ID

17470

Beskrivning

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

Länk

https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A

Nyckelord

Versioner (1)
  1. 2016-09-16 2016-09-16 -
Uppladdad den

16 september 2016

DOI

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Licens

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

Engelsk

Baseline Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 Formulär  
Patient administration
Beskrivning

Patient administration

Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Patient ID Number
Beskrivning

Patient ID Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Inclusion criteria (Continued)
Beskrivning

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?
Beskrivning

serum phosphorus

Datatyp

boolean

Alias
UMLS CUI [1]
C0202178
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Beskrivning

Respiratory Rate

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical Exam
Beskrivning

Physical Exam

Alias
UMLS CUI-1
C0031809
Date:
Beskrivning

Date of physical exam

Datatyp

date

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

General Appearance

Datatyp

integer

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

General appearance abnormal

Datatyp

text

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

physical examination of skin

Datatyp

integer

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

skin abnormal

Datatyp

text

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

physical examination of HEENT

Datatyp

integer

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

HEENT abnormal

Datatyp

text

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

physical examination of lymph nodes

Datatyp

integer

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

Lymph nodes abnormal

Datatyp

text

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

physical examination of heart

Datatyp

integer

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

heart abnormal

Datatyp

text

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

physical examination of lungs

Datatyp

integer

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

lung abnormal

Datatyp

text

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

physical examination of breast

Datatyp

integer

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

breasts abnormal

Datatyp

text

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

physical examination of abdomen

Datatyp

integer

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

abdomen abnormal

Datatyp

text

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

physical examination of external genitalia

Datatyp

integer

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

external genitalia abnormal

Datatyp

text

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

physical examination of pelvis

Datatyp

integer

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

pelvis abnormal

Datatyp

text

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

rectal examination

Datatyp

integer

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

rectum abnormal

Datatyp

text

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

physical examination of Extremities/Joints

Datatyp

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:
Beskrivning

extremities/joints abnormal

Datatyp

text

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

neurological examination

Datatyp

integer

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

neurological examination abnormal

Datatyp

text

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

mental status examination

Datatyp

integer

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

mental status examination abnormal

Datatyp

text

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

Laboratory Evaluations (Central Lab)

Alias
UMLS CUI-1
C0022877
Chemistry Sample Date
Beskrivning

ChemistryLabCollectedDate

Datatyp

date

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

Hematology Sample Date

Datatyp

date

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

Concomitant Medication

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Adverse Events
Beskrivning

Adverse Events

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

If yes, pease record on Adverse Events page 22.

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Tillbaka till toppen

Similar models

Baseline Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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