MedDRA 3.1 MedDRA V.5.1 MedDRA / 2002 9 12
MedDRA TERM SELECTION: POINTS TO CONSIDER Release 3.1 Based on MedDRA version 5.1 ICH-Endorsed Guide for MedDRA Users Application to Adverse Drug Reactions / Adverse Events & Medical and Social History & Indications 12 September 2002
Copyright ICH Secretariat (c/o IFPMA) Copying is permitted, with reference to source, but material in this publication may not be used in any documentation or electronic media which is offered for sale, without the prior permission of the copyright owner. IFPMA 30 rue de St- Jean P.O. Box 758 1211 Geneva 13 Switzerland Tel: +41 (22) 338 32 00 Fax: +41 (22) 338 32 99 JMO
1.0...1 1.1... 1 1.2 MedDRA... 1 1.3... 2 1.4... 2 2.0...2 2.1... 2 2.2... 3 2.3 LLT... 3 2.4... 3 2.5... 4 2.6... 4 3.0...5 3.1... 5 3.2... 6 3.3... 7 3.4... 7 3.5... 8 3.6... 8 3.7... 9 3.8... 10 3.9... 10 3.10... 11 3.11... 12 3.12... 13 3.13... 13 3.14... 14 3.15... 14 3.16... 14 3.17... 15 3.18... 15 3.19... 16 4.0...19 4.1 ICH Points to Consider :... 19 4.2 ICH Points to Consider... 19
1.0 ICH MedDRA 1 Points to Consider(PTC) ICH MedDRA ICH MedDRA MedDRA EU USA MSSO JMO 4.0 MedDRA V.5.0 1.1 MedDRA Points to Consider MedDRA MedDRA 1.2 MedDRA 1
(safety signals) / ADR/AE ADR/AE ADR/AE 1.3 MedDRA Points to Consider MedDRA MedDRA MedDRA PTC MedDRA MedDRA MedDRA MedDRA (MedDRA) MedDRA Introductory Guide 1.4 ADR/AE 2.0 2.1 2
3.3 2.2 (LLT) 2.3 LLT LLT( ) ( ) 2.4 2.4.1 MedDRA MedDRA MSSO (change request) HIV HIV viral load increased MedDRA 2.4.2 MedDRA brittle hair Hair texture abnormal NOS Hair disorder NOS 2.4.3 MedDRA MSSO (metastatic gallbladder cancer) MedDRA (Gallbladder cancer) NOS Metastases NOS NOS 3
2.5 2.5.1 ADR/AE, 2.5.2 ( abdominal pain) ( increased serum amylase) (increased serum lipase) (pancreatitis) 2.5.3 (anaphylactic reaction) (rash) (dyspnea) (hypotension) (laryngospasm) (anaphylactic reaction) (myocardial infarction) (chest pain) (dyspnea), (diaphoresis) ECG (ECG changes) (jaundice) (myocardial infarction) (jaundice) 2.6 4
Points to Consider MedDRA MedDRA MedDRA MedDRA SOC MedDRA MSSO MedDRA VIII (Factor deficiency) SOC SOC SOC 3.0 3.1 3.1.1 possible myocardial infarction Myocardial infarction 3.1.2 (chest pain) (dyspnea) (diaphoresis) (jaundice) (possible myocardial infarction) (myocardial infarction) (jaundice) (chest pain) (dyspnea) (diaphoresis) (jaundice) (possible myocardial infarction) (chest pain) (dyspnea) (diaphoresis) (jaundice) 5
3.1.3 pulmonary embolism (myocardial infarction) (congestive heart failure) pulmonary embolism (myocardial infarction) (congestive heart failure) 3.1.4 : (chest pain) (cyanosis) (shortness of breath) (blood pressure decreased) (pulmonary embolism) (myocardial infarction) (congestive heart failure) (Chest pain) (Cyanosis) (Shortness of breath) (Blood pressure decreased) : (pulmonary embolism) (myocardial infarction) (congestive heart failure) (chest pain) (cyanosis) (shortness of breath) (blood pressure decreased) (Chest pain) (Cyanosis) (Shortness of breath) (Blood pressure decreased) (Pulmonary embolism) (Myocardial infarction) (Congestive heart failure) 3.2 3.2.1 ADR/AE ADR/AE ADR/AE (death due to myocardial infarction) (Myocardial infarction) 3.2.2 ADR/AE MedDRA : (constipation) (ruptured bowel) (peritonitis) (sepsis) (patient died) (Constipation) (Perforated bowel) (Peritonitis) (Sepsis) 6
3.2.3 : (a patient was found dead) (Found dead) 3.3 2.1 3.3.1 : 1.6mEq/L (hyperkalemia with a serum potassium of 1.6 meq/l) (Potassium abnormal) 1.6mEq/L 3.3.2 : GU (GU pain) GU (genito-urinary) (gastric ulcer) (pain) (Pain) 3.3.3 (patient experienced every listed adverse event) (Unevaluable reaction) 3.4 3.4.1 2.5.3 3.4.2 (arrhythmia due to atrical fibrillation) (Atrial fibrillation) (hepatic function disorder (acute hepatitis) ) 7
(Hepatitis acute) 3.4.3 MedDRA (retinopathy due to diabetes) (Diabetic retinopathy) (rash with itching) (Itchy rash) 3.4.4 (diarrhea and vomiting) (Diarrhea) (Vomiting) DIC(DIC due to sepsis) DIC (Sepsis) (wrist fracture due to fall) (Wrist fracture) (Fall) 3.5 3.5.1 MedDRA (skin rash on face) (Rash on face) 3.5.2 MedDRA MedDRA (skin rash on chest) (Rash) 3.5.3 PT (skin rash on face and neck) (Skin rash) 3.6 3.6.1 MedDRA (pneumococcal pneumonia) 8
(Pneumococcal pneumonia) 3.6.2 MedDRA MedDRA (respiratory fungal infection) (Fungal infection) (respiratory fungal infection) (Respiratory infection) (respiratory fungal infection) (Fungal infection) (Respiratory infection) 3.7 3.7 ADR/AE 3.7.1 MedDRA (exacerbation of myasthenia gravis) (Myasthenia gravis aggravated) 3.7.2 3.7.2.1 MedDRA (halitosis worsened) (Halitosis) 3.7.2.2 (Condition aggravated) NOS(Disease progression NOS) (progression of Alzheimer s disease) (Alzheimer s disease) NOS(Disease progression NOS) (aggravation of jaundice) (Jaundice) (Condition aggravated) 9
3.8 MedDRA (congenital) MedDRA Version 5.1 3.8.1 SOC (congenital heart disease) (child born with heart disease) NOS(Congenital heart disease NOS) 3.8.2 MedDRA (hemangioma) PT ( Haemangioma acquired ) (Hemangioma)) (cholangiectasis) (Cholangiectasis acquired) 3.9 ADR/AE SOC 3.9.1 (patient had gallbladder surgery) NOS(Gallbladder operation NOS) (patient had tonsillectomy in childhood) (Tonsillectomy) 3.9.2 ADR/AE 10
(liver tranlplantation due to liver failure) (Liver failure) (Liver failure) (Liver transplant) (surgery for bleeding gastric ulcer) (Bleeding gastric ulcer) (Bleeding gastric ulcer) NOS(Gastric ulcer surgery) 3.10 SOC (increased) (decreased) (abnormal) (normal) hyper hypo SOC SOC SOC SOC 3.10.1 SOC b (cardiac output) (cardiac output) 3.10.2 ADR/AE 3.10.2.1 (hypoglycemia) (Hypoglycemia) (Hypoglycemia) SOC (decreased glucose) (Glucose decreased) (Glucose decreased) SOC 3.10.2.2 40mg/dl(glucose 40 mg/dl) (Glucose low) 3.10.2.3 40 (his glucose was 40) (Glucose abnormal) 11
3.10.3 K7.0mmol/L (elevated potassium, K7.0 mmol/l and hyperkalemia) (Hyperkalemia) 3.10.4 7.0mmol/L (alopecia, rash, and elevated potassium 7.0 mmol/l) (Alopecia) (Rash) (Potassium increased) 3.10.5 (abnormal liver function tests) (Abnormal liver function tests) SGPT SGOT LDH (increased alkaline phosphatase, increased SGPT, increased SGOT, and elevated LDH) 4 (Liver function tests raised) 1 4 3.11 3.11.1 ADR/AE (Drug maladministration) (Medication error) (medication was given intravenously instead of intramuscularly) (Wrong route of administration) 3.11.2 (nurse splashed an injectable drug in her eye) (Inadvertent exposure to drug) (Drug exposure via breast milk) 3.11.3 ( No adverse effect) 3.15 (medication was given intravenously 12
instead of intramuscularly without sequelae) (Wrong route of administration) (No adverse effect) 3.12 3.12.1 MedDRA Overdose Toxicity Poisoning HLT (Poisoning and toxicity) MedDRA Version 5.0 (overdose of pills) (Overdose) 3.12.2 (Stomach upset from study drug overdose) (Stomach upset) (Overdose) 3.12.3 (Overdose) (No adverse effect) 3.13 MedDRA 3.13.1 (Torsade de pointes with suspected drug interaction) (Torsade de pointes) (Drug interaction) 3.13.2 (Patient was started on an anit-seizure and heart medication and developed syncope) (Syncope) (Patient was already on anti-seizure medication and was started on a heart medication and anti-seuzure medicaiton levels increased) 13
(Drug level increased) 3.14 (No adverse effect) ADR/AE 3.11.3 3.12.3 MedDRA (Normal baby) (Normal electrocardiogram) (Sinus rhythm) 3.15 ADR/AE (a bold patient was pleased that he grew hair while on an antihypertentive) (Benefit unexpected) (Hair growth increased) 3.16 ADR/AE MedDRA 3.16.1. (antibiotic didn t work) (Lack of drug effect) (patient took drug, her headache didn t go away) (Drug ineffective) 3.16.2 (an epilectic 14
patient took an anti-convulsant, but the seizures continued unchanged) (Lack of drug effect) 3.16.3 HIV AIDS (AIDS patient taking anti-hiv drug died) (Lack of drug effect) 3.2 3.2 3.16.4 Increased Decreased Prolonged A (patient had increased effect from drug A) (Increased drug effect) A (patient had decreased effect from drug A) (Drug effect decreased) A (patient had prolonged effect from drug A) (Drug effect prolonged) 3.17 SOC SOC ADR/AE ADR/AE SOC (patient was abusing an analgesic) (Analgesic abuse) SOC MedDRA SOC (Disorder) SOC ADR/AE Social Circumstances SOC ( Alcoholic ) Disorder SOC (Alcoholism) (Drug addict) (Drug addiciton) 3.18 MedDRA 15
(history of gastrointestinal bleed and hysterectomy) (Gastrointestinal bleed) (Hysterectomy) (patient is a cigarette smoker with coronary artery disease) (Cigarette smoker) (Coronary artery disease) 3.19 3.19.1 3.19.1.1 [ hypertension ] Hypertension hypertensive ] chemotherapy for breast cancer 16
(Breast cancer) (medication for gastrointestinal problem) (Gastrointestinal disorder therapy) ( Gastrointestinal disorder) 3.19.1.2 MedDRA a patient had received chemotherapy NOS Chemotherapy NOS 3.19.2 Prevention and Prophylaxis 3.19.2.1 MedDRA prevention prophylaxis (arrhythmia prophylaxis) (arrhythmia prophylaxis) prevention of migraine (Migraine prophylaxis) 3.19.2.2 3.19.2.2.1 (prevention of miscarriage) (Miscarriage) 3.19.2.2.2 (prevention of miscarriage) (Prevention) 3.19.3 contrast agent for angiogram (Angiogram NOS) contrast agent for coronary angiogram ( Coronary angiogram) 3.19.4 (induction of anesthesia) (Induction of anesthesia) 3.19.5 SOC 3.9 17
testosterone replacement therapy (Androgen replacement therapy) thyroid replacement therapy (Thyroxine therapy) prenatal vitamin (Vitamin supplementation) 3.19.6 (Drug use for unknown indication) 1 MedDRA MSSO JMO 2 ADR/AE ICH CIOMS 3 (Drug) 18
4.0 4.1 ICH Points to Consider : Rapporteur: Margaret M. Westland Japan: Ministry of Health, Labour and Welfare: Kaori Nomura Japan Pharmaceutical Manufactures Association Yasuo Sakurai Japanese Maintenance Organization Reiji Tezuka Yuki Tada European Union: Commission of the European Communities Dolores Montero European Federation of Pharmaceutical Industries Associations Barry Hammond Reinhard Fescharek Canada: Health Canada Bill Wilson United States: US Food and Drug Administration Andrea Feight Toni Piazza-Hepp Pharmaceutical Research and Manufacturers of America Susan M. Lorenski MedDRA MSSO JoAnn Medbery 4.2 ICH Points to Consider Japan: Ministry of Health, Labour and Welfare Tamaki Fushimi 19
Kazuhiro Kemmotsu Emiko Kondo Kemji Kuramochi Takashi Yasukawa Japan Pharmaceutical Manufactures Association Akemi Ishikawa Satoru Mori Canada: Health Canada Heather Morrison United States: US Food and Drug Administration Miles Braun Brad Leissa Pharmaceutical Research and Manufacturers of America David Goldsmith Sidney Kahn 20