by the
MSSO.
Section 4, Summary of Changes, contains details on:

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



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.

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Version 23.0 Change Requests

2. VERSION 23.0 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 23.0 is a complex change version which means that changes may bemade at all levels of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 2,083 change requests processed for this version; 1,850 change requests wereapproved and implemented, and 225 change requests were not approved. There are, in
addition, 8 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 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 of theirsubscription.
Between MedDRA releases, the MSSO makes available weekly supplemental update
files, which are approved changes that will be implemented for the next MedDRA
version. Additionally, supplemental changes may be viewed in MedDRA Web-Based
Browser via the “supplemental view” feature. Supplemental information 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 23.0 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 23.0 (shown in Table 4-6) and thecorresponding information for Version 22.1. 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 23.0.

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Version 23.0 Change Requests

Figure 2-1 Net Changes of Terms per SOC

The changes in SOC General disorders and administrative site conditions and SOC
Congenital, familiar and genetic disorders was due to the complex changes to update
the placement of gene concepts in MedDRA. See sections 2.3 and 3.5 of thisdocument for more details. The number of changes in SOC Skin and subcutaneous
tissue disorders was mostly due to the addition of secondary links to “burn” PTs such as
PT Thermal burn, which have many underlying LLTs.
2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 23.0 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 29 July 2019 to 20 September 2019. Complex changes
were followed by further internal review and consensus discussions which resulted in
the final approved set of 12 complex changes.
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Version 23.0 Change Requests

The complex changes implemented in Version 23.0 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.
At the HLGT level: There was one High Level Group Term (HLGT) added and one
merged as a result of complex changes in Version 23.0. The changes are as follows:
New HLGTs
New HLGT

To SOC

Chromosomal abnormalities, genealterations and gene variants

Congenital, familial and genetic disorders

Table 2-1 New HLGTs

Merged HLGTs
HLGT

To HLGT

Chromosomal abnormalities
and abnormal gene carriers

Chromosomal abnormalities,
gene alterations and genevariants

SOC
Congenital, familial andgenetic disorders

Table 2-2 Merged HLGTs

At the HLT level: There were three High Level Terms (HLTs) added, three merged
and four moved as a result of complex changes in Version 23.0. The changes are as
follows:
New HLTs
New HLTTo SOC

Abdominal and gastrointestinal injuries
NEC

Injury, poisoning and procedural
complications

Gene mutations and other alterations NEC

Congenital, familial and genetic disorders

Genetic polymorphisms

Congenital, familial and genetic disorders
Table 2-3 New HLTs

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Version 23.0 Change Requests

Merged HLTs
HLT

To HLT

SOC

Abdominal injuries NEC

Abdominal andgastrointestinal injuries NEC

Injury, poisoning andprocedural complications

Acquired gene mutations andother alterations

Gene mutations and otheralterations NEC

Congenital, familial andgenetic disorders

Oral soft tissue pain andparaesthesia

Oral soft tissue signs andsymptoms

Gastrointestinal disorders

Table 2-4 Merged HLTs

Moved HLTs
HLT
Abnormal genecarriers
Autosomal
chromosomal
abnormalities
Chromosomal
abnormalities NEC

Sex chromosomal
abnormalities

From HLGT
Chromosomal
abnormalities
and abnormal
gene carriers
Chromosomal
abnormalities
and abnormal
gene carriers
Chromosomal
abnormalities
and abnormal
gene carriers
Chromosomal
abnormalities
and abnormal
gene carriers

To HLGT
Chromosomal
abnormalities, genealterations and genevariants
Chromosomal
abnormalities, genealterations and genevariants
Chromosomal
abnormalities, genealterations and genevariants
Chromosomal
abnormalities, genealterations and genevariants

SOC
Congenital, familial
and genetic disorders

Congenital, familial
and genetic disorders

Congenital, familial
and genetic disorders

Congenital, familial
and genetic disorders

Table 2-5 Moved HLTs

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New Developments in Version 23.0

3. NEW DEVELOPMENTS IN VERSION 23.0
3.1

BRAZILIAN PORTUGUESE MedDRA

The MSSO is pleased to announce that as of Version 23.0, Brazilian Portuguese
MedDRA will be available to support the use of MedDRA in Brazil. Brazilian Portuguese
MedDRA is provided to all users at no additional cost and includes the MedDRA term
files, availability in the MedDRA Web-Based Browser and all the related documentationthat is provided in other supported languages. Users may access Brazilian Portuguese
MedDRA from the MedDRA website in the same manner as other languages. The
MSSO will continue to maintain the European Portuguese translation of MedDRA.
Note that a Brazilian Portuguese Version Report and accessibility of Brazilian
Portuguese term information in MVAT will be available in September 2020 when
Version 23.1 debuts as there are not yet two Brazilian Portuguese versions to generate
a comparison. For any specific questions about Brazilian Portuguese MedDRA and how
to access it, please contact the MSSO Help Desk.
3.2

STANDARDISED MedDRA QUERIES (SMQs)

The SMQ Opportunistic infections was added in MedDRA Version 23.0. There are now
106 level 1 SMQs in production as of this version. In addition, there were 499 approved
PT changes to existing SMQs. To view changes to existing SMQs, please review the
MedDRA Version 23.0 Version Report.
Please see the MedDRA Version 23.0 SMQ Introductory Guide for detailed information
on new SMQ Opportunistic infections.

3.3

DEVICE PROBLEM TERMS

The MSSO added 114 terms and made 10 changes to existing terms as part of an
initiative to include additional device problems in MedDRA. See the table below for
examples.

LLT
Device fluid leakDevice overinfusion
Device difficult toprogramPT

HLT

Device leakage

Device issues NEC

Product issues

Device infusion
issue
Device difficult
to useDevice malfunction
events NEC
Medication errors,
product use errors
and issues NEC

Product issues

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Primary SOC

Injury, poisoning andprocedural
complications

6

New Developments in Version 23.0

LLT

PT

Incorrect
measurement bydeviceDeviceinformation
output issue

HLT
Device information
output issues

Primary SOC
Product issues

Table 3-1 Device Problem Terms

3.4

RARE AND ORPHAN DISEASESThe MSSO has added a set of 86 terms as part of an initiative to aid in coding
indications for rare and orphan diseases. See the table below for examples.
LLT

PT

HLT

Amyloid light-chain
amyloidosisPrimaryamyloidosis

Amyloidoses

Immune systemdisorders

Idiopathic CD4lymphocytopenia
FOXN1 deficient
severe combined
immunodeficiency

Idiopathic CD4lymphocytopenia

Leukopenias NEC

Blood and lymphatic
system disorders

Immune system

Combinedabnormalities
immunodeficiency congenital

Primary SOC

Congenital, familial
and genetic disorders

Table 3-2 Examples of Rare and Orphan Disease Terms

3.5

UPDATES TO THE PLACEMENT OF GENE CONCEPTS

In Version 23.0, several terminology grouping changes were incorporated in SOC
Congenital, familial and genetic disorders to improve the hierarchical placement of thegene concepts. HLGT Chromosomal abnormalities and abnormal gene carriers was
replaced with new HLGT Chromosomal abnormalities, gene alterations and genevariants to represent that SOC Congenital, familial and genetic disorders is intended tocover gene concepts, whether they are acquired or congenital.
HLT Gene mutations and other alterations NEC was added to new HLGT Chromosomal
abnormalities, gene alterations and gene variants, and former HLT Acquired genemutations and other alterations was merged into the new HLT Gene mutations andother alterations NEC. This new HLT groups all gene conditions and alterations such as
overexpressions, rearrangements, and mutations together, regardless of whether they
are congenital or acquired, and separates gene concepts from chromosomal concepts
which are represented in other HLTs of SOC Congenital, familial and genetic disorders.

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New Developments in Version 23.0

Also, new HLT Genetic polymorphisms was added to HLGT Chromosomal
abnormalities, gene alteration and gene variants. The creation of an HLT for genetic
polymorphisms, which are considered gene variants rather than gene alterations, aids inthe coding and retrieval of these concepts.
Section 6.3 of the Introductory Guide MedDRA Version 23.0 has been updated to reflect
these changes. Additionally, 186 modifications were made to update the placement of
the underlying PTs. See the examples in the table below.

PT Moved

From HLTIn SOCTo HLT

In SOC

Acquired genemutation

Acquired genemutations andother alterations

Generaldisorders andadministrationsite conditions

Gene mutations
and otheralterations NEC

Congenital,familial andgenetic
disordersAcquired
mitochondrial
DNA deletion

Acquired genemutations andother alterations

Generaldisorders andadministrationsite conditions

Genetic
mitochondrial
abnormalities
NEC

Congenital,familial andgenetic
disorders

NAT1
polymorphism

Acquired genemutations andother alterations

Generaldisorders andadministrationsite conditions

Genetic
polymorphisms

Congenital,familial andgenetic
disorders

Vascularendothelial
growth factor
overexpression

Acquired genemutations andother alterations

Generaldisorders andadministrationsite conditions

Gene mutations
and otheralterations NEC

Congenital,familial andgenetic
disordersTable 3-3 Gene concept placement updates

For more information on the complex changes, please see section 2.2.

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 23.0 change request processing period, the MSSO reviewed three
requests and implemented two of them. See below for details. The MSSO publishes
and updates a list of all proposals received and their status 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 your

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New Developments in Version 23.0

suggestion(s), and include a justification which explains why you think your proposal
should be implemented.
3.6.1 Review of “disseminated” or “systemic” concepts
The MSSO assessed the placement of existing terms containing “disseminated” or“systemic” to improve the consistency of their placement in MedDRA as part of aproactive review requested by a MedDRA User. As a result of this review, 27 changes
were made to better align these concepts and represent disseminated infection
concepts at the PT level. See the examples in the table below.
New PT

HLT

Primary SOC

Disseminatedtoxoplasmosis

Toxoplasma infections

Infections and infestations

Promoted LLT

From PTTo HLT

Primary SOC

Disseminatedblastomycosis

Blastomycosis

Blastomyces
infections

Infections and infestations

Table 3-4 Examples of updates to “disseminated” and “systemic” concepts

3.6.2 Placement of “abrasion” terms
A MedDRA user requested a review of existing abrasion terms for consistency ofplacement in MedDRA. After reviewing the mapping of existing abrasion LLTs to injury
PTs for appropriate representation of the underlying medical concept, the MSSO moved
six existing abrasion LLTs from their erosion PTs to corresponding injury PTs. In
addition, three new abrasion LLTs were added to corresponding injury PTs to improvecoding options. See the tables below for examples.
LLT Moved

From PT

To PT

Abrasion of teeth

Tooth erosion

Tooth injury

Injection site abrasion

Injection site
erosionInjection site injury

New LLTTo PT

Lip abrasion

Lip injury

Mouth abrasion

Mouth injury

Table 3-5 Changes to “abrasion” terms
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New Developments in Version 23.0

3.7

MedDRA MOBILE BROWSER MULTI-LINGUAL INTERFACEThe MSSO deployed a web-based mobile version of MedDRA Browser (MMB) in April
2019 designed to work on smartphones and tablet computers. In January 2020, theMMB was updated with a multi-lingual user interface (UI) for use on iOS and Android
mobile devices. Users may choose any of the MedDRA languages as the UI language,
including Chinese, Czech, Dutch, English, French, German, Hungarian, Italian,Japanese, Korean, Portuguese, Russian, and Spanish. In March 2020, with the releaseof Brazilian Portuguese MedDRA, the UI will also be available in Brazilian Portuguese.

Figure 3-1 Mobile MedDRA Browser Multi-lingual User Interface

To access the MMB, simply login using your MedDRA ID and Password. This password
is the same password used to access the MedDRA website and other applications suchas the Web-Based Browser and MVAT. If you don’t know your User ID and Password,
please use the MedDRA Self-Service Application.

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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 23.0. These tables are intended only as a reference. For detailed information on
the changes to Version 23.0, please see the MedDRA Version Report included within
the MedDRA download or in MVAT.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v22.1 v23.0

SOC

Total SOCs

0

27

27

New HLGTs

1

01

Merged HLGTs

1

0

1

Total HLGTs1

0

337

337

New HLTs303

Merged HLTs

3

0

3

Total HLTs1

0

1,737

1,737

HLGT

HLT

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

v22.1

v23.0

New PTs

294

346

Promoted LLTs

25

46

PT

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Summary of Changes

Level Change Request Action

v22.1

v23.0

Demoted PTs

73

57

Net Change1

246

335

Total PTs

23,95424,289

Table 4-2 Summary of Impact on PTs
1Net change of PTs equals the number of new PTs plus the number of promoted LLTs

minus the number of demoted PTs.
LLT Changes
Level

Currency Status

Net Change

v22.1

v23.0

LLT

Current Terms

913

71,60372,516

LLT

Non-current Terms

5

9,291

9,296

LLT

Total LLTs1

918

80,894

81,812

Table 4-3 Summary of Impact on LLTs

1Total LLTs include PTs as they are also in the LLT distribution file.

New SMQs
Level Net Change

v22.1

v23.0

1

1

105

106

2

0

82

82

3

0

20

20

4

0

16

16

5

0

2

2

Table 4-4 Summary of Impact on SMQs
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Summary of Changes

4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES
The table below summarizes the impact on MedDRA in Version 23.0. 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

Removed1

Modified

0

Added

1

Removed1

Modified

0

Added

7

Removed7

Modified

0

Added

3

Removed3

Modified

0

Added

848

Removed271

Modified

0

Added

984

Removed353

Modified

0

Added

392

Removed57

Modified

65

Added

918

Removed0Modified305

13

Summary of Changes

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added1

1

Removed0Modified

225

Added

4,484

Removed0Modified

187

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

1 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. Note that the number of LLTs also includes
PTs.

SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

HLTs3 HLGTs3

Blood andlymphatic systemdisorders

1,190

302

4,409

1,054

88

17

Cardiac disorders

1,509

366

2,455

648

36

10

Congenital,familial andgenetic disorders

4,036

1,594

4,036

1,594

100

19

Ear and labyrinth
disorders

445

95

872

226

17

6

Endocrine
disorders

689

196

1,887

576

38

9

Eye disorders

2,541

642

3,930

1,094

63

13

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Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

HLTs3 HLGTs3

Gastrointestinal
disorders

3,971

905

7,771

1,795

105

21

General disorders
and
2,464
administration site
conditions

992

3,395

1,335

35

7

Hepatobiliary
disorders

689

210

1,529

451

19

4

Immune systemdisorders

519

151

2,830

791

26

4

Infections andinfestations

7,373

2,035

7,756

2,147

149

12

Injury, poisoning
and procedural
complications

6,925

1,277

9,730

2,511

78

9

Investigations

14,1105,887

14,110

5,887

106

23

Metabolism andnutrition disorders

993

295

2,840

831

63

14

Musculoskeletaland connective
tissue disorders

2,667

487

6,849

1,406

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,722

2,003

9,528

2,330

202

39

Nervous systemdisorders

3,792

1,007

7,608

2,094

108

20

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Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

HLTs3 HLGTs3

Pregnancy,
puerperium andperinatalconditions

1,666

238

2,978

638

48

8

Product issues

812

173

831

182

21

2

Psychiatricdisorders

2,401

545

3,348

832

77

23

Renal and urinary
disorders

1,265

372

2,703

778

32

8

Reproductive
system andbreast disorders

1,801

509

4,395

1,236

52

16

Respiratory,
thoracic andmediastinal
disorders

1,793

557

4,395

1,205

49

12

Skin andsubcutaneous
tissue disorders

2,190

531

5,581

1,481

56

10

Socialcircumstances

649

279

649

279

20

7

Surgical andmedicalprocedures

5,218

2,315

5,218

2,315

141

19

Vasculardisorders

1,382

326

7,031

1,739

68

11

Total

81,812

24,289

Table 4-6 MedDRA Term Counts

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Summary of Changes
1Primary 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.
2Total 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.
3The HLT and HLGT counts are not necessarily unique values given MedDRA’s multi-

axiality (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.
The table below summarizes terms modified in English MedDRA Version 23.0.
Code

Level

Term Name in v22.1

Term Name in v23.0

10082763

PT

Anaesthesic ophthalmic
procedure

Anaesthetic ophthalmic
procedure

10082784

LLT

Anesthesic ophthalmic
procedure

Anesthetic ophthalmic
procedure

10082946

LLT

Biospy site redness

Biopsy site redness

10065430

PT

HER-2 positive breast cancer

HER2 positive breast cancer

10066896

PT

HER-2 positive gastric cancer

HER2 positive gastric cancer

10075638

PT

HER-2 protein overexpression

HER2 protein overexpression

10083042

PT

Macrophage inflammatory
protein - 1 alphaMacrophage inflammatory
protein-1 alpha10083045

PT

Macrophage inflammatory
protein 1-alpha decreased

Macrophage inflammatory
protein-1 alpha decreased

What’s New MedDRA Version 23.0
March 2020
00041617

Summary of Changes

Code10083049

Level
PT

Term Name in v22.1
Macrophage inflammatory
protein 1-alpha increased

Term Name in v23.0
Macrophage inflammatory
protein-1 alpha increased

Table 4-7 Modified PT/LLT Names

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects 3 terms at the LLT level in MedDRA Version 23.0 that had achange in currency status along with the rationale for the change.

Lowest Level Term

Currency
StatusChanged toEar, nose and throat
infection

Non-current

Pasteurella septica

Non-current

SVT

Non-current

Rationale
LLT Ear, nose and throat infection represents a
combination concept of three distinct infection site
concepts and therefore does not conform to MedDRA
rules.
LLT Pasteurella septica was changed to a status of
non-current status because this subspecies of
Pasteurella multocida is very rarely used incontemporary medical literature and clinicaldescriptions. Furthermore, the term is ambiguous as it
may refer to sepsis caused by the organism, or only thename of the organism itself, Pasteurella septica.
Although SVT is commonly used as an abbreviation ofSupraventricular tachycardia, the abbreviation is also
used to represent other conditions, such as superficial
vein thrombosis, subclavian vein thrombosis, sustained
ventricular tachycardia, and supraventriculartachyarrhythmia. Because SVT may represent a varietyof concepts, the status of LLT SVT was changed to
non-current.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 23.0
March 2020
00041618