ID

17477

Description

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

Keywords

Versions (2)
  1. 9/16/16 9/16/16 -
  2. 9/16/16 9/16/16 -
Uploaded on

September 16, 2016

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License

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

English

Compliance 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
Visit: Baseline
Description

Visit: Baseline

Alias
UMLS CUI-1
C1442488
Visit Date
Description

baseline date

Data type

date

Alias
UMLS CUI [1]
C1320303
# new tbls dispensed
Description

new tablet

Data type

integer

Alias
UMLS CUI [1]
C0677179
Dose Change
Description

*If yes, please record on Dose change page 20.

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Visit 2 (Day 14)
Description

Visit 2 (Day 14)

Alias
UMLS CUI-1
C0545082
Visit Date
Description

visit 2 date

Data type

date

Alias
UMLS CUI [1]
C1320303
# tbls remaining
Description

Tablets remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0993159
UMLS CUI [1,2]
C1527428
# new tbls dispensed
Description

new tablet

Data type

text

Alias
UMLS CUI [1]
C0677179
Dose Change
Description

*If yes, please record on Dose change page 20.

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Visit 3 (Day 28)
Description

Visit 3 (Day 28)

Visit Date
Description

visit 3 date

Data type

date

Alias
UMLS CUI [1]
C1320303
# tbls remaining
Description

Tablets remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0993159
UMLS CUI [1,2]
C1527428
# new tbls dispensed
Description

new tablet

Data type

text

Alias
UMLS CUI [1]
C0677179
Dose Change
Description

*If yes, please record on Dose change page 20.

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Visit 4 (Day 42)
Description

Visit 4 (Day 42)

Alias
UMLS CUI-1
C0545082
Visit Date
Description

visit 4 date

Data type

date

Alias
UMLS CUI [1]
C1320303
# tbls remaining
Description

Tablets remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0993159
UMLS CUI [1,2]
C1527428
# new tbls dispensed
Description

new tablet

Data type

text

Alias
UMLS CUI [1]
C0677179
Dose Change
Description

*If yes, please record on Dose change page 20.

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Visit 5 (Day 56/Early Termination)
Description

Visit 5 (Day 56/Early Termination)

Alias
UMLS CUI-1
C0545082
Visit Date
Description

visit 5 date

Data type

date

Alias
UMLS CUI [1]
C1320303
# tbls returned
Description

Tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C0993159
UMLS CUI [1,2]
C2699071
Comments
Description

Comments

Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Compliance 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
Visit: Baseline
C1442488 (UMLS CUI-1)
baseline date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
new tablet
Item
# new tbls dispensed
integer
C0677179 (UMLS CUI [1])
Dose change
Item
Dose Change
boolean
C1707811 (UMLS CUI [1])
Item Group
Visit 2 (Day 14)
C0545082 (UMLS CUI-1)
visit 2 date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Tablets remaining
Item
# tbls remaining
integer
C0993159 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
new tablet
Item
# new tbls dispensed
text
C0677179 (UMLS CUI [1])
Dose change
Item
Dose Change
boolean
C1707811 (UMLS CUI [1])
Item Group
Visit 3 (Day 28)
visit 3 date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Tablets remaining
Item
# tbls remaining
integer
C0993159 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
new tablet
Item
# new tbls dispensed
text
C0677179 (UMLS CUI [1])
Dose change
Item
Dose Change
boolean
C1707811 (UMLS CUI [1])
Item Group
Visit 4 (Day 42)
C0545082 (UMLS CUI-1)
visit 4 date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Tablets remaining
Item
# tbls remaining
integer
C0993159 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
new tablet
Item
# new tbls dispensed
text
C0677179 (UMLS CUI [1])
Dose change
Item
Dose Change
boolean
C1707811 (UMLS CUI [1])
Item Group
Visit 5 (Day 56/Early Termination)
C0545082 (UMLS CUI-1)
visit 5 date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Tablets returned
Item
# tbls returned
integer
C0993159 (UMLS CUI [1,1])
C2699071 (UMLS CUI [1,2])
Item Group
Comments
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
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