ID

25465

Description

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Keywords

Versions (4)
  1. 8/17/17 8/17/17 -
  2. 8/23/17 8/23/17 -
  3. 9/4/17 9/4/17 -
  4. 9/4/17 9/4/17 -
Uploaded on

September 4, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

visit 1 & 4 laboratory evaluation serum chemistry starting dose of ropinirole Parkinson's Disease 101468/166

English

visit 1 & 4 laboratory evaluation serum chemistry starting dose of ropinirole Parkinson's Disease 101468/166

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Description

patient's initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Number of Visit
Description

Number of Visit

Alias
UMLS CUI-1
C1549755
Number of Visit
Description

number of visit

Data type

integer

Alias
UMLS CUI [1]
C1549755
SERUM CHEMISTRY
Description

SERUM CHEMISTRY

Alias
UMLS CUI-1
C1883010
SERUM CHEMISTRY
Description

If not "Not Done", record the date of sample taking below.

Data type

text

Alias
UMLS CUI [1]
C1883010
Date of Sample
Description

If not "Not Done" above, fulfill this item.

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Sodium
Description

Sodium

Alias
UMLS CUI-1
C0337443
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Potassium
Description

Potassium

Alias
UMLS CUI-1
C0202194
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Creatinine
Description

Creatinine

Alias
UMLS CUI-1
C0201976
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Glucose (non-fasting)
Description

Glucose (non-fasting)

Alias
UMLS CUI-1
C0202042
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Calcium
Description

Calcium

Alias
UMLS CUI-1
C0201925
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Protein, total
Description

Protein, total

Alias
UMLS CUI-1
C0555903
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Albumin
Description

Albumin

Alias
UMLS CUI-1
C0201838
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Urea
Description

Urea

Alias
UMLS CUI-1
C0523961
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Bilirubin, total
Description

Bilirubin, total

Alias
UMLS CUI-1
C1278039
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Alkaline phosphatase
Description

Alkaline phosphatase

Alias
UMLS CUI-1
C0002059
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

AST(SGOT)
Description

AST(SGOT)

Alias
UMLS CUI-1
C0201899
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

ALT(SGPT)
Description

ALT(SGPT)

Alias
UMLS CUI-1
C0001899
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Albumin/globulin ratio
Description

Albumin/globulin ratio

Alias
UMLS CUI-1
C0201837
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Cholesterol
Description

Cholesterol

Alias
UMLS CUI-1
C1445957
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Creatine phosphokinase
Description

Creatine phosphokinase

Alias
UMLS CUI-1
C0010287
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Gamma glutamyl transferase (GGT)
Description

Gamma glutamyl transferase (GGT)

Alias
UMLS CUI-1
C0202035
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Globulin
Description

Globulin

Alias
UMLS CUI-1
C0877347
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Phosphate
Description

Phosphate

Alias
UMLS CUI-1
C0523826
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Triglycerides
Description

Triglycerides

Alias
UMLS CUI-1
C0202236
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

If result is clincally significant, enter a tickmark here. Otherwise leave this field empty.

Data type

text

Back to the top of the page

Similar models

visit 1 & 4 laboratory evaluation serum chemistry starting dose of ropinirole Parkinson's Disease 101468/166

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
Number of Visit
C1549755 (UMLS CUI-1)
Item
Number of Visit
integer
C1549755 (UMLS CUI [1])
number of visit
Code List
Number of Visit
CL Item
Study Period Visit 1 (Day -14-0) (1)
CL Item
Study Period VIsit 4 (Day 8) (2)
Item Group
SERUM CHEMISTRY
C1883010 (UMLS CUI-1)
Item
SERUM CHEMISTRY
text
C1883010 (UMLS CUI [1])
hematology
Code List
SERUM CHEMISTRY
CL Item
Not Done (Not Done)
CL Item
Done (Done)
date of sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Sodium
C0337443 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Potassium
C0202194 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Creatinine
C0201976 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Glucose (non-fasting)
C0202042 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Calcium
C0201925 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Protein, total
C0555903 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Albumin
C0201838 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Urea
C0523961 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Bilirubin, total
C1278039 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Alkaline phosphatase
C0002059 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
AST(SGOT)
C0201899 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
ALT(SGPT)
C0001899 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Albumin/globulin ratio
C0201837 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Cholesterol
C1445957 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Creatine phosphokinase
C0010287 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Gamma glutamyl transferase (GGT)
C0202035 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Globulin
C0877347 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Phosphate
C0523826 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Triglycerides
C0202236 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial