What’s New
MedDRA Version 18.1

MSSO-DI-6001-18.1.0
September 2015

Acknowledgements

ACKNOWLEDGEMENTS®

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What’s New MedDRA Version 18.1
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ii

Table of Contents

Table of Contents
1.

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

2.

VERSION 18.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 TRANSLATION CHANGES .............................................................................. 3
2.2.1

3.

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

NEW DEVELOPMENTS IN VERSION 18.1 ........................................................... 4
3.1 NEW SOC PRODUCT ISSUES TO BE IMPLEMENTED IN MedDRAVERSION 19.0 ........................................................................................................ 4
3.2 UPDATED MVAT .............................................................................................. 4
3.3 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 4
3.4 PROACTIVITY REQUESTS ............................................................................. 4
3.4.1
3.4.2

4.

Placement of haemorrhage and haematoma terms ............................ 5
Skin mycosis concepts ....................................................................... 6

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 ........................................................... 13

LIST OF FIGURES
Figure 2-1. Net Changes of Terms per SOC ....................................................... 3
LIST OF TABLES
Table 3-1 Primary SOC changes of hematoma terms .......................................... 5
Table 3-2 New secondary links for hemorrhage terms ......................................... 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

What’s New MedDRA Version 18.1
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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
18.0 and 18.1.
Section 2, Version 18.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 18.1, highlights changes in Version 18.1
related to change 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 18.1
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1Version 18.1 Change Requests

2. VERSION 18.1 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 18.1 is a simple change version which means that changes are madeonly at the PT and LLT levels of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There were a totalof 1,799 change requests processed for this version; 1,323 change requests wereapproved and implemented, and 431 change requests were not approved. There are, in
addition, 45 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 18.1 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 18.1 (shown in Table 4-6) and thecorresponding information for Version 18.0. 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 18.1.

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Version 18.1 Change Requests

Blood and lymphatic system disorders

27

Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders

8

Endocrine disorders

37
38

19

61

Eye disorders
Gastrointestinal disorders
General disorders and administration site…

44

Hepatobiliary disorders

81
89

68

Immune system disorders

113

Infections and infestations
Injury, poisoning and procedural complications

135

Investigations

32

Metabolism and nutrition disorders
Musculoskeletal and connective tissue…
Neoplasms benign, malignant and…

62
56

138

Nervous system disorders

28

Pregnancy, puerperium and perinatal…
Psychiatric disorders

27
28

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

12

Surgical and medical procedures

164

51
59
57
93

Vascular disorders

195

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 Version 18.1 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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New Developments in Version 18.1

3. NEW DEVELOPMENTS IN VERSION 18.1
3.1

NEW SOC PRODUCT ISSUES TO BE IMPLEMENTED IN MedDRA VERSION
19.0

The ICH MedDRA Management Board has confirmed the implementation of a 27th SOC
in March 2016 for MedDRA Version 19.0 which will be called Product issues. This new
SOC will include terms relevant for issues with product quality, devices, productmanufacturing and quality systems, supply and distribution, and counterfeit products
which are important as they may affect patient safety. More detailed information on
SOC Product issues can be found on the MedDRA website.
MedDRA users have the opportunity to review and comment on complex changes (e.g.,
HLGT and HLT changes) related to the new SOC which are posted on the change
request section of the MedDRA website. Comments are due by 25 September 2015.
3.2

UPDATED MVATThe MSSO is pleased to announce that an update to the MedDRA Version Analysis
Tool (MVAT) is available as of 28 May 2015. A MedDRA User ID and Password are
required to use the application. The MVAT’s new features include:
•
•
•
•
•

User interface available in all MedDRA languages
Report output available in all MedDRA languages
An improved history function
An option to filter report output by SOC
Improved report output related to MedDRA and SMQ changes

MVAT is free to all MedDRA users as part of a MedDRA subscription. Please view or
download a videocast from the Training Materials section of the MedDRA website
located under “Tools” to learn how to log into and use MVAT.
3.3

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs were introduced into MedDRA v18.1, but there were 292 approved
changes to existing SMQs. Only minor changes were made to the SMQ Introductory
Guide.
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 18.1 change request processing period, the MSSO evaluated fourWhat’s New MedDRA Version 18.1
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New Developments in Version 18.1

proactivity proposals submitted by MedDRA users. Of the four proposals, two were
implemented and two were not approved. See below for details on the implemented
requests. The MSSO publishes and updates a list of all proposals received and theirstatus on the Change Request section of the MedDRA website.
The MSSO is interested in learning about any ideas that users may have about“proactive” improvements to MedDRA. Please email your ideas for “proactive” MedDRA
improvements to the MSSO Help Desk. Be as specific as possible in describing yoursuggestion(s), and include a justification which explains why you think your proposal
should be implemented.
3.4.1 Placement of hemorrhage and hematoma terms
A MedDRA user asked the MSSO to review the primary SOC allocation for hemorrhage
and hematoma PTs to ensure consistency in the primary SOC allocation and to provide
criteria for when the primary SOC of these terms should be to SOC Injury, poisoning
and procedural complications.
The MSSO reviewed the placement of hemorrhage and hematoma terms in MedDRA
and, after careful consideration, 19 changes were implemented in MedDRA Version
18.1. Pairs of hemorrhage and hematoma terms that were not identically mapped intheir primary SOC representation were changed so that their primary mappings are
identical based on the site of manifestation or cause (i.e., injury). See the table below
for examples.
PT Name18.0 Primary SOC

18.1 Primary SOC

Adrenal haematoma

Injury, poisoning andprocedural complications

Endocrine disorders

Intra-abdominal
haematoma

Vascular disorders

Gastrointestinal disorders

Umbilical haematoma

Congenital, familial andgenetic disorders

Skin and subcutaneous
tissue disorders

Table 3-1 Primary SOC changes of hematoma terms

Additional secondary links were made for hemorrhage terms to SOC Injury, poisoning
and procedural complications . See examples below.

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New Developments in Version 18.1

PT Name

HLT

Secondary SOC

Adrenal haemorrhage

Abdominal injuries NEC

Injury, poisoning andprocedural complications

Laryngeal haemorrhage

Site specific injuries NEC

Injury, poisoning andprocedural complications

Renal haemorrhage

Renal and urinary tract
injuries NEC

Injury, poisoning andprocedural complications

Table 3-2 New secondary links for hemorrhage terms

Placement rules for the primary SOC of most PT concepts are dictated by the site ofmanifestation and as such it is not possible to consistently align corresponding
hemorrhage and hematoma PTs throughout all of MedDRA. Therefore, in order toretrieve all relevant cases of hemorrhage/hematoma, it may be necessary to leverageother resources such as SMQ Haemorrhages.
In addition, the proactivity request asked the MSSO to review and determine the criteria
for when the primary SOC is Injury, poisoning and procedural complications. The
MedDRA Introductory Guide Version 18.1 in section 6.12.1 provides information onplacement of concepts primary to SOC Injury, poisoning and procedural complications.

3.4.2 Skin mycosis concepts
The MSSO was requested to review the placement of “tinea” concepts for better andmore accurate placement in MedDRA. After reviewing this proposal, the MSSO made10 changes to better align tinea concepts. Many tinea PTs link to HLT Tinea Infections
but there were LLTs under these “tinea” PTs which did not indicate "tinea" but are moregeneral in nature. For example, LLT Foot infection fungal NOS was under PT Tinea
pedis and was moved to PT Fungal skin infection for more accurate placement.
Additionally, two PTs – PT Microsporum infection and PT Trichophytic granuloma weremoved from HLT Fungal infections NEC to HLT Tinea infections to better align theseconcepts.

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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 18.1. These tables are intended only as a reference. For detailed information on
the changes to Version 18.1, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level Change Request Action Net Change v18.0 v18.1
SOC

HLGT

HLT

Total SOCs

0

26

26

New HLGTs000

Merged HLGTs

0

0

0

Total HLGTs1

0

335

335

New HLTs000

Merged HLTs

0

0

0

Total HLTs1

0

1,721

1,721

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

MedDRA v18.1 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

v18.0

v18.1

New PTs

557

296

Promoted LLTs

23

21

Demoted PTs

43

50

Net Change1

537

267

Total PTs

21,345

21,612

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

751

v18.0

v18.1

74,22974,980

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

v18.0

v18.1

1

0

98

98

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 Version 18.0. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

HLT_PT.ASC

MDHIER.ASC

PT.ASC
LLT.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

543

Removed106

Modified

0

Added

589

Removed142

Modified

0

Added

317

Removed50

Modified

16

Added

751

9

Summary of Changes

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Removed0Modified

317

Added10Removed0Modified

214

Added

884

Removed0Modified

164

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

1,118

276

4,100

950

87

17

Cardiac disorders

1,379

311

2,263

562

36

10

Congenital,familial andgenetic disorders

3,306

1,242

3,306

1,242

98

19

Ear and labyrinth
disorders

420

83

766

193

17

6

Endocrine
disorders

639

178

1,687

496

38

9

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HLTs3 HLGTs3

10

Summary of Changes
LLTs*(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Eye disorders

2,388

568

3,588

949

64

13

Gastrointestinal
disorders

3,694

816

7,266

1,635

108

21

General disordersandadministration site
conditions

2,874

1,078

3,613

1,333

49

9

Hepatobiliary
disorders

625

182

1,416

404

19

4

Immune systemdisorders

435

129

2,444

646

26

4

Infections andinfestations

6,951

1,839

7,267

1,924

149

12

Injury, poisoning
and procedural
complications

6,187

1,007

8,475

2,013

69

8

Investigations

13,215

5,345

13,215

5,345

106

23

Metabolism andnutrition disorders

935

270

2,512

707

63

14

Musculoskeletaland connective
tissue disorders

2,385

425

6,160

1,176

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,373

1,893

9,032

2,163

201

39

SOC

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HLTs3 HLGTs3

11

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Nervous systemdisorders

3,427

892

6,784

1,793

107

20

Pregnancy,
puerperium andperinatalconditions

1,611

213

2,809

551

48

8

Psychiatricdisorders

2,229

502

3,031

714

78

23

Renal and urinary
disorders

1,180

336

2,499

690

32

8

Reproductive
system andbreast disorders

1,693

464

4,039

1,116

52

16

Respiratory,
thoracic andmediastinal
disorders

1,620

500

3,977

1,068

48

11

Skin andsubcutaneous
tissue disorders

1,970

466

4,498

1,282

56

10

Socialcircumstances

613

260

613

260

20

7

Surgical andmedicalprocedures

4,433

2,045

4,433

2,045

141

19

Vasculardisorders

1,280

292

6,361

1,503

68

11

Total

74,98021,612

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 two terms renamed in English MedDRA Version18.1.
Code

Level

Term Name in v18.0

Term Name in v18.1

10075460

PT

Blastic plasmacytoid dendritriccell neoplasia

Blastic plasmacytoid dendritic cell
neoplasia

10066379

LLT

Rhomboencephalitis

Rhombencephalitis

Table 4-7 Modified PT/LLT Names

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the 20 terms at the LLT level in MedDRA Version 18.1 thathave a change in their currency status along with the rationale for the change.

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Summary of Changes

Currency
StatusChanged to

Rationale

Current

Agranulocytic angina is a valid synonym for
Agranulocytosis and LLT Angina agranulocytic is acurrent LLT in MedDRA. Therefore, the status of natural
word order LLT Agranulocytic angina was changed tocurrent.

Infection systemic

Current

Systemic infection was added to MedDRA for Version
18.1 as a PT under HLT Infections NEC. Non-current LLTInfection systemic was moved from PT Sepsis to the new
PT Systemic infection and its status changed to current.

Ischaemic feet

Current

Ischaemic footCurrent

Ischemic feet

Current

Ischemic footCurrent

Pseudoaneurysm

Current

Lowest Level Term

Agranulocytic angina

Refeeding syndrome

Current

Blot haemorrhages

Non-current

Blot hemorrhages

Non-current

CHAD2DS2-VASc score
decreased

Non-current

CHAD2DS2-VASc scoreincreased

Non-current

What’s New MedDRA Version 18.1
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Based on a MedDRA user request, LLT Ischaemic feet
was changed from a status of non-current to current as it
is a recognized concept.
Based on a MedDRA user request, LLT Ischaemic footwas changed from a status of non-current to current as it
is a recognized concept.
Based on a MedDRA user request, LLT Ischemic feet
was changed from a status of non-current to current as it
is a recognized concept.
Based on a MedDRA user request, LLT Ischemic feet
was changed from a status of non-current to current as it
is a recognized concept.
The currency status of LLT Pseudoaneurysm waschanged to current because it is a commonly used valid
synonym of existing LLT False aneurysm.
The status of LLT Refeeding syndrome was changed tocurrent as it is a recognized clinical concept. Additionally
LLT Refeeding syndrome was promoted to a PT underprimary HLT Electrolyte imbalance NEC in SOC
Metabolism and nutrition disorders.
For clarification and to avoid translation issues, LLT Blot
haemorrhages was made non-current and replaced by a
new LLT Retinal blot haemorrhages.
For clarification and to avoid translation issues, LLT Blot
hemorrhages was made non-current and replaced by a
new LLT Retinal blot hemorrhages.
LLT CHAD2DS2-VASc score decreased was made noncurrent because of misspelling and its inappropriatequalifier "decreased". New PT CHA2DS2-VASc-score
was added under HLT Neurologic diagnostic procedures
as a replacement.
LLT CHAD2DS2-VASc score increased was made noncurrent because of misspelling. PT CHA2DS2-VASc
14

Summary of Changes

Lowest Level Term

Currency
StatusChanged to

Rationaleannual stroke risk high was under HLT Neurologic
diagnostic procedures as a replacement.

Dot and blot
haemorrhages

Non-current

Dot and blot
hemorrhages

Non-current

Dot haemorrhages

Non-current

Dot hemorrhages

Non-current

Drug dispensed withfalsified packaging

Non-current

Loss of teeth due toaccident, extraction, or
local periodontal diseaseNon-current

Ocular injection

Non-current

Unintentional device
misuseNon-current

For clarification and to avoid translation issues, LLT Dot
and blot haemorrhages was made non-current andreplaced by a new LLT Retinal dot and blot
haemorrhages.
For clarification and to avoid translation issues LLT Dot
and blot hemorrhages was made non-current andreplaced by a new LLT Retinal dot and blot hemorrhages.
For clarification and to avoid translation issues LLT Dot
haemorrhages was made non-current and replaced by a
new LLT Retinal dot haemorrhages.
For clarification and to avoid translation issues LLT Dot
hemorrhages was made non-current and replaced by a
new LLT Retinal dot hemorrhages.
LLT Drug dispensed with falsified packaging was madenon-current since it is a combination term which can becoded to LLT Drug dispensing error and/or an existing
counterfeit term.
LLT Loss of teeth due to accident, extraction, or local
periodontal disease is an ICD-inherited term andrepresents a combination of several potential causes andeffect. Changing the status of the term to non-current isin accordance with existing MedDRA rules.
The status of LLT Ocular injection was changed to noncurrent because it is ambiguous in meaning as it may
pertain to a procedure or a synonym for ocular
hyperaemia ("red eye").
Appendix B of the MedDRA Introductory Guide describes“misuse” as "the intentional and inappropriate use of a
product - over the counter or prescription - other than asprescribed or not in accordance with the authorized
product information”. Therefore, LLT Unintentional
device misuse was made non-current because misuse isan intentional act, not unintentional.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 18.1
September 2015
MSSO-DI-6001-18.1.0

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