Informatie:
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ID
17497
Beschrijving
An open label, dose titration study of sevelamer carbonate tablets dosed three times a day in hyperphosphatemic chronic kidney disease patients not on dialysis Name of Sponsor: Genzyme Europe BV Country: Netherlands https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Link
https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Trefwoorden
Versies (1)
- 18-09-16 18-09-16 -
Geüploaded op
18 september 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Adverse Event Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
Adverse Event Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
Similar models
Adverse Event Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient ID Number
Item
Patient ID Number
integer
C2348585 (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])
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])
C1706839 (UMLS CUI [1,2])
if <24 hrs, record duration
Item
Duration
text
C2826792 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to Study Treatment
integer
C1510821 (UMLS CUI [1])
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])
CL Item
None (0)
CL Item
Treatment adjusted (1)
CL Item
Treatment interrupted (2)
CL Item
Treatment discontinued (3)
CL Item
None (0)
CL Item
Medication (1)
CL Item
Non-drug therapy (2)
CL Item
Hospitalized (3)
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)