MedDRA 10.0 Review. Terminology Files: What you need to know. MedDRA Version 10.0 Terminology Frequency Distribution

Transcription

1 MedDRA 10.0 Review MedDRA Version Changes General Remarks Terminology Files: What you need to know MedDRA Version 10.0 Specific Changes Version 10.0 Changes Overview Changes in a Nutshell Changes Highlights MedDRA Version 10.0 Terminology Frequency Distribution MedDRA Version What's coming ahead?

2 MedDRA Changes - General Remarks There are two possible types of changes to MedDRA terminology: simple changes and complex changes. Simple changes are changes to the existing terminology that involve terms at the PT and LLT levels. There are two types of Simple changes: (1) changes introduced by subscribers request and (2) Maintenance changes (also referred to as Associate changes). Maintenance changes are generated as a by-product of other changes requested by subscribers, or changes introduced by the MedDRA Management Board to preserve consistency within the dictionary. Complex changes involve modifications to HLT, HLGT, and SOC terminology. Currently, the initial MedDRA terminology version release in one specific year (5.0, 6.0, 7.0, 8.0, 9.0) includes both simple and complex changes, and the subsequent release in the same year (5.1, 6.1, 7.1, 8.1, 9.1) represents a simple change of terminology. These changes are based on MedDRA subscribers' terminology change requests and on MedDRA terminology maintenance needs identified by MedDRA's maintenance organization reviewers. Please note that as a consequence of implementing some of these changes (e.g. demoting a multiaxial PT, adding a new HLT, etc.) it may be necessary to break the multiaxial links, to re-link the replacement terms, and/or to enable additional terms to be included within a particular SOC. All these changes may require modifications to your existing MedDRA coding, guideline development, and data retrieval practices. Back to MedRA 10.0 Review

3 Files Containing MedDRA Terminology,Documentation, and Terminology Changes Information Directory Folder File Name Description How to use it _ intguide.pdf MedDRA Introductory Guide is a language specific document that describes characteristics of MedDRA including rules, conventions, and terminology hierarchy To view requires Adobe Acrobat reader. smq_intguide.pdf whatsnew.pdf SMQ Introductory Guide is a document that describes SMQs basic concepts The "What's New" document provides a summary of all corresponding MedDRA version changes, modifications to terminology conventions, and information on other MedDRA-related activities To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader. _ asciidoc.pdf MedDRA ASCII Files Documentation contains MedDRA files' description and To view requires Adobe fields definitions. In addition, it Acrobat reader. contains all the information required to create MedDRA relational _ conseq.pdf MedDRA Consecutive File Documentation contains consecutive files' description and fields definitions. To view requires Adobe Acrobat reader. _ changereq_info.pdf sub_pot.pdf phonecard.pdf Change Request Information document provides all information regarding terminology change requests Subscriber Portfolio document contains details about your MedDRA subscription MedDRA MSSO Phone System provides information on how to access the MSSO by phone To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader. To view requires Adobe Acrobat reader.

4 _!!readme.txt Readme document contains a list of all documents included in each new MedDRA version release. To view requires any reader that supports *.txt files Directory Folder File Name Description How to use it llt.asc Lower Level Term file. Contains ALL LLT in the hierarchy including noncurrent terms Refer to PDF document ascii.pdf for a complete description of this file's content and how to format it to create a table in a relational database pt.asc Prefer Term file. Contains all PT in the hierarchy. hlt.asc High Level Term file. Contains all HLT in the hierarchy. hlgt.asc High Level Group Term file. Contains all HLGT in the hierarchy. soc.asc System Organ Class file. Contains all 26 SOCs in the hierarchy. mdhier.asc MedDRA Hierarchy file. Contains the MedDRA hierarchy excluding LLTs.

5 hlt_pt.asc PT & HLT codes file. Contains all PT-HLT associations. (most recent version hlgt_hlt.asc HLT & HLGT codes file.contains all HLT-HLGT associations. soc_hlgt.asc HLGT & SOC codes file. Contains all HLGT-SOC associations. spec.asc Special Search Categories (SSC) file. Contains a list of all Special Search Categories. spec_pt.asc Special Search Categories & PT file. Contains a list of all Special Search Categories (SSC) and the PTs included in each. SMQ_List.asc Standardised MedDRA Query (SMQ) list file. Contains a complete list of all production (means available for use) SMQs. SMQ_Content.asc Standardised MedDRA Query (SMQ) content file. Contains all production SMQs and their respective subordinate terms. intl_ord.asc International System Organ Class order file. Contains the serial code for international System Organ Class sort order (based on relative importance of each SOC)

6 Directory Folder File Name Description How to use it SeqAscii llt.seq Lower Level Term sequential file. Contains all LLT changes since previous version. conseq.pdf document to use in a relational SeqAscii pt.seq Prefer Term file. Contains all PT changes since previous version. conseq.pdf document to use in a relational SeqAscii hlt.seq High Level Term file. Contains all HLT changes since previous version. conseq.pdf document to use in a relational SeqAscii hlgt.seq High Level Group Term file. Contains all HLGT changes since previous version. conseq.pdf document to use in a relational SeqAscii soc.seq System Organ Class file. Contains all SOCs changes since previous version. conseq.pdf document to use in a relational SeqAscii mdhier.seq MedDRA Hierarchy file. Contains the MedDRA hierarchy changes since previous version. conseq.pdf document to use in a relational SeqAscii hlt_pt.seq PT & HLT codes file. Contains all PT-HLT changes since previous version. conseq.pdf document to use in a relational SeqAscii hlgt_hlt.seq HLT & HLGT codes file. Contains all HLT-HLGT changes since previous version. conseq.pdf document to use in a relational

7 (most recent version SeqAscii soc_hlgt.seq HLGT & SOC codes file.contains all HLGT-SOC associations. conseq.pdf document to use in a relational SeqAscii SeqAscii SeqAscii spec.seq spec_pt.seq intl_ord.seq Special Search Categories (SSC) file. Contains a list of all Special Search Categories changes since previous version. conseq.pdf document to use in a relational Special Search Categories & PT file. Contains a list of all Special conseq.pdf document to Search Categories (SSC) and use in a relational the PTs changes since previous version. International System Organ Class order file. Contains all changes to the serial code for international System Organ Class sort order (based on relative importance of each SOC) conseq.pdf document to use in a relational Directory Folder File Name Description How to use it MedDRA MSSO Downloads Page: so.com/translations/ downloads.htm _ MedDRAVersion Reports.xls MedDRA Verison Report file. Contains all MedDRA terminology changes since previous version release in a spreadsheet format. Microsoft Excel format. Very useful file for MedDRA version upgrade reviews. MedDRA MSSO Downloads Page: so.com/translations/ downloads.htm _ Detailed_WhatsNew Report.pdf Detailed What's New Report file. Contains all version changes in full detail. To view requires Adobe Acrobat reader. Very useful file for MedDRA version upgrade reviews. Back to MedDRA 10.0 Review

8 MedDRA 10.0 Changes: Overview MedDRA Terminology Version 10.0 released in March 1, 2007 contains both simple and complex changes. Following is a summary of the changes and several examples. To view a complete list of all terminology changes in version 10.0 go to: Version Report - (subscriber login required). Changes In a Nutshell Retirement of SSCs 17 Complex Changes Double Spaced Terms and Other Existing Errors New SMQs Back to MedDRA 10.0 Review Changes Highlights Featured HLGT Changes Featured HLT Changes Featured PT Changes New PTs Promoted LLTs

9 Featured LLT Changes New LLTs Demoted PTs Currency changes Featured SMQ Changes New SMQs MedDRA Version What's coming ahead? Back to MedDRA 10.0 Review

10 MedDRA Version 10.0 Specific Changes Changes In a Nutshell Retirement of SSCs Special Search Categories (SSCs) have been replaced by Standardized MedDRA Queries (SMQs).?SSCs have been a part of the terminology since Version 2.1 (March 1999). From Version 10.0 and on the MSSO will discontinue the maintenance and distribution of SSCs. However, SSCs will be available to MedDRA users as archive files at the MSSO download page. 17 Complex Changes Back These 17 complex changes involve HLGTs and HLTs only. Two HLGTs and five HLTs were renamed. Five HLTs were merged under other HLTs. In addition, five new HLTs were added to the hierarchy. Renamed HLGTs Old Name New Name Infections - pathogen class unspecified Infections - pathogen unspecified Neurological, special senses and psychiatric Neurological and special sense investigations investigations Renamed HLTs Old Name New Name Cardiac pacemaker therapeutic procedures Cardiac device therapeutic procedures Scalar conditions Scaly conditions Sepsis, bacteraemia and viraemia Sepsis, bacteraemia, viraemia and fungaemia NEC Injuries due to in utero exposure Pregnancy related accidental exposures and injuries Narcolepsy associated symptoms Narcolepsy and associated conditions Merged HLTs

11 Merged HLT Diabetic eye disorders NEC Variola viral infections Vaccinia viral infections Australia viral infections Congenital cardiac valve disorders Merged Under Ocular disorders NEC Orthopox viral infections Orthopox viral infections Flaviviral infections Congenital cardiovascular disorders NEC New HLTs Merged HLT Diabetic eye disorders NEC Variola viral infections Vaccinia viral infections Australia viral infections Congenital cardiac valve disorders Merged Under Ocular disorders NEC Orthopox viral infections Orthopox viral infections Flaviviral infections Congenital cardiovascular disorders NEC The following tables present all PTs contained within each new HLT. HLT Biochemical markers of bone metabolism PT C-telopeptide PT Deoxypyridinoline urine increased PT Deoxypyridinoline/creatinine ratio PT N-telopeptide PT N-telopeptide urine PT N-telopeptide urine abnormal PT N-telopeptide urine decreased PT N-telopeptide urine increased PT N-telopeptide urine normal PT Osteocalcin PT Osteocalcin decreased PT Osteocalcin increased PT Osteoprotegerin PT Osteoprotegerin decreased PT Osteoprotegerin increased PT Osteoprotegerin ligand PT Osteoprotegerin ligand decreased PT Pyridinoline urine PT Pyridinoline urine decreased PT Pyridinoline urine increased

12 HLT Psychiatric Investigations PT Mini mental status examination PT Mini mental status examination abnormal PT Mini mental status examination normal PT Neuropsychological test PT Neuropsychological test abnormal PT Psychiatric evaluation PT Psychiatric evaluation abnormal PT Psychiatric evaluation normal PT Psychiatric investigation HLT Contraceptive Methods Male PT Condom PT Male contraception PT Male sterilisation HLT Orthopox viral infections PT Cow pox PT Smallpox PT Eczema vaccinatum PT Post vaccination autoinoculation PT Vaccinia PT PT PT PT PT PT PT PT PT Paraneoplastic syndromes NEC Eaton-Lambert syndrome Hypercalcaemia of malignancy Polyneuropathy in malignant disease Paraneoplastic cerebellar degeneration Paraneoplastic pemphigus Paraneoplastic syndrome Acrokeratosis paraneoplastica Paraneoplastic retinopathy Paraneoplastic dermatomyositis Back

13 Double Spaced Terms and Other Existing Errors Several terms in MedDRA contained spelling errors and/or double spacing sometimes causing data retrieval problems. Following is a complete list of all the corrected terms. LLT_Name_v91 Aminorrhea Ano-rectal stenosis Ano-rectal ulcer Blastomyces pnemonia recurrent Cerebellar or brain stem contu w /o ment of open intcran wound, with prol oss cons and rtrn to pecl Cerebral revasculariztion synangiosis Chronic obstructive asthma (with obstructive pulmonary disease), wlo ment of status asthmaticus Cns complications of anesthesia or other sedation in labor and delivery, unspec as to eoc Cns comps of anesthesia or other sedat labor and delivered, with men of postpart comp Dyspepsia aggravated Human immunodeficiency virus, type 2 infection in conditions classified elsewhere and of unspec sit Hypothalamo-pituitary disorders Inappropriate device irritation of tissue Kaschin-Beck disease involving multiple sites Kaschin-Beck disease involving other specified sites Kaschin-Beck disease involving pelvic region and thigh Mouth ulceration aggravated Oedema abdomen NOS Oth closed skull frac with intcran inj of oth and unspec nature, with prol Icc, w/o rtrn to pecl Oth open skull frac with intcran inj of oth and unspec nature, with prolonged loss of Other current conditions classifiable elsewhere of mother, antepartum Pancreatic secretion decreased Pancreatic secretion increased PDA Repair patent ductus arteriosus Poisoning by mixed viral-ricket and bact vaccines, except combinations with pertussis component LLT_Name_v10 Amniorrhea Anorectal stenosis Anorectal ulcer Blastomyces pneumonia recurrent Cerebellar or brain stem contu w /o ment of open intcran wound, with prol_ loss cons and rtrn to pecl Cerebral revascularization synangiosis Chronic obstructive asthma (with obstructive pulmonary disease), w/o-ment of status asthmaticus Cns_complications of anesthesia or other sedation in labor and delivery, unspec as to eoc Cns_comps of anesthesia or other sedat labor and delivery, delivery, delivered, with men of postpart comp Dyspepsia-aggravated Human immunodeficiency virus, type 2_infection in conditions classified elsewhere and of unspec sit Hypothalamo-pituitary disorder Inappropriate device stimulation of tissue Kaschin-Beck disease_involving multiple sites Kaschin-Beck disease_involving other specified sites Kaschin-Beck disease_involving pelvic region and thigh Mouth ulceration-aggravated Oedema abdomen Oth closed skull frac with intcran inj of oth and unspec nature, with prol_loc, w /o rtrn to pecl Oth open skull frac with intcran inj of oth and unspec nature, w ith prolonged_loss of Other current conditions classifiable elsewhere of mother,_antepartum Pancreatic-secretion decreased Pancreatic-secretion increased PDA_Repair patent ductus arteriosus Poisoning by mixed viral-ricket and bact vaccines, except combinations with_pertussis component

14 Port-a-Cath insertion Progression of non small cell lung cancer Proteinuria aggravated Quadriplegia and quadriparesis of C1-C4, incomplete Sterilization NOS Subdural hem following inj, with open intcran wound, with moderate loc Portacath insertion Progression of non-small cell lung cancer Proteinuria-aggravated Quadriplegia and quadriparesis of_c1-c4, incomplete Sterilization Subdural hem following inj, with open intcran_wound, with moderate loc Back New SMQs 1. Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) (SMQ) 2. Convulsions (SMQ) 3. Cardiac failure (SMQ) 4. Dementia (SMQ) 5. Embolic and thrombotic events (SMQ) 6. Extrapyramidal syndrome (SMQ) 7. Malignancies (SMQ) 8. Pre-malignant disorders (SMQ) 9. Pseudomembranous colitis (SMQ) For more details about these new SMQs, go to Changes Highlights, Featured SMQ Changes. Back to Changes in a Nutshell Or Back to MedDRA 10.0 Review Back

15 MedDRA Version 10.0 Specific Changes Changes Highlights Featured HLGT Changes See previous section: 17 Complex Changes Back Featured HLT Changes See previous section: 17 Complex Changes Back Featured PT Changes New PTs new PTs. Following are some examples. Promoted LLTs-40 LLTs promoted to

16 PT Name PT Inner ear inflammation PT Ocular surface disease PT Localised intraabdominal fluid collection PT Regurgitation PT Stomach mass PT Catheter thrombosis PT Surgical failure PT Disuse syndrome PT Treatment failure PT Vaccine positive rechallenge PT Post procedural infection PT Superinfection fungal PT Superinfection viral PT Superinfection bacterial PT Weaning failure PT Procedural nausea PT Deep vein thrombosis postoperative PT Procedural vomiting PT Procedural headache PT Procedural dizziness PT Device misuse PT Tumour related complication PT Hemisensory neglect PT Visual midline shift syndrome PT Progressive relapsing multiple sclerosis PT Taciturnity PT Violent ideation PT Polymedication Promoted LLTs-40 LLTs promoted to PT. Following are some examples. PT Name PT Altered state of consciousness PT Angioedema PT Atrioventricular block complete PT Carotid artery bypass PT Elective procedure PT Elective surgery PT Multiple injuries PT Nasal inflammation

17 Back Featured LLT Changes New LLTs-527 new LLTs. Following are a few examples. LLT Name PT Name New LLT Medication after taste Pharmaceutical product complaint New LLT Drug side effect Adverse drug reaction New LLT Pharmacodynamic interaction Drug interaction New LLT Pharmacokinetic interaction Drug interaction New LLT Menoxenia Menstrual disorder New LLT Emmeniopathy Menstrual disorder New LLT Uncontrolled hypertension Hypertension Demoted PTs - 68 PT were demoted to LLT level in version Following are some examples. LLT Name (former PTs in version 9.1) ABO isoimmunisation Herpetic gingivostomatitis Adherent leukoma Herpetic stomatitis Angioneurotic oedema Impingement syndrome Anticonvulsant toxicity Intestinal spasm Arteriopathic disease Intra-nasal antrostomy Atrioventricular block third degree Intranasal numbness Bronchitis acute Intubation complication Bronchitis acute viral Isoimmunisation Buttock pain Latissimus dorsi flap Carotid artery atheroma Low tension glaucoma Catheter site bruise Pneumatic retinopexy Conductive keratoplasty Polytraumatism Corneal epithelium disorder Post procedural dizziness Cryoretinopexy Post procedural headache Dacryocanaliculitis infective Post procedural nausea Dacryocystitis infective Post procedural vomiting Death of child Postoperative infection Death of friend Pulmonary coccidioides Death of parent Rebound hypertension Death of sibling Regurgitation of food Death of spouse Renal papillitis necrotising Descemet's membrane disorder Retinal naevus Detached retina repair Ross river virus infection Difficult to wean from ventilator Sacral pain

18 Dry socket Epithelioma Extrinsic iliac vein compression Familiar hemiplegic migraine Genital pain female Genital pain male Genital pruritus female Genital pruritus male Genitalia external painful Hepatic trauma Single vessel bypass graft Streptococcal serology Streptococcal serology negative Streptococcal serology positive Superinfection lung Superinfection oral Therapy non-responder Uterine cervix hypertrophy Vascular ultrasound Vessel puncture site bruise Back Currency changes - the following 22 LLTs were made Non-Current (inactive) in version 10.0 LLT Name AML progression Asthenia legs Blood gases abnorm Collapsed semi conscious & shocked Congenital musculoskeletal abnorm Familiar hemiplegic migraine Fear, focus Gases blood abnorm Haemangioma-thrombocytopaenia syndrome Hesitancy/poor urinary stream Liver function tests multiple abnorm Mental disorders of mother Neck muscle torsion of No drug reaction Non-toxic multinodular goitre Non-toxic nodular goitre Non-toxic uninodular goitre Pseudothrombocytopaenia Spinal fluid abnorm Synovitis wrists & feet Thrombocytopaenia Visual evoked potentials abnorm. Back Featured SMQ Changes New SMQs

19 1. 1. Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) (SMQ) Adverse pregnancy outcome/reproductive Toxicity (incl neonatal disorders (SMQ) Reproductive toxicity (SMQ) PTs=115 LLTs=529 Pregnancy complications PTs=200 LLTs=1443 Congenital, familial and genetic disorders PTs=1010 LLTs=2847 Disorders of the offspring PTs=245 LLTs= Convulsions (SMQ) Convulsions (SMQ) PTs=52 LLTs= Cardiac failure (SMQ) - has broad and narrow terms search option. CIOMS working group is requesting input from users regarding the development of an algorithm for this SMQ. Cardiac Failure (SMQ) PTs=51 LLTs= Dementia (SMQ)

20 Dementia (SMQ) PTs=76 LLTs= Embolic and thrombotic events (SMQ) Embolic and thrombotic events (SMQ) Embolic and thrombotic events, arterial (SMQ) PTs=95 LLTs=403 Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (SMQ) PTs=98 LLTs=334 Embolic and thrombotic events, venous (SMQ) PTs=65 LLTs= Extrapyramidal syndrome (SMQ) Extrapyramidal syndrome (SMQ) Akathisia (SMQ) PTs=8 LLTs=62 Dyskinesia PTs=18 LLTs=113 Dystonia PTs=31 LLTs=203 Parkinson-like events PTs=30 LLTs= Malignancies (SMQ)

21 Malignancies (SMQ) Malignant or unspecified tumours (SMQ) PTs=1385 LLTs=6888 Malignancy related conditions (SMQ) PTs=35 LLTs=72 Malignancy related therapeutic and diagnostic procedures (SMQ) PTs=321 LLTs=805 Tumour makers (SMQ) PTs=19 LLTs=55 8. Pre-malignant disorders (SMQ) Premalignant disorders (SMQ) Blood premalignant disorders (SMQ) PTs=32 LLTs=118 Gastrointestinal premalignant disorders (SMQ) PTs=81 LLTs=262 Reproductive premalignant disorders (SMQ) PTs=37 LLTs=125 Skin premalignant disorders (SMQ) PTs=18 LLTs=91 9. Pseudomembranous colitis (SMQ) Pseudomembranous colitis (SMQ) PTs=29 LLTs=153

22 Back to New SMQs Back to MedDRA Changes Highlights Back to MedDRA 10.0 Review

23 MedDRA Version 10.0 Terminology Frequency Distribution by MedDRA Version Level Version Version Version Version Version Version Version SOC HLGT HLT 1,681 1,681 1,683 1,683 1,682 1,682 1,682 PT 16,449 16,559 16,751 16,976 17,320 17,505 17,719 LLT Current LLT's Non-current LLT's 61,204 52,253 8,951 61,704 52,740 8,964 62,348 53,370 8,978 62,950 53,967 8,983 63,817 54,834 8,983 64,620 55,621 8,999 65,147 56,125 9,022 Total 79,692 80,302 81,140 81,967 83,177 84,165 84,906 Back to MedDRA 10.0 Review

24 MedDRAVersion What's Coming Ahead? MedDRA terminology next release, version 10.1, is September SMQs in development/testing that will most likely be released in version 10.1 Acute central respiratory depression Gastrointestinal perforation, ulceration, haemorrhage or obstruction Oropharyngeal lesions Psychosis and psychotic disorders Thrombophlebitis Back to MedDRA Changes Highlights or Back to MedDRA 10.0 Review