ID

25933

Beschreibung

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

Stichworte

Versionen (1)
  1. 27.09.17 27.09.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. September 2017

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Maßeinheiten
  • 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.)
Beschreibung

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

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

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

Datentyp

boolean

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

Hematology: Collection Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Hemoglobin: Results
Beschreibung

Hemoglobin

Datentyp

float

Alias
UMLS CUI [1]
C0518015
Hemoglobin: Units
Beschreibung

Hemoglobin: Unit

Datentyp

text

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

Hemoglobin: Clinically Significant

Datentyp

boolean

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

Hematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0518014
Hematocrit: Units
Beschreibung

Hematocrit: Unit

Datentyp

text

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

Hematocrit: Clinically Significant

Datentyp

boolean

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

Red Blood Count

Datentyp

float

Alias
UMLS CUI [1]
C1287262
RBC: Units
Beschreibung

Red Blood Count: Unit

Datentyp

text

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

Red Blood Count: Clinically Significant

Datentyp

boolean

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

White Blood Count

Datentyp

float

Alias
UMLS CUI [1]
C0023508
WBC: Units
Beschreibung

White Blood Count: Unit

Datentyp

text

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

White Blood Count: Clinically Significant

Datentyp

boolean

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

Platelets

Datentyp

float

Alias
UMLS CUI [1]
C0005821
Platelets: Units
Beschreibung

Platelets: Unit

Datentyp

text

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

Clinically Significant

Datentyp

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.)
Beschreibung

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?*
Beschreibung

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

Datentyp

boolean

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

Serum Chemistry: Collection Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1883010
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Sodium: Result
Beschreibung

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Sodium: Units
Beschreibung

Sodium: Unit

Datentyp

text

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

Sodium: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1]
C2826633
Potassium: Result
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1]
C0202194
Potassium: Units
Beschreibung

Potassium: Unit

Datentyp

text

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

Potassium: Clinically Significant

Datentyp

boolean

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

Urea

Datentyp

float

Alias
UMLS CUI [1]
C0523961
Urea: Units
Beschreibung

Urea: Unit

Datentyp

text

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

Urea: Clinically Significant

Datentyp

boolean

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

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
Creatinine: Units
Beschreibung

Creatinine: Unit

Datentyp

text

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

Creatinine: Clinically Significant

Datentyp

boolean

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

Total Protein

Datentyp

float

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

Total Proteins: Unit

Datentyp

text

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

Total Protein: Clinically Significant

Datentyp

boolean

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

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Albumin: Units
Beschreibung

Albumin: Unit

Datentyp

text

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

Albumin: Clinically Significant

Datentyp

boolean

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

Globulin

Datentyp

float

Alias
UMLS CUI [1]
C0877347
Globulin: Units
Beschreibung

Globulin: Unit

Datentyp

text

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

Globulin: Clinically Significant

Datentyp

boolean

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

Total Bilirubin

Datentyp

float

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

Total Bilirubin: Unit

Datentyp

text

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

Total Bilirubin: Clinically Significant

Datentyp

boolean

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

AST

Datentyp

float

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

AST: Unit

Datentyp

text

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

AST: Clinically Significant

Datentyp

boolean

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

ALT

Datentyp

float

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

ALT: Unit

Datentyp

text

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

ALT: Clinically Significant

Datentyp

boolean

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

Alkaline Phosphatase

Datentyp

float

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

Alkaline Phosphatase: Unit

Datentyp

text

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

Alkaline Phosphatase: Clinically Significant

Datentyp

boolean

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

Calcium

Datentyp

float

Alias
UMLS CUI [1]
C0201925
Calcium: Units
Beschreibung

Calcium: Unit

Datentyp

text

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

Calcium: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1]
C2826633
Phosphate: Results
Beschreibung

Phosphate

Datentyp

float

Alias
UMLS CUI [1]
C0523826
Phosphate: Units
Beschreibung

Phosphate: Unit

Datentyp

text

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

Non-Fasting Glucose

Datentyp

float

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

Non-Fasting Glucose: Unit

Datentyp

text

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

Non-Fasting Glucose: Clinically Significant

Datentyp

boolean

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

Pregnancy Test (betaHCG)

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

Pregnancy Test

Datentyp

text

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

Type of Pregnancy Test

Datentyp

text

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

Date of Pregnancy Test

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
If YES, Result:
Beschreibung

Pregnancy Test Finding

Datentyp

text

Alias
UMLS CUI [1]
C0427777
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Laboratory Evaluations Ropinirole in Parkinson's Disease GSK 101468/196

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