MedDRA 3 CRC 2004 4 24 NPO DSRU Japan kubotape-tky@umin.ac.jp
MedDRA Medical Dictionary for Regulatory Activities Terminology MedDRA ICH: International Conference on Harmonisation SOC HLGT HLT PT LLT MedDRA ICH MSSO Maintenance and Support Service Organization MSSO [http://www.sjp.jp/08/0 1.htm]
MedDRA/J MedDRA/J ICH MedDRA MedDRA JMO: Japanese Maintenance OrganizationMSSO MedDRA MedDRA/J [http://www.sjp.jp/08/01.htm]
MedDRA (H16.3.30) ( 0330014 ) 1 B.2.i.2b B.2.i.1b ICH MedDRA/J Medical Dictionary for Regulatory Activities /J MedDRA MedDRA -PT MedDRA -LLT (0330011 ) ICH MedDRA/J Medical Dictionary for Regulatory Activities /J MedDRA MedDRA
(1)(Ver7.0) (System Organ Class SOC) 26 5 (High Level Group Term, HLGT ) 332 (High Level Term, HLT)1681 (Preferred Term, PT) 16449 (Lowest Level Term, LLT) 61204
Lowest Level Terms; LLT LLT PT LLT PT Preferred Terms; PT PT descriptor PT LLT
High Level Terms; HLT PT HLT High Level Group Terms; HLGT HLT System Organ Class ; SOC
MedDRA (2) (SOC) (HLGT) PT LLT (HLT) (PT) PT LLT (LLT) (LLT) (LLT) (LLT)
MedDRA (3) (SOC) (HLGT) (HLT) (PT) (LLT) (LLT) NOS: Not Otherwise Specified NEC: Not Elsewhere Classified
MedDRA (4) (Primary SOC) (HLGT) (SOC) (HLGT) 1 PT SOC 2 HLT HLGT (LLT) (LLT) (HLT) (PT) (LLT) (LLT) 2 SOC PT Primary SOC (LLT)
MedDRA (5) (Primary SOC) (HLGT) (Primary SOC) (HLGT) (Primary SOC) (HLGT) (HLT) (PT) (HLT) (PT) (HLT) (PT) (LLT) (LLT) (LLT) Primary SOC PT (LLT) (LLT)
MedDRA (6) (SOC) (SOC) (SOC) (SOC) (PT) (PT) (LLT) (LLT) (LLT) (SOC) (SOC) (PT) (PT) (LLT) (LLT) (LLT) (LLT) SOC-PT HLT, HLGT SOC-PT-LLT 3
SOC-PT MDHIER PT 16449 (V7.0) SOC-(HLGT-HLT)-PT23475 (V7.0) SOC PT 10453 SOC PT4243 (2-6) SOC PT 5996 MDHIER MedDRA 18 ASCII1 SOC-(HLGT-HLT)-PT (23475 ) SOC PT PrimarySOC primary_soc_fg Y
SOC SOC PT4243 ( PT 26% LLT10709 ( LLT 17%) SOCPT SOCPT MedDRA
Currency llt_currency LLT PTC = Points to Consider V3.2 2003.11.10) Llt_jcurr Currency Llt_jcurr Y llt_currency Y llt_currency Y Llt_jcurr N LLT llt_currency N LLT PT PT llt_currency Llt_jcurr NPT
Currency Y ICSR B.2.i.0 Y Y 15 10
MedDRA LLT, PT, HLT, HLGT, SOC (+Special Search Category, SSC ) ( 12) hlt-pt, hlgt-hlt, soc-hlgt (+Spcial Search Category-pt)( 4) MDHIER SOC SOC LLT, PT (WHO-ART, J-ART, COSTART, HARTS, ICD9, ICD9CM), PT(LLT ), Primary SOC(PT ) ICD10( ) kana( ), kana1( ), kana2( )
MedDRA Version LLT LLT V2.1 99.3 V2.2 99.6 V2.3 99.9 V2.4 99.12 V3.0 00.3 V3.1 00.6 V3.2 00.9 V3.3 00.12 V4.0 01.6 V4.1 01.11 V5.0 02.3 V5.1 02.9 V6.0 03.3 V6.1 03.9 V7.0 04.3
MedDRA Version PT PT PT PT = -
PT (1) Version7.0(2004 3 ) / (Version6.1(2003 9 ) / )PT PT 286 LLT 49 335 PT 179 LLT 286
PT (2) LLT 49 PT LLT PT (Generalised oedema ) PT (Anasarca) :PT LLT (Peripheral nerve palsy) PT (Peripheral paralysis) LLT PTLLT PT LLT
PT
MedDRA PT-LLT/ V6.0 6.1 V6.1 7.0 V6.0 7.0 # PT-LLT PT 12922 344 13220 LLT 234 306 468 PT LLT 1724 380 2176 PT-LLT 690 340 854 PT-LLT PT 13426 494 13790 PT-LLT 186 190 284 * V6.0 V6.1 NOS PT #:V6.0 V7.0
MedDRA Version PT-LLT PT
MedDRA Version PT-LLT PT LLT
PT-LLT(1) Version6.1 2003 9 PT Dyspepsia PT Stomach discomfort PT Gastrointestinal upset LLT Heartburn LLT Stomach upset LLT Stomach discomfort LLT Stomach heaviness Version7.0(2004 3 PT Dyspepsia PT Stomach discomfort LLT Heartburn LLT Stomach upset LLT Stomach discomfort LLT Stomach heaviness
PT-LLT(2) Version6.1 2003 9 PT Stomach discomfort LLT Stomach discomfort Version7.0(2004 3 PT Stomach discomfort PT Gastrointestinal upset LLT Stomach heaviness LLT Gastrointestinal discomfort PT Gastrointestinal discomfort LLT Stomach discomfort LLT Stomach heaviness LLT Gastrointestinal upset
PT-LLT(3) Version6.1 2003 9 PT Body temperature increased LLT Body temperature increased Version7.0(2004 3 PT Body temperature increased LLT Body temperature increased LLT High temperature LLT High temperature PT Pyrexia LLT Fever of unknown origin PT Pyrexia LLT Fever of unknown origin
PTLLTPT- LLT MedDRA WHO-ART J-ART COSTART MedDRA PT PT LLT MedDRA MedDRA
WHO-ART 2003 4 PT(Preferred Term ) 2,000 MedDRA PT16,449 IT Included Term) 3,032 MedDRA LLT 61,204 PT IT PT
Points To Consider (PTC) PTC 3.2 2003.11.10 Ver7.0 2004.03 SOC
PTC(1) (LLT)
PTC(2) ADR/AE MedDRA 2 DIC +DIC
PTC(3) MedDRA or H16.4.14 MedDRA/J (7.0)
LLT PT LLT MedDRA PTC PTLLT MedDRA Version
Version LLT LLT 2 LLT 3 LLT 2 LLT 2 LLT 4 LLT 1 LLT 3 Version6.1 PT PT 7 PT 2 PT 8 Version7.0 PT PT 5 PT 8 PT 4 LLT Version Version PT llt_currency, Llt_jcurr N Version
Version Control MedDRA MSSO Recommendation http://www.meddramsso.com/newweb2003/document_library/index.htm#newsletter Option1: Freeze Option2: Freeze Option3: trial Freeze Option4 trial Option5: Freeze Output Option6:ongoing basis
(1) Version6.1 2003 9 LLT 10039643 Schizophrenic psychoses LLT 10024938 Lower abdomen strange feeling of LLT 10015967 Eye swelling Version7.0(2004 LLT 10039643 Schizophrenic psychoses LLT 10024938 Lower abdomen strange feeling of LLT 10015967 Eye swelling Version+
(2) Version6.1 2003 9 PT Monoarthritis PT Localised osteoarthritis LLT Coxarthritis LLT Omarthrosis Version7.0(2004 PT Monoarthritis PT Localised osteoarthritis LLT Coxarthritis LLT Omarthritis LLT Omarthrosis Omarthritis Omarthrosis
(3) Version6.1 2003 9 PT Peripheral paralysis LLT Peripheral paralysis llt_currency Y Llt_jcurr Y Version7.0(2004 PT Peripheral paralysis LLT Peripheral paralysis Currency LLT Peripheral nerve palsy llt_currency Y Llt_jcurr N PT Peripheral nerve palsy LLT Peripheral nerve palsy llt_currency Y Llt_jcurr Y llt_currency Y Llt_jcurr Y Peripheral nerve palsy Currency
(4) 545 (H16.4) (JMO H16.04.02) MedDRA MEDIS-DC Category3 4575 LLT_s LLT PT 545
MedDRA MedDRA Granularity CIOMS 1994 5MEDDRA( MedDRA MEDDRA )Use of the terminology should decrease subjective choices during coding, cause as little loss as primary information as possible, --- Drug Info J 29: 1133-1143, 1995 LLT V7.0_1.4 CRC
MedDRA (1) LLT MedDRA(PTC LLT) LLT PT Version7.0 LLT PT : - LLT : :
MedDRA (2) MedDRA LLT Numbness PT Hypoaesthesia = MedDRA LLT Appetite impaired PT Decreased appetite PT Decreased appetite LLT Appetite suppressed LLT PT Anorexia PT Anorexia LLT Appetite absent Appetite lost MedDRA LLT
MedDRA (3) 1 2 PT= PT HLT-HLGT PT PT PT HLT HLGT SOC PT SOC PT SOC (SSC) 13 --V7.0)
MedDRA (4) / 1 PT PT PTC
2 PT PT 1 PT (Version7.0 ) PT (Digestion impaired, difficult) PT LLTPT LLT PT PT PT PT 1 LLT
3 PT PT 2 PT () PT MedDRA PT 1 LLT MedDRA 4 PT () PT (Anorexia) (Appetite lost)(appetite absent) LLT PT (Decreased appetite)( Appetite impaired)
MedDRA (5) PT PT (Version7.0)49/74 PT; PT;
MedDRA (6) Qualitative data MedDRA
MedDRA PT LLT LLT-PT PT / / 6 MSSO JMO
MedDRACRC (1) CRC MedDRA MedDRA
CRC (2)? What? Who? How? When
MedDRA CRC (3) / MedDRA PTC) MedDRA PT PT
ExMedDRA 2000 1 97 MedDRA <ExamineMedDRA > MDHIER 23475 V7.0 MedDRA JMO 2 NPO Yokotsuka M, Aoyama M, Kubota K. The Use of a Medical Dictionary for Regulatory Activities Terminology(MedDRA) in Prescription-Event Monitoring in Japan(J-PEM). International Journal of Medical Informatics, 57: 139-153, 2000.