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Introductory Guide for Standardised Meddra Queries (Smqs) Version 20.0

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Introductory Guide for Standardised Meddra Queries (Smqs) Version 20.0 Introductory Guide for Standardised MedDRA Queries (SMQs) Version 20.0 March 2017 000004 Acknowledgements Acknowledgements MedDRA® trademark is owned by IFPMA on behalf of ICH. Disclaimer and Copyright Notice This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided. The document is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document. The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder. SMQ Introductory Guide Version 20.0 ii March 2017 000004 Table of Contents TABLE OF CONTENTS 1. INTRODUCTION ...................................................................................... 3 1.1 DEFINITION OF A STANDARDISED MedDRA QUERY ......................... 3 1.2 BACKGROUND ....................................................................................... 3 1.3 DEVELOPMENT OF SMQS ..................................................................... 4 1.4 DESIGN CONCEPTS FOR SMQ CONTENT ........................................... 4 1.5 NOTES ON SMQ IMPLEMENTATION AND THE EXPECTATION OF QUERY RESULT ............................................................................... 7 2. INDIVIDUAL SMQS ................................................................................. 9 2.1 ACCIDENTS AND INJURIES (SMQ) ..................................................... 10 2.2 ACUTE CENTRAL RESPIRATORY DEPRESSION (SMQ) ................... 13 2.3 ACUTE PANCREATITIS (SMQ) ............................................................ 16 2.4 ACUTE RENAL FAILURE (SMQ) .......................................................... 18 2.5 AGRANULOCYTOSIS (SMQ) ................................................................ 20 2.6 ANAPHYLACTIC REACTION (SMQ) .................................................... 22 2.7 ANGIOEDEMA (SMQ) ........................................................................... 24 2.8 ANTICHOLINERGIC SYNDROME (SMQ) ............................................. 26 2.9 ARTHRITIS (SMQ) ................................................................................. 28 2.10 ASTHMA/BRONCHOSPASM (SMQ) ..................................................... 31 2.11 BILIARY DISORDERS (SMQ) ............................................................... 33 2.12 BREAST NEOPLASMS, MALIGNANT AND UNSPECIFIED (SMQ) ..... 37 2.13 CARDIAC ARRHYTHMIAS (SMQ) ........................................................ 39 2.14 CARDIAC FAILURE (SMQ) ................................................................... 42 2.15 CARDIOMYOPATHY (SMQ) .................................................................. 44 2.16 CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS (SMQ) ...... 47 2.17 CHRONIC KIDNEY DISEASE (SMQ) .................................................... 51 2.18 CONJUNCTIVAL DISORDERS (SMQ) .................................................. 56 2.19 CONVULSIONS (SMQ) .......................................................................... 58 2.20 CORNEAL DISORDERS (SMQ) ............................................................ 60 2.21 DEMENTIA (SMQ) ................................................................................. 62 2.22 DEMYELINATION (SMQ) ...................................................................... 65 2.23 DEPRESSION AND SUICIDE/SELF-INJURY (SMQ) ............................ 68 2.24 DRUG ABUSE, DEPENDENCE AND WITHDRAWAL (SMQ) ............... 71 SMQ Introductory Guide Version 20.0 iii March 2017 000004 Table of Contents 2.25 DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS SYNDROME (SMQ) .......................................................... 75 2.26 DYSLIPIDAEMIA (SMQ) ........................................................................ 81 2.27 EMBOLIC AND THROMBOTIC EVENTS (SMQ) ................................... 83 2.28 EOSINOPHILIC PNEUMONIA (SMQ) .................................................... 87 2.29 EXTRAPYRAMIDAL SYNDROME (SMQ) ............................................. 90 2.30 EXTRAVASATION EVENTS (INJECTIONS, INFUSIONS AND IMPLANTS) (SMQ) ................................................................................ 93 2.31 FERTILITY DISORDERS (SMQ) ............................................................ 95 2.32 GASTROINTESTINAL NONSPECIFIC INFLAMMATION AND DYSFUNCTIONAL CONDITIONS (SMQ) .............................................. 97 2.33 GASTROINTESTINAL PERFORATION, ULCERATION, HAEMORRHAGE OR OBSTRUCTION (SMQ) .................................... 100 2.34 GENERALISED CONVULSIVE SEIZURES FOLLOWING IMMUNISATION (SMQ) ....................................................................... 103 2.35 GLAUCOMA (SMQ) ............................................................................. 106 2.36 GUILLAIN-BARRE SYNDROME (SMQ) .............................................. 109 2.37 HAEMATOPOIETIC CYTOPENIAS (SMQ) .......................................... 113 2.38 HAEMODYNAMIC OEDEMA, EFFUSIONS AND FLUID OVERLOAD (SMQ) ............................................................................. 116 2.39 HAEMOLYTIC DISORDERS (SMQ) .................................................... 119 2.40 HAEMORRHAGES (SMQ) ................................................................... 121 2.41 HEARING AND VESTIBULAR DISORDERS (SMQ) ........................... 123 2.42 HEPATIC DISORDERS (SMQ) ............................................................ 126 2.43 HOSTILITY/AGGRESSION (SMQ) ...................................................... 132 2.44 HYPERGLYCAEMIA/NEW ONSET DIABETES MELLITUS (SMQ) .... 134 2.45 HYPERSENSITIVITY (SMQ) ................................................................ 138 2.46 HYPERTENSION (SMQ) ...................................................................... 140 2.47 HYPOGLYCAEMIA (SMQ) .................................................................. 143 2.48 HYPONATRAEMIA/SIADH (SMQ) ...................................................... 146 2.49 HYPOTONIC-HYPORESPONSIVE EPISODE (SMQ) .......................... 149 2.50 INTERSTITIAL LUNG DISEASE (SMQ) .............................................. 152 2.51 ISCHAEMIC COLITIS (SMQ) ............................................................... 154 2.52 ISCHAEMIC HEART DISEASE (SMQ) ................................................ 156 2.53 LACK OF EFFICACY/EFFECT (SMQ) ................................................ 158 2.54 LACRIMAL DISORDERS (SMQ) ......................................................... 160 2.55 LACTIC ACIDOSIS (SMQ)................................................................... 162 SMQ Introductory Guide Version 20.0 iv March 2017 000004 Table of Contents 2.56 LENS DISORDERS (SMQ) .................................................................. 164 2.57 LIPODYSTROPHY (SMQ) ................................................................... 167 2.58 MALIGNANCIES (SMQ) ...................................................................... 170 2.59 MALIGNANT LYMPHOMAS (SMQ) .................................................... 174 2.60 MEDICATION ERRORS (SMQ) ........................................................... 176 2.61 MYELODYSPLASTIC SYNDROME (SMQ) ......................................... 179 2.62 NEUROLEPTIC MALIGNANT SYNDROME (SMQ) ............................. 182 2.63 NONINFECTIOUS DIARRHOEA (SMQ) .............................................. 185 2.64 NONINFECTIOUS ENCEPHALITIS (SMQ) ......................................... 187 2.65 NONINFECTIOUS ENCEPHALOPATHY/DELIRIUM (SMQ) ............... 190 2.66 NONINFECTIOUS MENINGITIS (SMQ) ............................................... 194 2.67 OCULAR INFECTIONS (SMQ) ............................................................ 197 2.68 OCULAR MOTILITY DISORDERS (SMQ) ........................................... 199 2.69 OPTIC NERVE DISORDERS (SMQ) .................................................... 201 2.70 OROPHARYNGEAL DISORDERS (SMQ) ........................................... 203 2.71 OSTEONECROSIS (SMQ) ................................................................... 206 2.72 OSTEOPOROSIS/OSTEOPENIA (SMQ) ............................................. 209 2.73 OVARIAN NEOPLASMS, MALIGNANT AND UNSPECIFIED (SMQ) . 212 2.74 PERIORBITAL AND EYELID DISORDERS (SMQ) ............................. 214 2.75 PERIPHERAL NEUROPATHY (SMQ) ................................................. 216 2.76 PREGNANCY AND NEONATAL TOPICS (SMQ) ................................ 218 2.77 PREMALIGNANT DISORDERS (SMQ) ............................................... 223 2.78 PROSTATE NEOPLASMS, MALIGNANT AND UNSPECIFIED (SMQ) .................................................................................................. 227 2.79 PROTEINURIA (SMQ) ......................................................................... 229 2.80 PSEUDOMEMBRANOUS COLITIS (SMQ) .........................................
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