ID

25933

Description

Study ID: 101468/196 Clinical Study ID: 101468/196 Study Title: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00650104 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Parkinson DiseaseA Long-Term, Open-Label Continuation Study of Once Daily Adminstration of Ropinirole CR Tablets to Patients with Parkinson's Disease Who Completed the Previous Ropinirole CR Studies - 167 & 164 Laboratory Evaluations

Mots-clés

Versions (1)
  1. 27/09/2017 27/09/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

27 septembre 2017

DOI

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Licence

Creative Commons BY-NC-ND 3.0
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Laboratory Evaluations Ropinirole in Parkinson's Disease GSK 101468/196

Anglais

Laboratory Evaluations Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulaires  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Description

Patient Number

Type de données

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Description

Date of Visit

Type de données

date

Unités de mesure
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Hematology (Note: Please complete the clinically significant (Clin Sig) column for values out of normal range.)
Description

Hematology (Note: Please complete the clinically significant (Clin Sig) column for values out of normal range.)

Alias
UMLS CUI-1
C0474523
Hematology: Not Done?*
Description

* If patient is enrolling in this study within 4 weeks of completing 196, results obtained at the study completion visit may be inserted here.

Type de données

boolean

Alias
UMLS CUI [1]
C0474523
Date of Sample:
Description

Hematology: Collection Date

Type de données

date

Unités de mesure
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Hemoglobin: Results
Description

Hemoglobin

Type de données

float

Alias
UMLS CUI [1]
C0518015
Hemoglobin: Units
Description

Hemoglobin: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C1519795
Hemoglobin: Clin Sig
Description

Hemoglobin: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C2826633
Hematocrit: Result
Description

Hematocrit

Type de données

float

Alias
UMLS CUI [1]
C0518014
Hematocrit: Units
Description

Hematocrit: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C1519795
Hematocrit: Clin Sig
Description

Hematocrit: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C2826633
RBC: Results
Description

Red Blood Count

Type de données

float

Alias
UMLS CUI [1]
C1287262
RBC: Units
Description

Red Blood Count: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C1287262
UMLS CUI [1,2]
C1519795
RBC: Clin Sig
Description

Red Blood Count: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1287262
UMLS CUI [1,2]
C2826633
WBC: Result
Description

White Blood Count

Type de données

float

Alias
UMLS CUI [1]
C0023508
WBC: Units
Description

White Blood Count: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
WBC: Clin Sig
Description

White Blood Count: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C2826633
Platelets: Results
Description

Platelets

Type de données

float

Alias
UMLS CUI [1]
C0005821
Platelets: Units
Description

Platelets: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C1519795
Platelets: Clin Sig
Description

Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C2826633
C0005821 (Note: Please complete the clinically significant (Clin Sig) column for values out of normal range.)
Description

C0005821 (Note: Please complete the clinically significant (Clin Sig) column for values out of normal range.)

Alias
UMLS CUI-1
C1883010
Serum Chemistry: Not Done?*
Description

* IF patient is enrolling in this study within 4 weeks of completing 196, results obtained at the study completion visit may be inserted here.

Type de données

boolean

Alias
UMLS CUI [1]
C1883010
Date of Sample:
Description

Serum Chemistry: Collection Date

Type de données

date

Unités de mesure
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1883010
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Sodium: Result
Description

Sodium

Type de données

float

Alias
UMLS CUI [1]
C0337443
Sodium: Units
Description

Sodium: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C1519795
Sodium: Clin Sig
Description

Sodium: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1]
C2826633
Potassium: Result
Description

Potassium

Type de données

float

Alias
UMLS CUI [1]
C0202194
Potassium: Units
Description

Potassium: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C1519795
Potassium: Clin Sig
Description

Potassium: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C2826633
Urea: Result
Description

Urea

Type de données

float

Alias
UMLS CUI [1]
C0523961
Urea: Units
Description

Urea: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0523961
UMLS CUI [1,2]
C1519795
Urea: Clin Sig
Description

Urea: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0523961
UMLS CUI [1,2]
C2826633
Creatinine: Result
Description

Creatinine

Type de données

float

Alias
UMLS CUI [1]
C0201976
Creatinine: Units
Description

Creatinine: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519795
Creatinine: Clin Sig
Description

Creatinine: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C2826633
Protein, total: Results
Description

Total Protein

Type de données

float

Alias
UMLS CUI [1]
C0555903
Protein, total: Units
Description

Total Proteins: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C1519795
Protein, total: Clin Sig
Description

Total Protein: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C2826633
Albumin: Results
Description

Albumin

Type de données

float

Alias
UMLS CUI [1]
C0201838
Albumin: Units
Description

Albumin: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C1519795
Albumin: Clin Sig
Description

Albumin: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C2826633
Globulin: Results
Description

Globulin

Type de données

float

Alias
UMLS CUI [1]
C0877347
Globulin: Units
Description

Globulin: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0877347
UMLS CUI [1,2]
C1519795
Globulin: Clin Sig
Description

Globulin: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0877347
UMLS CUI [1,2]
C2826633
Bilirubin, total: Results
Description

Total Bilirubin

Type de données

float

Alias
UMLS CUI [1]
C0201913
Total Bilirubin: Units
Description

Total Bilirubin: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519795
Bilirubin, total: Clin Sig
Description

Total Bilirubin: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1]
C2826633
AST (SGOT): Results
Description

AST

Type de données

float

Alias
UMLS CUI [1]
C0201899
AST (SGOT): Units
Description

AST: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519795
AST (SGOT): Clin Sig
Description

AST: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C2826633
ALT (SGPT): Results
Description

ALT

Type de données

float

Alias
UMLS CUI [1]
C0201836
ALT (SGPT): Units
Description

ALT: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519795
ALT (SGPT): Clin Sig
Description

ALT: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C2826633
Alkaline Phosphatase: Results
Description

Alkaline Phosphatase

Type de données

float

Alias
UMLS CUI [1]
C0201850
Alkaline Phosphatase: Units
Description

Alkaline Phosphatase: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1519795
Alkaline Phosphatase: Clin Sig
Description

Alkaline Phosphatase: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C2826633
Calcium: Results
Description

Calcium

Type de données

float

Alias
UMLS CUI [1]
C0201925
Calcium: Units
Description

Calcium: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1519795
Calcium: Clin Sig
Description

Calcium: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1]
C2826633
Phosphate: Results
Description

Phosphate

Type de données

float

Alias
UMLS CUI [1]
C0523826
Phosphate: Units
Description

Phosphate: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C0523826
UMLS CUI [1,2]
C1519795
Glucose (non-fasting): Results
Description

Non-Fasting Glucose

Type de données

float

Alias
UMLS CUI [1,1]
C2347359
UMLS CUI [1,2]
C0337438
Glucose (non-fasting): Units
Description

Non-Fasting Glucose: Unit

Type de données

text

Alias
UMLS CUI [1,1]
C2347359
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C1519795
Glucose (non-fasting): Clin Sig
Description

Non-Fasting Glucose: Clinically Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C2347359
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C2826633
Pregnancy Test (betaHCG)
Description

Pregnancy Test (betaHCG)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Description

Pregnancy Test

Type de données

text

Alias
UMLS CUI [1]
C0032976
If YES, what type of pregnancy was performed?
Description

Type of Pregnancy Test

Type de données

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If YES, Date of Test:
Description

Date of Pregnancy Test

Type de données

date

Unités de mesure
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
If YES, Result:
Description

Pregnancy Test Finding

Type de données

text

Alias
UMLS CUI [1]
C0427777
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Similar models

Laboratory Evaluations Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Number
Item
Patient No.
text
C1830427 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Hematology (Note: Please complete the clinically significant (Clin Sig) column for values out of normal range.)
C0474523 (UMLS CUI-1)
Hematology
Item
Hematology: Not Done?*
boolean
C0474523 (UMLS CUI [1])
Hematology: Collection Date
Item
Date of Sample:
date
C0474523 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin: Results
float
C0518015 (UMLS CUI [1])
Hemoglobin: Unit
Item
Hemoglobin: Units
text
C0518015 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Hemoglobin: Clinically Significant
Item
Hemoglobin: Clin Sig
boolean
C0518015 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Hematocrit
Item
Hematocrit: Result
float
C0518014 (UMLS CUI [1])
Hematocrit: Unit
Item
Hematocrit: Units
text
C0518014 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Hematocrit: Clinically Significant
Item
Hematocrit: Clin Sig
boolean
C0518014 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Red Blood Count
Item
RBC: Results
float
C1287262 (UMLS CUI [1])
Red Blood Count: Unit
Item
RBC: Units
text
C1287262 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Red Blood Count: Clinically Significant
Item
RBC: Clin Sig
boolean
C1287262 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
White Blood Count
Item
WBC: Result
float
C0023508 (UMLS CUI [1])
White Blood Count: Unit
Item
WBC: Units
text
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
White Blood Count: Clinically Significant
Item
WBC: Clin Sig
boolean
C0023508 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Platelets
Item
Platelets: Results
float
C0005821 (UMLS CUI [1])
Platelets: Unit
Item
Platelets: Units
text
C0005821 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Clinically Significant
Item
Platelets: Clin Sig
boolean
C0005821 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Item Group
C0005821 (Note: Please complete the clinically significant (Clin Sig) column for values out of normal range.)
C1883010 (UMLS CUI-1)
Serum Chemistry
Item
Serum Chemistry: Not Done?*
boolean
C1883010 (UMLS CUI [1])
Serum Chemistry: Collection Date
Item
Date of Sample:
date
C1883010 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
Sodium
Item
Sodium: Result
float
C0337443 (UMLS CUI [1])
Sodium: Unit
Item
Sodium: Units
text
C0337443 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Sodium: Clinically Significant
Item
Sodium: Clin Sig
boolean
C2826633 (UMLS CUI [1])
Potassium
Item
Potassium: Result
float
C0202194 (UMLS CUI [1])
Potassium: Unit
Item
Potassium: Units
text
C0202194 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Potassium: Clinically Significant
Item
Potassium: Clin Sig
boolean
C0202194 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Urea
Item
Urea: Result
float
C0523961 (UMLS CUI [1])
Urea: Unit
Item
Urea: Units
text
C0523961 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Urea: Clinically Significant
Item
Urea: Clin Sig
boolean
C0523961 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Creatinine
Item
Creatinine: Result
float
C0201976 (UMLS CUI [1])
Creatinine: Unit
Item
Creatinine: Units
text
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Creatinine: Clinically Significant
Item
Creatinine: Clin Sig
boolean
C0201976 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Total Protein
Item
Protein, total: Results
float
C0555903 (UMLS CUI [1])
Total Proteins: Unit
Item
Protein, total: Units
text
C0555903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Total Protein: Clinically Significant
Item
Protein, total: Clin Sig
boolean
C0555903 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Albumin
Item
Albumin: Results
float
C0201838 (UMLS CUI [1])
Albumin: Unit
Item
Albumin: Units
text
C0201838 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Albumin: Clinically Significant
Item
Albumin: Clin Sig
boolean
C0201838 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Globulin
Item
Globulin: Results
float
C0877347 (UMLS CUI [1])
Globulin: Unit
Item
Globulin: Units
text
C0877347 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Globulin: Clinically Significant
Item
Globulin: Clin Sig
boolean
C0877347 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Total Bilirubin
Item
Bilirubin, total: Results
float
C0201913 (UMLS CUI [1])
Total Bilirubin: Unit
Item
Total Bilirubin: Units
text
C0201913 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Total Bilirubin: Clinically Significant
Item
Bilirubin, total: Clin Sig
boolean
C2826633 (UMLS CUI [1])
AST
Item
AST (SGOT): Results
float
C0201899 (UMLS CUI [1])
AST: Unit
Item
AST (SGOT): Units
text
C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
AST: Clinically Significant
Item
AST (SGOT): Clin Sig
boolean
C0201899 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT): Results
float
C0201836 (UMLS CUI [1])
ALT: Unit
Item
ALT (SGPT): Units
text
C0201836 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
ALT: Clinically Significant
Item
ALT (SGPT): Clin Sig
boolean
C0201836 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase: Results
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase: Unit
Item
Alkaline Phosphatase: Units
text
C0201850 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Alkaline Phosphatase: Clinically Significant
Item
Alkaline Phosphatase: Clin Sig
boolean
C0201850 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Calcium
Item
Calcium: Results
float
C0201925 (UMLS CUI [1])
Calcium: Unit
Item
Calcium: Units
text
C0201850 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Calcium: Clinically Significant
Item
Calcium: Clin Sig
boolean
C2826633 (UMLS CUI [1])
Phosphate
Item
Phosphate: Results
float
C0523826 (UMLS CUI [1])
Phosphate: Unit
Item
Phosphate: Units
text
C0523826 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Non-Fasting Glucose
Item
Glucose (non-fasting): Results
float
C2347359 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
Non-Fasting Glucose: Unit
Item
Glucose (non-fasting): Units
text
C2347359 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Non-Fasting Glucose: Clinically Significant
Item
Glucose (non-fasting): Clin Sig
boolean
C2347359 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,3])
Item Group
Pregnancy Test (betaHCG)
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
text
C0032976 (UMLS CUI [1])
Pregnancy Test
Code List
Was a pregnancy test performed?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (male or female not of childbearing potential) (NA (male or female not of childbearing potential))
Item
If YES, what type of pregnancy was performed?
text
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Pregnancy Test
Code List
If YES, what type of pregnancy was performed?
CL Item
Serum (Serum)
CL Item
Urine (Urine)
Date of Pregnancy Test
Item
If YES, Date of Test:
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If YES, Result:
text
C0427777 (UMLS CUI [1])
Pregnancy Test Finding
Code List
If YES, Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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