MedDRA 9.1 Review. MedDRA Version Changes - General Remarks. MedDRA 9.1 Changes Overview. MedDRA Version 9.1 Terminology Frequency Distribution

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1 MedDRA 9.1 Review MedDRA Version Changes - General Remarks MedDRA 9.1 Changes Overview MedDRA Version 9.1 Terminology Frequency Distribution

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 byproduct 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 9.1 Review

3 MedDRA 9.1 Changes: Overview MedDRA Terminology Version 9.1 released in September 1, 2006 contains simple changes only. These changes include the addition of new LLTs and PTs, LLTs promotions and demotions, LLT changes in the hierarchy (moved under another PT and Primary SOC reassignments), PTs demotions and Primary SOC changes, SSC changes including LLT & PT terms text changes, SMQ changes, and Currency changes. Version Report - (subscriber login required). Changes Highlights Featured LLT Changes New LLTs Demoted PTs Currency changes Featured PT Changes New PTs Promoted LLTs Featured SMQ Changes New SMQs MedDRA Version 10.0 What s coming ahead? Back to MedDRA 9.1 Review

4 Featured LLT Changes New LLTs Many of the new LLTs resulted from the inclusion in this version of MedDRA modified terms. Some term modifiers used in the dictionary are: Acute o LLT Acute myocardial reinfarction o LLT Acute pain o LLT Acute hemorrhage + LLT Acute haemorrhage o LLT Acute depression o LLT Acute drug intoxication Aggravated (interchangeable with Exacerbated and Worsened) o LLT Aggravated bleeding tendency o LLT Edema peripheral aggravated + LLT Oedema peripheral aggravated o LLT Interstitial pneumonia aggravated o LLT Acidosis aggravated o LLT Hepatitis A aggravated/llt Hepatitis B aggravated/llt Hepatitis C aggravated o LLT Spondylosis aggravated Chronic o LLT Chronic iron deficiency anemia o LLT Chronic abdominal pain o LLT Chronic diarrhea o LLT Chronic heartburn o LLT Chronic neutropenia o LLT Chronic fatigue Exacerbated (interchangeable with Aggravated and Worsened) o LLT Acute bacterial exacerbation of chronic bronchitis Procedure

5 o LLT Cox s maze procedure o LLT Bladder sling procedure Progression o LLT Progression of rheumatoid arthritis o LLT Progression of Alzheimer s disease o LLT Coronary artery disease progression o LLT Diabetes mellitus progression Prophylaxis of o LLT respiratory syncytial virus infection prophylaxis o LLT Opportunistic infection prophylaxis o LLT Febrile convulsion prophylaxis o LLT Gastritis prophylaxis o LLT Drug toxicity prophylaxis o LLT Myocardial infarct prophylaxis o LLT Prophylaxis against vitamin deficiency o LLT Prophylaxis antibiotic pre-surgical o LLT Asthma prophylaxis Recurrent o LLT Diarrhea recurrent + LLT Diarrhoea recurrent o LLT Oral candidiasis recurrent o LLT Toxoplasmosis recurrent o LLT Sinusitis recurrent o LLT Otitis media recurrent o LLT Malaria recurrent o LLT Headache recurrent o LLT Urticaria recurrent Subacute

6 o LLT Subacute necrotizing encephalomyopathy + LLT Subacute necrotising encephalomyopathy o LLT Subacute polyneuropathy o LLT Subacute pulmonary edema + LLT Subacute pulmonary oedema o LLT Subacute pericarditis Worsened/worsening (interchangeable with Aggravated and Exacerbated) o LLT Grave s ophthalmopathy worsened o LLT Chills worsened o LLT Weakness worsened o LLT Fibromyalgia worsened o LLT Bursitis worsened o LLT Metastatic pain worsened o LLT Burning sensation in joints worsened o LLT Nephrotic syndrome worsened Other interesting new LLTs are the following: LLT Avascular necrosis Horripilation Intentional dose decrease Intentional dose increase Intentional misuse by dose change Intentional misuse in dosing frequency Intestinal bacteria flora disturbance Life weariness Metritis Near fainting Near syncope Pigeon toe Postoperative shivering Premature battery depletion RB-ILD Shin splints SLE flare Small bowel series SvO2 decreased SvO2 increased SvO2 normal PT Osteonecrosis Piloerection Intentional drug misuse Intentional drug misuse Intentional drug misuse Intentional drug misuse Disbacteriosis Suicidal ideation Uterine inflammation Presyncope Presyncope Foot deformity Post procedural complication Device electrical finding Interstitial lung disease Medial tibial stress syndrome Systemic lupus erythematosus X-ray with contrast upper gastrointestinal tract Mixed venous blood saturation decreased Mixed venous blood saturation increased Mixed venous blood saturation normal

7 Systemic allergic reaction Unintentional use beyond labeled duration Unintentional use beyond labelled duration Hypersensitivity Medication error Medication error Demoted PTs Ninety three PT s were demoted to LLT level. Following is a list containing some of these. Asthma exacerbation prophylaxis Atrial bigeminy Atrioventricular block complete Cognitive deterioration Colitis pseudomembranous Comedone Coronary artery surgery Cryptogenic organizing pneumonia Difficulty in walking Dyspnoea exacerbated Excitability Facial dysmorphism Foetal hydantoin syndrome Foetal valproate syndrome General nutrition disorder Graft versus host disease in intestine Polymyalgia Polysubstance abuse Shoulder pain Stress incontinence Tendon repair Tuberculin test positive Unresponsive to pain stimuli Unresponsive to verbal stimuli Currency Changes Seven LLTs were resurrected and made current terms in this version. These LLT are the following: 1. Bullous eruption at injection site 2. Psychomotor development impaired 3. Syndrome uraemic 4. Syndrome uremic 5. Unresponsive to stimuli

8 6. Uraemic syndrome 7. Uremic syndrome Twenty three LLTs were made non-current. These are the following: 1. Abd. pain 2. Abdo pain 3. Bad taste 4. Bone swelling painful 5. Cervical smear pos class III to V 6. Cervical smear positive class (3-5) 7. Cramp in legs thighs 8. DBP 9. DBP decreased 10. DBP increased 11. Decreased tolerance 12. Feeling lack of 13. Keratosis pillaris 14. Lack of feeling 15. Malunion and nonunion of fracture 16. Nephro-uterectomy 17. Pacing threshold 18. Pain abdo 19. PIN - prostatic intraepithelial neoplasia 20. SBP 21. SBP decreased 22. SBP increased 23. Tolerance increased Back to MedDRA Changes: Overview

9 Featured PT Changes New PTs There are two hundred forty one new PTs in version 9.1. Following are some examples. Anaemia of pregnancy Intracardiac mass Dysmorphism Post-tussive vomiting Visceral congestion Metapneumovirus infection Retroviral rebound syndrome Administration site infection Vaccinia Post procedural pneumonia Post vaccination autoinoculation Inappropriate device therapy Post procedural haematuria Abdominal wound dehiscence Expired drug administered Weight bearing difficulty Early sexual debut Substance abuse Atherosclerosis prophylaxis Allergy prophylaxis Drug toxicity prophylaxis Opportunistic infection prophylaxis Prophylaxis urinary tract infection Supplementation therapy Promoted LLTs Thirty seven LLTs were promoted to PT level. Note that LLT Unresponsive to stimuli was first made current and then promoted to PT level. Following are some examples of promoted LLTs. Acute hepatic failure Application site rash Bacterial diarrhoea Coronary artery bypass Haemorrhagic anaemia Lip oedema Lip swelling Presyncope

10 Prophylaxis against graft versus host disease Pseudomembranous colitis Unresponsive to stimuli Vasomotor rhinitis Back to MedDRA Changes: Overview

11 Featured SMQ changes In previous versions Torsade de pointes/qt prolongation (SMQ) was a level 1 SMQ. However, this SMQ was demoted and merged with new Cardiac Arrhythmias (SMQ). The following table shows all developed SMQs so far including 13 new level 1 SMQs and their subordinate SMQs. SMQ Name SMQ Level Child PT LLT Rhabdomyolysis/myopathy (SMQ) Acute renal failure (SMQ) Hepatic disorders (SMQ) 1 5 Congenital, familial, neonatal and genetic disorders of the liver (SMQ) Liver infections (SMQ) Events specifically reported as alcohol-related (SMQ) Pregnancy-related hepatic disorders (SMQ) 2 2 Possible drug related hepatic disorders - comprehensive search (SMQ) Liver related investigations, signs and symptoms (SMQ) Cholestasis and jaundice of hepatic origin (SMQ) Possible liver-related coagulation and bleeding disturbances (SMQ) Possible drug related hepatic disorders - severe events only (SMQ) Hepatitis, non-infectious (SMQ) Liver neoplasms, malignant and unspecified (SMQ) Liver neoplasms, benign (SMQ) Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (SMQ) Haemolytic disorders (SMQ)

12 Severe cutaneous adverse reactions (SMQ) Anaphylactic reaction (SMQ) Acute pancreatitis (SMQ) Agranulocytosis (SMQ) Angioedema (SMQ) Asthma/bronchospasm (SMQ) Dyslipidaemia (SMQ) Haematopoietic cytopenias (SMQ) 1 4 Cytopenia and haematopoietic disorders affecting more than one type of blood cell (SMQ) Erythropenia (SMQ) Leukopenia (SMQ) Thrombocytopenia (SMQ) Lack of efficacy/effect (SMQ) Lactic acidosis (SMQ) Peripheral neuropathy (SMQ) Depression and suicide/self-injury (SMQ) Suicide/self-injury (SMQ) Haemorrhages (SMQ) 1 2 Haemorrhage terms (excl laboratory terms) (SMQ) Haemorrhage laboratory terms (SMQ) Hyperglycaemia/new onset diabetes mellitus (SMQ) Interstitial lung disease (SMQ) Ischaemic heart disease (SMQ) Myocardial infarction (SMQ) Neuroleptic malignant syndrome (SMQ) Systemic lupus erythematosus (SMQ) Taste and smell disorders (SMQ) Anticholinergic syndrome (SMQ) Cardiac arrhythmias (SMQ) 1 4 Possible arrhythmia related investigations, signs and symptoms (SMQ) Congenital and neonatal arrhythmias (SMQ) Torsade de pointes/qt prolongation (SMQ) [Demoted]

13 Cardiac arrhythmia terms (incl bradyarrhythmias and tachyarrhythmias) (SMQ) Bradyarrhythmias (incl conduction defects and disorders of sinus node function) (SMQ) Disorders of sinus node function (SMQ) Conduction defects (SMQ) Tachyarrhythmias (incl supraventricular and ventricular tachyarrhythmias) (SMQ) Supraventricular tachyarrhythmias (SMQ) Ventricular tachyarrhythmias (SMQ) Cerebrovascular disorders (SMQ) Central nervous system haemorrhages and cerebrovascular accidents (SMQ) Ischaemic cerebrovascular conditions (SMQ) Haemorrhagic cerebrovascular conditions (SMQ) Retroperitoneal fibrosis (SMQ) Shock (SMQ) Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (SMQ) Torsade de pointes, shock-associated conditions (SMQ) Hypovolaemic shock conditions (SMQ) Toxic-septic shock conditions (SMQ) Anaphylactic/anaphylactoid shock conditions (SMQ) Hypoglycaemic and neurogenic shock conditions (SMQ) Back to MedDRA Changes: Overview

14 MedDRAVersion 10.0 What s Coming Ahead? MedDRA 10.0 expected release is March/2007. Retirement of Special Search Categories (SSC) in March/2007, MedDRA version 10.0 SMQs in development/testing: Accidents and injuries Adverse pregnancy outcome/ reproductive toxicity Biliary disorders (incl cholelithiasis) Breast neoplasms malignant/unspecified Cardiac failure Cardiomyopathy Coagulation disorders Convulsions Corneal, retinal and optic nerve disorders Dementia Demyelinating disorders Drug abuse, dependence and withdrawal Embolic and thrombotic events Extrapyramidal syndrome Gastroenteritis/gastritis Gastrointestinal perforation, ulceration, haemorrhage or obstruction Guillain-Barre syndrome Hostility/aggression Hyponatraemia/SIADH Malignancies Non-infectious encephalopathy and meningitis Oedema, effusions and fluid overload Oropharyngeal lesions Ovarian malignant and unspecified neoplasms Pain Pre-malignant disorders Prostate cancer

15 Pseudomembranous colitis Psychosis Pulmonary hypertension Renal Disorders (incl nephropathy and nephrotic symdrome) Respiratory depression Secondary immunodeficiencies Serotonin syndrome Thrombophlebitis Uterine/fallopian malignant and unspecified neoplasms Vasculitis SMQs Future development: ARDS Drug-induced eosinophilic pneumonia Ear disorders Hypertension Hypotension Immune reconstitution syndrome Immunogenicity Back to MedDRA Changes: Overview or Back to MedDRA 9.1 Review

16 MedDRA Version 9.1 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 SOC HLGT HLT 1,681 1,681 1,683 1,683 1,682 1,682 PT 16,449 16,559 16,751 16,976 17,320 17,505 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 Total 79,692 80,302 81,140 81,967 83,177 84, 165 Back to MedDRA 9.1 Review