What’s New
MedDRA Version 17.1

MSSO-DI-6001-17.1.0
September 2014

Acknowledgements

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Table of Contents

Table of Contents
1.

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

2.

VERSION 17.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 TRANSLATION CHANGES .............................................................................. 3
2.2.1
2.2.2

3.

French Translation Review ................................................................. 3
Enhancing Translations at the LLT level ............................................. 4

NEW DEVELOPMENTS IN VERSION 17.1 ........................................................... 5
3.1 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 5
3.2 PROACTIVITY REQUESTS ............................................................................. 5
3.2.1
3.2.2

Hernia Terms ...................................................................................... 5
Pressure and Pain or Discomfort Terms ............................................. 6

3.3 SENSATION OF PRESSURE........................................................................... 6
3.4 DISCOMFORT .................................................................................................. 64.

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

LIST OF FIGURES
Figure 2-1. Net Changes of Terms per SOC ....................................................... 3
LIST OF TABLES
Table 3-1 Examples of hernia term changes ........................................................ 5
Table 3-2 Examples of changes to placement of “pressure” LLTs ....................... 6
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs ...................................... 7
Table 4-2 Summary of Impact on PTs ................................................................. 8
Table 4-3 Summary of Impact on LLTs ............................................................... 8
Table 4-4 Summary of Impact on SMQs ............................................................. 8
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 10
Table 4-6 MedDRA Term Counts ...................................................................... 12
Table 4-7 Modified PT/LLT Names .................................................................... 13
Table 4-8 LLT Currency Changes ..................................................................... 15

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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
17.0 and 17.1.
Section 2, Version 17.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 17.1, highlights changes in v17.1 related tochange request submissions, new initiatives, and information on Standardised MedDRA
Queries (SMQs).
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 17.1
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1Version 17.1 Change Requests

2. VERSION 17.1 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 v17.1 is a simple change version which means that changes are made at the
PT and LLT level only.
Change requests involve both MedDRA updates and SMQ changes. There were a totalof 1614 change requests processed for this version; 1214 change requests wereapproved and implemented, and 290 change requests were not approved. There are, in
addition, 110 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 English
language 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 oftheir subscription.
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
v17.1 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 v5.1 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 v17.1 (shown in Table 4-6) and the corresponding
information for v17.0. Additionally, term name changes and LLT currency statuschanges are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA v17.1.

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Version 17.1 Change Requests
47

Blood and lymphatic system disorders

23
24

Cardiac disorders
Congenital, familial and genetic disorders

12
20

Ear and labyrinth disorders
Endocrine disorders

50

Eye disorders

76

Gastrointestinal disorders

169

General disorders and administration site…
Hepatobiliary disorders

9
62
65

Immune system disorders
Infections and infestations

191

Injury, poisoning and procedural complications

169

Investigations

18

Metabolism and nutrition disorders

44
43

Musculoskeletal and connective tissue…
Neoplasms benign, malignant and…

63

Nervous system disorders

36

Pregnancy, puerperium and perinatal…

16
11

Psychiatric disorders
Renal and urinary disorders

36
43

Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders

88

Skin and subcutaneous tissue disorders
Social circumstances

7

Surgical and medical procedures
Vascular disorders

58
112

Figure 2-1. Net Changes of Terms per SOC

2.2

TRANSLATION CHANGES

2.2.1 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 several MedDRA releases. To assist MedDRA
users to understand changes that have been implemented, the MSSO has included a
spreadsheet in the French MedDRA v17.1 download which contains a list of all changes
made. This spreadsheet indicates which translation changes are conceptual changes(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 versionsof 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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Version 17.1 Change Requests

2.2.2 Enhancing Translations at the LLT level
Due to language and culture differences, not every English LLT has a unique translationin other languages. For example, LLTs with British/American spelling and lexical
variants (e.g., LLT Haemorrhage / LLT Hemorrhage, LLT Back pain / LLT Pain back)are often translated to the same term name. Additionally, synonymous LLTs may nothave a unique translation in every language (e.g., LLT Dry heaves and LLT Gagging
may not have different synonyms in the translated language). For this reason, duplicate
translations are permitted at the LLT level under the same PT for non-English
languages.
This maintenance approach, while helpful for consistency, is not always optimal as it
may reduce the number of terms in a translation. To enhance the MedDRA languages,
the MedDRA Management Board has approved a modification of the translation
maintenance rules to allow the use of the language specific synonyms in place of
duplicate translations where appropriate. See below for an example:

Code

English term

French term v17.0

French term v17.1

10063056

Faecaldisimpaction

Désimpaction
fécaleEvacuation d'unfécalome

10063058

Fecal
disimpaction

Désimpaction
fécaleDésimpaction fécale

These synonym translations must enhance the utility of the translation but retain themeaning of the original term. This enhancement has been applied proactively formany of the supported languages and will be part any future translation review.

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New Developments in Version 17.1

3. NEW DEVELOPMENTS IN VERSION 17.1
3.1

STANDARDISED MedDRA QUERIES (SMQs)

Two new level 1 SMQs were released into production in MedDRA v17.1: SMQ
Proteinuria and SMQ Tubulointerstitial diseases. There are now 96 level 1 SMQs in
production as of this version. Please see the MedDRA v17.1 SMQ Introductory Guide
for more information about the new SMQs including their inclusion and exclusion
criteria.
3.2

PROACTIVITY REQUESTS

The proactive maintenance process allows MedDRA users to propose general changes
to MedDRA outside of the established change request process to addressinconsistencies, make corrections, or suggest improvements. During the v17.1 change
request processing period, the MSSO evaluated four proactivity proposals submitted by
MedDRA users. Of the four proposals two were implemented and two were notapproved. 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.
3.2.1 Hernia Terms
A MedDRA user pointed out that the placements of incarcerated, strangulated, andobstructive hernia terms (e.g., LLT Incarcerated hernia under PT Hernia obstructive) are
not optimal as they are medically distinct concepts and should be represented
separately. After reviewing the current placement of these terms, the MSSO medical
team agreed these concepts should be represented as separate PTs. As a result of thisreview, the MSSO made 19 changes to existing terms and added 3 new PTs torepresent these concepts at the PT level. See below for examples.
Term Name

Level

ChangeFemoral hernia incarceratedPT

New PT

Hiatus hernia strangulated

PT

New PT

Incarcerated hernia

PT

Promoted LLTStrangulated hernia

PT

Promoted LLTTable 3-1 Examples of hernia term changes
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5New Developments in Version 17.1

3.2.2 Pressure and Pain or Discomfort Terms
In a proactivity request submitted by a MedDRA user, the MSSO was asked to review
inconsistencies in the mapping of LLTs containing “pressure” to PTs related to either“pain” or “discomfort.” As a result of this initiative, 9 changes to existing “pressure” terms
were made to align “pressure” with the concept of “discomfort,” rather than “pain.” Seebelow for examples.

LLT

PT in v17.0

PT in v17.1

Head pressure

HeadacheHead discomfort

Sensation of pressure in eye

Abnormal sensation in eye

Ocular discomfort

Sinus pressure

Sinus headacheParanasal sinus
discomfort

Demoted PT
Sensation of pressure

v17.1 PT
Discomfort

Table 3-2 Examples of changes to placement of “pressure” 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 v17.1.
These tables are intended only as a reference. For detailed information on the changes
to v17.1, please see the MedDRA Version Report included within the English language
download.
SOC, HLGT, HLT Changes
Level Change Request Action Net Change v17.0 v17.1
SOC

HLGT

HLT

Total SOCs

0

26

26

New HLGTs000

Merged HLGTs

0

0

0

Total HLGTs1

0

334

334

New HLTs000

Merged HLTs

0

0

0

Total HLTs1

0

1720

1720

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

MedDRA v17.1 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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7Summary of Changes

PT Changes
Level Change Request Action

PT

v17.0

v17.1

New PTs280

281

Promoted LLTs

41

32

Demoted PTs

69

64

Net Change1

252

249

Total PTs

20559

20808

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
LLT

Total LLTs1

584

v17.0

v17.1

72637

73221

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

v17.0

v17.1

1

2

94

96

2

0

82

82

3

0

20

20

4

0

12

12

5

0

2

2

Table 4-4 Summary of Impact on SMQs
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8Summary of Changes

4.2

SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES

The table below summarizes the impact on MedDRA in v17.1. The table is intended
only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

HLT_PT.ASC

MDHIER.ASC

PT.ASC

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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

562

Removed125

Modified

0

Added

612

Removed147

Modified

0

Added

313

Removed64

Modified129

Summary of Changes

LLT.ASC

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

584

Removed0Modified

395

Added1

2

Removed0Modified

210

Added

950

Removed0Modified

139

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

1093

265

4036

924

87

17

Cardiac disorders

1354

302

2208

543

36

10

Congenital,familial andgenetic disorders

3231

1208

3231

1208

98

19

Ear and labyrinth
disorders

416

81

760

190

17

6

Endocrine
disorders

604

167

1640

476

38

9

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HLTs3 HLGTs3

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Summary of Changes
LLTs*(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Eye disorders

2351

556

3514

925

64

13

Gastrointestinal
disorders

3636

796

7153

1587

109

21

General disordersandadministration site
conditions

2522

842

3160

1054

49

9

Hepatobiliary
disorders

609

175

1367

392

19

4

Immune systemdisorders

413

122

2338

613

26

4

Infections andinfestations

6829

1808

7140

1889

149

12

Injury, poisoning
and procedural
complications

6051

961

8033

1770

67

7

Investigations

12990

5226

12990

5226

106

23

Metabolism andnutrition disorders

917

265

2444

689

63

14

Musculoskeletaland connective
tissue disorders

2321

410

6000

1101

60

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8311

1867

8950

2118

201

39

SOC

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Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Nervous systemdisorders

3316

848

6546

1702

107

20

Pregnancy,
puerperium andperinatalconditions

1597

213

2765

542

48

8

Psychiatricdisorders

2187

486

2988

695

78

23

Renal and urinary
disorders

1151

323

2466

674

32

8

Reproductive
system andbreast disorders

1675

456

3989

1091

52

16

Respiratory,
thoracic andmediastinal
disorders

1579

476

3913

1042

48

11

Skin andsubcutaneous
tissue disorders

1932

449

4264

1176

56

10

Socialcircumstances

600

252

600

252

20

7

Surgical andmedicalprocedures

4325

1985

4325

1985

140

19

Vasculardisorders

1211

269

6109

1413

68

11

Total

73221

20808

HLTs3 HLGTs3

Table 4-6 MedDRA Term Counts

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Summary of Changes
1Primary count only includes the number of terms that are primarily linked to thedesignated SOC at either the LLT level or the PT level. The sums of primary LLTs andPTs match those in Tables 4-2 and 4-3.
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 4 terms renamed in MedDRA v17.1.
Code

Level

Term Name in v17.0

Term Name in v17.1

10006611

LLT

Burkitt's tumor or lymphoma
involving lymph nodes ofinguinal region and lower limb.

Burkitt's tumor or lymphoma
involving lymph nodes ofinguinal region and lower limb

10011488

LLT

Cryptococcal neoformans
meningitis

Cryptococcus neoformans
meningitis

10028284

LLT

Muscae volitanteMuscae volitantes

10074880

PT

Prevertebral soft issue swellingof cervical space

Prevertebral soft tissue swellingof cervical space

Table 4-7 Modified PT/LLT Names

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Summary of Changes

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the 11 terms at the LLT level in MedDRA v17.1 that have achange in their currency status along with the rationale for the change.

Lowest Level Term

Inappropriate formulationof drug administered

Currency
StatusChanged toCurrent

Rationale
Inappropriate formulation of drug administered is arecognized concept and will be made a current LLT.
Note that LLT Inappropriate formulation of vaccine
administered is also a current term in MedDRA.
LLT Adverse local tissue reaction was made non-current
because the concept could be interpreted to represent an
administration site reaction or any local tissue reaction.
To more specifically convey the nature of the concept,
the MSSO added LLT Adverse local tissue reaction
around prosthesis to PT Medical device site reaction.
The acronym ASPT could represent a number of differing
concepts such as "All Safety Precautions Taken","Asymptomatic Spontaneous Pneumothorax" and"Average Score Per Taxon"
Truncated words are generally made non-current in
MedDRA. Please note that the non-abbreviated spelling
LLT Coronary artery disease aggravated is available.
Truncated words are generally made non-current in
MedDRA. Please note that the spelled out LLT
Disseminated intravascular coagulation exists in
MedDRA.
Navicular fracture is ambiguous because it can refer tothe name of a bone in either the wrist or the foot. The
MSSO added LLT Scaphoid bone fracture to PT Wrist
fracture and LLT Tarsal navicular bone fracture to PT
Foot fracture to provide coding options for both possible
sites of navicular fracture.
Truncated words are generally made non-current in
MedDRA. The completely spelled out LLT Neuroleptic
malignant syndrome aggravated exists in MedDRA.
Overdose effect represents a combination term of
overdose and effect/event which can be represented byexisting individual terms.

Adverse local tissue
reaction

Non-current

ASPT

Non-current

Coronary artery disease
aggravat.

Non-current

Dissem. intravasc.
coagulation

Non-current

Navicular fracture

Non-current

Neuroleptic malignant
synd. aggr.

Non-current

Overdose effectNon-current

PruritisNon-current

LLT Pruritis is a misspelled word. The alternate correctspelling, LLT Pruritus, already exists in MedDRA.

Thyroid stim. hormone
decreased

Non-current

Truncated words are generally made non-current in
MedDRA. The completely spelled out LLT Thyroid
stimulating hormone decreased exists in MedDRA.

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Summary of Changes

Lowest Level TermThyroid stim. hormone
increased

Currency
StatusChanged to
Non-current

Rationale
Truncated words are generally made non-current in
MedDRA. The completely spelled out LLT Thyroid
stimulating hormone increased exists in MedDRA.

Table 4-8 LLT Currency Changes

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