PT Visual cortex atrophy PT Visual pathway disorder 3 of 6 PTs are primary to SOC Nervous system disorders Benefits: Multiaxial links enhance the utility of the grouping terms. This method overcomes the primary SOC limitations as described under Section 3.2.1. Limitations: Still displays only terms that are represented in one SOC or HLGT/HLT which may not include all terms related to a medical condition This method of display of PTs by both primary and secondary SOC assignments could lead to double counting of cases/events Section 4 STANDARDISED MedDRA QUERIES – 4.1 Introduction – Standardised MedDRA Queries (SMQs) were created to standardise identification and retrieval of safety data. SMQs are a joint effort of the Council for International Organizations of Medical Sciences (CIOMS) and ICH (including MSSO and JMO) representing both industry and regulatory authorities. An SMQ is a grouping of terms from one or more SOCs that relate to a defined medical condition or area of interest. The terms included relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc. that are associated with the medical condition or area of interest. Users should carefully read the Introductory Guide for Standardised MedDRA Queries (SMQs) before applying an SMQ to fully understand the scope of the SMQ and to properly apply search options such as algorithms and weightings. 4.2 SMQ Benefits – As with all MedDRA-based queries, users of SMQs should be aware of several factors that may influence data retrieval including database characteristics, data
PT Visual cortex atrophy PT Visual pathway disorder 3 of 6 PTs are primary to SOC Nervous system disorders Benefits: Multiaxial links enhance the utility of the grouping terms. This method overcomes the primary SOC limitations as described under Section 3.2.1. Limitations: Still displays only terms that are represented in one SOC or HLGT/HLT which may not include all terms related to a medical condition This method of display of PTs by both primary and secondary SOC assignments could lead to double counting of cases/events Section 4 – STANDARDISED MedDRA QUERIES 4.1 – Introduction Standardised MedDRA Queries (SMQs) were created to standardise identification and retrieval of safety data. SMQs are a joint effort of the Council for International Organizations of Medical Sciences (CIOMS) and ICH (including MSSO and JMO) representing both industry and regulatory authorities. An SMQ is a grouping of terms from one or more SOCs that relate to a defined medical condition or area of interest. The terms included relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc. that are associated with the medical condition or area of interest. Users should carefully read the Introductory Guide for Standardised MedDRA Queries (SMQs) before applying an SMQ to fully understand the scope of the SMQ and to properly apply search options such as algorithms and weightings. 4.2 – SMQ Benefits As with all MedDRA-based queries, users of SMQs should be aware of several factors that may influence data retrieval including database characteristics, data
9610-1700_DatRetPTC_R3.7_mar2014.docx