ID

24786

Beschreibung

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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  4. 04.09.17 04.09.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. August 2017

DOI

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laboratory evaluation serum chemistry determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

Englisch

laboratory evaluation serum chemistry determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beschreibung

patient's initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beschreibung

patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
SERUM CHEMISTRY
Beschreibung

SERUM CHEMISTRY

Alias
UMLS CUI-1
C1883010
SERUM CHEMISTRY
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1883010
Date of Sample
Beschreibung

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

Datentyp

date

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

Sodium

Alias
UMLS CUI-1
C0337443
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Potassium
Beschreibung

Potassium

Alias
UMLS CUI-1
C0202194
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Creatinine
Beschreibung

Creatinine

Alias
UMLS CUI-1
C0201976
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Glucose (non-fasting)
Beschreibung

Glucose (non-fasting)

Alias
UMLS CUI-1
C0202042
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Calcium
Beschreibung

Calcium

Alias
UMLS CUI-1
C0201925
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Protein, total
Beschreibung

Protein, total

Alias
UMLS CUI-1
C0555903
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Albumin
Beschreibung

Albumin

Alias
UMLS CUI-1
C0201838
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Urea
Beschreibung

Urea

Alias
UMLS CUI-1
C0523961
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Bilirubin, total
Beschreibung

Bilirubin, total

Alias
UMLS CUI-1
C1278039
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Alias
UMLS CUI-1
C0002059
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

AST(SGOT)
Beschreibung

AST(SGOT)

Alias
UMLS CUI-1
C0201899
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

ALT(SGPT)
Beschreibung

ALT(SGPT)

Alias
UMLS CUI-1
C0001899
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Albumin/globulin ratio
Beschreibung

Albumin/globulin ratio

Alias
UMLS CUI-1
C0201837
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Cholesterol
Beschreibung

Cholesterol

Alias
UMLS CUI-1
C1445957
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Creatine phosphokinase
Beschreibung

Creatine phosphokinase

Alias
UMLS CUI-1
C0010287
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Gamma glutamyl transferase (GGT)
Beschreibung

Gamma glutamyl transferase (GGT)

Alias
UMLS CUI-1
C0202035
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Globulin
Beschreibung

Globulin

Alias
UMLS CUI-1
C0877347
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Phosphate
Beschreibung

Phosphate

Alias
UMLS CUI-1
C0523826
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

Triglycerides
Beschreibung

Triglycerides

Alias
UMLS CUI-1
C0202236
Result
Beschreibung

result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beschreibung

unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beschreibung

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

Datentyp

text

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Ähnliche Modelle

laboratory evaluation serum chemistry determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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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