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Riliva_CRF_EudraCT - Nr. 2012-000108-13- Adverse event

1 forms  
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Adverse event
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Start date of adverse event
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C0808070
Serious Adverse Event
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Intensity
Description

Symptom intensity

Data type

text

Alias
UMLS CUI [1]
C0518690
Relation to study medication
Description

medication study; Relations

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0869014
Measures taken regarding study medication
Description

medication study; Measures

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0079809
Adverse event leading to study discontinuation
Description

Adverse Event Caused Study Discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C2826233
Adverse event end date
Description

Adverse Event End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
Adverse Event Outcome
Description

Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
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Similar models

Riliva_CRF_EudraCT - Nr. 2012-000108-13- Adverse event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Start date
Item
Start date of adverse event
date
C0808070 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Symptom intensity
Code List
Intensity
CL Item
slight, no effect on daily activities (e.g, cooking, shopping) (1)
CL Item
moderate, daily activity impaired (2)
CL Item
severe, daily activity not possible (3)
Item
Relation to study medication
text
C0013227 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
medication study
Code List
Relation to study medication
CL Item
no reasonable connection (1)
CL Item
reasonable connection (2)
Item
Measures taken regarding study medication
text
C0013227 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
medication study; Measures
Code List
Measures taken regarding study medication
CL Item
none (1)
CL Item
dose reduction (2)
CL Item
dose increase (3)
CL Item
temporarily stopped (4)
CL Item
ultimately stopped (5)
CL Item
unknown (6)
CL Item
not applicable (7)
Adverse Event Caused Study Discontinuation
Item
Adverse event leading to study discontinuation
boolean
C2826233 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse event end date
date
C2697886 (UMLS CUI [1])
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event Outcome
CL Item
restored (1)
CL Item
improved (2)
CL Item
still not improved (3)
CL Item
restored with permanent damage (4)
CL Item
death (5)
CL Item
unknown (6)
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