MedDRA® TERM SELECTION: · Web...

MedDRA TERM SELECTION:

MedDRA

ICHMedDRA

4.11

MedDRA Version 19.0

201631

ICHICH

ICH

ICHPTC-WGJMO

1

1.1 1

1.2 MedDRA1

1.3 1

1.4 2

1.5 MedDRA2

3

2.1 3

2.2 3

2.3 MedDRA3

2.4 LLT3

2.5 LLT4

2.6 5

2.7 5

2.8 5

2.9 5

2.10 6

7

3.1 7

3.2 9

3.2.1 9

3.2.2 9

3.2.3 9

3.2.4 10

3.3 10

3.3.1 10

3.3.2 10

3.3.3 10

3.4 11

3.4.1 11

3.4.2 11

3.4.3 11

3.5 12

3.5.1 12

3.5.2 12

3.5.3 MedDRA12

3.5.4 MedDRA13

3.5.5 13

3.6 13

3.6.1 MedDRA13

3.6.2 MedDRA14

3.7 14

3.7.1 MedDRA14

3.7.2 MedDRA14

3.7.3 14

3.8 15

3.8.1 MedDRA15

3.8.2 MedDRA15

3.9 15

3.10 16

3.10.1 16

3.10.2 17

3.11 17

3.11.1 17

3.11.2 18

3.11.3 18

3.12 19

3.12.1 19

3.13 19

3.13.1 19

3.13.2 20

3.14 20

3.14.1 20

3.14.2 21

3.14.3 21

3.14.4 21

3.14.5 22

3.15 22

3.15.1 22

3.15.2 25

3.16 25

3.16.1 26

3.16.2 26

3.16.3 26

3.16.4 27

3.17 27

3.18 28

3.18.1 28

3.18.2 29

3.19 29

3.19.1 29

3.19.2 29

3.20 30

3.20.1 30

3.20.2 30

3.21 30

3.21.1 30

3.21.2 30

3.22 31

3.23 31

3.23.1 31

3.23.2 31

3.23.3 31

3.24 32

3.24.1 32

3.24.2 32

3.25 33

3.26 33

3.26.1 33

3.26.2 34

3.26.3 34

3.26.435

3.26.5 35

3.26.6 35

3.26.7 36

3.27 36

3.27.1 36

3.27.2 36

3.28 37

3.28.1 37

3.28.2 37

3.28.3 37

39

4.1 39

4.1.1 39

4.1.2 40

4.2 40

4.3 ICH PTC-WG41

4.3.1 41

4.3.2 42

i

ICHMedDRAMedDRA

MedDRA Term Selection: Points to ConsiderICHMedDRAICHMedDRAMedDRA

EUMSSOJMO4.3

1.1

MedDRAMedDRA Term Selection: Points to Consider

MedDRA*

MedDRAMedDRA

*regulated biopharmaceutical industry

1.2 MedDRA

/AR/AE*MedDRAMedDRAAR/AEAR/AEAR/AE

*AR/AEadverse reactions/adverse events

1.3

MedDRAMedDRA

MedDRAICH(MedDRA)4.2

1.4

Preferred option

1.5 MedDRA

MSSOJMOMedDRA2Web 4.2

2.1

3.4

2.2

MedDRA

IT

2.3 MedDRA

MedDRA

SOC

MedDRA

MSSO

SOC

MedDRAPTVIII Factor VIII deficiencySOCSOCSOC

2.4 LLT

LLT

LLT

LLT

Lip sore

Lip sorePT Lip painPT

Lip sores

Sores lipPT CheilitisPT

Sore gums

Sore gumsPT Gingival painPT

Sores gum

Sores gumPT Noninfective gingivitis

PT

MedDRA

MedDRAInfertilityInfertility female Infertility maleLLT/PT

MedDRA

MedDRA

MedDRA

MedDRA

LLT

LLT4.2

2.5 LLT

LLT

JMOLLT

2.6

MedDRA

MedDRAMSSO

HBVHBV coinfectionMedDRA

2.7

MedDRA

LLT

Brittle hair

Hair breakage

MedDRAHair disorderHair breakage

2.8

MedDRA2.6

12AE

LLT

MedDRA

LLT LLT

LLT LLT

2.9

LLTLLTPTHLT,HLGT, SOC

2.10

AR/AE

3.1

LLT

LLT

3.1

suspicion ofprobablepresumedlikelyrule outquestionable differential

1

2

3

()

4

LLT

1

2

3

4

3.2

AR/AEAR/AE

3.3

3.2.1

AR/AEAR/AEAR/AE

LLT

3.2.2

HLGT

LLT

3.2.3

AR/AE

LLT

3.2.4

AR/AE

LLT

LLT

3.3

3.3.1

3.18

3.3.2

LLT

LLTPT

LLT3.18

3.3.3

LLT

3.4

3.4.13.4.3

3.4.1

LLT

1.6mEq/L

LLT: 1.6mEq/L

3.4.2

LLT

GU

GUGUgenito-urinarygastric ulcerPain

3.4.3

LLT

LLT

Unevaluable event

Ill-defined disorder

LLT

3.5

PT

PT

PT

AR/AE

3.5.1

3.1

LLT

3.5.2

LLT

3.5.3 MedDRA

MedDRA

LLT

3.5.4 MedDRA

AR/AE

LLT

MedDRAMedDRA

LLT

LLTLLTLLTHLTHLTLLTHLT

3.5.5

MedDRA3.9

LLT

3.6

3.6.1 MedDRA

LLT

3.6.2 MedDRA

LLT

3.7

3.7.1 MedDRA

LLT

3.7.2 MedDRA

LLT

LLT

LLT

3.7.3

LLTPTLLT

LLT

LLT LLT LLT PT

LLT LLT PT LLT

JMOLLT

3.8

3.8.1 MedDRA

LLT

3.8.2 MedDRA

LLT

3.9

AR/AE3.5.53.22

Aggravated, exacerbated, worsened

Recurrent

Progressive

LLT

LLTLLT

LLT

1

2

3.10

/

3.10.1

3.10.1.1

LLT

X

3.10.1.2

LLT3.21

LLT

X

3.10.2

/

LLT

X

X

X

3.11

MedDRA(congenital)MedDRA

3.11.1

SOC

LLT

PT/LLTSOC

3.11.2

SOCMedDRA

LLT

LLT/PTSOCSOCSOCSOCLLT/PT

45

LT/PTSOC

34

3.11.3

MedDRA

PT

LLT

LLT/PTSOC

LLTPTSOC

3.12

MedDRA

MedDRA

cancer carcinomaMedDRAB

tumo(u)rneoplasia

lump massneoplasia

3.12.1

tumorcancercarcinoma

LLT

3.13

SOCAR/AESOC

3.13.1

LLT

3.13.2

LLT

3.14

SOCincreaseddecreasedabnormalnormalhyper-hypo-SOCSOC

SOCSOCSOC

3.14.1

LLT

LLTSOC

LLT SOC

LLT

40mg/dl

LLT

40

LLT

3.14.2

LLT

K7.0mmol/L

LLT

3.14.3

LLT

7.0mmol/L

3.14.4

LLT

SGPTSGOTLDH

GPT

GOT

LDH

LLT

3.14.5

/

LLT

7.5 g/dl

LLT

SOCICH E2B

MedDRAE2B

3.15

3.15.1

MedDRAB

3.15.1.1

LLT

LLT3.18

3.15.1.2

AR/AE

LLT3.21

LLT

LLT

2

LLT

3.15.1.3

MedDRA

LLT

LLT

3.20

MedDRAB

3.15.1.4

3.18

LLT

LLTLLT

3.15.2

3.15.2.1

3.15.1

LLT

3.15.2.2

MedDRA

LLT

LLT

3.16

Misuse

Yes

/

Yes

3.16.1

Abuse

Yes

/

No

3.16.2

Addiction

Yes

/

No

3.16.3

Medication error

No

/

Yes

3.15

Off label use

Yes

Yes

3.27

*MisuseMisuseAbuse

MedDRA

3.16.1

MedDRAOTC

LLT

2

JMO MisuseLLT: Medication error

3.16.2

MedDRA

OTC

LLT

abuse3.24.13.24.2

3.16.3

MedDRA

LLT

MedDRA3.24.1

3.16.4

MedDRA

LLT

3.17

transmission3.28

LLT

C

LLT

3.18

HLTHLTHLTMedDRA

MedDRAMedDRAB

LLT

LLTLLT

LLT

LLTLLT

LLT

3.18.1

LLT

3.18.2

LLT 3.21

LLT

3.19

3.19.1

LLT

LLT

3.19.2

LLT

3.20

3.15.1.3

3.20.1

LLT

INR

3.20.2

LLT

3.21

3.21.1

LLTAR/AE3.15.1.2 3.18.2

LLT

3.21.2

3.22

LLTAR/AE

LLT

3.23

AR/AE

3.23.1

LLT

3.23.2

LLT

HIVAIDS

3.2

3.23.3

LLT

A

A

A

3.24

3.24.1

SOCSOCAR/AEAR/AESOC

LLT

SOCSOCMedDRASOCSOC

SOC

SOC

Alcoholic

Alcoholism

Drug abuser

Drug abuse

Drug addict

Drug addiction

Glue sniffer

Glue sniffing

Smoker

Nicotine dependence

abuseSOC

LLT

PT

Child abuse

Child abuse

Child abuser

Elder abuse

Elder abuse

Elder abuser

/ 3.24.2

3.24.2

LLTSOC

LLTPT

PTVictim of

LLT

LLTSOCPT

LLTSOCPT

3.25

LLT

3.26

SOCSOC

3.26.1

LLT

LLT

LLT

3.26.2

LLT

LLT

LLTLLTLLT

3.26.3

LLT

K-ras

3.26.4

MedDRApreventionprophylaxisMedDRA

LLT

MedDRA

LLT

3.26.5

LLT

3.26.6

SOC3.13

LLT

3.26.7

LLTDrug use for unknown indication

LLT

3.27

3.27.1

LLTLLTOff label use

LLT

LLT

3.27.2

/AR/AEAR/AEAR/AELLTPTLLTAR/AE

LLT

3.28

/

SOCHLGTHLGTHLTHLTHLTHLTMedDRALLTNavigating down

MedDRAB

3.28.1

LLT

3.28.2

LLT

3.28.3

MedDRAB

LLT

AB

LLT

4.1

4.1.1

MedDRA

1

2

LLT

3

LLT

LLT

4

LLT

LLT

LLT

MedDRA

LLT

MSSO/JMOMedDRAMSSOVersion ReportJMO MedDRAMedDRAMSSOMedDRAMedDRA Version Analysis Tool MVAT 4.2

4.1.2

MedDRAMSSOMedDRA4.2

MedDRA2ICH3MSSOGMT12:00

31MedDRA x.0

5 x.0

91MedDRA x.1

11 x.1

4.2

MedDRAMSSO(www.meddra.org)

MedDRA Introductory Guide

MedDRA Change Request Information document

MedDRA Web-Based Browser *

MedDRA Desktop Browser

MedDRA Version Report (lists all changes in new version) *

MedDRA Version Analysis Tool (compares any two versions) *

MSSOs Recommendations for Single Case Reporting using Semi-annual Version Control

MSSOs Recommendations for MedDRA Implementation and Versioning for Clinical Trials

Transition Date for the Next MedDRA Version

* MSSO ID PW

JMOJMOJMOhttps://www.pmrj.jp/jmoJMOIDPW

ICH (MedDRA)19.0

Change Request; CR

MedDRA/J V19.0

MedDRA/J

MedDRA/J BrowserJMO

MedDRA Desktop BrowserMSSO

MedDRA Version MVAT

4.3 ICH PTC-WG

4.3.1

Commission of the European Communities

Maria Luisa Casini

Kavita Chadda

European Federation of Pharmaceutical Industries and Associations

Hilary Vass*

Christina Winter

Health Canada

Valrie Bergeron

Lynn Macdonald

Japanese Maintenance Organization

Yutaka Nagao

Kazuyuki Sekiguchi

Mitsuru Takano

Japan Pharmaceutical Manufacturers Association

Yo Tanaka

Hitomi Takeshita

MedDRA MSSO

Judy Harrison

Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency

Daisuke Inoue

Miki Ohta

Daisuke Sato

Yasuko Inokuma

Kiyomi Ueno

Pharmaceutical Research and Manufacturers of America

Milbhor DSilva

US Food and Drug Administration

Sonja Brajovic#

Christopher Breder

Ministry of Food and Drug Safety, Korea

YuBin Lee

Kyung-Eun Yoon

World Health Organization

Daisuke Tanaka

*

#

4.3.2

Commission of the

European Communities

Dolores Montero; Carmen Kreft-Jais; Morell David; Sarah Vaughan

European Federation of Pharmaceutical Industries and Associations

Barry Hammond; Reinhard Fescharek

Health Canada

Alison Bennett; Heather Morrison; Polina Ostrovsky; Michelle Sguin;

Heather Sutcliffe; Bill Wilson

Japanese Maintenance Organization

Osamu Handa; Akemi Ishikawa; Yasuo Sakurai; Yuki Tada; Reiji Tezuka

Japan Pharmaceutical

Manufacturers Association

Takayoshi Ichikawa; Akemi Ishikawa; Satoru Mori; Yasuo Sakurai; Kunikazu Yokoi

MedDRA MSSO

JoAnn Medbery; Patricia Mozzicato

Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency

Yuhei Fukuta; Tamaki Fushimi; Wakako Horiki; Sonoko Ishihara; Makiko Isozaki; Kazuhiro Kemmotsu; Tatsuo Kishi; Chie Kojima; Emiko Kondo; Hideyuki Kondou; Kemji Kuramochi; Tetsuya Kusakabe; Kaori Nomura; Izumi Oba; Shinichi Okamura; Yoshihiko Sano; Nogusa Takahara; Kenichi Tamiya; Daisuke Tanaka; Shinichi Watanabe; Takashi Yasukawa; Go Yamamoto; Manabu Yamamoto; Nobuhiro Yamamoto

Pharmaceutical Research and Manufacturers of America

David Goldsmith; Sidney Kahn; Anna-Lisa Kleckner; Susan M. Lorenski; JoAnn Medbery; Margaret M. Westland

US Food and Drug Administration

Miles Braun; Andrea Feight; John (Jake) Kelsey; Brad Leissa; Toni Piazza-Hepp

1