ID

17470

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

Versiones (1)
  1. 16/9/16 16/9/16 -
Subido en

16 de septiembre de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Baseline Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

Inglés

Baseline Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 formularios  
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
Inclusion criteria (Continued)
Descripción

Inclusion criteria (Continued)

Alias
UMLS CUI-1
C1512693
1. Does the patient have a serum phosphorus >= 5. mg/dL (1.76 mmol/L) after the two week washout period?
Descripción

serum phosphorus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202178
Vital signs
Descripción

Vital signs

Alias
UMLS CUI-1
C0518766
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Descripción

Respiratory Rate

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical Exam
Descripción

Physical Exam

Alias
UMLS CUI-1
C0031809
Date:
Descripción

Date of physical exam

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
1. General Appearance
Descripción

General Appearance

Tipo de datos

integer

Alias
UMLS CUI [1]
C1148438
if abnormal, explain:
Descripción

General appearance abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C1704258
2. Skin
Descripción

physical examination of skin

Tipo de datos

integer

Alias
UMLS CUI [1]
C0436149
if abnormal, explain:
Descripción

skin abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0436149
3. HEENT
Descripción

physical examination of HEENT

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1512338
if abnormal, explain:
Descripción

HEENT abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1512338
4. Lymph Nodes
Descripción

physical examination of lymph nodes

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
if abnormal, explain:
Descripción

Lymph nodes abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0024204
5. Heart
Descripción

physical examination of heart

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
if abnormal, explain:
Descripción

heart abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0018787
6. Lungs
Descripción

physical examination of lungs

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
if abnormal, explain:
Descripción

lung abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0024109
7. Breasts
Descripción

physical examination of breast

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0006141
if abnormal, explain:
Descripción

breasts abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0006141
8. Abdomen
Descripción

physical examination of abdomen

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
if abnormal, explain:
Descripción

abdomen abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0000726
9. External Genitalia
Descripción

physical examination of external genitalia

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0227605
if abnormal, explain:
Descripción

external genitalia abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0227605
10. Pelvic
Descripción

physical examination of pelvis

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
if abnormal, explain:
Descripción

pelvis abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0030797
11. Rectal
Descripción

rectal examination

Tipo de datos

integer

Alias
UMLS CUI [1]
C0199900
if abnormal, explain:
Descripción

rectum abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0199900
12. Extremities/Joints
Descripción

physical examination of Extremities/Joints

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015385
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0022417
if abnormal, explain:
Descripción

extremities/joints abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0015385
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0022417
13. Neurological
Descripción

neurological examination

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027853
if abnormal, explain:
Descripción

neurological examination abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0027853
14. Mental Status
Descripción

mental status examination

Tipo de datos

integer

Alias
UMLS CUI [1]
C0278060
if abnormal, explain:
Descripción

mental status examination abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
Laboratory Evaluations (Central Lab)
Descripción

Laboratory Evaluations (Central Lab)

Alias
UMLS CUI-1
C0022877
Chemistry Sample Date
Descripción

ChemistryLabCollectedDate

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0007996
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0011008
Hematology Sample Date
Descripción

Hematology Sample Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Concomitant Medication
Descripción

Concomitant Medication

Are there any prior medication taken within the last 30 days?
Descripción

If yes, please record on Concomitant Medications on page 21.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Adverse Events
Descripción

Adverse Events

Alias
UMLS CUI-1
C0877248
Were there any adverse events since the last visit?
Descripción

If yes, pease record on Adverse Events page 22.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
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Similar models

Baseline Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 formularios
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
Inclusion criteria (Continued)
C1512693 (UMLS CUI-1)
serum phosphorus
Item
1. Does the patient have a serum phosphorus >= 5. mg/dL (1.76 mmol/L) after the two week washout period?
boolean
C0202178 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Physical Exam
C0031809 (UMLS CUI-1)
Date of physical exam
Item
Date:
date
C2826643 (UMLS CUI [1])
Item
1. General Appearance
integer
C1148438 (UMLS CUI [1])
General Appearance
Code List
1. General Appearance
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
General appearance abnormal
Item
if abnormal, explain:
text
C1148438 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
2. Skin
integer
C0436149 (UMLS CUI [1])
physical examination of skin
Code List
2. Skin
CL Item
Normal  (1)
CL Item
Abnormal  (2)
CL Item
Not Examined (3)
skin abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0436149 (UMLS CUI [1,2])
Item
3. HEENT
integer
C0031809 (UMLS CUI [1,1])
C1512338 (UMLS CUI [1,2])
physical examination of HEENT
Code List
3. HEENT
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
HEENT abnormal
Item
if abnormal, explain:
text
C0031809 (UMLS CUI [1,1])
C1512338 (UMLS CUI [1,2])
Item
4. Lymph Nodes
integer
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
physical examination of lymph nodes
Code List
4. Lymph Nodes
CL Item
Normal  (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
Lymph nodes abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Item
5. Heart
integer
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
physical examination of heart
Code List
5. Heart
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
heart abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Item
6. Lungs
integer
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
physical examination of heart
Code List
6. Lungs
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
lung abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Item
7. Breasts
integer
C0031809 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
physical examination of heart
Code List
7. Breasts
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
breasts abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Item
8. Abdomen
integer
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
physical examination of heart
Code List
8. Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
abdomen abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Item
9. External Genitalia
integer
C0031809 (UMLS CUI [1,1])
C0227605 (UMLS CUI [1,2])
physical examination of heart
Code List
9. External Genitalia
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
external genitalia abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0227605 (UMLS CUI [1,2])
Item
10. Pelvic
integer
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
physical examination of heart
Code List
10. Pelvic
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
pelvis abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Item
11. Rectal
integer
C0199900 (UMLS CUI [1])
physical examination of heart
Code List
11. Rectal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
rectum abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
Item
12. Extremities/Joints
integer
C0031809 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
physical examination of heart
Code List
12. Extremities/Joints
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
extremities/joints abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
Item
13. Neurological
integer
C0027853 (UMLS CUI [1])
physical examination of heart
Code List
13. Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
neurological examination abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Item
14. Mental Status
integer
C0278060 (UMLS CUI [1])
physical examination of heart
Code List
14. Mental Status
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
mental status examination abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Item Group
Laboratory Evaluations (Central Lab)
C0022877 (UMLS CUI-1)
ChemistryLabCollectedDate
Item
Chemistry Sample Date
date
C0007996 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology Sample Date
Item
Hematology Sample Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Concomitant Medication
Concomitant Medication
Item
Are there any prior medication taken within the last 30 days?
boolean
C2347852 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
adverse events
Item
Were there any adverse events since the last visit?
boolean
C0877248 (UMLS CUI [1])
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