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Adverse Event Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 forms  
Patient administration
Description

Patient administration

Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient ID Number
Description

Patient ID Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Diagnosis only (if known) OR Signs/Symptoms (List one per line)
Description

Diagnosis/Signs/Symptoms

Data type

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C1457887
Serious AE
Description

Serious AE

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Duration: Date of Onset
Description

Date of Onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Duration: Date of Cessation
Description

Date of Cessation

Data type

date

Alias
UMLS CUI [1]
C0806020
Duration applicable
Description

if <24 hrs, record duration (applicable)

Data type

boolean

Alias
UMLS CUI [1,1]
C2826792
UMLS CUI [1,2]
C1706839
Duration
Description

if <24 hrs, record duration

Data type

text

Measurement units
  • hh:mm
Alias
UMLS CUI [1]
C2826792
hh:mm
Severity
Description

Severity of adverse event

Data type

integer

Alias
UMLS CUI [1]
C1710066
Relationship to Study Treatment
Description

Relationship to Study Treatment

Data type

integer

Alias
UMLS CUI [1]
C1510821
Action Taken Regarding Study Treatment
Description

Action Taken Regarding Study Treatment

Data type

integer

Alias
UMLS CUI [1]
C1704758
Action Taken Other
Description

Action Taken Other

Data type

integer

Alias
UMLS CUI [1]
C1704758
Outcome
Description

Patient outcome

Data type

integer

Alias
UMLS CUI [1]
C1547647
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Similar models

Adverse Event Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient administration
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient ID Number
Item
Patient ID Number
integer
C2348585 (UMLS CUI [1])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Diagnosis/Signs/Symptoms
Item
Diagnosis only (if known) OR Signs/Symptoms (List one per line)
text
C0011900 (UMLS CUI [1])
C1457887 (UMLS CUI [2])
Serious AE
Item
Serious AE
boolean
C1519255 (UMLS CUI [1])
Date of Onset
Item
Duration: Date of Onset
date
C0574845 (UMLS CUI [1])
Date of Cessation
Item
Duration: Date of Cessation
date
C0806020 (UMLS CUI [1])
if <24 hrs, record duration (applicable)
Item
Duration applicable
boolean
C2826792 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
if <24 hrs, record duration
Item
Duration
text
C2826792 (UMLS CUI [1])
Item
Severity
integer
C1710066 (UMLS CUI [1])
Severity of adverse event
Code List
Severity
CL Item
Mild  (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to Study Treatment
integer
C1510821 (UMLS CUI [1])
Relationship to Study Treatment
Code List
Relationship to Study Treatment
CL Item
Not related (0)
CL Item
Remote/Unlikely (1)
CL Item
Possible (2)
CL Item
Probable (3)
CL Item
Definite (4)
Item
Action Taken Regarding Study Treatment
integer
C1704758 (UMLS CUI [1])
Action Taken Regarding Study Treatment
Code List
Action Taken Regarding Study Treatment
CL Item
None (0)
CL Item
Treatment adjusted (1)
CL Item
Treatment interrupted (2)
CL Item
Treatment discontinued (3)
Item
Action Taken Other
integer
C1704758 (UMLS CUI [1])
Action Taken Regarding Study Treatment
Code List
Action Taken Other
CL Item
None (0)
CL Item
Medication (1)
CL Item
Non-drug therapy (2)
CL Item
Hospitalized (3)
Item
Outcome
integer
C1547647 (UMLS CUI [1])
Patient outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Not yet recovered (3)
CL Item
Died (4)
CL Item
Ongoing at time of death (5)
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