MedDRA 10.1 Review. MedDRA Version 10.1 What s coming ahead? MedDRA Version Changes. General Remarks. Terminology Files: What you need to know

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1 MedDRA 10.1 Review MedDRA Version Changes General Remarks Terminology Files: What you need to know MedDRA Version 10.1 Specific Changes Version 10.1 Changes Overview Changes in a Nutshell Changes Highlights MedDRA Version 10.1 Terminology Frequency Distribution MedDRA Version 10.1 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 MedDRA 10.1 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 smqintguide.pdf whatsnew.pdf changereqinfo.pdf subpot.pdf phonecard.pdf!!readme.txt 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 MedDRA ASCII Files Documentation contains MedDRA files' description and fields definitions. In addition, it contains all the information required to create MedDRA relational MedDRA Consecutive File Documentation contains consecutive files' description and fields definitions. 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 Readme document contains a list of all documents included in each new MedDRA version release. any reader that supports *.txt files

4 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. hltpt.asc PT & HLT codes file. Contains all PT-HLT associations. (most recent version hlgthlt.asc HLT & HLGT codes file.contains all HLT-HLGT associations.

5 sochlgt.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. specpt.asc Special Search Categories & PT file. Contains a list of all Special Search Categories (SSC) and the PTs included in each. SMQList.asc Standardised MedDRA Query (SMQ) list file. Contains a complete list of all production (means available for use) SMQs. SMQContent.asc Standardised MedDRA Query (SMQ) content file. Contains all production SMQs and their respective subordinate terms. intlord.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) llt.seq Lower Level Term sequential file. Contains all LLT changes since previous version. pt.seq Prefer Term file. Contains all PT changes since previous version.

6 hlt.seq High Level Term file. Contains all HLT changes since previous version. hlgt.seq High Level Group Term file. Contains all HLGT changes since previous version. soc.seq System Organ Class file. Contains all SOCs changes since previous version. mdhier.seq MedDRA Hierarchy file. Contains the MedDRA hierarchy changes since previous version. hltpt.seq PT & HLT codes file. Contains all PT-HLT changes since previous version. hlgthlt.seq HLT & HLGT codes file. Contains all HLT-HLGT changes since previous version. (most recent version sochlgt.seq HLGT & SOC codes file.contains all HLGT-SOC associations. spec.seq Special Search Categories (SSC) file. Contains a list of all Special Search Categories changes since previous version. specpt.seq Special Search Categories & PT file. Contains a list of all Special Search Categories (SSC) and the PTs changes since previous version.

7 intlord.seq 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) MedDRA MSSO Downloads Page: om/translations/download s.htm MedDRAVersionReports.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: om/translations/download s.htm DetailedWhatsNewReport.pdf Detailed What's New Report file. Contains all version changes in full detail. Very useful file for MedDRA version upgrade reviews. Back to MedDRA 10.1 Review

8 MedDRA 10.1 Changes: Overview MedDRA Terminology Version 10.1 released in September 1, 2007 contains only simple changes. Following is a summary of the changes and several examples. To view a complete list of all terminology changes in version 10.1 go to: Version Report - (subscriber login required). Back to MedDRA 10.1 Review

9 Changes In a Nutshell Globalization of MedDRA - Addition of peculiar terms requested by nonnative English speakers Drug Abuse and Dependence terms mapping disconnect EMA - Volume 9A reporting compliance issues New SMQs Back to MedDRA 10.1 Review Changes Highlights Featured PT Changes New PTs Promoted LLTs Featured LLT Changes New LLTs Demoted PTs Currency changes Back to MedDRA 10.1 Review MedDRA Version 10.1 What s coming ahead? Back to MedDRA 10.1 Review

10 Changes In a Nutshell Globalization of MedDRA - Addition of peculiar terms requested by non-native English speakers MedDRA is used by investigators all over the world. This version includes peculiar terms not so frequently used in English speaking countries but which are commonly used in certain cultures. For example, the English term Paludism referring to malaria, is frequently used as such in Spanish speaking countries ( Paludismo ). Back Drug Abuse and Dependence terms mapping disconnect The location in the MedDRA hierarchy of Drug Abuse and Dependence has been a source of confusion and a stumbling block in the process of data search, retrieval, and analysis. In earlier versions of MedDRA Abuse terms existed under SOC Social circumstances while dependence terms were located under SOC Psychiatric disorders. Depending on the adverse event verbatim reports were mapped to one of these two SOCs which created some challenges for data users. However, if the term refers to a person, Drug abuser then the mapping goes into SOC Social circumstances. In summary, MedDRA version 10.1 SOC Psychiatric disorders, HLT Substance-related disorders include the following PTs: PT Name PT Alcohol abuse PT Alcohol problem PT Alcohol withdrawal syndrome PT Alcoholic hangover PT Alcoholism PT Dependence PT Dopamine dysregulation syndrome PT Drug abuse PT Drug dependence PT Drug dependence, antepartum PT Drug dependence, postpartum PT Drug withdrawal syndrome PT Drug withdrawal syndrome neonatal PT Intentional drug misuse PT Intentional overdose PT Multiple drug overdose intentional PT Neonatal complications of substance abuse PT Nicotine dependence PT Polysubstance dependence PT Substance abuse PT Tobacco abuse PT Tobacco withdrawal symptoms PT Withdrawal syndrome

11 Back European Union - Volume 9A reporting compliance issues In support of the European Union reporting requirements, version 10.1 includes the following terms: LLTName PTName HLTName HLGTName SOCName Transmission of an infectious agent via a Infectious Ancillary infectious Infections and medicinal product transmissions topics infestations Transmission of an infectious agent via a medicinal product Suspected transmission of an infectious agent via a medicinal product Transmission of an infectious agent via a medicinal product Infectious transmissions Ancillary infectious topics Infections and infestations Back New SMQs 1. Accidents and injuries (SMQ) 2. Acute central respiratory depression (SMQ) 3. Biliary disorders (SMQ) 4. Drug abuse, dependence and withdrawal (SMQ) 5. Extravasation events (injections, infusions and implants) (SMQ) 6. Gastrointestinal nonspecific inflammation and dysfunctional (SMQ) 7. Gastrointestinal perforation, ulceration, haemorrhage or obstruction (SMQ) 8. Guillain-Barre syndrome (SMQ) 9. Hostility/aggression (SMQ) 10. Hyponatraemia/SIADH (SMQ) 11. Noninfectious encephalitis (SMQ) 12. Noninfectious encephalopathy/delirium (SMQ) 13. Noninfectious meningitis (SMQ) 14. Oropharyngeal disorders (SMQ) 15. Psychosis and psychotic disorders (SMQ) 16. Pulmonary hypertension (SMQ) 17. Thrombophlebitis (SMQ) Torsade de pointes/qt prolongation (SMQ) was promoted to a free standing SMQ. Back to Changes in a Nutshell

12 Changes Highlights Featured PT Changes New PTs new PTs. Following are some examples. PT HLT HLGT SOC Cardiac valve disorders Heart valve incompetence Cardiac valve disorders Cardiac disorders Dysmyelination Abdominal wall haematoma Oral mucosal erythema Gingival erythema Bloody peritoneal effluent Oral disorder Gastrointestinal sounds abnormal Apparent death No adverse drug reaction No adverse event No adverse reaction Adverse reaction Disease complication Puncture site induration Metabolic and nutritional Lysosomal storage disorders disorders congenital Abdominal wall Abdominal hernias and other abdominal wall Congenital, familial and genetic disorders Gastrointestinal disorders Oral soft tissue signs and symptoms Oral soft tissue Gastrointestinal disorders Dental and gingival Gingival disorders Gastrointestinal disorders Peritoneal and retroperitoneal haemorrhages Peritoneal and retroperitoneal Gastrointestinal disorders Oral soft tissue disorders Oral soft tissue Gastrointestinal disorders Abdominal findings abnormal General signs and symptoms Adverse effect absent Adverse effect absent Adverse effect absent Therapeutic and nontherapeutic responses General signs and symptoms Administration site reactions Gastrointestinal signs and symptoms General system disorders General system disorders General system disorders General system disorders Therapeutic and nontherapeutic effects (excl toxicity) General system disorders Administration site reactions Gastrointestinal disorders General disorders and administration site General disorders and administration site General disorders and administration site General disorders and administration site General disorders and administration site General disorders and administration site General disorders and administration site General disorders and administration site Mucosal pigmentation Mucosal findings abnormal General system disorders Lower respiratory tract and Infections - pathogen Infections and Pleural infection bacterial lung infections unspecified infestations Sepsis, bacteraemia, viraemia and fungaemia Infections - pathogen Infections and Endotoxaemia unspecified infestations Rotavirus infection Rotaviral infections Viral infectious disorders Infections and

13 infestations Perihepatic abscess Abdominal and gastrointestinal infections Infections - pathogen unspecified Infections and infestations Quality of life decreased Investigations Investigations, imaging and histopathology procedures Investigations Type 2 diabetes mellitus Diabetes mellitus (incl subtypes) Glucose metabolism disorders (incl diabetes mellitus) Metabolism and nutrition disorders Type 1 diabetes mellitus Diabetes mellitus (incl subtypes) Glucose metabolism disorders (incl diabetes mellitus) Metabolism and nutrition disorders Pregnancy on contraceptive Unintended pregnancies Umbilical granuloma Sleep-related eating disorder Parasomnias Umbilical cord complications Pregnancy, labour, delivery and postpartum Neonatal and perinatal Sleep disorders and disturbances Pregnancy, puerperium and perinatal Pregnancy, puerperium and perinatal Psychiatric disorders Psychiatric and behavioural Psychiatric decompensation Psychiatric symptoms symptoms Sleep disorders and Confusional arousal Parasomnias disturbances Disturbances in initiating and Sleep disorders and Hyposomnia maintaining sleep disturbances Pharyngeal disorder Pharyngeal disorders (excl infections and neoplasms) Upper respiratory tract disorders (excl infections) Psychiatric disorders Psychiatric disorders Psychiatric disorders Respiratory, thoracic and mediastinal disorders Prescription form tampering Criminal activity Legal issues Social circumstances Antiretroviral therapy Astringent therapy Antiinfective therapies Therapeutic procedures Therapeutic procedures and supportive care Therapeutic procedures and supportive care Surgical and medical procedures Surgical and medical procedures Back

14 Featured LLT Changes New LLTs 458 new LLTs. Demoted PTs 95 PT were demoted to LLT level in version Currency changes the following 13 LLTs currency changed in version 10.1 LLT Version 10.1 Currency Ischialgia Current Laryngotracheobronchitis Current Pregnancy disorder Current Raised liver enzymes Current Reaction nonspecific Current Acute glomerulonephritis with lesion of rapidly progressive glomerulonephritis Non-current Elevated venous pressure during dialysis Non-current Glomerulonephritis rapidly progressive chronic Non-current Haemorrhage ant chamber eye Non-current Hemorrhage ant chamber eye Non-current Injection site redness mass Non-current Laryngotracheo bronchitis Non-current Na Non-current Back Back to MedDRA Changes Highlights

15 MedDRA Version 11.0 What s Coming Ahead? MedDRA terminology next release, version 11.0, is March Back to MedDRA Changes Highlights or Back to MedDRA 10.1 Review

16 MedDRA Version 10.1 Terminology Frequency Distribution by MedDRA Version Level Version 7.0 Version 7.1 Version 8.0 Version 8.1 Version 9.0 Version 9.1 Version 10.0 Version 10.1 SOC HLGT HLT 1,681 1,681 1,683 1,683 1,682 1,682 1,682 1,682 PT 16,449 16,559 16,751 16,976 17,320 17,505 17,719 17,867 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, ,125 9,022 65, ,580 9,025 Total 79,692 80,302 81,140 81,967 83,177 84, ,906 85,536 Back to MedDRA 10.1 Review