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