ID

25465

Beschrijving

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

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Versies (4)
  1. 17-08-17 17-08-17 -
  2. 23-08-17 23-08-17 -
  3. 04-09-17 04-09-17 -
  4. 04-09-17 04-09-17 -
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4 september 2017

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

Engels

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

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beschrijving

patient's initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beschrijving

patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Number of Visit
Beschrijving

Number of Visit

Alias
UMLS CUI-1
C1549755
Number of Visit
Beschrijving

number of visit

Datatype

integer

Alias
UMLS CUI [1]
C1549755
SERUM CHEMISTRY
Beschrijving

SERUM CHEMISTRY

Alias
UMLS CUI-1
C1883010
SERUM CHEMISTRY
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C1883010
Date of Sample
Beschrijving

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

Datatype

date

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

Sodium

Alias
UMLS CUI-1
C0337443
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Potassium
Beschrijving

Potassium

Alias
UMLS CUI-1
C0202194
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Creatinine
Beschrijving

Creatinine

Alias
UMLS CUI-1
C0201976
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Glucose (non-fasting)
Beschrijving

Glucose (non-fasting)

Alias
UMLS CUI-1
C0202042
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Calcium
Beschrijving

Calcium

Alias
UMLS CUI-1
C0201925
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Protein, total
Beschrijving

Protein, total

Alias
UMLS CUI-1
C0555903
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Albumin
Beschrijving

Albumin

Alias
UMLS CUI-1
C0201838
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Urea
Beschrijving

Urea

Alias
UMLS CUI-1
C0523961
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Bilirubin, total
Beschrijving

Bilirubin, total

Alias
UMLS CUI-1
C1278039
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Alkaline phosphatase
Beschrijving

Alkaline phosphatase

Alias
UMLS CUI-1
C0002059
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

AST(SGOT)
Beschrijving

AST(SGOT)

Alias
UMLS CUI-1
C0201899
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

ALT(SGPT)
Beschrijving

ALT(SGPT)

Alias
UMLS CUI-1
C0001899
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Albumin/globulin ratio
Beschrijving

Albumin/globulin ratio

Alias
UMLS CUI-1
C0201837
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Cholesterol
Beschrijving

Cholesterol

Alias
UMLS CUI-1
C1445957
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Creatine phosphokinase
Beschrijving

Creatine phosphokinase

Alias
UMLS CUI-1
C0010287
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Gamma glutamyl transferase (GGT)
Beschrijving

Gamma glutamyl transferase (GGT)

Alias
UMLS CUI-1
C0202035
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Globulin
Beschrijving

Globulin

Alias
UMLS CUI-1
C0877347
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Phosphate
Beschrijving

Phosphate

Alias
UMLS CUI-1
C0523826
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

Triglycerides
Beschrijving

Triglycerides

Alias
UMLS CUI-1
C0202236
Result
Beschrijving

result

Datatype

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschrijving

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

Datatype

text

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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