lines (e.g., SMQ Haematopoietic leukopenia) are included. A user may wish to select only the sub-search SMQ Haematopoietic thrombocytopenia in this instance. 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.
Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 19.0 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 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. Example as of MedDRA Version 19.0. OTHER TERMINOLOGY MedDRA Version 19.0 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)
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. Example as of MedDRA Version 19.0. Preferred Terms Events/Cases Comment MedDRA Version 18.1 MedDRA Version 19.0 Metastatic pain 15 0 (no longer a PT) In MedDRA Version 18.1, Metastatic pain was a PT and in Version 19.0 it was demoted to an LLT under PT Cancer pain Cancer pain 5 20 Figure 3 – Impact of MedDRA version changes – demotion of a PT Example as of MedDRA Version 18.1 and 19.0 Figure 4 – Primary SOC output listing, MedDRA Version 17.1 – example. Note that some PTs are multiaxial, however, this figure shows only the primary SOC assignments MedDRA Version 21. English Alphabetical Order MedDRA Version 21. Internationally Agreed Order Blood and lymphatic system disorders Infections and infestations Cardiac disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Congenital, familial and genetic disorders Blood and lymphatic system disorders Ear and labyrinth disorders Immune system disorders Endocrine disorders Endocrine disorders Eye disorders Metabolism and nutrition disorders Gastrointestinal disorders Psychiatric disorders General disorders and administration site conditions Nervous system disorders Hepatobiliary disorders Eye disorders Immune system disorders Ear and labyrinth disorders