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

Mots-clés

Versions (4)
  1. 17/08/2017 17/08/2017 -
  2. 23/08/2017 23/08/2017 -
  3. 04/09/2017 04/09/2017 -
  4. 04/09/2017 04/09/2017 -
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4 septembre 2017

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

Anglais

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

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Description

patient's initials

Type de données

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Description

patient number

Type de données

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

Type de données

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.

Type de données

text

Alias
UMLS CUI [1]
C1883010
Date of Sample
Description

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

Type de données

date

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

Sodium

Alias
UMLS CUI-1
C0337443
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Potassium
Description

Potassium

Alias
UMLS CUI-1
C0202194
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Creatinine
Description

Creatinine

Alias
UMLS CUI-1
C0201976
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Glucose (non-fasting)
Description

Glucose (non-fasting)

Alias
UMLS CUI-1
C0202042
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Calcium
Description

Calcium

Alias
UMLS CUI-1
C0201925
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Protein, total
Description

Protein, total

Alias
UMLS CUI-1
C0555903
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Albumin
Description

Albumin

Alias
UMLS CUI-1
C0201838
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Urea
Description

Urea

Alias
UMLS CUI-1
C0523961
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Bilirubin, total
Description

Bilirubin, total

Alias
UMLS CUI-1
C1278039
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Alkaline phosphatase
Description

Alkaline phosphatase

Alias
UMLS CUI-1
C0002059
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

AST(SGOT)
Description

AST(SGOT)

Alias
UMLS CUI-1
C0201899
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

ALT(SGPT)
Description

ALT(SGPT)

Alias
UMLS CUI-1
C0001899
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Albumin/globulin ratio
Description

Albumin/globulin ratio

Alias
UMLS CUI-1
C0201837
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Cholesterol
Description

Cholesterol

Alias
UMLS CUI-1
C1445957
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Creatine phosphokinase
Description

Creatine phosphokinase

Alias
UMLS CUI-1
C0010287
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Gamma glutamyl transferase (GGT)
Description

Gamma glutamyl transferase (GGT)

Alias
UMLS CUI-1
C0202035
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Globulin
Description

Globulin

Alias
UMLS CUI-1
C0877347
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Phosphate
Description

Phosphate

Alias
UMLS CUI-1
C0523826
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Triglycerides
Description

Triglycerides

Alias
UMLS CUI-1
C0202236
Result
Description

result

Type de données

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Type de données

text

Retour au début de la page

Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
Retour au début de la page 

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