What is the current version of medDra

What's new in MedDRA version 18.0

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1 What's New MedDRA Version 18.0

2 Indication of source Indication of source The MedDRA trademark is the property of IFPMA on behalf of ICH. Copyright, Disclaimer and Terms of Use This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license, provided that ICH's copyright is mentioned in the respective document becomes. In the event of an adaptation, change or translation of the document, appropriate measures must be taken to clearly identify, delimit or otherwise identify any changes made to the original document or based on it. Any impression that the adaptation, modification or translation has been approved or promoted by ICH must be avoided. This document is provided "as is" and "without warranty of any kind". In no event shall ICH or the authors of the original document be liable for any claims, claims for damages or other liabilities arising from the use of this document. The above-mentioned permissions do not apply to content provided by third parties. Accordingly, in the case of documents where copyright is the vested right of a third party, permission must be obtained from the copyright owner. ii

3 Table of contents Table of contents 1. OVERVIEW OF VERSION 18.0 REQUESTS FOR CHANGES TERMINOLOGY CHANGES COMPLEX CHANGES TRANSLATION CHANGES Revision of the French translation NEW DEVELOPMENTS IN VERSION UPDATES OF PRODUCT USE CONCEPTS A 27th SOC WILL BE OVERVIEWED IN THE MEDDRA VERSION 19.0 OF THE MEDDRA VERSION. SMQS) PROACTIVE REQUESTS FOR CHANGES Terms related to the use of medication Position terms Classification of terms relating to backbone / spinal and spinal / spinal column Pharmacogenomic biomarkers in drug labeling SUMMARY OF THE CHANGES SUMMARY OF THE IMPACT ON THE MEDICAL IMPACT FILES NUMBER OF MedDRA TERMS RENAMED PT AND LLT TERMS CHANGE OF STATUS CURRENT / NOT CURRENT OF LLT TERMS 19 LIST OF ILLUSTRATIONS Fig ng 2-1. Changes to the terms in the respective SOC ... 3 LIST OF TABLES Table 2-1 New HLGTs ... 4 Table 2-2 New HLTs ... 4 Table 2-3 Merged HLTs ... 5 Table 3-1 Renamed SMQs ... 9 iii

4 Table of Contents Table 3-2 Examples of Job Terms that have been added to MedDRA Table 3-3 Examples of changes in terms related to backbone / spinal and spinal / vertebral body ... 11 Table 3-4 Examples of new pharmacogenomic biomarker terms Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs 12 Table 4-2 Summary of Impact on PTs Table 4-3 Summary of Impact on LLTs Table 4-4 Summary of Impact on SMQs Table 4-5 Summary the effects on entries in MedDRA files Table 4-6 Number of MedDRA terms Table 4-7 Modified PT / LLT terms Table 4-8 Change in LLT status iv

5 Overview 1. OVERVIEW This What's New document provides information about sources and types of changes made to MedDRA (Medical Dictionary for Regulatory Activities) terminology between Version 17.1 and Version 18.0. Section 2, Version 18.0, Change Requests, provides a summary of the information about the number of change requests processed for this version. Section 3, New Developments in Version 18.0, highlights changes made in Version 17.0 based on change requests, new initiatives, and information regarding Standardized MedDRA Queries (SMQs). Section 4, Summary of Changes, provides details on: History of Terms Effect of this version on terminology (in tables) Effect on entries in MedDRA files Number of MedDRA terms and SMQs List of modified LLT terms (lowest level) and PT - Terms (preferred terms) List of changes in the update status of all LLTs in MedDRA. All updated documents pertaining to this version are on distribution media in Adobe Portable Document Format (PDF) or, in the case of some documents, Microsoft Excel. The !! Readme.txt file contains a complete listing. The MSSO (Maintenance and Support Services Organization) help desk can be reached internationally free of charge at the International AT&T number or under 1

6 Version 18.0 Change Requests 2. VERSION 18.0 CHANGE REQUESTS 2.1 TERMINOLOGY CHANGES Changes to MedDRA terminology are based on change requests and proactive requests from MedDRA users as well as internal change requests. Internal change requests can originate from maintenance activities of the MSSO as well as from special working groups with the participation of the MSSO. MedDRA v18.0 is a complex change release, which means that changes can be made at all levels of the MedDRA hierarchy. Change requests include MedDRA updates as well as SMQ changes. In the context of this version, a total of change requests were processed; of these, change requests were accepted and included in the terminology and 280 change requests were rejected. In addition, 31 change requests in this version were postponed for later consideration and decision. Information about specific changes (e.g. terms added, LLT increased, PT decreased, PT primary SOC changes, etc.) that have been made since the previous MedDRA release can be downloaded from the Version Report with each respective English version of MedDRA . In addition, users can use the MedDRA Version Analysis Tool (MVAT) if necessary. This is an online tool that compares any two versions of MedDRA, including the non-consecutive versions, to detect changes. The output from MVAT is similar to the version report. MVAT is made available to MedDRA users free of charge as part of the subscription. Between MedDRA releases, MSSO will provide files in the form of a weekly supplementary update that includes approved changes that will be included in the next MedDRA release. With the help of these additional files, users can see what changes will be included in the next release. An explanation of all changes considered (approved and rejected) under MedDRA Version 18.0 can be downloaded as a detailed cumulative report in the English version of MedDRA. Users can also review individual change requests from version 5.1 up to and including the current version in WebCR. Figure 2-1 (below) summarizes all of the System Organ Class (SOC) changes and can be useful in assessing the impact of changes on a particular area of ​​MedDRA. This data is derived from the difference in counts between primary and secondary PT / LLTs, HLTs, and HLGTs for version 18.0 (as shown in Table 4-6) and the corresponding information for version 17.1. Also included in Figure 2-1 are changes to the terminology and LLT status. 2

7 Version 18.0 Change Requests Section 4 contains a summary of the changes in MedDRA version General disorders and administration site conditions Eye disorders Surgical and medical interventions Endocrine disorders Respiratory, thoracic and mediastinal disorders Reproductive system and breast disorders Skin and subcutaneous tissue disorders Renal disorders and urinary tract Blood and lymphatic system disorders Gastrointestinal disorders Immune system disorders Nervous system disorders Ear and labyrinth disorders Vascular disorders Benign, malignant and unspecific neoplasms (including heart disorders Infections and parasitic disorders Congenital, familial and genetic disorders Liver and biliary disorders Psychiatric disorders Pregnancy, puerperium and perinatal diseases Skeletal muscle, connective tissue and bone diseases n Social Circumstances Metabolic and Nutritional Disorders Investigations Injury, Poisoning, and Procedural Complications Figure 2-1. Changes to terms in the relevant SOC 2.2 COMPLEX CHANGES The complex change proposals considered in version 18.0 include changes submitted by users and special initiatives, as well as changes identified internally by the MSSO in the course of processing change requests. Complex change suggestions were posted on the MedDRA website for feedback from the MedDRA user community from July 7, 2014 to August 1, 2014. The complex changes were then subjected to further internal review and consensus discussions, which resulted in the final approved set of 16 complex changes. The complex changes in version 18.0 are summarized below. Specific details can be found under Related Documents in the Change Request section of the MedDRA website. 3

8 Version 18.0 Change requests At the SOC level: The existing SOCs were not changed. At the HLGT level: As a result of the complex changes in version 18.0, a new High Level Grouping Term (HLGT) has been added and no HLGTs have been merged. The changes were as follows: New HLGTs New HLGT Product Use Issues On SOC Injury, Poisoning, and procedural complications Table 2-1 New HLGTs At the HLT level: As a result of the complex changes in version 18.0, eight new highs became high Level Terms (HLTs) added and seven HLTs merged. The changes were as follows: New HLTs New HLT Abdominal hernias ANE Limb fractures Fractures and dislocations of the limbs Applications outside of the indications in the specialist information Overdoses ANE Patient positioning Problems with the use of a product ANE Underdoses ANE To SOC Diseases of the gastrointestinal tract Skeletal and connective muscles Injury, poisoning, and procedural complications Injury, poisoning and procedural complications Injury, poisoning and procedural complications Surgical and Medical Injury, poisoning and procedural complications Injury, poisoning and procedural complications Table 2-2 New LDSs Combined HLTs Combined HLT To HLT SOC Hernias of the abdominal cavity NNE Abdominal hernias NNE Gastrointestinal disorders 4

9 Version 18.0 Change requests Merged HLT to HLT SOC Abdominal hernias of unspecific localization Abdominal hernias ANE Diseases of the gastrointestinal tract Fractures of the lower limbs Fractures and dislocations of the lower limbs Overdoses Fractures of the upper limbs Fractures and dislocations of the upper limbs Fractures and dislocations of the limbs Fractures of the limbs and dislocations of the limbs and limb dislocations Skeletal muscle, connective tissue and bone disorders Injury, poisoning and procedural complications Injury, poisoning and procedural complications Skeletal muscle, connective tissue and bone diseases Injury, poisoning and procedural complications Table 2-3 Compiled HLTs 2.3 TRANSLATIONS Revision of the French translation In an effort to revise and improve the French version MedDRA's MSSO is currently reviewing the translation of terms from English to French. This is an ongoing process that is expected to span multiple MedDRA approvals. So that French MedDRA users can see what changes have been made, the MSSO has added a table in the French-language download of MedDRA version 18.0 that contains a list of all changes made. This table shows which translation changes are conceptual changes (i.e., changes in meaning) compared to changes that are minor corrections, such as changes in meaning. B. Spelling or changes to diacritical marks. This table will be added to all future French-language versions of MedDRA until the review is completed. If users would like to submit a translation correction of one or more terms in a non-English version of MedDRA, please refer to the Change Request section on the MedDRA website. 5

10 New Developments In Version NEW DEVELOPMENTS IN VERSION UPDATES TO PRODUCT USE CONCEPT Several MedDRA users have requested complex and related changes, including searches for new terms to better organize the placement of product use concepts, including concepts related to medication errors, over and underdosing, as well as concepts relating to misuse and applications outside of the indication in the specialist information. The MSSO reviewed the feedback contained in these proposals and, in collaboration with the ICH M1 Points to Consider working group, developed a structure that allows better organization of product use concepts. The following points briefly describe the approach used. For specific details, see Implemented Complex Changes for Version 18.0 in the Change Request section of the MedDRA website. A new HLGT product use issue has been added to SOC injury, poisoning and procedural complications, to related product usage concepts (medication errors, misuse, uses outside of the prescription in the prescribing information, overdosing and underdosing) to simplify coding and finding group in one place without the need for extensive multiaxial links. The new HLGT Product Use Problems contains four new HLTs: o The HLGT Product Use Problems ANE involves a mixture of misuse, deliberate use and other non-specific concepts of use. This new HLT receives two new PT concepts in addition to the existing non-specific use PTs: The PT problem with product use includes non-specific product use concepts that are not specifically identified as medication errors, uses outside of the indication in the specialist information, misuse, etc. The PT problem with the deliberate use of a product includes problem concepts that are known to be deliberate, but not specifically identified as misuse or applications outside of the indication in the product information. o The HLT overdosing ANE contains overdosing concepts that are not necessarily misadministration. This HLT replaces the HLT overdosing. o The HLT underdosing ANE contains underdosing concepts that are not necessarily incorrect administrations. 6th

11 New developments in version 18.0 o The HLT Applications outside the indication in the specialist information contains concepts in connection with applications outside the indication in the specialist information. 3.2 A 27th SOC WILL BE IMPLEMENTED IN MEDDRA VERSION 19.0 The ICH-MedDRA Management Board has approved the creation of an additional (27th) system organ class in MedDRA. This 27th SOC, which has not yet been named, is being created to include non-clinical or non-patient-related concepts. These terms cover issues relating to medical devices and are important from a regulatory point of view as they can have an indirect impact on patient safety. Initially, the 27th SOC will include terms relating to quality problems of a product, which are defined as anomalies that can arise in the context of the manufacture / labeling, packaging, shipping, handling or storage of medical devices. The existing HLGT Quality Matters of Products will be moved from the SOC General Diseases and Disorders at the Administration Site to the new SOC and supplemented with new terms that relate specifically to the manufacturing process. The impact on organizations not involved in product manufacturing or product quality is expected to be minimal. The 27th SOC is expected to be implemented in MedDRA version 19.0 in March 2016. The MSSO will provide detailed information on the 27th SOC through documents, webinars, s, and other means of communication well in advance of the implementation date planned for 2016. If you have any questions about the 27th SOC, please contact the MSSO Help Desk. 3.3 SCOPE OF MEDDRA: GUIDE REVISIONS Section 1.5 (Scope of Terminology) in the MedDRA Version 18.0 Guide is being revised. The revised wording addresses the types of medical products and concepts supported by MedDRA and the potential for terminology to be expanded to include new subject areas. These revisions are the result of the recommendations of the Blue Ribbon Panel regarding the scope of MedDRA, which were endorsed by the MedDRA Management Board. The relevant formulations are shown below as an excerpt.MedDRA terminology applies to all phases of human drug development, with the exception of animal toxicology. MedDRA's scope includes medical, health, and regulatory concepts related to such preparations. Effects on the state of health and malfunctions of devices (e.g. PT infection in connection with a medical device and PT instrument failure) are also recorded. In addition, the terminology can support other types of products that are regulated in at least one area, such as food or cosmetics. 7th

12 New Developments in Version 18.0 In consultation with the MedDRA Management Board, the scope of the terminology can be expanded to include additional medical or health-related and regulatory concepts that are developed based on cooperation with relevant experts. The addition of new subject areas is subject to the normal MSSO maintenance process. 3.4 NEW WEB-BASED BROWSER MSSO is pleased to announce that the new MedDRA Web-Based Browser (WBB) has been available since December 1st, 2014. A MedDRA user ID and password are required for use. The new WBB has similar features to the current MedDRA desktop browser and also includes several new features. Users will be able to: Browse the MedDRA hierarchy and SMQs Search for MedDRA terms or codes and SMQs View multiple supported languages ​​at the same time Use the Research Bin to collect terms for analysis and research View the term history View the term detail information Export from search results to a spreadsheet. Access to the special features of MedDRA's Japanese translation. The WBB is available free of charge to all MedDRA subscribers as part of the subscription. To learn how to log in and use the WBB, please view or download the videocast located in the Education Materials section of the MedDRA website under Tools. A user guide is also available. 3.5 STANDARDIZED MEDDRA INQUIRIES (SMQS) Two new Level 1 SMQs have been released into production in MedDRA Version 18.0: SMQ Respiratory Insufficiency and SMQ Tendopathies and Ligament Disorders. At the time of this release, there are now 98 level 1 SMQs in production. Details of the new SMQs, including their inclusion and exclusion criteria, can be found in the MedDRA Release SMQ Guide. In addition to the new SMQs, four SMQs related to vascular disorders or central nervous system conditions have been renamed to MedDRA Version 18.0. Terms relating to the spinal cord are included in these SMQs in addition to terms relating to the brain, so renaming these SMQs better reflects the anatomical locations concerned. The renamed SMQs are in the following table. 8th

13 New developments in version 18.0 Former SMQ designation Cerebrovascular diseases (SMQ) Cerebrovascular diseases, without specifying whether hemorrhagic or ischemic (SMQ) Ischemic cerebrovascular diseases (SMQ) New SMQ designation Vascular diseases of the central nervous system (SMQ) Vascular diseases of the central nervous system Haemorrhagic or ischemic (SMQ) Ischemic vascular diseases of the central nervous system (SMQ) Haemorrhagic cerebrovascular diseases (SMQ) Haemorrhagic vascular diseases of the central nervous system (SMQ) Table 3-1 Renamed SMQs 3.6 General PROACTIVE MAINTENANCE CHANGES outside of the MEDICAL REQUEST allows to propose the established change request process. These proactive requests can relate to inconsistencies and suggest corrections or improvements. The MSSO evaluated five proactive maintenance proposals from MedDRA users in the MedDRA version. Of these five proposals, four were implemented and one was rejected. For details of implemented proposals, see below under the Change Request section of the MedDRA website, the MSSO publishes and updates a list of all proposals received and their status. The MSSO is interested in user suggestions for proactive improvements to MedDRA. Please send your ideas for proactive MedDRA improvements to the MSSO Help Desk via. Be as specific as possible about your suggestions and tell us why you think your suggestion should be implemented Terms related to drug use A MedDRA user requested a revision of a phrase referring to the use of Drug Related Terms for Potential Inclusion in MedDRA. Based on a review of the MSSO, most of the requested terms are either direct equivalents or very similar concepts in MedDRA. A total of three new terms have been added (PT clinical trial participant, PT intending to conceive, and PT interruption of drug procurement process) and the status of LLT 9

14 New developments in version 18.0 No drugs in stock changed to not up-to-date, as this ambiguous concept could refer to both a single patient who does not have enough drugs on hand and a problem with the drug procurement process MSSO asked to consider adding more site concepts (e.g. administration site) to give MedDRA users more coding options. Based on this revision, a total of 224 new concepts have been added, mainly on the SOC General Disorders and Administration Site Disorders. The MSSO's approach was to add a set of administration site terms similar to the existing injection site terms and to fill in any gaps related to the injection site, infusion site, application site and medical location Apparatus exist. Appropriate secondary links have been added for new terms based on the MedDRA rules and conventions described in the MedDRA Guide. Examples of added terms are shown in the following table. Soft tissues are uniform. Many of these terms come from the terms vertebral body, backbone and back. Of the total LLTs, PTs, HLTs and HLGTs of the MedDRA terms in question, 12 change requests were implemented in order to ensure a uniform use of these terms. The 10

15 New developments in version 18.0 Changes related to the uniformity of the term definition, the term status and the hierarchical relationships. For examples see below The status of the LLT spinal haematoma has been changed to not up-to-date as it is an ambiguous term. Spinal could refer to the spinal cord or the bone structure or vertebrae (see also section 4.5). MedDRA Version 17.1 MedDRA Version 18.0 LLT Status LLT Status Spinal Haematoma Current Spinal Haematoma Not Current Table 3-3 Examples of changes in terms related to backbone / spinal and spinal / vertebral body Section 5.1 of the MedDRA Guide will be updated and a statement will be included to explain that, for the purposes of MedDRA, terms related to vertebral column and spinal are used synonymously with concepts relating to vertebral body and spinal column, instead of terms relating to the spinal cord, except when spinal clearly represents a neurological concept, such as in PT claudication Spinalis Pharmacogenomic Biomarkers in Drug Labeling A MedDRA user asked the MSSO to consider adding additional medically relevant pharmacogenomic biomarker terms to MedDRA to allow further options for coding and analysis. After considering the proposal, the MSSO MedDRA added 72 new medically relevant pharmacogenomic terms and made changes to four existing terms. Examples are in the following table. New PT Primary HLT Primary SOC HLA-B * 5701- determination positive Cell marker analyzes Investigations General illnesses HER2-Protein- acquired gene mutations and other complaints of overexpression Changes Place of administration New LLT PT Primary SOC ESR1-positive Estrogen receptor determination positive Investigations PgR positive Progesterone determination positive Investigations Table 3 -4 Examples of new pharmacogenomic biomarker terms 11

16 Summary of Changes 4. SUMMARY OF CHANGES 4.1 SUMMARY OF IMPACT ON TERMINOLOGY The following tables summarize the effects of MedDRA terminology in version 18.0 (see Tables 4-1 through 4-5). These tables are for reference only. Detailed information regarding changes in version 18.0 can be found in the MedDRA Release Report, which can be downloaded from the English language download. Changes - SOCs, HLGTs, HLTs Level Change Request Activity Pure Changes v17.1 v18.0 SOC Total SOCs New HLGTs HLGT Merged HLGTs Total HLGTs New HLTs HLT Merged HLTs Total HLTs Table 4-1 Summary of the impact on SOCs, HLGTs, HLTs 1 Pure Changes to HLGTs / HLTs are equal to the number of new HLGTs / HLTs minus the number of merged HLGTs / HLTs. Changes - PTs Level Change Request Activity v17.1 v18.0 PT New PTs Elevated LLTs

17 Summary of Changes Change Request Activity Level v17.1 v18.0 Decreased PTs Pure Changes Total PTs Table 4-2 Summary of Impact on PTs 1 Pure changes of PTs equals the number of new PTs plus the number of LLTs promoted minus the number of PTs decreased. Changes - LLTs level Change request activity Pure changes v17.1 v18.0 LLT Total LLTs Table 4-3 Summary of the effects on the LLTs 1 Total LLTs include PTs, as these are also represented as LLTs. New SMQs Level Pure Changes v17.1 v Table 4-4 Summary of Impact on SMQs 13

18 Summary of Changes 4.2 SUMMARY OF EFFECT ON ENTRIES IN MEDDRA FILES The following table summarizes the effects on MedDRA terminology in version 18.0. This table is for reference only. INTL_ORD.ASC SOC.ASC SOC_HLGT.ASC HLGT.ASC HLGT_HLT.ASC HLT.ASC HLT_PT.ASC Added 0 Removed 0 Modified 0 Added 0 Removed 0 Modified 0 Added 1 Removed 0 Modified 0 Added 1 Removed 0 Modified 0 Added 8 Removed 7 Modified 0 Added 8 Removed 7 Modified 0 Added Removed 189 Modified 0 Added MDHIER.ASC Removed 221 Modified 0 Added 580 PT.ASC Removed 43 Modified 16 LLT.ASC Added

19 Summary of Changes SMQ_LIST.ASC 1 SMQ_CONTENT.ASC Removed 0 Modified Added Removed 0 Modified 212 Added Removed 0 Modified Table 4-5 Summary of Effects on Entries in MedDRA Files 1 The number of SMQs added includes both level 1 and level 1 SMQs also the SMQs of the subgroup search. 4.3 NUMBER OF MEDDRA TERMS This table contains the number of terms broken down 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 and secondary) 2 PTs (primary and secondary) 2 3 HLTs HLGTs 3 Blood and lymphatic system disorders Heart disease Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine Disorders

20 Summary of Changes SOC LLTs * (Primary) 1 PTs (Primary) 1 LLTs * (Primary and Secondary) 2 PTs (Primary and Secondary) 2 3 HLTs HLGTs 3 Eye Disorders Gastrointestinal Disorders General Disorders and Administration Site Disorders Liver and Biliary Disorders of the immune system Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutritional disorders Skeletal muscle, connective tissue and bone diseases Benign, malignant and unspecific neoplasms (including cysts and polyps)

21 Summary of Changes SOC LLTs * (primary) 1 PTs (primary) 1 LLTs * (primary and secondary) 2 PTs (primary and secondary) 2 3 HLTs HLGTs 3 Nervous system disorders Pregnancy, puerperium and perinatal disorders Psychiatric disorders Renal and Urinary Tract Reproductive System and Breast Disorders Respiratory, Thoracic and Mediastinal Disorders Skin and Subcutaneous Tissue Disorders Social Conditions Surgical and Medical Interventions Vascular Disorders Total Table 4-6 Number of MedDRA Terms 17

22 Summary of Changes 1 The primary count contains the number of terms that are primarily associated with the Designated SOC at either the LLT level or the PT level. The sums of the primary LLTs and PTs are the same as in Table 4-2 and The total includes the number of terms that are both primarily and secondarily associated with the designated SOC at either the LLT level or the PT level. Thus, the sums of the total number of LLTs and PTs are greater than those given in Tables 4-2 and 4-3. 3 The number of HLTs and HLGTs do not necessarily refer to unique values, given the multiaxiality of MedDRA (see Section 2.2 of the Guide, Understanding Multiaxiality). Some LDS are counted in more than one SOC. For example, the HLT Congenital Diseases of the Connective Tissue and the HLGT Congenital Diseases of the Musculoskeletal System and Connective Tissue are counted in the SOC Congenital, familial and genetic diseases as well as in the SOC skeletal muscle, connective tissue and bone diseases. The sums of HLTs and HLGTs are greater than the PT AND LLT TERMS REENAMED in table As part of MedDRA's ongoing maintenance work, existing PTs and LLTs can be used to correct misspellings, double spaces, upper and lower case or other relevant errors that the Meet MedDRA Renaming Criteria, Be Renamed (Modified). This renaming requirement retains the original MedDRA code of the term and preserves its original meaning, thereby making it easier to reuse the same MedDRA code for the renamed PT / LLTs. The following table is a list of the seven terms renamed in the English MedDRA Version 18.0. Code level Designation in v17.1 Designation in v LLT Biliocutaneus fistula Biliocutaneous fistula PT Blastic plasmacytoid denditric cell neoplasia Blastic plasmacytoid dendritric cell neoplasia PT C-KIToid receptor assay C-kit receptor assay PT Eagles syndrome Eagle's syndrome LLT Nipple alveolar complex resection Nipple areolar complex resection 18

23 Summary of changes Code level Designation in v17.1 Designation in v LLT Peter's anomaly Peters anomaly LLT Well's syndrome Wells syndrome Table 4-7 Modified PT / LLT designations 4.5 CHANGE OF THE STATUS CURRENT / NOT CURRENT OF LLT TERMS The following table represents the nine LLT-level terms in MedDRA Version 18.0 that have undergone a status change and the basic principles that have been applied. Lowest Level Term (LLT) Abdominal Pain Nonexudative senile macular degeneration of retina Abdominal pain Adenomegaly Breast excision Status changed to Current Current Current Not current Not current Basic principle of the changes The change to Status current adds this commonly used slang term, to improve the coding options in English as well as in other languages. Both existing English-language LLTs, the LLT Nonexudative senile macular degeneration of retina and the hyphenated LLT Non-exudative senile macular degeneration of retina are accepted as correct spellings of the expression. The change to the current status adds this commonly used slang term to improve coding options in English and other languages. This concept can be represented by one of the multiple existing LLTs under the PT lymphadenopathy, e.g. B. LLT swollen lymph nodes) Although in clinical practice breast excision refers primarily to the excision of part of the breast, the term can also be interpreted as a synonym for mastectomy. Therefore, to clarify the concept, the status of the LLT breast excision is changed to not up-to-date and replaced by a new LLT excision of a breast nodule with PT breast nodule removal. 19th

24 Summary of changes Term of the lowest level (LLT) Open fracture of c5-c7, with unspecific spinal cord injury No medication available Spinal hematoma status changed to Not current Not current Not current Basic principle of the changes This LLT represents a combination concept that does not comply with the MedDRA conventions corresponds to. This change was made as part of a proactive request to revise the classification of spinal terms as opposed to terms related to the condition of vertebral bodies. See the Out of Stocked Drugs section can be viewed as ambiguous, as this term could refer to both an individual patient who is short of drugs and a problem with the drug procurement process. Spinal hematoma is an ambiguous term because spinal can refer to the spinal cord as well as the bone structure or vertebral body.This change was made as part of a proactive request to revise the classification of spinal terms as opposed to terms related to the condition of vertebral bodies. See section Table 4-8 Change of LLT status 20