cWhat’s New
MedDRA Version 19.1

MSSO-DI-6001-19.1.0
September 2016

Acknowledgements

ACKNOWLEDGEMENTS®

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What’s New MedDRA Version 19.1
September 2016
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ii

Table of Contents

Table of Contents
1.

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

2.

VERSION 19.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 TRANSLATION CHANGES .............................................................................. 3
2.2.1

3.

Translation Review ............................................................................. 3

NEW DEVELOPMENTS IN VERSION 19.1 ........................................................... 4
3.1 PROPOSAL TO REASSIGN PRIMARY SOC OF VASCULAR TERMS ........... 4
3.2 PAEDIATRIC AND GENDER ADVERSE EVENT TERM LISTS....................... 4
3.3 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 4
3.4 PROACTIVITY REQUESTS ............................................................................. 5
3.4.1
3.4.2
3.4.3

4.

Review of “Device type” and “Device Event” Terms in MedDRA ........ 5
Representation of Organ/Body Site Enlargement versus Hypertrophy6
Review Inconsistency in the Mapping of Specific “Wound” Terms ..... 7

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 ........................................................... 17

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ........................................................ 3
Figure 3-1 LLTs Under PT Wound as of v19.1 .................................................... 8
LIST OF TABLES
Table 3-1 Promoted and Moved Organ/body Site Enlargement Terms ............... 6
Table 3-2 New Injury / Wound PTs...................................................................... 7
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

What’s New MedDRA Version 19.1
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iii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
19.0 and 19.1.
Section 2, Version 19.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 19.1, highlights changes in Version 19.1
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:•

Term history•

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

Impact on the records in MedDRA files•

MedDRA term and SMQ counts•

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

All LLTs in MedDRA that had a currency status change.

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

What’s New MedDRA Version 19.1
September 2016
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1Version 19.1 Change Requests

2. VERSION 19.1 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 19.1 is a simple change version which means that changes may bemade only at the PT and LLT levels of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There were a totalof 1,672 change requests processed for this version; 1,362 change requests wereapproved and implemented, and 266 change requests were not approved. There are, in
addition, 44 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 19.1 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 19.1 (shown in Table 4-6) and thecorresponding information for Version 19.0. 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 19.1.

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Version 19.1 Change Requests

28
36

Blood and lymphatic system disorders
Cardiac disorders

54
50
42
51

Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders

125

Gastrointestinal disorders
General disorders and administration site conditions

9

Hepatobiliary disorders
Immune system disorders

43
37

95

Infections and infestations

246

Injury, poisoning and procedural complications

173

Investigations

39

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

65
68

114

Nervous system disorders
Pregnancy, puerperium and perinatal conditions
Product issues

-14

9
38
29

Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances

13

61

83
84

Surgical and medical procedures
Vascular disorders

74

103

Figure 2-1 Net Changes of Terms per SOC

2.2

TRANSLATION CHANGES

2.2.1 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 19.1

3. NEW DEVELOPMENTS IN VERSION 19.1
3.1

PROPOSAL TO REASSIGN PRIMARY SOC OF VASCULAR TERMS

Periodically the MSSO has received requests from MedDRA users to consider
reassigning the primary SOC of vascular terms from the site of manifestation to SOC
Vascular disorders for consistency and data retrieval purposes. The MSSO consulted
with the MedDRA Expert Panel to review recent proposals to reassign the primary SOC
of certain vascular terms, including those relating to the carotid artery. After reviewing
these proposals, the Expert Panel recommended adhering to the established MedDRA
rule which is that PTs relating to diseases or signs and symptoms are assigned to theprime manifestation site SOC as the primary SOC. At its meeting in Lisbon, Portugal inJune 2016, the MedDRA Management Board supported the Expert Panel’s
recommendation not to change the primary SOC assignment for vascular terms.
There are other approaches to retrieval of vascular concepts instead of changing the
primary SOC allocation. Vascular terms can be retrieved and viewed by means ofsecondary SOC analyses as described in the MedDRA Data Retrieval and
Presentation: Points to Consider document. In addition, there are SMQs focusing on
vascular events to aid in identification of potential cases independent of the hierarchy or
primary SOC allocation including SMQ Embolic and thrombotic events,
SMQ Haemorrhages, and SMQ Vasculitis, etc.

3.2

PAEDIATRIC AND GENDER ADVERSE EVENT TERM LISTSIn April 2016, the MSSO conducted a survey on the utility and extent of use of the
MSSO Best Practice documents and Paediatric and Gender Adverse Event Term Lists.
The results of the survey indicated a low level of use of the Paediatric and Gender Lists;they did not meet users’ needs as paediatric and gender related adverse events are
best identified by demographic data fields rather than specific adverse event terms.
The MedDRA Management Board supported that the MSSO discontinue maintenanceof the Paediatric and Gender Lists as of MedDRA Version 19.0. The last versions of thelists (MedDRA Version 19.0) and their supporting documentation are archived on the
MedDRA website for reference.
3.3

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs were introduced into MedDRA v19.1, but there were 187 approved
changes to existing SMQs. Only minor changes were made to the SMQ Introductory
Guide.

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New Developments in Version 19.1

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 19.1 change request processing period, the MSSO evaluated six
proactivity proposals submitted by MedDRA users. Three of the six proposals were
implemented in this release. See below for details on the implemented requests. 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 Review of “Device type” and “Device Event” Terms in MedDRA
The MSSO was requested to review inconsistencies against the general convention thatevents/findings concepts are placed at the PT level and devices causing event/findings
are placed on the LLT level (e.g., Pump reservoir issue, Lead dislodgement, andDevice lead damage are represented are represented at the PT level).
The MSSO performed a review of the PTs and LLTs under HLGT Device issues and
HLGT Complications associated with device and concluded that, in general, device type
terms are subordinate LLTs under the appropriate device event term PTs. There are
justifiable exceptions such as certain stent complications (e.g., endo-leaks, where theevent and device type are linked), and the representation at the PT level of certain
device components which are present in many devices, such as batteries, leads,
syringes, or needles.
However, two PTs were identified which did not warrant PT status and, to be consistent
with similar device type terms, are better placed as LLTs under a more general device
term. The MSSO implemented the following changes:•

PT Pump reservoir issue was demoted under PT Device issue•

PT Feeding tube complication was demoted under PT Complications associatedwith device

The general convention has been to place device type terms as LLTs to device event
PTs. However, MedDRA has evolved in response to users’ requests to add certain
device type terms when these devices are widely used or have a particular clinicalrelevance. Therefore, the MSSO will update section 6.8.2 and 6.19.2 of the MedDRA
Introductory Guide to describe the general conventions for representing device events
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New Developments in Version 19.1

and types, and the relevant exceptions that are made reflecting the evolution of users’
needs in device reporting.
3.4.2 Representation of Organ/Body Site Enlargement versus Hypertrophy
A MedDRA user requested the MSSO review the current representation of organ/bodysite enlargement versus hypertrophy of the same organ/site for more consistentplacement. For the liver and kidney, hypertrophy and enlargement/-megaly areseparated on the PT level, whereas for other body sites such breast, salivary andparotid glands, clitoris, genital labia and uterus, these concepts are grouped as
PTs/LLTs. For example, PT Salivary gland enlargement has subordinate to it LLTSalivary gland hypertrophy, LLT Salivary gland hyperplasia, and LLT Salivary glandswelling.
The MSSO reviewed the both the correctness of PT/LLT subordination, and possible
concept duplication (over-representation) at the PT level. A total of 15 changes weremade including 9 LLT promotions, 1 PT demotion, 4 LLT moves and 1 term rename.
See below for examples.
Promoted LLTs
Term name

Level in v19.0

Level in v19.1

Primary HLTPrimary SOC

Aortic valve
thickening

LLT

PT

Aortic valvulardisorders

Cardiacdisorders

Left ventricularenlargement

LLT

PT

Myocardial
disorders NEC

Cardiacdisorders

Right ventricularenlargement

LLT

PT

Myocardial
disorders NEC

CardiacdisordersMoved LLTs
LLT

PT v19.0

PT v19.1

Gallbladder wall thickening

Gallbladder disorder

Gallbladder enlargement

Tumor enlargement

Neoplasm

Neoplasm progression

Table 3-1 Promoted and Moved Organ/body Site Enlargement Terms

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New Developments in Version 19.1

3.4.3 Review Inconsistency in the Mapping of Specific “Wound” Terms
A MedDRA user requested the MSSO move site specific LLT terms under PT Wound(e.g., LLT Lower limb wound; LLT Open wound of back; LLT Open wound of ear) to site
specific PTs under HLT Site specific injuries NEC for improved reporting and analysis.
The MSSO implemented a total of 258 changes including changing the status of 94
LLTs under PT Wound to non-current because these terms represent combinations of
two or more concepts, many of which were incorporated into the initial version of
MedDRA. Examples include LLT Open wound of auricle, uncomplicated and LLT Openwound of cheek, complicated. All of the LLTs under PT Wound which pertain toanatomically-specific wound sites (e.g., LLT Lower limb wound), including those with a
non-current status, were moved to a respective PT that corresponds to a site of injury.
In situations where no appropriate PT was available a new site specific PT was added.
See the table below for examples.
PT

Primary HLTPrimary SOC

Abdominal wall wound

Abdominal injuries NEC

Injury, poisoning andprocedural complications

Nasal injury

Site specific injuries NEC

Injury, poisoning andprocedural complications

Paranasal sinus injury

Site specific injuries NEC

Injury, poisoning andprocedural complications

Thyroid gland injury

Site specific injuries NEC

Injury, poisoning andprocedural complications

Trunk injury

Site specific injuries NEC

Injury, poisoning andprocedural complications

Table 3-2 New Injury / Wound PTs

The graphic below shows how PT Wound and its revised group of subordinate
LLTs appear in MedDRA Version 19.1.

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New Developments in Version 19.1

Figure 3-1 LLTs under PT Wound as of v19.1

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8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 19.1. These tables are intended only as a reference. For detailed information on
the changes to Version 19.1, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level Change Request Action Net Change v19.0 v19.1
SOC

HLGT

HLT

Total SOCs

0

27

27

New HLGTs000

Merged HLGTs

0

0

0

Total HLGTs1

0

335

335

New HLTs000

Merged HLTs

0

0

0

Total HLTs1

0

1,732

1,732

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

MedDRA v19.1 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.

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9Summary of Changes

PT Changes
Level Change Request Action

PT

v19.0

v19.1

New PTs

367

298

Promoted LLTs

25

34

Demoted PTs

84

42

Net Change1

308

290

Total PTs

21,92022,210

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

v19.0

v19.1

LLT

Current Terms

553

66,66967,222

LLT

Non-current Terms

97

9,149

9,246

LLT

Total LLTs1

650

75,81876,468

Table 4-3 Summary of Impact on LLTs
1

Total LLTs include PTs as they are included together in the LLT distribution file.
New SMQs
Level Net Change

v19.0

v19.1

1

0

101

101

2

0

82

82

3

0

20

20

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10Summary of Changes

Level Net Change

v19.0

v19.1

4

0

12

12

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 the MedDRA files in Version 19.1.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

HLT_PT.ASC

MDHIER.ASC

What’s New MedDRA Version 19.1
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Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

542

Removed92

Modified

0

Added

572

11

Summary of Changes

PT.ASC

LLT.ASC

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Removed114

Modified

0

Added

332

Removed42

Modified

22

Added

650

Removed0Modified

375

Added10Removed0Modified

217

Added

534

Removed0Modified

267

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

1,130

281

4,166

978

88

17

Cardiac disorders

1,406

325

2,312

587

36

10

Congenital,familial andgenetic disorders

3,395

1,287

3,395

1,287

98

19

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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

Ear and labyrinth
disorders

424

84

800

199

17

6

Endocrine
disorders

659

183

1,739

514

38

9

Eye disorders

2,414

583

3,660

981

64

13

Gastrointestinal
disorders

3,785

838

7,428

1,676

108

21

General disordersandadministration site
conditions

2,385

965

3,156

1,240

36

7

Hepatobiliary
disorders

645

190

1,448

419

19

4

Immune systemdisorders

448

136

2,522

669

26

4

Infections andinfestations

7,051

1,887

7,379

1,977

149

12

Injury, poisoning
and procedural
complications

6,375

1,085

8,822

2,191

71

8

Investigations

13,4105,460

13,410

5,460

106

23

Metabolism andnutrition disorders

932

274

2,593

733

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

2,472

443

6,317

1,222

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,456

1,932

9,139

2,218

202

39

Nervous systemdisorders

3,501

922

6,971

1,860

107

20

Pregnancy,
puerperium andperinatalconditions

1,623

218

2,826

561

48

8

Product issues

549

139

558

145

21

2

Psychiatricdisorders

2,312

506

3,138

728

78

23

Renal and urinary
disorders

1,185

343

2,541

716

32

8

Reproductive
system andbreast disorders

1,710

471

4,122

1,136

52

16

Respiratory,
thoracic andmediastinal
disorders

1,676

512

4,089

1,099

48

11

Skin andsubcutaneous
tissue disorders

2,022

483

4,597

1,316

56

10

Socialcircumstances

625

266

625

266

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

4,576

2,097

4,576

2,097

141

19

Vasculardisorders

1,302

300

6,568

1,578

68

11

Total

76,46822,210SOC

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.
The table below lists the eleven terms modified in English MedDRA Version 19.1.

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Summary of Changes

Code

Level

Term Name in v19.0

Term Name in v19.1

10054205

PT

Aeromona infection

Aeromonas infection

10002464

LLT

Angiomimmunoblastic (AILD,LgX (Kiel Classification)

Angioimmunoblastic (AILD, LgX(Kiel Classification))

10002465

LLT

Angiomimmunoblastic (AILD,LgX (Kiel Classification)
recurrent

Angioimmunoblastic (AILD, LgX(Kiel Classification)) recurrent

10002466

LLT

Angiomimmunoblastic (AILD,LgX (Kiel Classification)refractory

Angioimmunoblastic (AILD, LgX(Kiel Classification)) refractory

10002467

LLT

Angiomimmunoblastic (AILD,LgX (Kiel Classification) stage I

Angioimmunoblastic (AILD, LgX(Kiel Classification)) stage I

10002468

LLT

Angiomimmunoblastic (AILD,LgX (Kiel Classification) stage II

Angioimmunoblastic (AILD, LgX(Kiel Classification)) stage II

10002469

LLT

Angiomimmunoblastic (AILD,LgX (Kiel Classification) stage
III

Angioimmunoblastic (AILD, LgX(Kiel Classification)) stage III

10002470

LLT

Angiomimmunoblastic (AILD,LgX (Kiel Classification) stage
IV

Angioimmunoblastic (AILD, LgX(Kiel Classification)) stage IV

10077707

PT

Cornelia de-Lange syndrome

Cornelia de Lange syndrome

10016690

LLT

Finger top hypertrophy

Finger tip hypertrophy

10071084

PT

Follicle-stimulating hormone
deficiency

Follicle stimulating hormone
deficiency

Table 4-7 Modified PT/LLT Names

What’s New MedDRA Version 19.1
September 2016
MSSO-DI-6001-19.1.0

16

Summary of Changes

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the 97 terms at the LLT level in MedDRA Version 19.1 thathave a change in their currency status along with the rationale for the change.

Lowest Level Term

Agoraphobia with panic
attacks

Bilateral recurrent
paralysis

Currency
StatusChanged to

Rationale

Non-current

The concept of Panic disorder with agoraphobia in DSM5 is now represented by two separate terms and the
combination concept LLT Agoraphobia with panic attacks
will be changed to non-current.

Non-current

Due to its ambiguity LLT Bilateral recurrent paralysis wasmade non-current and replaced with LLT Bilateral
recurrent laryngeal nerve paralysis to more fully
represent this concept.

Tongue red swollen pain

Non-current

Set of 94 Wound LLTs

Non-current

LLT Tongue red swollen pain warranted a change instatus from current to non-current, because the term
represents a combination of three individual concepts,
and MedDRA generally avoids such combination terms.
The concepts of this term can be represented by split
coding, for example: LLT Tongue redness plus LLT
Swollen tongue plus LLT Tongue pain.
A total of 94 LLTs under PT Wound were changed to astatus of non-current because these terms represent
combinations of two or more concepts, most of whichwere incorporated into the initial versions of MedDRA.
Examples include LLT Open wound of auricle,
uncomplicated and LLT Open wound of cheek,
complicated. Such terms can be represented in MedDRA
by one or more single concepts These changes were partof a proactivity request to review an inconsistency in theplacement of site specific “Wound” terms under PT
Wound. See section 3. The specific list of terms can beobtained from MVAT or the Version Report included in
the MedDRA release package.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 19.1
September 2016
MSSO-DI-6001-19.1.0

17