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]LW]

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I sticjirjkz`j jkmtklciry le o`jkmia t`rokclalhy

KMD kcktkitkv`

Lfn`mtkv`

Zl sdir` r`huaitlry kcelroitklc kct`rcitklciaay iflut o`jkmia

prljumts us`j fy duoics.

O`jJVI

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Zl sdir` kcelroitklc r`hirjkch -

O`jkmia prljumt r`hkstritklc

Jlmuo`ctitklc

]ie`ty olcktlrkch

F`elr` icj iet`r ipprlvia elr s`aa.

O`jJVI > Ps`

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9. PB O`jkmkc`s Mlctrla Ih`cmy's (OMI) o`jkmia t`rokclalhy.

6. Xlraj D`iatd Lrhickzitklc Ijv`rs` V`imtklc

=. Z rokclalhy (XDL-IVZ)

:. Kct`rcitklcia Maisskekmitklc le Jks`is`s wktd Makckmia Oljkekmitklc (KMJ

MO)

0. Mljkch ]yoflas elr i Zd`siurus le Ijv`rs` V`imtklc Z ros (ML]ZIVZ

5. Nipic`s` Ijv`rs` V`imtklc Z`rokclalhy (N-IVZ)

O`jJVI > Fisks

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O`jJVI kcmauj`s t`rokclalhy elr

]yoptlos

]khcs

Jks`is`s

Jkihcls`s

Kcv`stkhitklcs

]kt`s

Zd`rip`utkm kcjkmitklcs

]urhkmia icj o`jkmia prlm`jur`s

O`jkmia, slmkia icj eiokay dkstlry t`ros

O`jJVI > Mlct`cts

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Oikctikc`j fy

Zd` O`jJVI Oikct`cicm` icj ]upplrt ]`rvkm`s Lrhickzitklc (O]]L

Ps`j fy

Zd`rip`utkm Wrljumts Jkr`mtlrit` (Miciji)

Ellj icj Jruh Ijokckstritklc (P])

Wdiroim`utkmia icj fklalhkmia oicueimtur`rs

]`v`ria oinlr r`huaitlry iutdlrktk`s

Mloolc Z`mdckmia Jlmuo`ct

O`jJVI > Eucmtklckch

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Mlcskst`cmy it kct`rcitklcia a`v`a

@isy mlopirkslcs

J`mr`is`j td` alss lr jkstlrtklc le kcelroitklc

Koprlv`j `ee`mtkv`c`ss le o`jkmia prljumt r`huaitklc wlrajwkj`

O`jJVI > Vla`

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]ticjirj

Lp`ritkchWrlm`jur`s

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Kj`ctkey td` r`splcskfa` p`rslc elr `imd tisb.

J`smrkf` imtklcs (wdit ks tl f` mlopa`t`j).

Zrikc stiee.

Olcktlr skt` p`relroicm`.

]LWs ir` us`j tl

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F` i HV@IZ makckmia r`s`irmd skt`

Elr td` splcslr

Elr ylur pitk`cts

Elr ylur lrhickzitklc

Elr ylur lwc prle`ssklcia j`v`alpo`ct

Zd` Oikc Lfn`mtkv`

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]ticjirj Lp`ritkch Wrlm`jur`s (]LW) ir`>

i s`t le kcstrumtklcs wktd td` elrm` le i jkr`mtkv` tdit j`ekc`s lr

sticjirjkz s i prlm`jur` lr sp`mkekm eucmtklc

ic `ee`mtkv` mitiayst tl jrkv` p`relroicm` koprlv`o`ct icj koprl

lrhickzitklcia r`suats

mr`it` td` a`v`a le quiakty icj imm`pt`j primtkm` elr i sp`mkekm

prlm`jur`

td` elucjitklc le `v`ry hllj quiakty syst`o

Xdit ir` ]LWs

Eiokakirkz td` `ctkr` r`s`irmd t`io lc td` sp`mkekm tisbs p`relro

fy td` j`pirto`cts pirtkmkpitkch kc td` r`s`irmd prltlmla

@jumit` td` jruh mlopicy/kcv`stkhitlr lc r`huaitlry hukj`akc

icj ]LWs iar`ijy kc paim` elr j`pirto`cts sumd is rijklal

cuma`ir o`jkmkc` icj rijkitklc td`ripy kc td` p`relroicm` le j

tl-jiy prlm`jur`s

Zrikc murr`ct icj c`w `opaly``s tl issur` mlcskst`ct p`relroic

le td` r`s`irmd prltlmla

]LWs> Ic @jumitklcia Zlla

]LW Zlpkms

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Wr`pirkch icj ]ufokttkch Kcktkia KVF Jlmuo`cts

Wr`pirkch icj ]ufokttkch Mlctkcukch V`vk`w KVF

Jlmuo`cts

Wr`pirkch icj ]ufokttkch Io`cjo`ct KVF Jlmuo`cts

@stifaksdkch icj Zrikckch td` Makckmia ]tujy Z`io, icj

j`a`hitkch V`splcskfkaktk`s

@stifaksdkch ]tujy Eka`s

@stifaksdkch ]lurm` Jlmuo`cts

]LW Zlpkms

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]tujy ]ufn`mt V`mrukto`ct Waic

Mlctimtkch icj ]md`juakch Wlt`ctkia ]tujy ]ufn`mts elr ic Kcktkia Ukskt

Lftikckch Kcelro`j Mlcs`ct erlo i Wlt`ctkia ]tujy ]ufn`mt

@crlaakch i ]ufn`mt

V`mlrjkch ]ufn`mt Jiti

Oibkch Mlrr`mtklcs lc ]tujy Jlmuo`cts

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Olcktlrkch ]ufn`mt Mlopakicm` Jurkch i ]tujy

V`splcjkch tl i Makckmia Dlaj Lrj`r

V`m`kvkch icj ]tlrkch Kcv`stkhitklcia Jruhs

Jruh icj ]tujy ]uppay Zricse`r F`tw``c ]kt`s

Jksp`cskch ]tujy Jruhs tl ]tujy ]ufn`mts

Kj`ctkeykch icj V`plrtkch Ijv`rs` @v`cts

Wimbkch, Aif`akch, icj ]dkppkch ]iopa`s

Kj`ctkeykch icj V`plrtkch Wrltlmla J`vkitklcs

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Ijjktklcia Zlpkms

Mlctimt wktd plt`ctkia splcslrs

Fujh`t r`vk`w icj j`t`rokcitklcs

Wr`-stujy stujy skt` vkskt

Kcktkitklc ]kt` Ukskt

Olcktlr Ukskts

Iujkts

Jiti oicih`o`ct

]tujy malsur`

Alch t`ro stlrih`

Xrktkch ]LWs

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J`v`alp i t`opait` elr td` ]LW tl f` us`j tdrluhdlut td` jlmuo`ct.

Wlt`ctkia `a`o`cts le td` ]LW

D`ij`r tkta`, lrkhkcia v`rsklc jit`, r`vksklc jit`, `ee`mtkv` jit`, ipprlv`j f

Wurpls` wdy lc` dis td` plakmy

V`splcskfkaktk`s wdl td` plakmy p`rtikcs tl

Kcstrumtklc/Wrlm`jur`s dlw tl immlopaksd td` kt`os le td` plakmy

V`e`r`cm`s wdit td` plakmy ks fis`j lc

Ipp`cjkx slurm` jlmuo`cts/mis` r`plrt elros

Xrktkch ]LWs

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Wrlm`ss Oippkch elr Xrktkch ]LWs

J`t`rokc` wdkmd makckmia skt` tisb c``js oippkch.

Aiy lut iaa td` st`ps murr`ctay us`j tl mlopa`t` tdit tisb.

Oippkch kcvlav`s tibkch `imd st`p kc td` tisb icj oibkch kt olr`

`eekmk`ct icj `isk`r tl elaalw.

@xiopa`

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Wrlm`ss Oippkch elr Oibkch i Mup le

Mlee``

Wrkoiry ]t`p

@xiopa`

@csur` td`mlee`` oib`r

ks r`ijy

Ijj td`mlee``

Ijj td`wit`r

Zurc lc td`oimdkc`

]`rv` td`mlee``

]`mlcjiry ]t`p

7/29/2019 MedDRA n SOP

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y p

@csur` td` mlee``oib`r ks r`ijy

@csur` td`oimdkc` kspauhh`j kc

@csur` mirie` ks

`opty icj ma`ic

Ijj td` mlee``

Waim` i ekat`r kctd` fisb`t

O`isur` td`mlee``

Ijj td` wit`r

Xikt uctkamlee`` disstlpp`j j

Zurc lc td`oimdkc`

]`rv` td` mlee``

Ps` td` mirie`tl o`isur` td`wit`r

Waim` td` mirie`lc td` d`itkch`a`o`ct

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Kopa`o`ctkch icj Olcktlrkch ]LWs

]LWs sdluaj f` kctrljum`j hrijuiaay.

Wrklrktkz` olst r`a`vict ]LWs icj pr`s`ct td`o ekrst.

Wrkcmkpa` Kcv`stkhitlr sdluaj ipprlv` iaa ]LWs ic

j`skhcit` ic `ee`mtkv` jit`.

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Kopa`o`ctkch icj Olcktlrkch ]LWs

]LWs sdluaj f` r`vk`w`j lc i r`huair fisks (usuiaay iccui

tl `csur` plakmy fis`j r`huaitklcs ir` up-tl-jit`.

Wr`vklus v`rsklcs le ]LWs sdluaj f` r`tikc`j.

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]LW Zrikckch

Iaa stiee sdluaj div` ]LW trikckch.

Zrikckch sdluaj f` jlmuo`ct`j.

]LW sdluaj f` imm`sskfa` tl stiee.

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