Related events that may have been represented by a single term in another terminology may be represented by more than one MedDRA PTs. The potential impact of this on signal detection should be kept in mind. Multiaxiality Multiaxiality means that a PT may exist in more than one SOC. This allows terms to be grouped in different, but medically appropriate, ways (e.g., by aetiology or organ system). Each PT is assigned one primary SOC; all other SOC assignments for that PT are called “secondary”. Having a single primary SOC prevents double counting of events when outputting data from all SOCs. All possible secondary SOC assignments for any given PT may not be present in MedDRA. However, new or revised SOC assignments can be created as a result of the change request process. Primary SOC assignment rules Primary SOC assignment rules are described in the MedDRA Introductory Guide. These rules affect the way terms are placed in MedDRA and determine their data display by SOC. Because these rules allow for terms related to a particular medical condition to be in more than one SOC, users should be familiar with the general structure and content of all MedDRA SOCs to be sure that data are not overlooked. Example Type of Disorder Primary SOC Rule Example Comment Congenital All terms for congenital disorders have as their primary SOC assignment SOC Congenital, familial and genetic disorders PT Congenital absence of bile ducts has a primary SOC assignment of SOC Congenital, familial and genetic disorders and a secondary SOC assignment of SOC Hepatobiliary disorders The secondary SOC assignment for these terms is their “site of manifestation” SOC Neoplastic All terms for malignant and benign neoplasms (except cysts and polyps) have as their primary SOC assignment SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) PT Skin cancer has a primary SOC assignment of SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) and a secondary SOC assignment of SOC Skin and Cyst and polyp terms are an exception to this rule. The primary SOC assignment for cyst and polyp terms is the “site of manifestation” SOC, and the secondary SOC is SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Preferred Term Primary SOC Post procedural haemorrhage Injury, poisoning and procedural complications Chest pain General disorders and administration site conditions MedDRA Versioning MedDRA is updated twice yearly. Version “X.0” contains both simple and complex changes; version “X.1” contains only simple changes. Organisations should be aware of the types of MedDRA changes for their possible impact on data output. Types of MedDRA Changes Simple Changes Complex Changes Add a PT (new medical concept) Move an existing PT from one HLT to another Demote a PT to LLT level Add or remove a link to an existing PT Add an LLT Move an existing LLT from one PT to another Promote an LLT to PT level Make a current LLT non-current or a LLT current Changing the primary SOC allocation Changes to SMQs Add or change multiaxial links Add new grouping terms Merge existing grouping terms Restructure a SOC Add a new SOC Both simple and complex changes impact retrieval and presentation strategies. Users should read the documentation provided with each MedDRA release, especially the What’s New document. The MSSO and JMO provide tools to assist the user in comparing the changes between MedDRA versions. The Version Report (provided by the MSSO and JMO) is a spreadsheet listing all changes between the current version of MedDRA and the one previous to it; this spreadsheet is provided with each new release of MedDRA. The MSSO also provides the MedDRA Version Analysis Tool (MVAT) that facilitates identification and understanding of the impact of changes between any two MedDRA versions, including non-consecutive ones (see Appendix, Section 6.1 of this document; also, see Section 4.1.1 of the MedDRA Term Selection: Points to Consider document).
SMQ and MedDRA Grouping Terms Data retrieved using MedDRA grouping terms (HLGTs, HLTs) may differ from those retrieved using a related SMQ. Example Comparison – SMQ and Grouping Terms Cardiac arrhythmia is a suspected issue (e.g., by review of a primary SOC output of all data). If events retrieved by using HLGT Cardiac arrhythmias are compared to those retrieved by SMQ Cardiac arrhythmias, more events may be retrieved by the SMQ because it includes additional terms from other SOCs such as SOC Investigations. CUSTOMISED SEARCHES MedDRA allows for a variety of searching options as described above. However, there will be situations when a customised search is needed. Modified MedDRA Query Based on an SMQ Do not modify the term content or structure of an SMQ unless there is a compelling reason to do so since altering it in any way makes it non-standard (see Section 4.4). If an SMQ is modified in any way, it should be referred to as a “modified MedDRA query based on an SMQ”. All modifications to the original SMQ should be documented. If a modified MedDRA query based on an SMQ is to be used on an ongoing basis, version updates and maintenance of the query are the responsibility of the organisation that created it. Example Modified MedDRA Queries based on SMQs Additional PTs are needed A product is being investigated for a possible safety signal of dementia, and the user wishes to use SMQ Dementia. For this particular product, PT Disturbance in attention may be needed. Exclusion of PTs An antipsychotic product is being investigated for potential QT prolongation and also has a well-described association with hypotension and fainting. When using SMQ Torsade de pointes/QT prolongation (broad search), the user may wish to exclude PT Syncope to prevent excess “noise” in data retrieval.
Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 19.0 PREFERRED TERMS No. of EVENTS Infection 15 Upper respiratory tract infection Nasopharyngitis Infection Lower respiratory tract infection Skin infection 7 2 1 4 1 Abdominal pain 9 Abdominal pain Abdominal pain upper Abdominal tenderness 4 3 2 Accidental injury 4 Injury Laceration Ligament sprain Back injury 1 1 1 1 Figure 1 – How data coded to a single concept from another terminology may be expressed by several PTs in MedDRA. Example as of MedDRA Version 19.0. OTHER TERMINOLOGY MedDRA Version 19.0 Reported Event (% subjects) Coded Term (% subjects) Body System/SOC (% subjects) PT (% subjects) SOC (% subjects) Hyperglycaemia (4.1) Hyperglycaemia (10.5) Metabolism & nutritional disorders (10.5) Hyperglycaemia (4.1) Metabolism and nutrition disorders (4.1) Increased blood sugar (2.7) Glucose increased (2.2) Blood glucose high (1.0) Blood glucose increased (6.4) Investigations (6.4) Increasing glucoses (0.5)
Figure 2 – Multiple MedDRA terms may be used to code similar medical conditions included in a “disorder SOC”; associated laboratory findings are in SOC Investigations. Example as of MedDRA Version 19.0. Preferred Terms Events/Cases Comment MedDRA Version 18.1 MedDRA Version 19.0 Metastatic pain 15 0 (no longer a PT) In MedDRA Version 18.1, Metastatic pain was a PT and in Version 19.0 it was demoted to an LLT under PT Cancer pain Cancer pain 5 20 Figure 3 – Impact of MedDRA version changes – demotion of a PT Example as of MedDRA Version 18.1 and 19.0 Figure 4 – Primary SOC output listing, MedDRA Version 17.1 – example. Note that some PTs are multiaxial, however, this figure shows only the primary SOC assignments MedDRA Version 21.1 English Alphabetical Order MedDRA Version 21.1 Internationally Agreed Order Blood and lymphatic system disorders Infections and infestations Cardiac disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Congenital, familial and genetic disorders Blood and lymphatic system disorders Ear and labyrinth disorders Immune system disorders Endocrine disorders Endocrine disorders Eye disorders Metabolism and nutrition disorders Gastrointestinal disorders Psychiatric disorders General disorders and administration site conditions Nervous system disorders Hepatobiliary disorders Eye disorders Immune system disorders Ear and labyrinth disorders