C

What’s New
MedDRA Version 22.0

March 2019000271

Acknowledgements

ACKNOWLEDGEMENTS
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What’s New MedDRA Version 22.0
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Table of Contents

Table of Contents
1.

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

2.

VERSION 22.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 33.

NEW DEVELOPMENTS IN VERSION 22.0 ........................................................... 6
3.1 RUSSIAN MedDRA .......................................................................................... 6
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 6
3.2.1
Update to the SMQ Spreadsheet ........................................................ 6
3.3 PROACTIVITY REQUESTS ............................................................................. 7
3.3.1
Placement of Anesthesia terms........................................................... 7
3.3.2
Review of Chemical burns and corrosive injuries ................................ 8
3.4 MedDRA WEB-BASED BROWSER 3.0 ......................................................... 84.

SUMMARY OF CHANGES ................................................................................... 10
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ....................................... 10
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 12
4.3 MedDRA TERM COUNTS .............................................................................. 13
4.4 MODIFIED PT AND LLT NAMES ................................................................... 16
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 17

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
Figure 3-1 SMQ PT Codes ................................................................................... 7
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....................................................................................... 5
Table 3-1 Moved Anesthesia Terms .................................................................... 8
Table 3-2 Modifications to Chemical burn terms ................................................. 8
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs .................................... 10
Table 4-2 Summary of Impact on PTs ............................................................... 11
Table 4-3 Summary of Impact on LLTs ............................................................. 11
Table 4-4 Summary of Impact on SMQs ........................................................... 12
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 13
Table 4-6 MedDRA Term Counts ...................................................................... 16
Table 4-7 Modified PT/LLT Names.................................................................... 17
Table 4-8 LLT Currency Changes ..................................................................... 19

What’s New MedDRA Version 22.0
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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
21.1 and 22.0.
Section 2, Version 22.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 22.0, highlights changes in Version 22.0
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:•

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•

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 22.0
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Version 22.0 Change Requests

2. VERSION 22.0 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 22.0 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 was a totalof 1,541 change requests processed for this version; 1,333 change requests wereapproved and implemented, and 207 change requests were not approved. There is, inaddition, one change request 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. Additionally, supplemental changes may be viewed in MedDRA Web-Based
Browser via the “supplemental view” feature. Supplemental information 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 22.0 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 22.0 (shown in Table 4-6) and thecorresponding information for Version 21.1. 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 22.0.

What’s New MedDRA Version 22.0
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Version 22.0 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…
Hepatobiliary disorders
Immune system disorders
Infections and infestations
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Musculoskeletal and connective tissue…
Neoplasms benign, malignant and…
Nervous system disorders
Pregnancy, puerperium and perinatal…
Product issues
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders

51

27
11

117

31
30

73

16

89

48
53

130

41
87

120
144

52

13
26

153

49
36

60

150

4
122

159

Figure 2-1 Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 22.0 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 30 July 2018 to 21 September 2018. Complex changes
were followed by further internal review and consensus discussions which resulted in
the final approved set of 16 complex changes.
The complex changes implemented in Version 22.0 are summarized below. Please see
the “Related Documents” on the Change Request section of the MedDRA website for
specific details.

What’s New MedDRA Version 22.0
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Version 22.0 Change Requests

At the SOC level: No changes were made to existing SOCs.
At the HLGT level: There were two High Level Group Terms (HLGTs) added and two
merged as a result of complex changes in Version 22.0. The changes are as follows:
New HLGTs
New HLGT

To SOC

Cardiac disorders, signs and symptoms
NEC

Cardiac disorders

Vascular infections and inflammations

Vascular disorders

Table 2-1 New HLGTs

Merged HLGTs
HLGT

To HLGT

SOC

Cardiac disorder signs andsymptoms

Cardiac disorders, signs andsymptoms NEC

Cardiac disorders

Vascular inflammations

Vascular infections andinflammations

Vascular disorders

Table 2-2 Merged HLGTs

At the HLT level: There were six High Level Terms (HLTs) added and six merged as aresult of complex changes in Version 22.0. The changes are as follows:
New HLTs
New HLTTo SOC

Aortic infections and inflammations

Vascular disorders

Arterial infections and inflammations

Vascular disorders

Gingival disorders, signs and symptoms
NEC

Gastrointestinal disorders

Hallucinations (excl sleep-related)

Psychiatric disorders

Perception disturbances NEC

Psychiatric disorders

What’s New MedDRA Version 22.0
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Version 22.0 Change Requests

New HLTTo SOC

Thoracic spinal cord and nerve root
disorders

Nervous system disorders

Table 2-3 New HLTs

Merged HLTs
HLT

To HLT

SOC

Aortic inflammatory disorders

Aortic infections andinflammations

Vascular disorders

Arterial inflammations

Arterial infections andinflammations

Vascular disorders

Gingival discolourations

Gingival disorders, signs andsymptoms NEC

Gastrointestinal disorders

Gingival disorders NEC

Gingival disorders, signs andsymptoms NEC

Gastrointestinal disorders

Gingival pains

Gingival disorders, signs andsymptoms NEC

Gastrointestinal disorders

Perception disturbances

Perception disturbances NEC

Psychiatric disorders

Table 2-4 Merged HLTs

What’s New MedDRA Version 22.0
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5

New Developments in Version 22.0

3. NEW DEVELOPMENTS IN VERSION 22.0
3.1

RUSSIAN MedDRA

The MSSO is pleased to announce that as of Version 22.0, Russian MedDRA will beavailable to MedDRA users. Russian MedDRA is provided to all users at no additional
cost and includes the MedDRA term files, availability in the MedDRA Web-Based
Browser and all the related documentation that is provided in other supported
languages. Users may access Russian MedDRA from the MedDRA website in the samemanner as other languages. Note that a Russian version report and accessibility ofRussian term information in MVAT will be available in September 2019 when Version
22.1 debuts as there are not yet two Russian versions to generate a comparison. For
any specific questions about Russian MedDRA and how to access it, please contact the
MSSO Help Desk.
3.2

STANDARDISED MedDRA QUERIES (SMQs)

New SMQ Hypokalaemia was added in MedDRA Version 22.0. There are now 104 level
1 SMQs in production as of this version. Additionally, there were 389 approved changes
to existing SMQs. To view changes to existing SMQs, please review the MedDRA
Version 22.0 Version Report.
Please see the MedDRA Version 22.0 SMQ Introductory Guide for detailed information
on new SMQ Hypokalaemia.
3.2.1 Update to the SMQ Spreadsheet
The MSSO provides an SMQ spreadsheet in the English MedDRA download package
for the purpose of offering SMQ information to users that may not have the resources ortools to work with the SMQ files (i.e., smq_list.asc and smq_content.asc). The SMQ
spreadsheet is updated for each MedDRA Version and includes SMQ hierarchicalinformation, a list of narrow and broad scope PTs in each SMQ, a summary of the level
1 SMQs and list of active and inactive PT counts for each SMQ.
As of MedDRA Version 22.0, an additional report will be included in the SMQ
spreadsheet that lists the active PT codes for both narrow and broad scope searches
for each SMQ. This new report will allow users to quickly copy the PT codes for the
purposes of inserting them directly into a query. Hierarchical SMQs will include the PT
codes of all subordinate SMQs. For algorithmic SMQs, the broad scope search includes
all active PTs from all categories; if users wish to use the algorithmic search approach,they will need to apply the specific algorithm based on categories that is described in
the SMQ Introductory Guide to their query. See the example below. Users may also
extract SMQ information via the “SMQ Export” feature of the MedDRA Web-Based
Browser and Desktop Browser.

What’s New MedDRA Version 22.0
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New Developments in Version 22.0

Figure 3-1 SMQ PT Codes

Note that the PT Codes shown in the figure above are not a complete listing and would
extend further out to the right in the SMQ PT Codes report.

3.3

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 22.0 change request processing period, the MSSO received andimplemented two requests from MedDRA users. See below for details. The MSSO
publishes and updates a list of all proposals received and their status on the Change
Request section of the MedDRA website.
The MSSO is interested in learning about any ideas that users may have about“proactive” improvements to MedDRA. Please email your ideas for “proactive” MedDRA
improvements to the MSSO Help Desk. Be as specific as possible in describing yoursuggestion(s), and include a justification which explains why you think your proposal
should be implemented.
3.3.1 Placement of Anesthesia terms
Based on a request by a MedDRA user, the MSSO reviewed anesthesia terms toconsider more optimal placement in MedDRA. As a result of this review, new PT
Anaesthesia oral was added to primary HLT Oral soft tissue signs and symptoms in
SOC Gastrointestinal disorders with a secondary link to HLT Paraesthesias anddysaesthesias in SOC Nervous system disorders to represent anesthesia terms
separately from hypoesthesia terms. As a result, nine existing LLTs were moved fromPT Hypoaesthesia oral to new PT Anaesthesia oral. See the table below for examples.

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New Developments in Version 22.0
LLT Name

PT v21.1

PT v22.0

Anaesthesia lip

Hypoaesthesia oral

Anaesthesia oral

Anaesthesia oral mucosa

Hypoaesthesia oral

Anaesthesia oral

Anaesthesia tongue

Hypoaesthesia oral

Anaesthesia oral

Table 3-1 Moved Anesthesia Terms

Additionally, for consistency of placement, the following PTs were moved from HLT
Sensory abnormalities NEC to HLT Paraesthesias and dysaesthesias: PT Anaesthesia
dolorosa, PT Anaesthesia, PT Hemianaesthesia, and PT Thermoanaesthesia.

3.3.2

Review of Chemical burns and corrosive injuries

The MSSO reviewed a proactivity request to consider modifications to the placement ofexisting chemical burn and corrosive injury terms. Based in this review, a total of six
changes were made to existing terms for more consistent placement in MedDRA. For
example, two PTs were demoted to reduce over-granulation of anatomically closely
related concepts. See below for details:
PT Demoted to LLT

Under PT

In SOC

Chemical iritis

Chemical burns of eye

Injury, poisoning andprocedural complications

Chemical eye injury

Chemical burns of eye

Injury, poisoning andprocedural complications

Table 3-2 Modifications to Chemical burn terms

3.4

MedDRA WEB-BASED BROWSER 3.0

An update to the MedDRA Web-Based Browser (WBB) is available as of October 2018.
The update includes the following enhancements:
•
•
•
•
•

An option to view supplemental updates
SMQ analysis
Hierarchy analysis
More advanced searching via additional Boolean and string operators
An option to include the secondary SOC path in exports of search results, theresearch bin, and hierarchy analysis reports

The MSSO has developed a videocast that focuses on the new features of the WBB.
The videocast is available for download or for direct viewing under the Tools
What’s New MedDRA Version 22.0
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8

New Developments in Version 22.0

section/MedDRA Web-Based Browser section on the Training Materials page with thetitle “WBB 3.0 Enhancements.”
To access the WBB, simply login using your MedDRA ID and Password. This password
is the same password used to access the MedDRA website. If you don’t know your User
ID and Password, please use the MedDRA Self-Service Application.

What’s New MedDRA Version 22.0
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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 22.0. These tables are intended only as a reference. For detailed information on
the changes to Version 22.0, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v21.1 v22.0

SOC

Total SOCs

0

27

27

New HLGTs

202

Merged HLGTs

2

0

2

Total HLGTs1

0

337

337

New HLTs606

Merged HLTs

6

0

6

Total HLTs1

0

1,737

1,737

HLGT

HLT

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

1 Total net change of HLGTs or HLTs equals the number of new HLGTs or HLTs minus

the number of respective merged HLGTs or HLTs.

What’s New MedDRA Version 22.0
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Summary of Changes

PT Changes
Level Change Request Action

PT

v21.1

v22.0

New PTs

347

327

Promoted LLTs

19

42

Demoted PTs

65

50

Net Change1

301

319

Total PTs

23,38923,708

Table 4-2 Summary of Impact on PTs
1Net change of PTs equals the number of new PTs plus the number of promoted LLTs

minus the number of demoted PTs.
LLT Changes
Level

Currency Status

Net Change

v21.1

v22.0

LLT

Current Terms

748

70,22970,977

LLT

Non-current Terms

7

9,278

9,285

LLT

Total LLTs1

755

79,50780,262

Table 4-3 Summary of Impact on LLTs

1Total LLTs include PTs as they are also in the LLT distribution file.

What’s New MedDRA Version 22.0
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Summary of Changes

New SMQs
Level Net Change

v21.1

v22.0

1

1

103

104

2

0

82

82

3

0

20

20

4

0

16

16

5

0

2

2

Table 4-4 Summary of Impact on SMQs

4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES
The table below summarizes the impact on MedDRA in Version 22.0. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

What’s New MedDRA Version 22.0
March 2019000271

Added

0Removed0Modified

0

Added

0

Removed0Modified

0

Added

2

Removed2

Modified

0

Added

2

Removed2

Modified

0

Added

13

Removed13

Modified

0

Added

6

Removed6

Modified012Summary of Changes

HLT_PT.ASC

MDHIER.ASC

PT.ASC

LLT.ASC

Added

658

Removed158

Modified

0

Added

856

Removed320

Modified

0

Added

369

Removed50

Modified

4

Added

755

Removed0Modified339

1

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

1

Removed0Modified

223

Added

1,062

Removed0Modified

145

Table 4-5 Summary of Impact on Records in MedDRA Files

1 The number of SMQs added includes both top level (Level 1) and sub-search SMQs.

4.3

MedDRA TERM COUNTS

The table below shows term counts by SOC for HLGTs, HLTs, primary and secondary
PTs and LLTs, and primary PTs and LLTs. Note that the number of LLTs also includes
PTs.

SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,155

293

4,343

1,036

88

17

Cardiac disorders

1,481

357

2,418

633

36

10

What’s New MedDRA Version 22.0
March 2019000271

HLTs3 HLGTs3

13

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Congenital,familial andgenetic disorders

3,714

1,441

3,714

1,441

98

19

Ear and labyrinth
disorders

442

93

844

218

17

6

Endocrine
disorders

680

193

1,849

566

38

9

Eye disorders

2,501

623

3,824

1,051

63

13

Gastrointestinal
disorders

3,926

881

7,700

1,750

106

21

General disordersandadministration site
conditions

2,538

1,030

3,439

1,361

36

7

Hepatobiliary
disorders

673

203

1,504

443

19

4

Immune systemdisorders

498

144

2,723

742

26

4

Infections andinfestations

7,289

1,984

7,652

2,085

149

12

Injury, poisoning
and procedural
complications

6,800

1,242

9,522

2,429

78

9

Investigations

13,921

5,785

13,921

5,785

106

23

Metabolism andnutrition disorders

977

287

2,755

798

63

14

What’s New MedDRA Version 22.0
March 2019000271

HLTs3 HLGTs3

14

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Musculoskeletaland connective
tissue disorders

2,636

479

6,727

1,357

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,669

1,990

9,462

2,312

202

39

Nervous systemdisorders

3,730

987

7,430

2,024

108

20

Pregnancy,
puerperium andperinatalconditions

1,641

229

2,953

623

48

8

Product issues

664

159

681

167

21

2

Psychiatricdisorders

2,382

536

3,274

806

77

23

Renal and urinary
disorders

1,240

361

2,653

756

32

8

Reproductive
system andbreast disorders

1,769

498

4,282

1,201

52

16

Respiratory,
thoracic andmediastinal
disorders

1,755

544

4,327

1,177

49

12

Skin andsubcutaneous
tissue disorders

2,146

518

4,988

1,425

56

10

Socialcircumstances

642

275

642

275

20

7

What’s New MedDRA Version 22.0
March 2019000271

HLTs3 HLGTs3

15

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Surgical andmedicalprocedures

5,037

2,258

5,037

2,258

141

19

Vasculardisorders

1,356

318

6,882

1,688

68

11

Total

80,262

23,708SOC

HLTs3 HLGTs3

Table 4-6 MedDRA Term Counts
1Primary count only includes the number of terms that are primarily linked to thedesignated SOC at either the LLT level or the PT level. The sums of primary LLTs andPTs match those in Tables 4-2 and 4-3.
2Total count includes the number of terms that are both primarily and secondarily linked

to the designated SOC at either the LLT level or the PT level. Therefore, the sums of
total LLTs and PTs are greater than those in Tables 4-2 and 4-3.
3The HLT and HLGT counts are not necessarily unique values given MedDRA’s multi-

axiality (see Section 2.2 of the Introductory Guide for a discussion of multi-axiality).
There are some HLTs that are counted in more than one SOC. For example, HLT
Connective tissue disorders congenital and HLGT Musculoskeletal and connective
tissue disorders congenital are counted in both SOC Congenital, familial and genetic
disorders and SOC Musculoskeletal and connective tissue disorders. The sums of HLTs
and HLGTs are greater than those found in Table 4-1.
4.4

MODIFIED PT AND LLT NAMESAs part of ongoing MedDRA maintenance activities, existing PTs and LLTs can be
modified (renamed) to correct for misspelling, double spacing, capitalization, or othererrors that meet the renaming criteria in MedDRA. This rename provision retains theoriginal MedDRA code of the term and preserves its original meaning.
The table below summarizes terms modified in English MedDRA Version 22.0.

What’s New MedDRA Version 22.0
March 201900027116

Summary of Changes

Code

Level

Term Name in v21.1

Term Name in v22.0

10066910

PT

Lumbar syndrome

LUMBAR syndrome

10047372

LLT

Vesicouretral reflux unspecified
or without reflux nephropathy

Vesicoureteral reflux
unspecified or without reflux
nephropathy

10047373

LLT

Vesicouretral reflux with reflux
nephropathy NOS

Vesicoureteral reflux with reflux
nephropathy NOS

10047374

LLT

Vesicouretral reflux with reflux
nephropathy, bilateral

Vesicoureteral reflux with reflux
nephropathy, bilateral

10047375

LLT

Vesicouretral reflux with reflux
nephropathy, unilateral

Vesicoureteral reflux with reflux
nephropathy, unilateral

Table 4-7 Modified PT/LLT Names

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects 11 terms at the LLT level in MedDRA Version 22.0 that hada change in currency status along with the rationale for the change.
Currency
StatusChanged to

Rationale

LUMBAR syndrome

Current

LUMBAR syndrome was changed to a status of current
as it is a recognized concept often characterized by alarge infantile hemangioma on the lower back often
extending down to the leg. Other features are urogenitaltract malformations, spinal cord defects, bone
deformities, anorectal malformations, and arterial
anomalies. In MedDRA Version 22.0, LLT LUMBAR
syndrome was promoted to a PT and linked to primary
HLT Vascular anomalies congenital NEC in SOC
Congenital, familial and genetic disorders, secondary
HLT Cardiovascular neoplasms benign in SOC
Neoplasms benign, malignant and unspecified (incl cysts
and polyps).

PET scanCurrent

LLT PET scan was changed to a status of current
because it is a commonly used and non-ambiguous
concept.

Lowest Level Term

What’s New MedDRA Version 22.0
March 201900027117

Summary of Changes

Lowest Level Term

Currency
StatusChanged toAcute renal failure withlesion of tubular necrosis

Non-current

Aspiration bronchial

Non-current

Aspiration tracheal

Non-current

Cardialgia

Non-current

Loss of thoracic lordosis

Non-current

Raised TG

Non-current

Tracheal aspiration

Transienthypogammaglobulinaemia

Rationale
Although acute renal failure can result from tubular
necrosis secondary to exposure to a toxin or ischemic
damage to the tubules, the concepts combined in LLTAcute renal failure with lesion of tubular necrosis can becoded separately. All of the other combination terms ofthis type presently subordinate to PT Acute kidney injury
have been changed to a non-current status.
LLT Aspiration bronchial was changed to a status of noncurrent and replaced with LLT Aspiration into bronchus
to clarify the concept and to provide a term that is distinct
from the investigation term represented by LLT Bronchialaspiration procedure.
LLT Aspiration tracheal was changed to a status of noncurrent and replaced with LLT Aspiration into trachea toclarify the concept and to provide a term that is distinct
from the investigation term represented by LLT Tracheal
aspiration procedure.
LLT Cardialgia was changed to a status of non-current
because it is ambiguous as it is defined as pain in andaround the heart and has been used to represent
heartburn in addition to heart pain.
The vertebral column is constituted by a succession of
three physiological curves: lumbar lordosis, dorsal
kyphosis, cervical lordosis. LLT Loss of thoracic lordosis,
which is intended to represent the loss of a physiologic
thoracic lordosis, does not exist in normal spine
curvatures.
LLT Raised TG was changed to a status of non-current
due to its ambiguity as it may represent many medical
concepts such as: triglyceride; tendon graft; testosterone
glucuronide; tocogram; total gastrectomy; toxic goiter;transmissible gastroenteritis; treated group; tricuspid
gradient; trigeminal ganglion; tumor growth, etc.

Non-current

LLT Tracheal aspiration was changed to a status of noncurrent and replaced by new LLT Aspiration into trachea
which was added for clarification of the concept.

Non-current

The status of LLT Transient hypogammaglobulinaemia
was changed to non-current because "Transient" canrefer to unspecified transient hypogammaglobulinaemia
in adults or to transient hypogammaglobulinemia of
infancy.

What’s New MedDRA Version 22.0
March 201900027118

Summary of Changes

Lowest Level Term

Transienthypogammaglobulinemia

Currency
StatusChanged to

Rationale

Non-current

The status of LLT Transient hypogammaglobulinemia
was changed to non-current because "transient" canrefer to unspecified transient hypogammaglobulinemia in
adults or to transient hypogammaglobulinemia of
infancy.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 22.0
March 201900027119