ID

24786

Beskrivning

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

Nyckelord

Versioner (4)
  1. 2017-08-17 2017-08-17 -
  2. 2017-08-23 2017-08-23 -
  3. 2017-09-04 2017-09-04 -
  4. 2017-09-04 2017-09-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 augusti 2017

DOI

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Creative Commons BY-NC 3.0
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laboratory evaluation serum chemistry determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

Engelsk

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

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beskrivning

patient's initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beskrivning

patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
SERUM CHEMISTRY
Beskrivning

SERUM CHEMISTRY

Alias
UMLS CUI-1
C1883010
SERUM CHEMISTRY
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C1883010
Date of Sample
Beskrivning

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

Datatyp

date

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

Sodium

Alias
UMLS CUI-1
C0337443
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Potassium
Beskrivning

Potassium

Alias
UMLS CUI-1
C0202194
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Creatinine
Beskrivning

Creatinine

Alias
UMLS CUI-1
C0201976
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Glucose (non-fasting)
Beskrivning

Glucose (non-fasting)

Alias
UMLS CUI-1
C0202042
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Calcium
Beskrivning

Calcium

Alias
UMLS CUI-1
C0201925
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Protein, total
Beskrivning

Protein, total

Alias
UMLS CUI-1
C0555903
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Albumin
Beskrivning

Albumin

Alias
UMLS CUI-1
C0201838
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Urea
Beskrivning

Urea

Alias
UMLS CUI-1
C0523961
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Bilirubin, total
Beskrivning

Bilirubin, total

Alias
UMLS CUI-1
C1278039
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Alkaline phosphatase
Beskrivning

Alkaline phosphatase

Alias
UMLS CUI-1
C0002059
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

AST(SGOT)
Beskrivning

AST(SGOT)

Alias
UMLS CUI-1
C0201899
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

ALT(SGPT)
Beskrivning

ALT(SGPT)

Alias
UMLS CUI-1
C0001899
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Albumin/globulin ratio
Beskrivning

Albumin/globulin ratio

Alias
UMLS CUI-1
C0201837
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Cholesterol
Beskrivning

Cholesterol

Alias
UMLS CUI-1
C1445957
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Creatine phosphokinase
Beskrivning

Creatine phosphokinase

Alias
UMLS CUI-1
C0010287
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Gamma glutamyl transferase (GGT)
Beskrivning

Gamma glutamyl transferase (GGT)

Alias
UMLS CUI-1
C0202035
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Globulin
Beskrivning

Globulin

Alias
UMLS CUI-1
C0877347
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Phosphate
Beskrivning

Phosphate

Alias
UMLS CUI-1
C0523826
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Triglycerides
Beskrivning

Triglycerides

Alias
UMLS CUI-1
C0202236
Result
Beskrivning

result

Datatyp

integer

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Beskrivning

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

Datatyp

text

Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

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