ID

17497

Descripción

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

Palabras clave

  1. 18/9/16 18/9/16 -
Subido en

18 de septiembre de 2016

DOI

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Licencia

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

Patient administration
Descripción

Patient administration

Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Patient ID Number
Descripción

Patient ID Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Adverse Event
Descripción

Adverse Event

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

Diagnosis/Signs/Symptoms

Tipo de datos

text

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

Serious AE

Tipo de datos

boolean

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

Date of Onset

Tipo de datos

date

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

Date of Cessation

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Duration applicable
Descripción

if <24 hrs, record duration (applicable)

Tipo de datos

boolean

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

if <24 hrs, record duration

Tipo de datos

text

Unidades de medida
  • hh:mm
Alias
UMLS CUI [1]
C2826792
hh:mm
Severity
Descripción

Severity of adverse event

Tipo de datos

integer

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

Relationship to Study Treatment

Tipo de datos

integer

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

Action Taken Regarding Study Treatment

Tipo de datos

integer

Alias
UMLS CUI [1]
C1704758
Action Taken Other
Descripción

Action Taken Other

Tipo de datos

integer

Alias
UMLS CUI [1]
C1704758
Outcome
Descripción

Patient outcome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1547647

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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])
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])
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])
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])
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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