disorders have as their primary SOC assignment SOC Congenital, familial and genetic disorders ducts has a primary SOC assignment of SOC Congenital, familial and genetic disorders and a secondary SOC assignment of SOC Hepatobiliary disorders 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 subcutaneous tissue disorders 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) Infectious All terms for infectious disorders have as their primary SOC assignment SOC Infections and infestations PT Enterocolitis infectious has a primary SOC assignment of SOC Infections and infestations and a secondary SOC assignment of SOC Gastrointestinal disorders The secondary SOC assignment for these terms is their “site of manifestation” SOC If a PT links to more than one of these three SOCs, the following priority is used to determine the primary SOC: SOC Congenital, familial and genetic disorders SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC Infections and infestations 2.5.3.2 Non multiaxial SOCs Terms in the following three SOCs do not have multiaxial links: SOC Investigations SOC Surgical and medical procedures
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
# Regulatory Chair † Former Rapporteur 6.2.2 Former members of the ICH Points to Consider Working Group Affiliation Member Commission of the European Communities Dolores Montero Carmen Kreft-Jais Morell David European Federation of Pharmaceutical Industries and Associations Barry Hammond†; Reinhard Fescharek† Health Canada Alison Bennett, Heather Morrison; Michelle Séguin; Heather Sutcliffe; Bill Wilson Japanese Maintenance Organization Osamu Handa; Akemi Ishikawa; Yasuo Sakurai; Yuki Tada Japan Pharmaceutical Manufacturers Association Takayoshi Ichikawa; Akemi Ishikawa; Satoru Mori; Yasuo Sakurai; Kunikazu Yokoi MedDRA MSSO JoAnn Medbery; Patricia Mozzicato Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Tamaki Fushimi; Wakako Horiki; Kazuhiro Kemmotsu; Tatsuo Kishi; Chie Kojima; Emiko Kondo; Hideyuki Kondou; Kemji Kuramochi; Tetsuya Kusakabe; Kaori Nomura; Izumi Oba; Shinichi Okamura; Yoshihiko Sano; Nogusa Takahara; Kenichi Tamiya; Daisuke Tanaka; Shinichi Watanabe; Takashi Yasukawa; Go Yamamoto; Manabu Yamamoto; Nobuhiro Yamamoto Pharmaceutical Research and Manufacturers of America David Goldsmith; Sidney Kahn; Susan M. Lorenski; Margaret M. Westland† US Food and Drug Administration Miles Braun; Andrea Feight; John (Jake) Kelsey†; Brad Leissa; Toni
Piazza-Hepp † Former Rapporteur 6.3 – Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 17.0 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 Skin 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 OTHER TERMINOLOGY MedDRA Version 17.0 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)