Reference:ICH ICH E2A Guideline 1994 II A. 3. - Revision history

Gxplex admin: 1 revision imported

2026-07-16T11:50:28Z

1 revision imported

← Older revision	Revision as of 13:50, 16 July 2026
(No difference)

GxPlexBot: Migrate to Template:ReferenceData for PageForms (GxPlexBot)

2026-07-16T10:56:14Z

Migrate to Template:ReferenceData for PageForms (GxPlexBot)

@@ Line 1: / Line 1: @@
-{{#set:
+{{ReferenceData
-|HasDocument=Document:ICH ICH E2A Guideline 1994
+|has_document=Document:ICH ICH E2A Guideline 1994
-|RefScope=G
+|module=5
-|RefDocPart=II A. 3.
+|unit=5.1.4
-|RefLanguage=EN
+|scope=G
-|RefTags=TAG-00331-Une-irk ++ TAG-00003-Adv-cht ++ TAG-00244-Def-ini ++ TAG-00034-Inv-Bro
+|doc_part=II A. 3.
-|RefModule=5
+|language=EN
-|RefUnit=5.1.4
+|entry_by=Florian Adragna
 }}

gxplex>GxPlexBot: Import from GxPlex Excel

2026-07-15T15:29:01Z

Import from GxPlex Excel

← Older revision	Revision as of 17:29, 15 July 2026
(No difference)

imported>GxPlexBot: Import from GxPlex Excel

2026-07-15T15:29:01Z

Import from GxPlex Excel

← Older revision		Revision as of 17:29, 15 July 2026
Line 4:		Line 4:
	\|RefDocPart=II A. 3.		\|RefDocPart=II A. 3.
	\|RefLanguage=EN		\|RefLanguage=EN
	\|~~RefTagsEN~~=		\|RefTags=TAG-00331-Une-irk ++ TAG-00003-Adv-cht ++ TAG-00244-Def-ini ++ TAG-00034-Inv-Bro
	\|~~RefTagsOriginal~~=		\|RefModule=5
	\|~~RefTagsFR~~=		\|RefUnit=5.1.4
	}}		}}

Line 14:		Line 14:
	\|-		\|-
	! colspan="2" class="gplx-infobox-header" \| Reference Details		! colspan="2" class="gplx-infobox-header" \| Reference Details
			\|-
			! Module
			\| Module 5 — Unit 5.1.4
	\|-		\|-
	! Scope		! Scope
Line 30:		Line 33:
	\|		\|
	\|-		\|-
	! Tags ~~(EN)~~		! Tags
	\|		\| [[Glossary:TAG-00331-Une-irk\|Unexpected adverse reaction]], [[Glossary:TAG-00003-Adv-cht\|Adverse reaction]], [[Glossary:TAG-00244-Def-ini\|Definition]], [[Glossary:TAG-00034-Inv-Bro\|Investigator's brochure]]
	\|-
	~~! Tags (original language)~~
	\|
	\|-
	~~! Tags (FR)~~
	\|
	\|-		\|-
	! Comment		! Comment

Gxplex admin: 1 revision imported

2026-06-29T13:29:06Z

1 revision imported

← Older revision	Revision as of 15:29, 29 June 2026
(No difference)

gxplex>GxPlexBot: Import from GxPlex Excel

2026-06-29T13:27:17Z

Import from GxPlex Excel

← Older revision		Revision as of 15:27, 29 June 2026
Line 11:		Line 11:
	{{:Document:ICH ICH E2A Guideline 1994}}		{{:Document:ICH ICH E2A Guideline 1994}}

	{\| class="gplx-infobox"		{\| class="wikitable gplx-infobox"
	\|-		\|-
	! colspan="2" class="gplx-infobox-header" \| Reference Details		! colspan="2" class="gplx-infobox-header" \| Reference Details

Gxplex admin: 1 revision imported

2026-06-29T13:08:14Z

1 revision imported

← Older revision	Revision as of 15:08, 29 June 2026
(No difference)

gxplex>GxPlexBot: Import from GxPlex Excel

2026-06-29T13:06:54Z

Import from GxPlex Excel

← Older revision	Revision as of 15:06, 29 June 2026
(No difference)

Gxplex admin: 1 revision imported

2026-06-29T12:52:11Z

1 revision imported

← Older revision	Revision as of 14:52, 29 June 2026
(No difference)

gxplex>GxPlexBot: Import from GxPlex Excel

2026-06-29T12:27:21Z

Import from GxPlex Excel

← Older revision		Revision as of 14:27, 29 June 2026
Line 9:		Line 9:
	}}		}}

	~~== Document Information ==~~
	{{:Document:ICH ICH E2A Guideline 1994}}		{{:Document:ICH ICH E2A Guideline 1994}}

	~~== Reference Details ==~~		{\| class="gplx-infobox"
	{\| class="~~wikitable" style="width:100%;~~"
	\|-		\|-
	! ~~scope~~="~~row~~" ~~style~~="~~width:200px;~~" \| Scope		! colspan="2" class="gplx-infobox-header" \| Reference Details
			\|-
			! Scope
	\| G		\| G
	\|-		\|-
	! ~~scope="row" style="width:200px;" \|~~ Document part		! Document part
	\| II A. 3.		\| II A. 3.
	\|-		\|-
	! ~~scope="row" style="width:200px;" \|~~ Language		! Language
	\| EN		\| EN
	\|-		\|-
	! ~~scope="row" style="width:200px;" \|~~ Original entry by		! Original entry by
	\| Florian Adragna		\| Florian Adragna
	\|-		\|-
	! ~~scope="row" style="width:200px;" \|~~ Contributors		! Contributors
	\|		\|
	\|-		\|-
	! ~~scope="row" style="width:200px;" \|~~ Tags (EN)		! Tags (EN)
	\|		\|
	\|-		\|-
	! ~~scope="row" style="width:200px;" \|~~ Tags (original language)		! Tags (original language)
	\|		\|
	\|-		\|-
	! ~~scope="row" style="width:200px;" \|~~ Tags (FR)		! Tags (FR)
	\|		\|
	\|-		\|-
	! ~~scope="row" \|~~ Comment		! Comment
	\| Definition of unexpected adverse drug reaction		\| Definition of unexpected adverse drug reaction
	\|}		\|}

	== ~~Text~~ ==		== Content ==
	Unexpected Adverse Drug Reaction		Unexpected Adverse Drug Reaction
	An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). (See section III.C.)		An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). (See section III.C.)