4.10.3 Algorithmic SMQs An algorithm provides for a combination of terms which – if retrieved in a single case – are more likely to identify a case of interest than isolated broad search terms (see table below). The broad terms of algorithmic SMQs are subdivided into categories that could be groupings of organ-specific signs or symptoms, laboratory terms, etc. (Note: the broad search categories are labeled B, C, D, etc.). Using an algorithm may reduce the amount of “noise” (i.e., non-relevant cases). Using an algorithmic SMQ without applying the algorithm (i.e., simply applying the narrow and broad searches) will yield different results from those obtained using the algorithm. Example Algorithmic SMQ (SMQ Anaphylactic reaction)* Category B – Upper airway/Respiratory Category C – Angioedema/Urticaria, etc. Category D – Cardiovascular/Hypotension Acute respiratory failure Allergic oedema Blood pressure decreased Asthma Angioedema Blood pressure diastolic decreased Bronchial oedema Erythema Blood pressure systolic decreased Algorithm: Case = A (Narrow terms – not included in the table) Or term from Category B and term from Category C Or term from either Category B or Category C plus term from Category D * Not all terms in these categories are listed in the table SMQ Systemic lupus erythematosus is an algorithmic SMQ with assigned weights for its included PTs (e.g., PT Pleural effusion = 3); a total weighted score greater than 6 suggests a case of interest. Users should not assume that all software tools support algorithmic SMQs.
Communities Carmen Kreft Jais European Federation of Pharmaceutical Industries Associations Hilary Vass** Christina Winter* Health Canada Alison Langevin Lynn Macdonald Japanese Maintenance Organization Osamu Handa Kazuyuki Sekiguchi Reiji Tezuka Japan Pharmaceutical Manufacturers Association Yo Tanaka MedDRA MSSO Patricia Mozzicato Ministry of Health, Labour and Welfare Izumi Oba Daisuke Tanaka Pharmaceutical Research and Manufacturers of America Susan M. Lorenski JoAnn Medbery US Food and Drug Administration John (Jake) Kelsey* Toni Piazza-Hepp * Current co-Rapporteurs ** Acting Rapporteur for June 2010 meeting of Working Group 6.2.2 Former members of the ICH Points to Consider Working Group Affiliation Member Commission of the European Communities Dolores Montero European Federation of Pharmaceutical Industries Associations Barry Hammond†; Reinhard Fescharek† Health Canada Heather Morrison; Michelle Séguin; Heather Sutcliffe; Bill Wilson Japanese Maintenance Organization Akemi Ishikawa; Yasuo Sakurai; Yuki Tada Japan Pharmaceutical Manufacturers Association Takayoshi Ichikawa; Akemi Ishikawa; Satoru Mori; Yasuo Sakurai; Kunikazu Yokoi
MedDRA MSSO JoAnn Medbery Ministry of Health, Labour and Welfare Tamaki Fushimi; Wakako Horiki; Kazuhiro Kemmotsu; Tatsuo Kishi; Chie Kojima; Emiko Kondo; Kemji Kuramochi; Tetsuya Kusakabe; Kaori Nomura; Yoshihiko Sano; Kenichi Tamiya; Takashi Yasukawa; Manabu Yamamoto; Nobuhiro Yamamoto Pharmaceutical Research and Manufacturers of America David Goldsmith; Sidney Kahn; Margaret M. Westland† US Food and Drug Administration Miles Braun; Andrea Feight; Brad Leissa † Former Rapporteur 6.3 – Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 14.0 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 Joint sprain Back injury 1 1 1 1 Figure 1 – How data coded to a single PT from another terminology may be expressed by several PTs in MedDRA
OTHER TERMINOLOGY MedDRA Version 14.0 Reported Event (% subjects) Coded Term (% subjects) Body System/SOC (% subjects) PT (% subjects) SOC (% subjects) Hyperglycaemia (4.1) Hyperglycemia (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 MedDRA Version 13.1 Number of Events at PT Level Malignant neoplasm progression (PT) 15 Neoplasm malignant 5 MedDRA Version 14.0 Number of Events at PT Level Malignant neoplasm progression (no longer a PT) 0 Neoplasm malignant 20