cWhat’s New
MedDRA Version 20.0

March 2017
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Acknowledgements

ACKNOWLEDGEMENTS®

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Table of Contents

Table of Contents
1.

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

2.

VERSION 20.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 3
2.3 TRANSLATION CHANGES .............................................................................. 6
2.3.1

3.

Translation Review ............................................................................. 6

NEW DEVELOPMENTS IN VERSION 20.0 ........................................................... 7
3.1 REVISIONS TO MEDICATION ERROR AND PRODUCT USE ISSUESHIERARCHIES........................................................................................................ 7
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 8
3.3 UNQUALIFIED TEST NAME LIST .................................................................... 9
3.4 PROACTIVITY REQUESTS ............................................................................. 9
3.4.1
3.4.2

4.

Gradation of chemical burns ............................................................. 10
Provide options that convey a reduction in visual ability ................... 10

SUMMARY OF CHANGES ................................................................................... 12
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ....................................... 12
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 14
4.3 MedDRA TERM COUNTS .............................................................................. 15
4.4 MODIFIED PT AND LLT NAMES ................................................................... 18
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 19

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ........................................................ 3
Figure 3-1 Medication error and Product use issues hierarchy ........................... 7
Figure 3-2 Malignancies (SMQ) Hierarchy ........................................................... 9
LIST OF TABLES
Table 2-1 New HLGTs ......................................................................................... 4
Table 2-2 Merged HLGTs .................................................................................... 4
Table 2-3 New HLTs ........................................................................................... 5
Table 2-4 Merged HLTs....................................................................................... 6
Table 2-5 Moved HLTs ........................................................................................ 6
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs .................................... 12
Table 4-2 Summary of Impact on PTs ............................................................... 13
Table 4-3 Summary of Impact on LLTs ............................................................. 13
Table 4-4 Summary of Impact on SMQs ........................................................... 14
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Table of Contents

Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 15
Table 4-6 MedDRA Term Counts ...................................................................... 18
Table 4-7 Modified PT/LLT Names.................................................................... 19
Table 4-8 LLT Currency Changes ..................................................................... 20

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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
19.1 and 20.0.
Section 2, Version 20.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 20.0, highlights changes in Version 20.0
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 20.0 Change Requests

2. VERSION 20.0 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 20.0 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 3,405 change requests processed for this version; 3,066 change requests wereapproved and implemented, and 331 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. 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 20.0 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 20.0 (shown in Table 4-6) and thecorresponding information for Version 19.1. 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 20.0.

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Version 20.0 Change Requests

Figure 2-1 Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 20.0 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 27 July 2016 to 23 September 2016. Complex changes
were followed by further internal review and consensus discussions which resulted in
the final approved set of 31 complex changes.
The complex changes implemented in Version 20.0 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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Version 20.0 Change Requests

At the HLGT level: Four new High Level Group Terms (HLGTs) were added, two
HLGTs were merged as a result of complex changes in Version 20.0. The changes are
as follows:
New HLGTs
New HLGT

To SOC

Medication errors and other product use errors
and issues

Injury, poisoning and procedural complications

Off label uses and intentional productmisuses/use issues

Injury, poisoning and procedural complications

Overdoses and underdoses NEC

Injury, poisoning and procedural complications

Respiratory tract signs and symptoms

Respiratory, thoracic and mediastinal
disordersTable 2-1 New HLGTs

Merged HLGTs
Merged HLGTTo HLGTTo SOC

Medication errors

Medication errors andother product use errors
and issues

Injury, poisoning andprocedural complications

Product use issues

Medication errors andother product use errors
and issues

Injury, poisoning andprocedural complications

Table 2-2 Merged HLGTs

HLGT Moves: No HLGT moves were made.
At the HLT level: There were 14 new High Level Terms (HLTs) added, eight HLTs
merged, and three moved as a result of complex changes in Version 20.0. The changes
are as follows:

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Version 20.0 Change Requests

New HLTs
New HLTTo SOC

Fungal upper respiratory tract infections

Respiratory, thoracic and mediastinal
disorders

Intentional product misuses

Injury, poisoning and procedural complications

Intentional product use issues

Injury, poisoning and procedural complications

Medication errors, product use errors andissues NEC

Injury, poisoning and procedural complications

Product administration errors and issues

Injury, poisoning and procedural complications

Product confusion errors and issues

Injury, poisoning and procedural complications

Product dispensing errors and issues

Injury, poisoning and procedural complications

Product monitoring errors and issues

Injury, poisoning and procedural complications

Product preparation errors and issues

Injury, poisoning and procedural complications

Product prescribing errors and issues

Injury, poisoning and procedural complications

Product selection errors and issues

Injury, poisoning and procedural complications

Product storage errors and issues in the
product use system

Injury, poisoning and procedural complications

Product transcribing errors andcommunication issues

Injury, poisoning and procedural complications

Substance related and addictive disorders

Psychiatric disorders

Table 2-3 New HLTs

Merged HLTs
Merged HLT

To HLTIntercepted medication errors

Product selection errors andissuesInjury, poisoning andprocedural complications

Maladministrations

Product administration errors
and issues

Injury, poisoning andprocedural complications

Medication errors NEC

Medication errors, productuse errors and issues NEC

Injury, poisoning andprocedural complications

Medication monitoring errors

Product monitoring errors andissuesInjury, poisoning andprocedural complications

Product use issues NEC

Medication errors, productuse errors and issues NEC

Injury, poisoning andprocedural complications

Sleep disorders due togeneral medical condition

Sleep disorders NEC

Psychiatric disorders

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Version 20.0 Change Requests

Merged HLT

To HLT

SOC

Sleep disorders related toanother mental condition

Sleep disorders NEC

Psychiatric disorders

Substance-related disorders

Substance related andaddictive disorders

Psychiatric disorders

Table 2-4 Merged HLTs

HLT Moves
HLT

From HLGTTo HLGTIn SOC

Lower respiratory
tract signs andsymptoms

Respiratory
disorders NEC

Respiratory tract signs
and symptoms

Respiratory, thoracic
and mediastinal
disorders

Respiratory signs
and symptoms NEC

Respiratory
disorders NEC

Respiratory tract signs
and symptoms

Respiratory, thoracic
and mediastinal
disordersUpper respiratory
tract signs andsymptoms

Respiratory
disorders NEC

Respiratory tract signs
and symptoms

Respiratory, thoracic
and mediastinal
disordersTable 2-5 Moved HLTs

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 several MedDRA releases and will
result in updates to term names in the respective translations of MedDRA. The list ofterms 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 translation of a term or
terms in any non-English or non-Japanese translation of MedDRA.

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New Developments in Version 20.0

3. NEW DEVELOPMENTS IN VERSION 20.0
3.1

REVISIONS TO MEDICATION ERROR AND PRODUCT USE ISSUESHIERARCHIESThe addition of HLGT Product use issues in MedDRA Version 18.0 has caused some
confusion because it forced users to make a somewhat artificial distinction between
product use issues in the newly added HLGT and medication error concepts in existing
HLGT Medication errors. In practice, some of these concepts may overlap. For
example, there were terms such as PT Extra dose administered under HLGT
Medication errors that do not specify error or accidental, and there were neutral terms in
HLT Product use issues NEC such as PT Drug administered to patient of inappropriate
age that could represent a medication error, misuse, or off label use, depending on thecircumstances. To address this issue, the MSSO solicited input from the MedDRA
Expert Panel and the ICH M1 Points to Consider Working Group on revisions to the
medication error and product use issues hierarchies. The resulting complex change
proposal was posted for feedback from the MedDRA user community. See the figure
below for the new hierarchy implemented in MedDRA Version 20.0.

Figure 3-1 Medication error and Product use issues hierarchy

The new hierarchy groups the medication errors and unspecified product use issues
terms together under new HLGT Medication errors and other product use errors andissues avoiding the forced classification between these sometimes overlapping
concepts. Additional advantages of the new hierarchy include:
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New Developments in Version 20.0•

New HLTs have been added such as HLT Product dispensing errors and issues
which correspond to the various stages in the medication/product use process(prescribing, storage, dispensing, preparation for administration, andadministration)•

Intercepted medication errors have been moved under relevant stage HLTs; forexample, PT Intercepted drug prescribing error is under HLT Product prescribing
errors and issues•

By referring to “product,” the HLTs cover not only medication error/issues but
other product concepts such as device use errors/issues•

Intentional concepts such as have been separated from errors/unspecified
issues and now reside in HLGT Off label uses and intentional productmisuses/use issues•

Intentional and unspecified overdose and underdose terms are grouped
separately in HLGT Overdoses and underdoses NEC. Accidental overdose andunderdose terms are in HLT Product administration errors and issues.

For detailed information on the placement of PTs in the revised hierarchy, please use
the Web-Based Browser.

3.2

STANDARDISED MedDRA QUERIES (SMQs)

No new level 1 SMQs were added in MedDRA Version 20.0. There were structuralchanges to existing SMQs. This included the addition of four level 4 sub-search SMQs
(two each) to level 3 Malignant tumours (SMQ) and level 3 Tumours of unspecified
malignancy (SMQ) which are under level 1 SMQ Malignancies. This was the result ofwork by the CIOMS SMQ Implementation Working Group to further enhance specificity
options for case identification. The two sub-search SMQs added under Malignant
tumours (SMQ) are:••Haematological malignant tumours (SMQ)
Non-haematological malignant tumours (SMQ)

The two sub-search SMQs added under Tumours of unspecified malignancy (SMQ) are:••Haematological tumours of unspecified malignancy (SMQ)
Non-haematological tumours of unspecified malignancy (SMQ)

See the graphic below which shows the full hierarchy of Malignancies (SMQ).

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New Developments in Version 20.0

Figure 3-2 Malignancies (SMQ) Hierarchy

The PTs originally under Malignant tumours (SMQ) and Tumours of unspecified
malignancy (SMQ) have been moved under the appropriate sub-search SMQs. For
more information about the sub-search SMQs added to Malignancies (SMQ) please see
the MedDRA Version 20.0 SMQ Introductory Guide.
3.3

UNQUALIFIED TEST NAME LIST

The MSSO has developed an Unqualified Test Name Term List and an explanatory
document which are available for MedDRA users to download from the support
documentation section of the MedDRA website. Unqualified test name terms, e.g., PT
Blood glucose, are intended for use only in the test name data element in datatransmission standards and are not meant for use in other data fields capturing
information such as adverse events/adverse reactions or medical history.
The Unqualified Test Name Term List is an optional tool to help regulatory authority andindustry users as a standardized list to check data quality by identifying theinappropriate use of unqualified test name terms in data fields other than the test namedata element. The list is a comprehensive list of all unqualified test name terms at thePreferred Term (PT) and Lowest Level Term (LLT) levels in SOC Investigations.It is
maintained and updated by the MSSO with every MedDRA release in spreadsheet
form. Please contact the MSSO Help Desk if you have any questions.
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
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New Developments in Version 20.0

requests may address inconsistencies, make corrections, or suggest improvements.
During the Version 20.0 change request processing period, the MSSO evaluated four
proactivity proposals submitted by MedDRA users. Of the four proposals, two were
implemented and two were not approved. See below for details on the implemented
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.
3.4.1 Gradation of chemical burns
The MSSO reviewed a request to consider adding a set of terms for gradation ofchemical burns to MedDRA. After careful review, the following PTs were added to
MedDRA for Version 20.0:• PT First degree chemical burn of skin
• PT Second degree chemical burn of skin
• PT Third degree chemical burn of skin
• PT Fourth degree chemical burn of skin
These terms were added to primary HLT Chemical injuries in SOC Injury, poisoning andprocedural complications with a secondary link to HLT Dermatitis ascribed to specificagent in SOC Skin and subcutaneous tissue disorders. Additionally, the MSSO switched
the positions of PT Chemical injury and LLT Chemical burn so that Chemical burn is a
PT and Chemical injury is an LLT. Elevating Chemical burn to the PT level aligns thisconcept with the new PTs and could be used in situations where the stage of chemicalburn is not known.
3.4.2 Provide options that convey a reduction in visual ability
A MedDRA user requested that the MSSO provide consistent coding options thatconvey a reduction in visual ability, including a differentiation between reduction invisual acuity (sharpness of vision) and other reductions in vision. After performing areview, the MSSO has taken the following actions:•

A total of 12 LLTs were moved from PT Visual acuity reduced to PT Visual
impairment for better conceptual term alignment. Examples include LLT Vision
decreased and LLT Poor vision. For similar reasons, LLT Transient partial visualloss was moved from PT Visual acuity reduced transiently to PT Blindness
transient.

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New Developments in Version 20.0•

While MedDRA includes an extensive variety of LLTs subordinate to PTs such as
PT Visual acuity reduced and PT Visual impairment which convey a reduction ofvisual ability, there may not always be clear categorical distinctions among terms
pertaining to blindness, partial vision loss, and other concepts relating to visual
impairment. To address this situation, the MSSO will propose new HLT Visual
impairment and blindness (excl colour blindness) for the next MedDRA Version
21.0 Complex Change review to group such terms.

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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 20.0. These tables are intended only as a reference. For detailed information on
the changes to Version 20.0, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level Change Request Action Net Change v19.1 V20.0
SOC

HLGT

HLT

Total SOCs

0

27

27

New HLGTs

4

04

Merged HLGTs

2

0

2

Total HLGTs1

2

335

337

New HLTs

14

0

14

Merged HLTs

8

0

8

Total HLTs1

6

1,732

1,738

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

v19.1

V20.0

New PTs

298

324

Promoted LLTs

34

24

Demoted PTs

42

59

Net Change1

290

289

Total PTs

22,21022,499

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

v19.1

V20.0

LLT

Current Terms

773

67,222

67,995

LLT

Non-current Terms

7

9,246

9,253

LLT

Total LLTs1

780

76,46877,248

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

v19.1

V20.0

1

0

101

101

2

0

82

82

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Summary of Changes

Level Net Change

v19.1

V20.0

3

0

20

20

4

4

12

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 20.0. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

HLT_PT.ASC

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Added

0Removed0Modified

0

Added

0

Removed0Modified

0

Added

4

Removed2

Modified

0

Added

4

Removed2

Modified

0

Added

21

Removed15

Modified

0

Added

14

Removed8

Modified

0

Added

705

Removed220

Modified014

Summary of Changes
MDHIER.ASC

PT.ASC

LLT.ASC

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

843

Removed335

Modified

0

Added

348

Removed59

Modified

13

Added

780

Removed0Modified

430

Added1

4

Removed0Modified

217

Added

8,203

Removed

7,386

Modified

1

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

1,135

284

4,196

989

88

17

Cardiac disorders

1,430

335

2,344

601

36

10

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HLTs3 HLGTs3

15

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Congenital,familial andgenetic disorders

3,462

1,311

3,462

1,311

98

19

Ear and labyrinth
disorders

428

87

807

204

17

6

Endocrine
disorders

668

187

1,756

520

38

9

Eye disorders

2,432

592

3,701

998

64

13

Gastrointestinal
disorders

3,807

847

7,486

1,697

108

21

General disordersandadministration site
conditions

2,412

977

3,213

1,265

36

7

Hepatobiliary
disorders

650

191

1,455

423

19

4

Immune systemdisorders

457

142

2,567

687

26

4

Infections andinfestations

7,079

1,907

7,430

2,000

149

12

Injury, poisoning
and procedural
complications

6,496

1,128

9,024

2,259

78

9

Investigations

13,512

5,518

13,512

5,518

106

23

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HLTs3 HLGTs3

16

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2Metabolism andnutrition disorders

939

277

2,620

743

63

14

Musculoskeletaland connective
tissue disorders

2,511

444

6,384

1,238

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,490

1,942

9,196

2,237

202

39

Nervous systemdisorders

3,531

938

7,085

1,898

107

20

Pregnancy,
puerperium andperinatalconditions

1,633

222

2,848

572

48

8

Product issues

589

145

596

149

21

2

Psychiatricdisorders

2,341

508

3,170

740

76

23

Renal and urinary
disorders

1,202

350

2,567

728

32

8

Reproductive
system andbreast disorders

1,715

475

4,147

1,150

52

16

Respiratory,
thoracic andmediastinal
disorders

1,696

519

4,151

1,114

49

12

Skin andsubcutaneous
tissue disorders

2,054

489

4,670

1,341

56

10

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HLTs3 HLGTs3

17

Summary of Changes
LLTs*(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2Socialcircumstances

635

271

635

271

20

7

Surgical andmedicalprocedures

4,632

2,107

4,632

2,107

141

19

Vasculardisorders

1,312

306

6,613

1,601

68

11

Total

77,24822,499SOC

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.
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.

What’s New MedDRA Version 20.0
March 2017
00000118

Summary of Changes

The table below lists four terms modified in English MedDRA Version 20.0.
Code

Level

Term Name in v19.1

Term Name in v20.0

10012410

LLT

deQuervain's thyroiditis

De Quervain thyroiditis

10078658

PT

Medical device site
hyperhydrosis

Medical device site hyperhidrosis

10044669

LLT

Trihammer pulse

Trip-hammer pulse

10050509

LLT

Urinary bladder perforationinteroperative

Urinary bladder perforation
intraoperative

Table 4-7 Modified PT/LLT Names

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the 11 terms at the LLT level in MedDRA Version 20.0 thathave a change in their currency status along with the rationale for the change.
Currency
StatusChanged to

Rationale

Angioedema of larynx

Current

Based on a MedDRA user request, LLT Angioedema of
larynx was changed to a status of current as it is a valid
concept.

Rash tongue

Current

LLT Rash tongue was made current to enhance coding
options for reported verbatim terms.

Non-current

LLT Edema limbs-trunk of was changed to a non-current
status because it represents a vague concept.

Extended oligoarthritis

Non-current

The status of LLT Extended oligoarthritis under PT
Juvenile idiopathic arthritis was changed to non-current
to avoid confusion with rare reports of extended
oligoarthritis in adults. A more specific LLT Extended
juvenile oligoarthritis was added under PT Juvenile
idiopathic arthritis.

LE-like rashNon-current

Because of the ambiguity of the abbreviation,”LE,” thestatus of LLT LE-like rash was changed to non-current.

Lowest Level Term

Edema limbs-trunk of

What’s New MedDRA Version 20.0
March 2017
00000119

Summary of Changes

Lowest Level Term

Currency
StatusChanged toOedema limbs-trunk of

Non-current

Product difficult toremoveNon-current

Product reconstitution
issue

Non-current

Sore inflamed tongue

Non-current

Systemic erythematosusrashNon-current

Twilight visionNon-current

Rationale
LLT Oedema limbs-trunk of was changed to a noncurrent status because it represents a vague concept.
Based on MedDRA user feedback, LLT Product difficult
to remove has been used in practice to represent
different concepts. It has largely been used to code
patient/consumer complaints that a topical product isdifficult to remove from its application site, leaving a
residue, which is a quality issue. It has also been used tocode reports that the product is difficult to remove frompackaging. Given that the term has different
interpretations and it is ambiguous, it has been madenon-current. Note that terms have been added to provide
specificity in coding the two concepts described above LLT Topical product difficult to remove from applicationsite under PT Product quality issue and LLT Productpackaging difficult to open under PT Product use
complaint.
PT Product reconstitution issue was demoted to an LLT
under new PT Product reconstitution quality issue andchanged to a status of non-current. “Productreconstitution issue” is an ambiguous term as it can beinterpreted as a product quality issue resulting from anissue with reconstitution or it can be interpreted as a
medication error in the preparation of a product such as
an inappropriate technique used in reconstitution.
LLT Sore inflamed tongue was changed to a status of
non-current because it represents a combination of two
concepts and the term "sore" could have multiple
interpretations. Sore tongue is represented by existing
LLT Sore tongue; Inflamed tongue is represented byexisting LLT Inflammation tongue.
The status of LLT Systemic erythematosus rash (PTSystemic lupus erythematosus rash) was changed to
non-current because it is an ambiguous term and it is notclear that it specifically refers to a systemic lupus
erythematosus rash
Because “Twilight vision” is the normal ability to see in
reduced illumination, the term as worded does not
represent a vision disorder per se. Therefore, LLT
Twilight vision was changed from current to non-current
status.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 20.0
March 2017
00000120