MedDRA 14.0 Review MedDRA Version Changes General Remarks MedDRA Version 14.0 Specific Changes Version 14.0 Changes Overview Changes in a Nutshell

Transcription

1 MedDRA 14.0 Review MedDRA Version Changes General Remarks MedDRA Version 14.0 Specific Changes Version 14.0 Changes Overview Changes in a Nutshell Changes Highlights MedDRA Version 14.0 Terminology Frequency Distribution MedDRA Version What's coming ahead?

2 MedDRA Changes - General Remarks There are two possible types of changes in the MedDRA terminology: simple change and complex changes. Simple changes are changes to the existing terminology that involve terms at the PT and LLT levels. There are two types of Simple changes: (1) changes introduced by subscribers request and (2) Maintenance changes (also referred to as Associate changes). Maintenance changes are generated as a byproduct of other changes requested by subscribers, or changes introduced by the MedDRA Management Board to preserve consistency within the dictionary. Complex changes involve modifications within the entire hierarchy, including the HLT, HLGT, and SOC terminology. Currently, the initial MedDRA terminology version release in one specific year (12.0, 13.0) includes both simple and complex changes, and the subsequent release in the same year (12.1, 13.1) represents a simple change of terminology. These changes are based on MedDRA subscribers' terminology change requests and on MedDRA terminology maintenance needs identified by MedDRA's maintenance organization reviewers. Please note that as a consequence of implementing some of these changes (e.g. demoting a multiaxial PT, adding a new HLT, etc.) it may be necessary to break the multiaxial links, to re-link the replacement terms, and/or to enable additional terms to be included within a particular SOC. All these changes may require modifications to your existing MedDRA coding, guideline development, and data retrieval practices. Keep in mind that changes involve both MedDRA terminology updates as well as Standardized MedDRA Queries (SMQ). Back to MedDRA 14.0 Review

3 MedDRA 14.0 Changes: Overview Changes In a Nutshell Complex Changes New Terms and Modified PTs and LLTs Impact Standardized MedDRA Queries (SMQs) Changes Highlights Featured PT Changes s Promoted LLTs Featured LLT Changes New LLTs Demoted PTs Currency changes Back to MedDRA 14.0 Review

4 Changes In a Nutshell Complex Changes The complex changes implemented in Version 14.0 are summarized below. At the SOC level: No changes were made to existing SOC terms and no new SOCs were added in Version At the HLGT level: No changes were made to existing HLGT terms and no new HLGTs were added in Version At the HLT level: There were 6 new High Level Terms (HLTs) added, 1 HLT renamed and 5 HLTs merged as a result of the complex changes in Version In addition 3 multi-axial HLTs were made uni-axial by removing one of their links. They are as follows: New HLTs Acquired mutations NEC to HLGT General system disorders NEC Disorders of purine metabolism to HLGT Purine and pyrimidine metabolism disorders Disorders of pyrimidine metabolism to HLGT Purine and pyrimidine metabolism disorders Enteroviral infections NEC to HLGT Viral infectious disorders Peritoneal fluid and membrane function analyses to HLGT Gastrointestinal investigations Social issues NEC to HLGT Lifestyle issues Renamed HLTs v13.1 Capnocytophagia infections to Capnocytophaga infections in v14.0 Merged HLTs Enteroviral infections to HLT Enteroviral infections NEC Picornaviral infections to HLT Viral infections NEC Purine metabolism disorders NEC to HLT Disorders of purine metabolism Pyrimidine metabolism disorders NEC to HLT Disorders of pyrimidine metabolism Social issues to HLT Social issues NEC HLT link changes HLT unlinked Purine metabolism disorders congenital from HLGT Purine and pyrimidine metabolism disorders HLT unlinked Pyrimidine metabolism disorders congenital from HLGT Purine and pyrimidine metabolism disorders HLT unlinked Renal disorders congenital from HLGT Renal disorders (excl nephropathies) Back

5 New Terms and Modified PTs and LLTs Impact As a result of adding the new HLTs, new PTs were added and existing PTs were moved or secondary links established. Some of the following actions occurred: Acquired mutations NEC was added as an HLT under HLGT: General system disorders NEC. HLT Acquired mutations NEC is intended to cover all mutations acquired by a somatic cell after conception. PT Acquired gene mutation, PT Acquired mitochondrial DNA deletion and PT Acquired mitochondrial DNA mutation will be moved to new HLT Acquired mutations NEC. The HLT Social issues will be merged into new HLT Social issues NEC. Substance use will be under this new HLT Social issues NEC. In V13.0 HLT: Picornaviral infections has only one PT Foot and mouth disease; therefore in V14.0 the HLT: Picornaviral infections was merged under HLT: Viral infections NEC. The PT Foot and mouth disease is now appropriately under HLT: Viral infections NEC. Existing HLT: Enteroviral infections will be merged into new HLT: Enteroviral infections NEC. HLT: Enteroviral infections NEC will contain PTs that represent infections which cannot be attributed to the specific serotypes already represented at the HLT level. In addition HLT: Renal disorders congenital (a multi-axial HLT ) was unlinked from HLGT: Renal disorders (excl nephropathies). This change allows for specific placement of congenital renal disorders according to the SOC of the anatomical site of manifestation, and thus groups congenital renal disorders with their counterpart acquired terms. As a result of adding a new HLT: Peritoneal fluid and membrane function analyses to HLGT Gastrointestinal investigations the following PTs : PT: Effective peritoneal surface area increased PT: Peritoneal effluent analysis PT: Peritoneal effluent abnormal PT: Peritoneal effluent erythrocyte count PT: Peritoneal effluent erythrocyte count increased PT: Peritoneal effluent leukocyte count PT: Peritoneal effluent leukocyte count increased PT: Peritoneal effluent platelet count PT: Peritoneal effluent specific gravity PT: Peritoneal fluid analysis

6 PT: Peritoneal fluid analysis normal PT: Peritoneal fluid analysis abnormal would move from their current HLT: Gastrointestinal histopathology procedures to the new HLT: Peritoneal fluid and membrane function analyses. The PT: Peritoneal equilibration test would move from current HLT: Renal function analyses to the new HLT: Peritoneal fluid and membrane function analyses. Back

7 Standardized MedDRA Queries (SMQs) There are now 85 level 1 SMQs in production as of this version 14.0 New Developments in Version 14.0: Inactive SMQ In Version 14.0 :SMQ Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) was made inactive and replaced with SMQ Pregnancy and neonatal topics (SMQ). List of sub search SMQs in SMQ Pregnancy and neonatal topics: SMQ Congenital, familial and genetic disorders SMQ Foetal disorders SMQ Lactation related topics (incl neonatal exposure through breast milk) SMQ Neonatal disorders SMQ Normal pregnancy conditions and outcomes SMQ Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) SMQ Termination of pregnancy and risk of abortion Renamed SMQ s A total of 4 SMQs were renamed in MedDRA Version SMQ Haematopoietic cytopenias affecting more than one type of blood cell from previous SMQ Name: Cytopenia and haematopoietic disorders affecting more than one type of blood cell. SMQ Haematopoietic erythropenia from previous SMQ Name: Erythropenia SMQ Haematopoietic leucopenia from previous SMQ Name: Leukopenia SMQ Haematopoietic thrombocytopenia from previous SMQ Name: Thrombocytopenia Malignant or unspecified SMQs Two new sub-search SMQs have been added to malignant and/or unspecified SMQs to allow users to retrieve malignant only event cases; events/cases of neoplasms of unspecified malignancy or a combination of malignant and unspecified neoplasm events/cases. New sub search SMQs have been added to the following existing SMQs: Biliary neoplasms malignant and unspecified Breast neoplasms, malignant and unspecified Liver neoplasms, malignant and unspecified Malignant or unspecified tumours Ovarian neoplasms, malignant and unspecified Prostate neoplasms, malignant and unspecified Uterine and fallopian tube neoplasms, malignant and unspecified Skin neoplasms, malignant and unspecified

8 The PTs under the existing Malignant or unspecified SMQs have been moved to the respective malignant only or unspecified malignancy sub search SMQs. SMQ Premalignant disorders 130 PTs in the five sub search SMQs of SMQ Premalignant disorders have been made inactive. In addition all terms in the five sub search SMQs have been made narrow in scope. Back Back to MedDRA 14.0 Review

9 MedDRA Version 14.0 Specific Changes Changes Highlights Featured PT Changes PT Changes: new PTs - 23 Promoted LLTs - 45 demoted PTs - Net new 167 PTs Thus making a total of 19,086 PTs in v14.0 Following are several examples: Version 14.0 PT Allergic myocarditis Limbal swelling Device kink Metabolic cardiomyopathy Right ventricular heave Ventricular dyssynchrony Branchio-oto-renal syndrome Congenital hypercoagulation Spina bifida cystica Corneal thickening Eccentric fixation Colon dysplasia Nicotinic stomatitis Capsule physical issue Promoted LLT Promoted LLT Promoted LLT Microsomia Out of specification test results s and Promoted LLTs Back

10 Featured LLT Changes New LLTs 358 new LLTs Demoted PTs 45 PTs were demoted to LLT level in version 14.0 Currency changes 13 LLTs had a currency change in version non-current LLTs became current, -10 current LLTs became non-current (examples below) 1 LLT and 5 PTs were modified in version 14.0 (text modification) Thus in version 14.0 there are a total of 69,019 LLTs of which 59,940 are current and 9,079 are non-current. ANF positive APA APA negative APA positive CF positive Device firing issue DU GU Positive ANF Unable to focus Allergy to plants FOB positive LVF LLT Version 14.0 Currency Current Current Current LLT Currency Changes

11 Level Version 13.1 Version 14.0 code LLT Capnocytophagia Capnocytophaga infection infection NOS NOS PT Capnocytophagia Capnocytophaga infection infection PT Capnocytophagia test positive Capnocytophaga test positive PT Eastern cooperative oncology group performance status Eastern Cooperative Oncology Group performance status PT Eastern cooperative oncology group performance status Eastern Cooperative Oncology Group performance improved status improved PT Eastern cooperative oncology group performance status Eastern Cooperative Oncology Group performance worsened status worsened Modified PT and LLT Names Back Back to MedDRA 14.0 Review

12 MedDRA Version 14.0 Terminology Frequency Distribution by MedDRA Version Level Version 9.1 Version Version Version Version Version Version Version Version Version SOC HLGT HLT 1,682 1,682 1,682 1,688 1,688 1,699 1,699 1,709 1,709 1,710 PT 17,505 17,719 17,867 18,075 18,209 18,483 18,641 18,786 18,919 19,086 LLT 64,620 65,147 65,605 66,135 66,587 67,159 67,503 68,258 68,661 69,019 Current LLT's 55,621 56,125 56,580 57,104 57,556 58,124 58,451 59,190 59,589 59,940 LLT's 8,999 9,022 9,025 9,031 9,031 9,035 9,052 9,068 9,072 9,079 Back to MedDRA 14.0 Review

13 MedDRA Version What's Coming Ahead? The next MedDRA terminology release, version 14.1, is scheduled for September Back to MedDRA 14.0 Review