C

What’s New
MedDRA Version 21.0

March 2018
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Acknowledgements

ACKNOWLEDGEMENTS
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What’s New MedDRA Version 21.0
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Table of Contents

Table of Contents
1.

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

2.

VERSION 21.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 3
2.3 TRANSLATION CHANGES .............................................................................. 5
2.3.1
Translation Review ............................................................................. 5

3.

NEW DEVELOPMENTS IN VERSION 21.0 ........................................................... 6
3.1 PATIENT PROBLEM CODES .......................................................................... 6
3.2 PILOT ICD10 TO MedDRA MAPPING OF INFECTION TERMS ...................... 6
3.3 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 7
3.4 PROACTIVITY REQUESTS ............................................................................. 7
3.4.1
Complex Changes Related to the review of foreign body terms ......... 74.

SUMMARY OF CHANGES ..................................................................................... 9
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 9
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 11
4.3 MedDRA TERM COUNTS .............................................................................. 12
4.4 MODIFIED PT AND LLT NAMES ................................................................... 15
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 16

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
LIST OF TABLES
Table 2-1 New HLTs ........................................................................................... 4
Table 2-2 Merged HLTs....................................................................................... 4
Table 2-3 Moved HLT .......................................................................................... 5
Table 3-1 New Terms added for Patient Problem List ........................................ 6
Table 3-2 New Terms added for ICD10 Pilot Mapping ........................................ 6
Table 3-3 Foreign Body Term Related Complex Change .................................... 8
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs ...................................... 9
Table 4-2 Summary of Impact on PTs ............................................................... 10
Table 4-3 Summary of Impact on LLTs ............................................................. 10
Table 4-4 Summary of Impact on SMQs ........................................................... 11
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 12
Table 4-6 MedDRA Term Counts ...................................................................... 15
Table 4-7 Modified PT/LLT Names.................................................................... 16
Table 4-8 LLT Currency Changes ..................................................................... 17

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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
20.1 and 21.0.
Section 2, Version 21.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 21.0, highlights changes in Version 21.0
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:•

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.

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Version 21.0 Change Requests

2. VERSION 21.0 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 21.0 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 were a totalof 1,575 change requests processed for this version; 1,360 change requests wereapproved and implemented, and 203 change requests were not approved. There are, in
addition, 12 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. 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 21.0 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 21.0 (shown in Table 4-6) and thecorresponding information for Version 20.1. 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 21.0.

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Version 21.0 Change Requests

26
34

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

16

Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders

75

35
38

73

General disorders and administration site conditions

16

Hepatobiliary disorders
Immune system disorders

96

68

Infections and infestations

150
163

Injury, poisoning and procedural complications
Investigations

62
70

Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)

101
118

Nervous system disorders

49
29
27
25
41
53

Pregnancy, puerperium and perinatal conditions
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

-2

213

83

63

145

Figure 2-1 Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 21.0 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 28 July 2017 to 22 September 2017. Complex changes
were followed by further internal review and consensus discussions which resulted in
the final approved set of 10 complex changes.
The complex changes implemented in Version 21.0 are summarized below. Please see
the “Related Documents” on the Change Request section of the MedDRA website for
specific details.

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Version 21.0 Change Requests

At the SOC level: No changes were made to existing SOCs.
At the HLGT level: No changes were made to existing HLGTs.
At the HLT level: There were four new High Level Terms (HLTs) added, five HLTs
merged, and one moved as a result of complex changes in Version 21.0. The changes
are as follows:
New HLTs
New HLTTo SOC

Anaesthetic and allied procedural
complications
Chest and respiratory tract injuriesNEC
Musculoskeletal and connective tissue
conditions NEC
Visual impairment and blindness (exclcolour blindness)

Injury, poisoning and procedural
complications
Injury, poisoning and procedural
complications
Musculoskeletal and connective tissue
disorders
Eye disorders

Table 2-1 New HLTs

Merged HLTs
HLT
Anaesthetic complications
Blindness (excl colour
blindness)
Chest and lung injuriesNEC
Musculoskeletal andconnective tissue signs andsymptoms NEC
Partial vision loss

To HLT

SOC

Anaesthetic and allied
procedural complications
Visual impairment andblindness (excl colour
blindness)
Chest and respiratory tract
injuries NEC
Musculoskeletal andconnective tissue
conditions NEC
Visual impairment andblindness (excl colour
blindness)

Injury, poisoning andprocedural complications
Eye disorders
Injury, poisoning andprocedural complications
Musculoskeletal andconnective tissue
disorders
Eye disorders

Table 2-2 Merged HLTs

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Version 21.0 Change Requests

HLT Moves
HLT

From HLGTTo HLGTIn SOC

Bartonella
infections

Rickettsial
infectious disorders

Bacterial infectious
disorders

Infections andinfestations

Table 2-3 Moved HLT

2.3

TRANSLATION CHANGES

2.3.1 Translation Review
As part of our regular quality process, the MSSO is conducting a review of terms
translated from English into the supported MedDRA languages, except Japanese. This
will be an ongoing effort that is expected to last through MedDRA Version 21.1
(September 2018) and will result in updates to term names in the respective translationsof MedDRA. The list of terms updated will be available in the associated version reports
included in the MedDRA download for each language. Please see the Change Request
section of the MedDRA website if you wish to request an improvement in the translationof a term or terms in any non-English or non-Japanese translation of MedDRA.

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5

New Developments in Version 21.0

3. NEW DEVELOPMENTS IN VERSION 21.0
3.1

PATIENT PROBLEM CODESIn MedDRA Version 21.0 38 new terms were added as a result of a terminology
interoperability initiative to map a set of patient problem codes to MedDRA. See thetable below for examples.

PT

Primary HLTPrimary SOC

Discharge

General signs andsymptoms NEC

Tissue injury

Non-site specific injuries Injury, poisoning andNECprocedural complications

LLT

PT

Thrombus

Thrombosis

General disorders andadministration site conditions

Primary SOC
Vascular disorders

Table 3-1 New Terms added for Patient Problem List

3.2

PILOT ICD10 TO MedDRA MAPPING OF INFECTION TERMS

As part of another terminology interoperability initiative, the MSSO conducted a pilot
study of the feasibility of mapping of 919 ICD10 Chapter 1 terms (Certain infectious andparasitic diseases) and a corresponding set of 7079 terms in SOC Infections andinfestations. As a result of this pilot study, the MSSO added 59 new terms and madethree changes to existing terms. See below for new term examples:PT

Primary HLTPrimary SOC

Brazilian purpuric fever

Haemophilus infections

Infections and infestations

Rocio virus infection

Flaviviral infections

Infections and infestations

LLT

PT

Generalized tularemia

Tularaemia

Primary SOC
Infections and infestations

Table 3-2 New Terms added for ICD10 Pilot Mapping

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New Developments in Version 21.0

3.3

STANDARDISED MedDRA QUERIES (SMQs)

New SMQ Dehydration was added in MedDRA Version 21.0. There are now 103 level 1
SMQs in production as of this version. Additionally, there were 295 approved changes
to existing SMQs. To view changes to existing SMQs, please review the MedDRA
Version 21.0 Version Report.
Please see the MedDRA Version 21.0 SMQ Introductory Guide for detailed informationon the new SMQ Dehydration.

3.4

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 21.0 change request processing period, the MSSO implemented
complex changes as a follow on task to a proactivity proposal implemented in MedDRA
Version 20.1. 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 yoursuggestion(s), and include a justification which explains why you think your proposal
should be implemented.

3.4.1 Complex Changes Related to the review of foreign body terms
In MedDRA Version 20.1 the MSSO moved site specific LLTs under PT Foreign body toa more appropriate placement in MedDRA as part of a proactivity request. For example,
LLT Foreign body in nose was moved from PT Foreign body to new PT Foreign body inrespiratory tract. As a follow up action to complete this request, the MSSO replaced one
HLT to broaden the scope of terms represented underneath it.
HLT Chest and lung injuries NEC was replaced with new HLT Chest and respiratory
tract injuries NEC to accommodate terms pertaining to parts of the respiratory tract suchas the nose and pharynx and not just the lungs, such as PT Foreign body in respiratory
tract. Please see the table below.

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New Developments in Version 21.0

New HLTOld HLT

Chest and respiratory Chest and lungtract injuries NEC
injuries NEC

SOC
Injury, poisoning andprocedural
complications

Table 3-3 Foreign Body Term Related Complex Change

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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 21.0. These tables are intended only as a reference. For detailed information on
the changes to Version 21.0, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v20.1 v21.0

SOC

Total SOCs

0

27

27

New HLGTs000

Merged HLGTs

0

0

0

Total HLGTs1

0

337

337

New HLTs404

Merged HLTs

5

0

5

Total HLTs1

-1

1,738

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.

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Summary of Changes

PT Changes
Level Change Request Action

PT

v20.1

v21.0

New PTs

288

342

Promoted LLTs

24

25

Demoted PTs

37

53

Net Change1

275

314

Total PTs

22,77423,088

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

v20.1

v21.0

LLT

Current Terms

774

68,757

69,531

LLT

Non-current Terms

8

9,269

9,277

LLT

Total LLTs1

782

78,02678,808

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

v20.1

v21.0

1

1

102

103

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 21.0. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

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Added

0Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

5

Removed6

Modified

0

Added

4

Removed5

Modified011

Summary of Changes

HLT_PT.ASC

MDHIER.ASC

PT.ASC

LLT.ASC

Added

694

Removed204

Modified

0

Added

721

Removed218

Modified

0

Added

367

Removed53

Modified

9

Added

782

Removed0Modified252

1

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

1

Removed0Modified

222

Added

1,006

Removed0Modified

124

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.

SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,159

295

4,270

1,015

88

17

Cardiac disorders

1,460

347

2,393

620

36

10

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HLTs3 HLGTs3

12

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Congenital,familial andgenetic disorders

3,566

1,360

3,566

1,360

98

19

Ear and labyrinth
disorders

435

90

822

213

17

6

Endocrine
disorders

678

190

1,804

543

38

9

Eye disorders

2,472

608

3,762

1,023

63

13

Gastrointestinal
disorders

3,852

866

7,588

1,727

108

21

General disordersandadministration site
conditions

2,486

1,003

3,327

1,311

36

7

Hepatobiliary
disorders

663

199

1,481

434

19

4

Immune systemdisorders

469

143

2,648

717

26

4

Infections andinfestations

7,210

1,957

7,565

2,056

149

12

Injury, poisoning
and procedural
complications

6,665

1,185

9,295

2,349

78

9

Investigations

13,7395,659

13,739

5,659

106

23

Metabolism andnutrition disorders

965

284

2,697

773

63

14

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HLTs3 HLGTs3

13

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Musculoskeletaland connective
tissue disorders

2,575

458

6,551

1,280

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,575

1,964

9,308

2,271

202

39

Nervous systemdisorders

3,600

956

7,242

1,943

107

20

Pregnancy,
puerperium andperinatalconditions

1,641

225

2,910

597

48

8

Product issues

647

155

657

161

21

2

Psychiatricdisorders

2,355

522

3,213

766

76

23

Renal and urinary
disorders

1,225

353

2,619

740

32

8

Reproductive
system andbreast disorders

1,743

486

4,205

1,175

52

16

Respiratory,
thoracic andmediastinal
disorders

1,727

534

4,236

1,149

49

12

Skin andsubcutaneous
tissue disorders

2,095

499

4,803

1,376

56

10

Socialcircumstances

640

273

640

273

20

7

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HLTs3 HLGTs3

14

Summary of Changes
LLTs*(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2Surgical andmedicalprocedures

4,820

2,166

4,820

2,166

141

19

Vasculardisorders

1,346

311

6,745

1,636

68

11

78,80823,088SOC

Total

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 21.0.
Code

Level

Term Name in v20.1

Term Name in v21.0*

LLT

Example: Angioimmunoblastic(AILD, LgX (Kiel Classification))

Example: Angioimmunoblastic(AILD, LgX) (Kiel Classification)

10007041

LLT

Calve-Perthe's disease

Calve-Perthes disease

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Summary of Changes

Code

Level

Term Name in v20.1

Term Name in v21.0*

LLT

Example: Carcinoma colon
Duke’sExample: Carcinoma colon
Dukes

10053329

PT

Parovarian cystectomy

Paraovarian cystectomy

10034735

LLT

Perthes' disease

Perthes disease10048016

LLT

Wood worker's lung

Woodworker's lung

Table 4-7 Modified PT/LLT Names* There were 35 terms updated to correct the spelling of “Duke’s” classification concepts
to “Dukes” and 7 updates to adjust the parentheses of terms with “(AILD, LgX (KielClassification))” to “(AILD, LgX) (Kiel Classification)”. For the complete list of terms,
please see the MedDRA 21.0 Version Report or use MVAT.

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the 8 terms at the LLT level in MedDRA Version 21.0 thathave a change in their currency status along with the rationale for the change.

Lowest Level Term

Currency
StatusChanged to

Betaglobulin

Non-current

Betaglobulin abnormal

Non-current

Betaglobulin normal

Non-current

Blood tryptase absent

Non-current

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Rationale
The concept Beta globulin is normally expressed in
medical literature using two words. Accordingly, LLT
Betaglobulin, under PT Beta globulin, was changed fromcurrent to non-current status. The current LLT Beta
globulin correctly represents the concept.
The concept Beta globulin is expressed in medical
literature using two words. Accordingly, LLT Betaglobulin
abnormal, under PT Beta globulin abnormal, waschanged from current to non-current status. The current
LLT Beta globulin abnormal correctly represents theconcept.
The concept Beta globulin is expressed in medical
literature using two words. Accordingly, LLT Betaglobulin
normal, under PT Beta globulin normal, was changed
from current to non-current status. The current LLT Beta
globulin normal correctly represents the concept.
Tryptase is a normal protein in mast cells with areference range of < 11.4 ng/mL.The concept of blood16

Summary of Changes

Lowest Level Term

Currency
StatusChanged toBlood tryptase present

Non-current

Lumbar syndrome

Non-current

Mucosal thickness

Non-current

Urine oxalate present

Non-current

Rationale
tryptase being absent has no meaning and therefore LLT
Blood tryptase absent was changed to a non-current
status.
Tryptase is a normal protein in mast cells with areference range of < 11.4 ng/mL. The qualifier “present”
does not convey any value and therefore LLT Bloodtryptase present was changed to a non-current status.
The more specific term for this disorder, LLT Lumbar
facet syndrome, has been added under PT Facet joint
syndrome for MedDRA Version 20.1. LLT Lumbar
syndrome is a vague term and was made non-current.
LLT Mucosal thickness was changed to a status of noncurrent and replaced by the more appropriate LLT
Mucosal thickening.
Oxalate in urine is a normal finding up to a certain level
and the qualifier "present" does not convey any value.

Table 4-8 LLT Currency Changes

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