ID

25464

Description

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

Keywords

Versions (5)
  1. 8/17/17 8/17/17 -
  2. 8/23/17 8/23/17 -
  3. 8/23/17 8/23/17 -
  4. 9/4/17 9/4/17 -
  5. 9/4/17 9/4/17 -
Uploaded on

September 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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visit 1 & 4 laboratory evaluation hematology starting dose of ropinirole Parkinson's Disease 101468/166

English

visit 1 & 4 laboratory evaluation hematology starting dose of ropinirole Parkinson's Disease 101468/166

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Description

patient's initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Number of Visit
Description

Number of Visit

Alias
UMLS CUI-1
C1549755
Number of Visit
Description

number of visit

Data type

integer

Alias
UMLS CUI [1]
C1549755
HEMATOLOGY
Description

HEMATOLOGY

Alias
UMLS CUI-1
C0474523
HEMATOLOGY
Description

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

Data type

text

Alias
UMLS CUI [1]
C0474523
Date of Sample
Description

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

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Hemoglobin
Description

Hemoglobin

Alias
UMLS CUI-1
C0019046
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
PCV
Description

PCV

Alias
UMLS CUI-1
C1534868
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
RBC
Description

RBC

Alias
UMLS CUI-1
C0014772
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
MCH
Description

MCH

Alias
UMLS CUI-1
C0369183
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
MCHC
Description

MCHC

Alias
UMLS CUI-1
C0474535
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
Platelets
Description

Platelets

Alias
UMLS CUI-1
C0005821
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
WBC
Description

WBC

Alias
UMLS CUI-1
C0023508
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
DIFFERENTIAL: Neutrophils (segs)
Description

DIFFERENTIAL: Neutrophils (segs)

Alias
UMLS CUI-1
C0229640
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
DIFFERENTIAL: Neutrophils (bands)
Description

DIFFERENTIAL: Neutrophils (bands)

Alias
UMLS CUI-1
C3661517
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
DIFFERENTIAL: Lymphocytes
Description

DIFFERENTIAL: Lymphocytes

Alias
UMLS CUI-1
C0024264
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
DIFFERENTIAL: Monocytes
Description

DIFFERENTIAL: Monocytes

Alias
UMLS CUI-1
C0026473
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
DIFFERENTIAL: Eosinophils
Description

DIFFERENTIAL: Eosinophils

Alias
UMLS CUI-1
C0200638
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
DIFFERENTIAL: Basophils
Description

DIFFERENTIAL: Basophils

Alias
UMLS CUI-1
C0200641
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
Other
Description

Other

Alias
UMLS CUI-1
C0205394
Result
Description

result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Units
Description

unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Clin Sig
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826633
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Similar models

visit 1 & 4 laboratory evaluation hematology starting dose of ropinirole Parkinson's Disease 101468/166

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Number of Visit
C1549755 (UMLS CUI-1)
Item
Number of Visit
integer
C1549755 (UMLS CUI [1])
number of visit
Code List
Number of Visit
CL Item
Study Period Visit 1 (Day -14-0) (1)
CL Item
Study Period VIsit 4 (Day 8) (2)
Item Group
HEMATOLOGY
C0474523 (UMLS CUI-1)
Item
HEMATOLOGY
text
C0474523 (UMLS CUI [1])
hematology
Code List
HEMATOLOGY
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
Hemoglobin
C0019046 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
PCV
C1534868 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
RBC
C0014772 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
MCH
C0369183 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
MCHC
C0474535 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Platelets
C0005821 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
WBC
C0023508 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
DIFFERENTIAL: Neutrophils (segs)
C0229640 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
DIFFERENTIAL: Neutrophils (bands)
C3661517 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
DIFFERENTIAL: Lymphocytes
C0024264 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
DIFFERENTIAL: Monocytes
C0026473 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
DIFFERENTIAL: Eosinophils
C0200638 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
DIFFERENTIAL: Basophils
C0200641 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
Item Group
Other
C0205394 (UMLS CUI-1)
result
Item
Result
integer
C1274040 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Clin Sig
text
C2826633 (UMLS CUI [1])
clinically significant
Code List
Clin Sig
CL Item
Clin Sig (Clin Sig)
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