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 MedDRA query “modified based on an All modifications to the original SMQ should be documented. SMQ”. 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 A product is being investigated for a possible safety signal of Additional PTs are dementia, and the user wishes to use SMQ Dementia. For this needed particular product, PT Disturbance in attention may be needed. 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 Exclusion of PTs pointes/QT prolongation (broad search), the user may wish to exclude PT Syncope to prevent excess in data “noise” retrieval.
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.
000241_datretptc_r3_16_sep2018.docx