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 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:
Membership of the ICH Points to Consider Working Group Current members of the ICH Points to Consider Working Group Affiliation Member Commission of the European Communities Maria Luisa Casini Kavita Chadda European Federation of Pharmaceutical Industries and Associations Hilary Vass* Christina Winter† Health Canada Alison Bennett Polina Ostrovsky Lynn Macdonald Japanese Maintenance Organization Yutaka Nagao Kazuyuki Sekiguchi Mitsuru Takano Reiji Tezuka Japan Pharmaceutical Manufacturers Association Yo Tanaka Hitomi Takeshita MedDRA MSSO Judy Harrison Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Yuhei Fukuta Miki Ohta Daisuke Sato Makiko Isozaki Kiyomi Ueno Pharmaceutical Research and Manufacturers of America Milbhor D’Silva JoAnn Medbery US Food and Drug Administration Sonja Brajovic# Christopher Breder Ministry of Food and Drug Safety, Korea YuBin Lee Kyung-Eun Yoon World Health Organization Daisuke Tanaka * Current Rapporteur # Regulatory Chair † Former Rapporteur
Figure9b – The upper bar of each pair represents numbers of reports from Consumers (blue) and the lower bar reports from Health Care Professionals (red) (Population 2) Figure 10 – For a small dataset, a display of PTs may be adequate SOC Infections and infestations Primary SOC Analysis Adverse Event (MedDRA v18.0) 25 mg MyDrug (N=44) Placebo (N=15) SOC Infections and infestations 14 (31.8%) 4 (26.7%) PT Upper respiratory tract infection 5 2 PT Sinusitis 3 0 PT Urinary tract infection 2 1 PT Ear infection 2 0 PT Viral infection 2 0 PT Bronchitis 1 0 PT Influenza 1 0 PT Localised infection 0 1 PT Lower respiratory tract infection 1 0 PT Pneumonia 1 0 PT Tooth abscess 1 0 Secondary SOC Analysis (same data as above) Adverse Event (MedDRA v18.0) 25 mg MyDrug (N=44) Placebo (N=15) SOC Respiratory, thoracic and mediastinal disorders PT Upper respiratory tract infection 5 2 PT Sinusitis 3 0 PT Bronchitis 1 0 PT Influenza 1 0 PT Lower respiratory tract infection 1 0 PT Pneumonia 1 0