cWhat’s New
MedDRA Version 19.0

MSSO-DI-6001-19.0.0
March 2016

Acknowledgements

ACKNOWLEDGEMENTS®

MedDRA trademark is owned by IFPMA on behalf of ICH.

Disclaimer and Copyright NoticeThis document is protected by copyright and may be used, reproduced, incorporated
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What’s New MedDRA Version 19.0
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iiTable of Contents

Table of Contents
1.

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

2.

VERSION 19.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 3
2.3 TRANSLATION CHANGES .............................................................................. 7
2.3.1

3.

French Translation Review ................................................................. 7

NEW DEVELOPMENTS IN VERSION 19.0 ........................................................... 8
3.1 NEW SOC PRODUCT ISSUES ........................................................................ 8
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 8
3.3 UPDATED MedDRA DESKTOP BROWSER .................................................... 9
3.4 UPDATE TO MVAT DATA IMPACT REPORTS ............................................... 9
3.5 PROACTIVITY REQUESTS ........................................................................... 10
3.5.1
3.5.2
3.5.3
3.5.4

4.

Changes in SOC Psychiatric disorders ............................................. 10
Maternal, Fetal and Neonatal terms.................................................. 11
Surgical shunts versus spontaneous shunts..................................... 11
Non- traumatic LLTs under HLTs implying trauma ........................... 12

SUMMARY OF CHANGES ................................................................................... 13
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ....................................... 13
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 15
4.3 MedDRA TERM COUNTS .............................................................................. 16
4.4 MODIFIED PT AND LLT NAMES ................................................................... 19
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 20

LIST OF FIGURES
Figure 2-1. Net Changes of Terms per SOC ....................................................... 3
LIST OF TABLES
Table 2-1 New SOC ............................................................................................ 4
Table 2-2 New HLGTs ......................................................................................... 4
Table 2-3 Merged HLGTs .................................................................................... 4
Table 2-4 Moved HLGTs ..................................................................................... 4
Table 2-5 New HLTs ........................................................................................... 5
Table 2-6 Merged HLTs....................................................................................... 6
Table 2-7 Moved HLTs ........................................................................................ 6
Table 3-1 Example of changes in SOC Psychiatric disorders ........................... 10
Table 3-2 Example of fetal terms....................................................................... 11
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Table of Contents

Table 3-3 Example of shunt term changes ........................................................ 11
Table 3-4 LLTs under HLTs implying trauma .................................................... 12
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs .................................... 13
Table 4-2 Summary of Impact on PTs ............................................................... 14
Table 4-3 Summary of Impact on LLTs ............................................................. 14
Table 4-4 Summary of Impact on SMQs ........................................................... 15
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 16
Table 4-6 MedDRA Term Counts ...................................................................... 19
Table 4-7 Modified PT/LLT Names.................................................................... 20
Table 4-8 LLT Currency Changes ..................................................................... 21

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iv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
18.1 and 19.0.
Section 2, Version 19.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 19.0, highlights changes in Version 19.0
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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1Version 19.0 Change Requests

2. VERSION 19.0 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 19.0 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 2,264 change requests processed for this version; 1,814 change requests wereapproved and implemented, and 419 change requests were not approved. There are, in
addition, 31 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 19.0 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 19.0 (shown in Table 4-6) and thecorresponding information for Version 18.1. 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 19.0.

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Version 19.0 Change Requests

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 conditions
Hepatobiliary disorders
Immune system disorders
Infections and infestations

-609

72
39
82
8
32
46
94
38
64
70

374

Injury, poisoning and procedural complications

135

Investigations
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system disorders
Pregnancy, puerperium and perinatal conditions

67
141
101
142
18

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

86
39
26
78
73
5
92

Vascular disorders

740

197

Figure 2-1. Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 19.0 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 6 August 2015 to 25 September 2015. Complex
changes were followed by further internal review and consensus discussions which
resulted in the final approved set of 32 complex changes.
The complex changes implemented in Version 19.0 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 19.0 Change Requests

At the SOC level: One SOC was added. Please see section 3.1 for information on the
new SOC Product issues.
New SOCNew SOC
Product issues
Table 2-1 New SOC

At the HLGT level: Two new High Level Grouping Terms (HLGTs) were added, two
HLGTs were merged and one moved as a result of complex changes in Version 19.0.
The changes are as follows:
New HLGTs
New HLGT

To SOC

Product quality, supply, distribution,
manufacturing and quality system issues

Product issues

Somatic symptom and related disorders

Psychiatric disorders

Table 2-2 New HLGTs

Merged HLGTs
Merged HLGTTo HLGTTo SOC

Product quality issues

Product quality, supply,
distribution, manufacturingand quality system issues

Product issues

Somatoform and factitious
disorders

Somatic symptom andrelated disorders

Psychiatric disorders

Table 2-3 Merged HLGTs

HLGT Moves
HLGT
Device issues

From SOC
General disorders andadministration site
conditions

To SOC
Product issues

Table 2-4 Moved HLGTs

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Version 19.0 Change Requests

At the HLT level: There were 16 new High Level Terms (HLTs) added, five HLTs
merged, and five moved as a result of complex changes in Version 19.0. The changes
are as follows:
New HLTs
New HLTTo SOC

Anaphylactic and anaphylactoid responses

Immune system disorders

Counterfeit, falsified and substandard products

Product issues

Device site reactions

Injury, poisoning and procedural complications
Psychiatric disordersIntellectual disabilities

Nervous system disorders

Intercepted medication errors

Injury, poisoning and procedural complications

Manufacturing facilities and equipment issues

Product issues

Manufacturing issues NEC

Product issues

Manufacturing laboratory controls issues

Product issues

Manufacturing materials issues

Product issues

Manufacturing production issues

Product issues
Blood and lymphatic system disorders

Marginal zone lymphomas NEC

Neoplasms benign, malignant and unspecified(incl cysts and polyps)

Paraphilias and paraphilic disorders

Psychiatric disorders

Product distribution and storage issues

Product issues

Product supply and availability issues

Product issues

Somatic symptom disorders

Psychiatric disorders

Varicose veins NEC

Vascular disorders
Table 2-5 New HLTs

Merged HLTs
Merged HLT

To HLT

Anaphylactic responses

Anaphylactic andanaphylactoid responses

Mental retardations

Intellectual disabilities

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SOC
Immune system disorders
Psychiatric disorders
Nervous system disorders
5Version 19.0 Change Requests

Merged HLT

To HLT

SOC

Paraphilias

Paraphilias and paraphilic
disorders

Psychiatric disorders

Somatoform disorders

Somatic symptom disorders

Psychiatric disorders

Varicose veins non-site
specific

Varicose veins NEC

Vascular disorders

Table 2-6 Merged HLTs

HLT Moves
HLT

From SOCTo HLGT

Product contaminationand sterility issues

General disorders andadministration site
conditions

Product quality, supply,
distribution,
manufacturing and quality
system issues

Product label issues

General disorders andadministration site
conditions

Product quality, supply,
distribution,
manufacturing and quality
system issues

Product packaging
issuesGeneral disorders andadministration site
conditions

Product quality, supply,
distribution,
manufacturing and quality
system issues

Product physicalissuesGeneral disorders andadministration site
conditions

Product quality, supply,
distribution,
manufacturing and quality
system issues

General disorders andadministration site
conditions

Product quality, supply,
distribution,
manufacturing and quality
system issues

Product quality issues
NEC

In SOC
Product issues

Product issues

Product issues

Product issues

Product issues

Table 2-7 Moved HLTs

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Version 19.0 Change Requests

2.3

TRANSLATION CHANGES

2.3.1 French Translation Review
In an effort to review and improve the French translation of MedDRA, the MSSO is
conducting a review of the translation of terms from English into French. This will be an
ongoing effort that is expected to last until MedDRA Version 19.1. To assist MedDRA
users to understand changes that have been implemented, the MSSO has included a
spreadsheet in the French MedDRA Version 19.0 download which contains a list of allchanges made. This spreadsheet indicates which translation changes are conceptualchanges (i.e., change in meaning) versus those that are minor corrections such as
spelling or modifications to diacritical marks. This spreadsheet will be included in all
future versions of the French translation of MedDRA until the review is complete.
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 version of
MedDRA.

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7New Developments in Version 19.0

3. NEW DEVELOPMENTS IN VERSION 19.0
3.1

NEW SOC PRODUCT ISSUESThe ICH MedDRA Management Board confirmed the implementation of new SOC
Product issues for MedDRA Version 19.0. This new SOC includes terms relevant for
issues with product quality, devices, product manufacturing and quality systems, supply
and distribution, and counterfeit products. One of the goals of incorporating productquality terms into MedDRA is to support the recording of product quality issues and any
associated adverse events using a single terminology. It is envisaged that the productquality terms, including those relating to manufacturing and distribution, may be used toreport product defects to regulatory authorities and may also be used in organizations’internal databases to track and trend quality issues or deviations.
As defined in the MedDRA Introductory Guide, for the purposes of MedDRA,a productcan refer to various types of products intended for human use such as drugs(prescription and over the counter), biologics, vaccines, combination products, devices,
nutraceuticals, dietary supplements, etc. Furthermore, the terminology may also support
other types of products which are regulated in at least one region such as food orcosmetics.
The addition of SOC Product issues to MedDRA brings the total number of SOCs to 27.
The new SOC has the same five level hierarchical structure as the existing SOCs andexpresses multi-axiality where appropriate (e.g., PT Transmission of an infectious agent
via product is represented in both in SOC Product issues and SOC Infections andinfestations). For MedDRA Version 19.0, SOC Product issues contains two HLGTs:
HLGT Device issues which moved from SOC General disorders and administration site
conditions and new HLGT Product quality, supply, distribution, manufacturing andquality system issues which replaces HLGT Product quality issues and contains a mix
of five existing product quality HLTs and eight new HLTs added in MedDRA Version
19.0. In addition, eight PTs were added to this new HLGT and new terms will continue
to be added in future MedDRA releases based on input from users.
For additional information on the implementation of SOC Product issues, please see
Section 2 of this document and the 27th SOC page on the MedDRA website.
3.2

STANDARDISED MedDRA QUERIES (SMQs)

Three new level 1 SMQs were released into production in MedDRA Version 19.0:•••

SMQ Drug reaction with eosinophilia and systemic symptoms syndrome
SMQ Hypoglycaemia
SMQ Medication errors

There are now 101 level 1 SMQs in production as of this version.

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8New Developments in Version 19.0

In addition to three new SMQs, SMQ Pulmonary hypertension has been revised due tothe publication of an updated definition, classification, and revised diagnostic criteria for
pulmonary hypertension. This new information impacted the original case identification
parameters for the SMQ and, as a result, the CIOMS SMQ Working Group has
extensively updated the documentation and term list based on testing in order to reflect
the contemporary disease criteria of this condition.
Please see the MedDRA Version 19.0 SMQ Introductory Guide for more information,
including inclusion and exclusion criteria, about the new SMQs and the revision of SMQ
Pulmonary hypertension.
3.3

UPDATED MedDRA DESKTOP BROWSERThe MSSO is pleased to announce that an updated MedDRA Desktop Browser (MDB
Version 4.0) was made available for download on 8 October 2015. The updated MDB
has the following enhancements:•

User interface more closely resembles the Web-Based Browser (WBB)•

User interface can be displayed in all MedDRA languages•

Ability to export search results and Research Bin to local file system•

Option to filter search results by primary SOC•

Support for Japanese synonyms and J-Currency

The MDB is free to all MedDRA users and is part of your subscription. To download the
new version of the desktop browser, click here (User ID and password required). To
learn about the new features of MDB 4.0, please view or download the MDB 4.0
videocast from the Training Materials section of the MedDRA.org website located under“Tools.”Please contact the MSSO Help Desk if you have any questions.
3.4

UPDATE TO MVAT DATA IMPACT REPORTS

Based on MedDRA user feedback, the MSSO made an update in November 2015 to
the MVAT Data Impact reports. MVAT 2.0, which debuted in May 2015, included anenhanced “LLTs under different PTs” report to address user requests for more
information about LLT changes.
While helpful to some, the enhanced report provided too much information for others
and caused confusion. To address this situation, the MSSO has updated MVAT to
include the original “LLTs under different PTs” Data Impact report while keeping theenhanced report for those users who find it helpful. The enhanced report has beenrenamed to “Comprehensive LLT Changes” to avoid confusion with the original report.
If you have any questions, please contact the MSSO Help Desk.
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9New Developments in Version 19.0

3.5

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 19.0 change request processing period, the MSSO evaluated fiveproactivity proposals submitted by MedDRA users. Of the five proposals, four were
implemented and one was 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.
3.5.1 Changes in SOC Psychiatric disorders
The MSSO made changes in SOC Psychiatric disorders to better align MedDRA withthe latest version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
and the common use of mental disorder concepts among medical, educational, andother professionals. There were a total of 98 changes, including complex changes
implemented which consisted of 35 new terms and 63 changes to existing terms. See
the table below for examples of new terms and changes to existing terms.

New PT Name

Speech sound disorder
Illness anxiety disorder
Selective eating disorder

Demoted PT

Phonological disorder
Hypochondriasis
Feeding disorder of infancy or
early childhood

New Term Examples
Primary HLTCommunications disorders
Somatic symptom disorders
Eating disorders NEC

Term Move Examples
To New PT

Primary SOC

Psychiatric disorders
Psychiatric disorders
Psychiatric disorders

HLT

Speech sound disorder
Illness anxiety disorder

Communications disorders
Somatic symptom disorders

Selective eating disorder

Eating disorders NEC

Table 3-1 Example of changes in SOC Psychiatric disorders

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10New Developments in Version 19.0

3.5.2 Maternal, Fetal and Neonatal terms
The MSSO was asked to consider adding a set of terms to MedDRA for use as astandardized international grading system being developed for maternal, fetal, andneonatal adverse events. The system will be used to support clinical trials and the terms
will be based on MedDRA terms. While maternal and neonatal concepts are alreadywell represented in MedDRA, certain recognized fetal concepts were not in theterminology and were needed for inclusion in the grading system. Based on this reivew,
a total of 18 new terms were added. See below for examples.
New PT Name

Primary HLT

Foetal compartment fluid
collection

Primary SOC

Foetal complications NEC

Dyskinesias and movement
disorders NEC
Foetal and neonatal imaging
Foetal renal imaging abnormal
procedures
Foetal movement disorderPregnancy, puerperium andperinatal conditions
Nervous system disorders
Investigations

Table 3-2 Example of fetal terms

3.5.3 Surgical shunts versus spontaneous shunts
The MSSO was asked to review the placement of surgical shunts versus spontaneous
shunts for consistency in MedDRA. Shunt terms that can only refer to surgicalprocedures are placed in SOC Surgical and medical procedures; shunt terms that can
only refer to anatomical/pathophysiologic conditions/disorders are placed in theappropriate "disorder" SOC. For other shunt concepts that could represent either aprocedure or a condition/disorder, the unqualified shunt term is considered to represent
the condition/disorder and a counterpart term qualified with the word "procedure"
represents the surgical procedure concept. Based on this rationale, 2 new terms wereadded and changes were made to 11 existing “shunt” terms. See below for several
examples.
LLT Move

From PT

Mesocaval shunt

Portal shunt

Portacaval shunt

Portal shunt

Femoral-popliteal shunt

Vascular shunt

To PT

Portal shuntprocedure (new PT)
Portal shuntprocedure (new PT)
Peripheral artery
bypass (existing PT)

Primary SOC

Surgical andmedical procedures
Surgical andmedical procedures
Surgical andmedical procedures

Table 3-3 Example of shunt term changes

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11New Developments in Version 19.0

3.5.4 Non- traumatic LLTs under HLTs implying trauma
A MedDRA user pointed out that there are terms at the LLT level which specify nontraumatic (or similar wording) under a PT concept which loses the non traumatic aspectwith a primary link to SOC Injury, poisoning and procedural complications or to HLTs
implying trauma. Examples include:
LLT

Non-traumatic
extradural
haemorrhage

Non-traumatic ruptureof patellar tendon

PT

Epidural haemorrhage

Tendon rupture

HLT

Primary - Cerebral
injuries NEC;
Secondary Traumatic central
nervous systemhaemorrhages,
Nervous systemhaemorrhagic
disordersPrimary - Muscle,
tendon and ligament
injuries; Secondary Tendon disorders

SOC
Primary - Injury,
poisoning andprocedural
complications;
Secondary –Nervous systemdisorders, VasculardisordersPrimary - Injury,
poisoning andprocedural
complications;
Secondary Musculoskeletal andconnective tissue
disordersTable 3-4 LLTs under HLTs implying trauma

The MSSO determined that it is appropriate to keep the primary SOC allocation of SOC
Injury, poisoning and procedural complications even for non-traumatic concepts
because, in the case of tendon and muscle tissues for example, the broad concept of“injury” can apply to other damaging factors in addition to trauma such as changes due
to aging, inflammation, fibrosis, and drug effects.
The MSSO noted that there were four non-traumatic LTTs under PT Epidural
haemorrhage in HLT Traumatic central nervous system haemorrhages (see one
example in the table above). This placement under a “trauma” HLT is not appropriate;however, to move them would require the creation of a new, qualified non-traumatic PT
for epidural hemorrhage with the possibility of setting a precedent for the addition ofunqualified and qualified (traumatic and non-traumatic) terms for multiple hemorrhage
terms at various anatomical sites. It is not practical from a pharmacovigilance
perspective to create combination hemorrhage terms reflecting both etiology andanatomical location therefore the best solution with a minimal impact on legacy data
was to change the status of the LLT Non-traumatic extradural haemorrhage and LLT
Non-traumatic extradural hemorrhage to non-current. The two other non-traumatic
LLTs, LLT Nontraumatic extradural haemorrhage and LLT Nontraumatic extradural
hemorrhage, were already non-current. See section 4.5 LLT Currency Status Changes.
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12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 19.0. These tables are intended only as a reference. For detailed information on
the changes to Version 19.0, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level Change Request Action Net Change v18.1 v19.0
SOC

HLGT

HLT

Total SOCs

1

26

27

New HLGTs

202

Merged HLGTs

2

0

2

Total HLGTs1

0

335

335

New HLTs

16

0

16

Merged HLTs

5

0

5

Total HLTs1

11

1,721

1,732

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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13Summary of Changes

PT Changes
Level Change Request Action

PT

v18.1

v19.0

New PTs

296

367

Promoted LLTs

21

25

Demoted PTs

50

84

Net Change1

267

308

Total PTs

21,612

21,920

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

v18.1

v19.0

LLT

Current Terms

831

65,83866,669LLT

Non-current Terms

7

9,142

9,149

LLT

Total LLTs1

838

74,98075,818

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

v18.1

v19.0

1

3

98

101

2

0

82

82

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14Summary of Changes

Level Net Change

v18.1

v19.0

3

0

20

20

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 MedDRA in Version 19.0. 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

1

Removed0Modified

0

Added

1

Removed0Modified

0

Added

3

Removed3

Modified

0

Added

2

Removed2

Modified

0

Added

23

Removed12

Modified

0

Added

16

Removed5

Modified

0

Added

854

Removed248

Modified015

Summary of Changes
MDHIER.ASC

PT.ASC

LLT.ASC

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

1070

Removed435

Modified

0

Added

392

Removed84

Modified

142

Added

838

Removed0Modified

518

Added1

3

Removed0Modified

214

Added

4112

Removed0Modified

234

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

1,125

278

4,152

971

88

17

Cardiac disorders

1,395

316

2,289

574

36

10

Congenital,familial andgenetic disorders

3,360

1,269

3,360

1,269

98

19

What’s New MedDRA Version 19.0
March 2016
MSSO-DI-6001-19.0.0

HLTs3 HLGTs3

16

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Ear and labyrinth
disorders

422

84

771

196

17

6

Endocrine
disorders

650

179

1,711

504

38

9

Eye disorders

2,402

575

3,626

964

64

13

Gastrointestinal
disorders

3,738

828

7,340

1,656

108

21

General disordersandadministration site
conditions

2,363

957

3,125

1,227

36

7

Hepatobiliary
disorders

631

188

1,441

417

19

4

Immune systemdisorders

447

135

2,495

658

26

4

Infections andinfestations

6,992

1,860

7,315

1,948

149

12

Injury, poisoning
and procedural
complications

6,266

1,044

8,716

2,141

71

8

Investigations

13,3055,390

13,305

5,390

106

23

Metabolism andnutrition disorders

922

271

2,563

724

63

14

What’s New MedDRA Version 19.0
March 2016
MSSO-DI-6001-19.0.0

HLTs3 HLGTs3

17

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Musculoskeletaland connective
tissue disorders

2,452

440

6,272

1,204

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,426

1,919

9,098

2,198

202

39

Nervous systemdisorders

3,495

906

6,893

1,825

107

20

Pregnancy,
puerperium andperinatalconditions

1,620

216

2,820

558

48

8

Product issues

557

144

566

150

21

2

Psychiatricdisorders

2,301

504

3,109

720

78

23

Renal and urinary
disorders

1,182

340

2,525

703

32

8

Reproductive
system andbreast disorders

1,701

468

4,058

1,123

52

16

Respiratory,
thoracic andmediastinal
disorders

1,660

506

4,037

1,086

48

11

Skin andsubcutaneous
tissue disorders

1,996

473

4,552

1,301

56

10

Socialcircumstances

617

261

617

261

20

7

What’s New MedDRA Version 19.0
March 2016
MSSO-DI-6001-19.0.0

HLTs3 HLGTs3

18

Summary of Changes
LLTs*(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2Surgical andmedicalprocedures

4,498

2,072

4,498

2,072

141

19

Vasculardisorders

1,295

297

6,514

1,555

68

11

Total

75,81821,920SOC

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 19.0
March 2016
MSSO-DI-6001-19.0.0

19Summary of Changes

The table below lists the one term modified in English MedDRA Version19.0.
Code

Level

Term Name in v18.1

10065413

PT

PaO2/FIO2 ratio decreased

Term Name in v19.0
PaO2/FiO2 ratio decreased

Table 4-7 Modified PT/LLT Names

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the 9 terms at the LLT level in MedDRA Version 19.0 thathave a change in their currency status along with the rationale for the change.

Lowest Level Term

Currency
StatusChanged to

Subaortic stenosis,
congenital

Current

Catheter thrombosis

Non-current

Device misuse

Non-current

LE rashNon-current

Non-traumatic extradural
haemorrhage

Non-current

Non-traumatic extradural
hemorrhage

Non-current

Panic disorder withagoraphobia

Non-current

What’s New MedDRA Version 19.0
March 2016
MSSO-DI-6001-19.0.0

Rationale
The status of non-current LLT Subaortic stenosis,
congenital was made current and moved from PT
Congenital aortic valve stenosis under a more
appropriate - PT Hypertrophic cardiomyopathy.
Subaortic stenosis, congenital it is not a valvular issue,
but is a hypertrophy of the subaortic myocardium and asynonym of idiopathic hypertrophic subaortic stenosis.
Since catheter thrombosis can be interpreted in two ways
(thrombosis in catheter or related to catheter), the MSSO
changed the status of LLT Catheter thrombosis to noncurrent. A new LLT Catheter related thrombosis wasadded under the new PT Device related thrombosis.
Device misuse can be interpreted as a term for coding
circumstances other than those described in the
MedDRA concept description of misuse, therefore, it wasmade non-current because of its potential ambiguity.
The status of LLT LE rash was made non-current
because of its potential ambiguity and uncommon use.
For consistency with similar already non-current LLTs,
e.g., LLT Nontraumatic extradural haemorrhage, thestatus of LLT Non-traumatic extradural haemorrhage waschanged to non-current.
For consistency with similar already non-current LLTs,
e.g., LLT Nontraumatic extradural haemorrhage, thestatus of LLT Non-traumatic extradural hemorrhage waschanged to non-current.
PT Panic disorder with agoraphobia was demoted under
new PT Panic disorder and was made non-current as it20Summary of Changes

Lowest Level Term

Currency
StatusChanged to

Rationale
represents a combination between two separate
concepts.

Solvent administeredwithout active ingredientNon-current

SufferingNon-current

LLT Solvent administered without active ingredient
combines two concepts: a drug administration error and a
preparation error. Placement either under PT Productpreparation error or under PT Wrong technique inproduct usage process does not represent the additional
concept of an administration error. A single term cannot
represent both important concepts and so instead, theconcepts can be represented by LLT Product preparation
error and LLT Drug administration error and/or LLT
Missed dose.
A new LLT Emotional suffering was added under PT
Emotional distress for clarification of the nature of theconcept of "suffering".

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 19.0
March 2016
MSSO-DI-6001-19.0.0

21