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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