ID

24786

Descripción

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

Palabras clave

Versiones (4)
  1. 17/8/17 17/8/17 -
  2. 23/8/17 23/8/17 -
  3. 4/9/17 4/9/17 -
  4. 4/9/17 4/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

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

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Descripción

patient's initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Descripción

patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
SERUM CHEMISTRY
Descripción

SERUM CHEMISTRY

Alias
UMLS CUI-1
C1883010
SERUM CHEMISTRY
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C1883010
Date of Sample
Descripción

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

Tipo de datos

date

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

Sodium

Alias
UMLS CUI-1
C0337443
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Potassium
Descripción

Potassium

Alias
UMLS CUI-1
C0202194
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Creatinine
Descripción

Creatinine

Alias
UMLS CUI-1
C0201976
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Glucose (non-fasting)
Descripción

Glucose (non-fasting)

Alias
UMLS CUI-1
C0202042
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Calcium
Descripción

Calcium

Alias
UMLS CUI-1
C0201925
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Protein, total
Descripción

Protein, total

Alias
UMLS CUI-1
C0555903
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Albumin
Descripción

Albumin

Alias
UMLS CUI-1
C0201838
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Urea
Descripción

Urea

Alias
UMLS CUI-1
C0523961
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Bilirubin, total
Descripción

Bilirubin, total

Alias
UMLS CUI-1
C1278039
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Alkaline phosphatase
Descripción

Alkaline phosphatase

Alias
UMLS CUI-1
C0002059
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

AST(SGOT)
Descripción

AST(SGOT)

Alias
UMLS CUI-1
C0201899
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

ALT(SGPT)
Descripción

ALT(SGPT)

Alias
UMLS CUI-1
C0001899
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Albumin/globulin ratio
Descripción

Albumin/globulin ratio

Alias
UMLS CUI-1
C0201837
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Cholesterol
Descripción

Cholesterol

Alias
UMLS CUI-1
C1445957
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Creatine phosphokinase
Descripción

Creatine phosphokinase

Alias
UMLS CUI-1
C0010287
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Gamma glutamyl transferase (GGT)
Descripción

Gamma glutamyl transferase (GGT)

Alias
UMLS CUI-1
C0202035
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Globulin
Descripción

Globulin

Alias
UMLS CUI-1
C0877347
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Phosphate
Descripción

Phosphate

Alias
UMLS CUI-1
C0523826
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Triglycerides
Descripción

Triglycerides

Alias
UMLS CUI-1
C0202236
Result
Descripción

result

Tipo de datos

integer

Alias
UMLS CUI [1]
C1274040
Units
Descripción

unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Descripción

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

Tipo de datos

text

Volver a la parte superior de la página

Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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