C

What’s New
MedDRA Version 22.1

September 2019000353

Acknowledgements

ACKNOWLEDGEMENTS
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*MedDRA trademarks which had been registered by IFPMA on behalf of ICH are in the process of being transferred to ICH.

What’s New MedDRA Version 22.1
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Table of Contents

Table of Contents
1.

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

2.

VERSION 22.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2

3.

NEW DEVELOPMENTS IN VERSION 22.1 ........................................................... 4
3.1 KOREAN MedDRA ........................................................................................... 4
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 4
3.3 PROACTIVITY REQUESTS ............................................................................. 4
3.4 MedDRA MOBILE BROWSER 3.0 ................................................................... 5
3.5 MedDRA VERSION ANALYSIS TOOL (MVAT) 3.0 .......................................... 5
3.5.1“Orphan” LLTs in SMQs ...................................................................... 64.

SUMMARY OF CHANGES ..................................................................................... 7
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 7
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ........................... 9
4.3 MedDRA TERM COUNTS .............................................................................. 10
4.4 MODIFIED PT AND LLT NAMES ................................................................... 13
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 14

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
Figure 3-1 Mobile MedDRA Browser .................................................................... 5
Figure 3-2 MVAT 3.0 ............................................................................................ 6
LIST OF TABLES
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs ...................................... 7
Table 4-2 Summary of Impact on PTs ................................................................. 8
Table 4-3 Summary of Impact on LLTs ............................................................... 8
Table 4-4 Summary of Impact on SMQs ............................................................. 9
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 10
Table 4-6 MedDRA Term Counts ...................................................................... 13
Table 4-7 Modified PT/LLT Names.................................................................... 14
Table 4-8 LLT Currency Changes ..................................................................... 15

What’s New MedDRA Version 22.1
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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
22.0 and 22.1.
Section 2, Version 22.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 22.1, highlights changes in Version 22.1
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.

What’s New MedDRA Version 22.1
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New Developments in Version 22.1

2. VERSION 22.1 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 22.1 is a simple change version which means that changes are madeonly at the PT and LLT levels of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 1,533 change requests processed for this version; 1,358 change requests wereapproved and implemented, and 174 change requests were not approved. There is, inaddition, one change request 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 22.1 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 22.1 (shown in Table 4-6) and thecorresponding information for Version 22.0. 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 22.1.

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New Developments in Version 22.1

Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders and administration site…
Hepatobiliary disorders
Immune system disorders
Infections and infestations
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Musculoskeletal and connective tissue…
Neoplasms benign, malignant and…
Nervous system disorders
Pregnancy, puerperium and perinatal…
Product issues
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders

31

11
6

68
22

52
52

7

71
61

31
24
16
21
16

70

122

190

58
115

31

89

55

101

6
67

92

Figure 2-1 Net Changes of Terms per SOC

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New Developments in Version 22.1

3. NEW DEVELOPMENTS IN VERSION 22.1
3.1

KOREAN MedDRA

The MSSO is pleased to announce that as of Version 22.1, Korean MedDRA will beavailable to MedDRA users. Korean 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 documentation that is provided in other supported
languages. Users may access Korean MedDRA from the MedDRA website in the samemanner as other languages. Note that a Korean Version Report and accessibility of
Korean term information in MVAT will be available in March 2020 when Version 23.0
debuts as there are not yet two Korean versions to generate a comparison. For any
specific questions about Korean MedDRA and how to access it, please contact the
MSSO Help Desk.
3.2

STANDARDISED MedDRA QUERIES (SMQs)

New SMQ Sepsis was added in MedDRA Version 22.1. There are now 105 level 1
SMQs in production as of this version. Based on a review by regulatory and industry
experts and endorsed by the CIOMS SMQ Implementation Working Group, Sepsis(SMQ) was created as an additional stand-alone SMQ and the relevant sepsis terms(55) in Agranulocytosis (SMQ) were made inactive. An additional 8 terms reflective of
the hematologic changes associated with agranulocytosis were added to existing SMQ
Agranulocytosis. In total, there were 331approved PT changes to existing SMQs. Toview changes to existing SMQs, please review the MedDRA Version 22.1 Version
Report.
Please see the MedDRA Version 22.1 SMQ Introductory Guide for detailed information
on new SMQ Sepsis and changes to existing SMQ Agranulocytosis.
3.3

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 22.1 change request processing period, there were no open
proactivity proposals that completed review. Two proposals are currently under review
and are expected to be completed for the MedDRA Version 23.0 processing period. 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

What’s New MedDRA Version 22.1
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New Developments in Version 22.1

suggestion(s), and include a justification which explains why you think your proposal
should be implemented.
3.4

MedDRA MOBILE BROWSER 3.0

The MSSO deployed a mobile version of MedDRA Browser (MMB) in April 2019
designed to work on smart phones and tablet computers. The mobile browser is a web
based application that has many of the features of the Web-Based Browser including:••••Search MedDRA Term and Codes
Browse the MedDRA hierarchy and SMQs
Review term history
Review term details

Figure 3-1 Mobile MedDRA Browser

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.
3.5

MedDRA VERSION ANALYSIS TOOL (MVAT) 3.0

The newest update to the MedDRA Version Analysis Tool (MVAT) is available for use
as of June 2019. The following updates have been added to MVAT:••

An option to include Secondary SOC output in the Version or Data Impact reports
Display changes between upcoming changes in the next release (Supplemental
data) and the latest released version of MedDRA

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New Developments in Version 22.1

Figure 3-2 MVAT 3.0

To learn the new features of MVAT 3.0, please view or download the MVAT 3.0
videocast from the Training Materials section of the MedDRA.org website located under“Tools.”To access the MVAT, simply login using your MedDRA ID and Password. This
password is the same password used to access the MedDRA website and otherapplications such as the Web-Based Browser. If you don’t know your MedDRA ID and
Password, please use the MedDRA Self-Service Application to retrieve them.

3.5.1 “Orphan” LLTs in SMQs
The latest update of the MedDRA Version Analysis Tool (MVAT 3.0) contains a newreport showing LLT changes in SMQs. These changes result from SMQ maintenanceperformed by the MSSO including the addition of new PTs to SMQs and changes toexisting LLTs such as promotions, demotions, and moves. During the course of
MedDRA maintenance, an LLT may move from a PT that is in an SMQ to a PT that is
not in an SMQ, in which case it is called an “orphan” LLT. These “orphan” LLTs arechanged to an inactive status in the SMQ content file so that they no longer appear in
the active term list of their original SMQ.
Due to an error in the SMQ implementation process, some of the inactive “orphan” LLTs
had additional SMQ attributes modified such as scope and category. These SMQ
attribute changes affected 11 “orphan” LLTs in MedDRA Versions 21.0 to 22.0 and willappear in the new MVAT LLT changes in SMQ report. The inadvertent changes to the“orphan” LLTs have no impact on the use of any SMQs. The process error has been
fixed and will not affect MedDRA Version 22.1 and future versions. Please contact theHelp Desk at mssohelp@meddra.org if more details are needed.

What’s New MedDRA Version 22.1
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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 22.1. These tables are intended only as a reference. For detailed information on
the changes to Version 22.1, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v22.0 v22.1

SOC

Total SOCs

0

27

27

New HLGTs000

Merged HLGTs

0

0

0

Total HLGTs1

0

337

337

New HLTs000

Merged HLTs

0

0

0

Total HLTs1

0

1,737

1,737

HLGT

HLT

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

MedDRA v22.1 is a simple change version which means changes are only made at the
PT and LLT levels of the MedDRA hierarchy; hence there are no changes in the number
of HLTs and HLGTs.
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.

What’s New MedDRA Version 22.1
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Summary of Changes

PT Changes
Level Change Request Action

PT

v22.0

v22.1

New PTs

327

294

Promoted LLTs

42

25

Demoted PTs

50

73

Net Change1

319

246

Total PTs

23,70823,954

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

v22.0

v22.1

LLT

Current Terms

626

70,97771,603

LLT

Non-current Terms

6

9,285

9,291

LLT

Total LLTs1

632

80,26280,894

Table 4-3 Summary of Impact on LLTs

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

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Summary of Changes

New SMQs
Level Net Change

v22.0

v22.1

1

1

104

105

2

0

82

82

3

0

20

20

4

0

16

16

5

0

2

2

Table 4-4 Summary of Impact on SMQs

4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES
The table below summarizes the impact on MedDRA in Version 22.1. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

What’s New MedDRA Version 22.1
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Added

0Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified09Summary of Changes

HLT_PT.ASC

MDHIER.ASC

PT.ASC

LLT.ASC

Added

530

Removed125

Modified

0

Added

566

Removed149

Modified

0

Added

319

Removed73

Modified

13

Added

632

Removed0Modified252

1

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

1

Removed0Modified

224

Added

1020

Removed0Modified

281

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

Blood andlymphatic systemdisorders

1,169

297

4,367

1,043

88

17

Cardiac disorders

1,487

359

2,426

637

36

10

What’s New MedDRA Version 22.1
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HLTs3 HLGTs3

10

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Congenital,familial andgenetic disorders

3,760

1,465

3,760

1,465

98

19

Ear and labyrinth
disorders

445

95

848

220

17

6

Endocrine
disorders

683

195

1,866

571

38

9

Eye disorders

2,521

633

3,857

1,070

63

13

Gastrointestinal
disorders

3,939

889

7,734

1,767

106

21

General disordersandadministration site
conditions

2,568

1,037

3,492

1,379

36

7

Hepatobiliary
disorders

676

203

1,509

444

19

4

Immune systemdisorders

503

145

2,764

764

26

4

Infections andinfestations

7,333

2,000

7,701

2,104

149

12

Injury, poisoning
and procedural
complications

6,861

1,259

9,610

2,462

78

9

Investigations

14,044

5,856

14,044

5,856

106

23

Metabolism andnutrition disorders

982

289

2,781

803

63

14

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HLTs3 HLGTs3

11

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Musculoskeletaland connective
tissue disorders

2,652

484

6,771

1,369

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,686

1,997

9,482

2,319

202

39

Nervous systemdisorders

3,758

994

7,512

2,053

108

20

Pregnancy,
puerperium andperinatalconditions

1,660

234

2,977

630

48

8

Product issues

679

160

696

168

21

2

Psychiatricdisorders

2,386

539

3,288

810

77

23

Renal and urinary
disorders

1,246

365

2,667

763

32

8

Reproductive
system andbreast disorders

1,790

506

4,351

1,221

52

16

Respiratory,
thoracic andmediastinal
disorders

1,782

553

4,367

1,192

49

12

Skin andsubcutaneous
tissue disorders

2,163

523

5,059

1,453

56

10

Socialcircumstances

646

277

646

277

20

7

What’s New MedDRA Version 22.1
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HLTs3 HLGTs3

12

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Surgical andmedicalprocedures

5,109

2,277

5,109

2,277

141

19

Vasculardisorders

1,366

323

6,931

1,707

68

11

Total

80,89423,954SOC

HLTs3 HLGTs3

Table 4-6 MedDRA Term Counts
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 22.1.

What’s New MedDRA Version 22.1
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Summary of Changes

Code

Level

Term Name in v22.0

Term Name in v22.1

10066910

PT

LUMBAR syndrome

Lumbar syndrome

10082481

LLT

Obstructive sialadentitis

Obstructive sialadenitis

10082301

LLT

Serous incision site discharge

Incision site serous discharge

10082394

LLT

Severe achondroplasia with
developmental delay andacanthosis nigrican

Severe achondroplasia with
developmental delay andacanthosis nigricans

LLT

Transnasal humified rapidinsufflation ventilator exchange

Transnasal humidified rapidinsufflation ventilatoryexchange10082536

Table 4-7 Modified PT/LLT Names

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects 6 terms at the LLT level in MedDRA Version 22.1 that had achange in currency status along with the rationale for the change.
Currency
StatusChanged to

Rationale

Non-current

Although LLT Hepatomegaly tenderness has been an
LLT since MedDRA Version 2.1, this combination
concept term may compromise signal detection if theterm is selected to represent both hepatomegaly andhepatic tenderness. LLT Hepatomegaly tenderness isbest represented with individual terms such as LLTLiver tenderness and LLT Hepatomegaly.

Hypersomnia related toanother mental conditionNon-current

LLT Hypersomnia related to another mental condition
was changed to a non-current status because theconcept “another mental condition” is vague.

Insomnia related to anothermental conditionNon-current

LLT Insomnia related to another mental condition waschanged to a non-current status because the concept“another mental condition” is vague.

Non-current

LLT Lepromatous leprosy (type l) was changed to astatus of non-current because it is ambiguous and notconsistent with current classifications which do notinclude a “type l”.

Lowest Level Term

Hepatomegaly tenderness

Lepromatous leprosy (type l)What’s New MedDRA Version 22.1
September 201900035314

Summary of Changes

Lowest Level Term

Currency
StatusChanged to

Lumbar syndrome

Non-current

Other and unspecified
nonspecific immunologicalfindings

Non-current

Rationale“Lumbar syndrome” and “LUMBAR syndrome” are twodifferent concepts distinguished only by thecapitalization. Because many data systems do notrecognize nor differentiate upper case from lower casecharacters, terms PT Congenital LUMBAR syndrome
and LLT Lumbar pain syndrome were added in
MedDRA Version 22.1 to avoid this issue. As a result,
LLT Lumbar syndrome was changed to a status of noncurrent.
LLT Other and unspecified nonspecific immunologicalfindings was changed to a status of non-current
because “findings” is a rather ambiguous term that does
not represent a clear meaning.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 22.1
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