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MedDRAについて - dsrujp.org

meddra . 3 CRC . 2004 4 24 .. NPO DSRU Japan . meddra Medical Dictionary for Regulatory Activities Terminology meddra meddra ICH .. MSSO Maintenance and Support Service Organization . ICH: . International Conference MSSO . on Harmonisation . SOC . HLGT .. HLT PT . LLT 5 [ ].. meddra /J . meddra /J ICH . meddra .. meddra . JMO: Japanese Maintenance Organization MSSO . meddra . meddra /J .. [ ]. meddra .. ( ). ( 0330014 ) 1 . 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 .. meddra (1)( ).

MedDRA: Medical Dictionary for Regulatory Activities Terminology •MedDRAは、医薬品に関連 する国際間の情報交換を迅 速かつ的確に行うため、国

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Transcription of MedDRAについて - dsrujp.org

1 meddra . 3 CRC . 2004 4 24 .. NPO DSRU Japan . meddra Medical Dictionary for Regulatory Activities Terminology meddra meddra ICH .. MSSO Maintenance and Support Service Organization . ICH: . International Conference MSSO . on Harmonisation . SOC . HLGT .. HLT PT . LLT 5 [ ].. meddra /J . meddra /J ICH . meddra .. meddra . JMO: Japanese Maintenance Organization MSSO . meddra . meddra /J .. [ ]. meddra .. ( ). ( 0330014 ) 1 . 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 .. meddra (1)( ).

2 (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 (HLT) PT .. LLT LLT . (PT) .. (LLT) (LLT). (LLT) (LLT). meddra (3). (SOC). (HLGT). (HLT).. (PT) . (LLT). (LLT). NOS: Not Otherwise Specified NEC: Not Elsewhere Classified meddra (4). (SOC). (Primary SOC).. (HLGT) (HLGT). 1 PT 2 . (HLT).

3 SOC SOC . 2 PT. HLT HLGT (PT) Primary SOC. (LLT). (LLT). (LLT) (LLT). (LLT). meddra (5).. (Primary SOC) (Primary SOC) . (Primary SOC). (HLGT) (HLGT) (HLGT). (HLT) . (HLT).. (HLT). (PT) (PT) (PT). (LLT) (LLT) (LLT) (LLT) (LLT). Primary SOC PT . 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 ( ). SOC-(HLGT-HLT)-PT 23475 ( ). SOC PT 10453 . SOC PT4243 . (2-6) SOC PT 5996 . MDHIER . meddra 18 ASCII 1 . SOC-(HLGT-HLT)-PT (23475 ) . SOC PT PrimarySOC primary_soc_fg Y .. SOC . SOC . PT4243 ( PT 26% LLT10709 ( LLT 17%).)

4 SOC PT .. SOC PT .. meddra .. Currency . llt_currency . LLT .. PTC = Points to Consider ). 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 N PT .. Currency . Y .. ICSR .. 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 . 80000. 58560 61204. 60000 51083 55638.

5 46258 47337. 40000. 20000. 0. 99_3V21 00_3V30 01_6V40 02_3V50 03_3V60 04_3V70. _ Version . meddra Version PT. PT . 20000 15709 16341 16449. 14287. 15000 11193 11778. 10000. 5000. 0. 99_3V21 00_3V30 01_6V40 02_3V50 03_3V60 04_3V70. _ Version PT . PT = - . PT (1) . (2004 3 ) / . ( (2003 9 ) / )PT. PT 286 LLT 49 335 . PT 179 LLT . 286 .. 8 . PT (2) .. LLT 49 . PT LLT . PT . (Generalised oedema ). PT (Anasarca) . :PT LLT . (Peripheral nerve palsy). PT (Peripheral paralysis) LLT . PT LLT . PT LLT . PT . "NOS" .. 3000. 2500. 2000 . 1500 . 1000 . 500. 0. V21 V30 V30 V40 V40 V50 V50 V60 V60 V70. 99 00 00 01 01 02 02 03 03 04.

6 Version . meddra PT-LLT / . #. 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. * NOS PT .. # . meddra Version . PT-LLT . 1500 1068. 1000 751 832. 500 240 284. 0. V21 V30 V30 V40 V40 V50 V50 V60 V60 V70 99 00 00 01 01 02 02 03 03 04. Version . PT . meddra Version . PT-LLT . 1417. 1500. 854. 1000 668 605. 500 233. 0. V21 V30 V30 V40 V40 V50 V50 V60 V60 V70 99 00 00 01 01 02 02 03 03 04. Version . PT LLT . PT-LLT (1) . 2003 9 . PT PT PT . Dyspepsia Stomach discomfort Gastrointestinal upset LLT LLT LLT LLT . Heartburn Stomach Stomach Stomach upset discomfort heaviness (2004 3.)

7 PT PT . Dyspepsia Stomach discomfort LLT LLT LLT LLT . Heartburn Stomach Stomach Stomach upset discomfort heaviness PT-LLT (2) . 2003 9 . PT PT . Stomach discomfort Gastrointestinal upset LLT LLT LLT . Stomach discomfort Stomach Gastrointestinal heaviness discomfort (2004 3 . PT PT . Stomach discomfort Gastrointestinal discomfort LLT LLT . Stomach LLT . Stomach discomfort Gastrointestinal upset heaviness PT-LLT (3) . 2003 9 . PT PT . Body temperature Pyrexia increased LLT LLT . Body temperature LLT Fever of increased High temperature unknown origin (2004 3 . PT . Body temperature PT . Pyrexia increased LLT LLT LLT . Body temperature High temperature Fever of increased unknown origin PT LLT PT- LLT meddra .))

8 meddra . WHO-ART PT PT LLT . J-ART.. COSTART .. meddra . meddra .. WHO-ART . 3500. 3000. 2500. 2000 PT. 1500 IT. 1000. 500. 0. 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03.. 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 .. SOC .. PTC (1).. (LLT) .. PTC (2).. ADR/AE .. meddra . 2 .. DIC +DIC .. PTC (3).. meddra .. or .. meddra /J . ( ) . LLT . PT LLT .. meddra PTC . PT LLT .. meddra .. Version . Version LLT. LLT 2 PT . LLT 3 PT 7 . LLT 2 PT 2 . LLT 2 PT 8 . LLT 4 PT . LLT 1 PT 5 . LLT 3 PT 8 . PT 4 . LLT Version Version.

9 PT . llt_currency, Llt_jcurr N . Version .. Version Control meddra MSSO Recommendation #newsletter Option1: Option4 trial . Freeze . Option2: . Freeze . Option5: . Option3: Freeze . Output . trial . Freeze Option6:ongoing basis .. (1) . 2003 9 . LLT 10039643 Version+ . Schizophrenic psychoses . LLT 10024938 . Lower abdomen strange feeling of LLT 10015967 Eye swelling (2004 . LLT 10039643 . Schizophrenic psychoses LLT 10024938 . Lower abdomen strange feeling of LLT 10015967 Eye swelling (2) . 2003 9 . PT PT . Monoarthritis Localised osteoarthritis LLT LLT . Coxarthritis Omarthrosis .. (2004 . PT PT . Monoarthritis Localised osteoarthritis LLT LLT LLT.))

10 Coxarthritis Omarthritis Omarthrosis Omarthritis Omarthrosis . (3) . 2003 9 . PT Currency . Peripheral paralysis . LLT LLT . Peripheral paralysis Peripheral nerve palsy llt_currency Y Llt_jcurr Y llt_currency Y Llt_jcurr N . (2004 . PT PT . Peripheral paralysis Peripheral nerve palsy LLT LLT . Peripheral paralysis Peripheral nerve palsy llt_currency Y Llt_jcurr Y llt_currency Y Llt_jcurr Y . Peripheral nerve palsy Currency . (4). 545 ( ). (JMO LLT_s LLT PT. ) .. meddra .. MEDIS-DC .. Category3 . 4575 .. 545 . meddra .. meddra Granularity .. CIOMS 1994 5 meddra ( 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.)