ID

15685

Beschreibung

Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

Stichworte

Versionen (1)
  1. 08.06.16 08.06.16 -
Hochgeladen am

8. Juni 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Nerventra Study Adverse event log

Englisch

Nerventra Study Adverse event log

1 Formulare  
Demographic Information
Beschreibung

Demographic Information

Protocol Number
Beschreibung

Protocol Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Visit Type
Beschreibung

i.e "Screening"

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Beschreibung

Visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Study site number
Beschreibung

Study site

Datentyp

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C1709561
Section blank
Beschreibung

Blank

Datentyp

boolean

Alias
UMLS CUI [1]
C0750479
Ongoing adverse events
Beschreibung

Ongoing adverse events

Date of automatic update
Beschreibung

Date of automatic update

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205554
UMLS CUI [1,3]
C1519814
Date of manual update
Beschreibung

Date of manual update

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C1519814
Adverse event
Beschreibung

Adverse event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Visit Type
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Adverse events log Baseline
Beschreibung

Adverse events log Baseline

Adverse event
Beschreibung

Adverse event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Beschreibung

Adverse event intermittent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205267
Time since dose
Beschreibung

Time since dose

Datentyp

time

Alias
UMLS CUI [1]
C0946444
Time since dose unknown
Beschreibung

Time since dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0946444
Prior to first dose
Beschreibung

Prior to first dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C3469597
Date of onset
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
Is the Adverse Event Ongoing?
Beschreibung

Adverse Event Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826663
Adverse Event less than one day
Beschreibung

Adverse Event less than one day

Datentyp

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Beschreibung

Severity

Datentyp

text

Alias
UMLS CUI [1]
C0439793
Serious (If yes, complete SAE report)
Beschreibung

Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0205404
Action Taken with Study Treatment
Beschreibung

Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1]
C2826626
If study drug is discontinued, is this the primary AE?
Beschreibung

Primary AE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C0877248
Outcome to event
Beschreibung

Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Relation to study drug
Beschreibung

Drugs

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Adverse events Visit 1
Beschreibung

Adverse events Visit 1

Adverse event
Beschreibung

Adverse event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Beschreibung

Adverse event intermittent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205267
Time since dose
Beschreibung

Time since dose

Datentyp

time

Alias
UMLS CUI [1]
C0946444
Time since dose unknown
Beschreibung

Time since dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0946444
Prior to first dose
Beschreibung

Prior to first dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C3469597
Date of onset
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
Is the Adverse Event Ongoing?
Beschreibung

Adverse Event Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826663
Adverse Event less than one day
Beschreibung

Adverse Event less than one day

Datentyp

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Beschreibung

Severity

Datentyp

text

Alias
UMLS CUI [1]
C0439793
Serious (If yes, complete SAE report)
Beschreibung

Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0205404
Action Taken with Study Treatment
Beschreibung

Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1]
C2826626
If study drug is discontinued, is this the primary AE?
Beschreibung

Primary AE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C0877248
Outcome to event
Beschreibung

Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Relation to study drug
Beschreibung

Drugs

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Nerventra Study Adverse event log

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Demographic Information
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI [1])
Blank
Item
Section blank
boolean
C0750479 (UMLS CUI [1])
Item Group
Ongoing adverse events
Date of automatic update
Item
Date of automatic update
date
C0011008 (UMLS CUI [1,1])
C0205554 (UMLS CUI [1,2])
C1519814 (UMLS CUI [1,3])
Date of manual update
Item
Date of manual update
date
C0011008 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C1519814 (UMLS CUI [1,3])
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Item Group
Adverse events log Baseline
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Adverse event intermittent
Item
Adverse event intermittent
boolean
C0877248 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
Time since dose
Item
Time since dose
time
C0946444 (UMLS CUI [1])
Time since dose
Item
Time since dose unknown
boolean
C0946444 (UMLS CUI [1])
Prior to first dose
Item
Prior to first dose
boolean
C0332152 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Adverse Event Ongoing
Item
Is the Adverse Event Ongoing?
boolean
C2826663 (UMLS CUI [1])
Adverse Event less than one day
Item
Adverse Event less than one day
boolean
C3843198 (UMLS CUI [1])
Severity
Item
Severity
text
C0439793 (UMLS CUI [1])
Serious
Item
Serious (If yes, complete SAE report)
boolean
C0205404 (UMLS CUI [1])
Action Taken with Study Treatment
Item
Action Taken with Study Treatment
text
C2826626 (UMLS CUI [1])
Primary AE
Item
If study drug is discontinued, is this the primary AE?
boolean
C0205225 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event Outcome
Item
Outcome to event
text
C1705586 (UMLS CUI [1])
Drugs
Item
Relation to study drug
text
C0013227 (UMLS CUI [1])
Item Group
Adverse events Visit 1
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Adverse event intermittent
Item
Adverse event intermittent
boolean
C0877248 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
Time since dose
Item
Time since dose
time
C0946444 (UMLS CUI [1])
Time since dose
Item
Time since dose unknown
boolean
C0946444 (UMLS CUI [1])
Prior to first dose
Item
Prior to first dose
boolean
C0332152 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Adverse Event Ongoing
Item
Is the Adverse Event Ongoing?
boolean
C2826663 (UMLS CUI [1])
Adverse Event less than one day
Item
Adverse Event less than one day
boolean
C3843198 (UMLS CUI [1])
Severity
Item
Severity
text
C0439793 (UMLS CUI [1])
Serious
Item
Serious (If yes, complete SAE report)
boolean
C0205404 (UMLS CUI [1])
Action Taken with Study Treatment
Item
Action Taken with Study Treatment
text
C2826626 (UMLS CUI [1])
Primary AE
Item
If study drug is discontinued, is this the primary AE?
boolean
C0205225 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event Outcome
Item
Outcome to event
text
C1705586 (UMLS CUI [1])
Drugs
Item
Relation to study drug
text
C0013227 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video