MedDRA 9.1 Review
MedDRA Version Changes - General Remarks MedDRA 9.1 Changes Overview
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.
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 - http://www.meddramsso.com/Translations/downloads.htm (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?
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 Example:
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) Example:
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 Example:
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) Example:
o LLT Acute bacterial exacerbation of chronic bronchitis ♦ Procedure
Example:
o LLT Cox’s maze procedure o LLT Bladder sling procedure ♦ Progression
Example:
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
Example:
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 Example:
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
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) Example:
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 PT Avascular necrosis Osteonecrosis
Horripilation Piloerection Intentional dose decrease Intentional drug misuse
Intentional dose increase Intentional drug misuse Intentional misuse by dose change Intentional drug misuse Intentional misuse in dosing frequency Intentional drug misuse Intestinal bacteria flora disturbance Disbacteriosis
Life weariness Suicidal ideation
Metritis Uterine inflammation
Near fainting Presyncope Near syncope Presyncope Pigeon toe Foot deformity
Postoperative shivering Post procedural complication Premature battery depletion Device electrical finding RB-ILD Interstitial lung disease Shin splints Medial tibial stress syndrome SLE flare Systemic lupus erythematosus
Small bowel series X-ray with contrast upper gastrointestinal tract SvO2 decreased Mixed venous blood saturation decreased SvO2 increased Mixed venous blood saturation increased SvO2 normal Mixed venous blood saturation normal
Systemic allergic reaction Hypersensitivity Unintentional use beyond labeled duration Medication error Unintentional use beyond labelled duration 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
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
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
Prophylaxis against graft versus host disease Pseudomembranous colitis
Unresponsive to stimuli Vasomotor rhinitis
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) 1 44 261
Acute renal failure (SMQ) 1 37 208
Hepatic disorders (SMQ) 1 5
♦ Congenital, familial, neonatal and genetic disorders of the
liver (SMQ) 2 23 56
♦ Liver infections (SMQ) 2 63 106
♦ Events specifically reported as alcohol-related (SMQ) 2 5 11
♦ Pregnancy-related hepatic disorders (SMQ) 2 2
♦ Possible drug related hepatic disorders - comprehensive
search (SMQ) 2 4
♦ Liver related investigations, signs and symptoms
(SMQ) 3 65 190
♦ Cholestasis and jaundice of hepatic origin (SMQ) 3 13 50
♦ Possible liver-related coagulation and bleeding
disturbances (SMQ) 3 29 55
♦ Possible drug related hepatic disorders - severe
events only (SMQ) 3 4
♦ Hepatitis, non-infectious (SMQ) 4 14 42
♦ Liver neoplasms, malignant and unspecified
(SMQ) 4 17 102
♦ Liver neoplasms, benign (SMQ) 4 7 12
♦ Hepatic failure, fibrosis and cirrhosis and
other liver damage-related conditions (SMQ) 4 44 172
Severe cutaneous adverse reactions (SMQ) 1 43 263 Anaphylactic reaction (SMQ) 1 74 606 Acute pancreatitis (SMQ) 1 47 226 Agranulocytosis (SMQ) 1 65 206 Angioedema (SMQ) 1 81 457 Asthma/bronchospasm (SMQ) 1 33 134 Dyslipidaemia (SMQ) 1 44 196 Haematopoietic cytopenias (SMQ) 1 4
♦ Cytopenia and haematopoietic disorders affecting more than
one type of blood cell (SMQ) 2 20 93
♦ Erythropenia (SMQ) 2 26 108 ♦ Leukopenia (SMQ) 2 57 91 ♦ Thrombocytopenia (SMQ) 2 13 30 Lack of efficacy/effect (SMQ) 1 18 32 Lactic acidosis (SMQ) 1 19 56 Peripheral neuropathy (SMQ) 1 54 323
Depression and suicide/self-injury (SMQ) 1 1 53 331
♦ Suicide/self-injury (SMQ) 2 12 27
Haemorrhages (SMQ) 1 2
♦ Haemorrhage terms (excl laboratory terms) (SMQ) 2 310 1411
♦ Haemorrhage laboratory terms (SMQ) 2 89 140
Hyperglycaemia/new onset diabetes mellitus (SMQ) 1 80 387
Interstitial lung disease (SMQ) 1 48 168
Ischaemic heart disease (SMQ) 1 1 35 144
♦ Myocardial infarction (SMQ) 2 29 147
Neuroleptic malignant syndrome (SMQ) 1 59 430
Systemic lupus erythematosus (SMQ) 1 84 457
Taste and smell disorders (SMQ) 1 11 50
Anticholinergic syndrome (SMQ) 1 45 678
Cardiac arrhythmias (SMQ) 1 4
♦ Possible arrhythmia related investigations, signs and
symptoms (SMQ) 2 23 115
♦ Congenital and neonatal arrhythmias (SMQ) 2 16 25
♦ Cardiac arrhythmia terms (incl bradyarrhythmias and
tachyarrhythmias) (SMQ) 2 2 8 24
♦ Bradyarrhythmias (incl conduction defects and
disorders of sinus node function) (SMQ) 3 2 2 1
♦ Disorders of sinus node function (SMQ) 4 7 23
♦ Conduction defects (SMQ) 4 27 121
♦ Tachyarrhythmias (incl supraventricular and
ventricular tachyarrhythmias) (SMQ) 3 2 5 31
♦ Supraventricular tachyarrhythmias (SMQ) 4 10 60
♦ Ventricular tachyarrhythmias (SMQ) 4 12 58
Cerebrovascular disorders (SMQ) 1 1 15 27
♦ Central nervous system haemorrhages and cerebrovascular
accidents (SMQ) 2 2 28 131
♦ Ischaemic cerebrovascular conditions (SMQ) 3 55 140
♦ Haemorrhagic cerebrovascular conditions (SMQ) 3 31 164
Retroperitoneal fibrosis (SMQ) 1 40 209
Shock (SMQ) 1 6
♦ Shock-associated circulatory or cardiac conditions (excl
torsade de pointes) (SMQ) 2 40 157
♦ Torsade de pointes, shock-associated conditions (SMQ) 2 29 96
♦ Hypovolaemic shock conditions (SMQ) 2 24 97
♦ Toxic-septic shock conditions (SMQ) 2 25 96
♦ Anaphylactic/anaphylactoid shock conditions (SMQ) 2 26 122
♦ Hypoglycaemic and neurogenic shock conditions (SMQ) 2 24 98
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
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
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 26 26 26 26 26 26 HLGT 332 332 332 332 332 332 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
