ID

39166

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

  1. 12/3/19 12/3/19 -
  2. 12/6/19 12/6/19 -
  3. 1/9/20 1/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 6, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

Screening - Medical History; PD Stage Prior Med; PR/ Conmeds

Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Description

Study Name

Data type

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
General Medical History - Cardiovascular Risk Factors
Description

General Medical History - Cardiovascular Risk Factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0850624
Cardiovascular Risk Factor
Description

Cardiovascular Risk Factor

Data type

integer

Alias
UMLS CUI [1]
C0850624
Cardiovascular Risk Factor Status
Description

Cardiovascular Risk Factor Status

Data type

integer

Alias
UMLS CUI [1,1]
C0850624
UMLS CUI [1,2]
C0449438
Family history - Cardiovascular Risk Factors
Description

Family history - Cardiovascular Risk Factors

Alias
UMLS CUI-1
C0241889
UMLS CUI-2
C0850624
Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only; e.g. biological mother or father, biological brother or sister, biological son or daughter (half siblings are considered first degree relatives)?
Description

Family history | Premature coronary artery disease | Gender | Age | First Degree Relative | Mother (person); Natural parent | Father (person); Natural parent | Brothers; Natural parent | Sister; Natural parent | Natural parent; Natural parent | Daughter; Natural parent

Data type

text

Alias
UMLS CUI [1]
C0241889
UMLS CUI [2]
C1867743
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
UMLS CUI [5]
C1517194
UMLS CUI [6,1]
C0026591
UMLS CUI [6,2]
C0337465
UMLS CUI [7,1]
C0015671
UMLS CUI [7,2]
C0337465
UMLS CUI [8]
C0337527
UMLS CUI [9]
C0337514
UMLS CUI [10]
C0037683
UMLS CUI [11]
C0011011
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
Medical Condition
Description

Medical Condition

Data type

integer

Alias
UMLS CUI [1]
C0012634
Medical Condition Status
Description

Medical Condition Status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Tobacco Use
Description

Tobacco Use

Alias
UMLS CUI-1
C0543414
What is the subject's tobacco use history?
Description

What is the subject's tobacco use history?

Data type

integer

Alias
UMLS CUI [1]
C0841002
Provide average tobacco used per week in units, using the measurement below
Description

1 cigar = 7 cigarettes 1 gram (0.03 oz) of tobacco = 1 cigarette

Data type

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0585296
Parkinson's Disease History
Description

Parkinson's Disease History

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0262926
A modified Hoehn and Yahr stage is to be obtained while 'Off'
Description

A modified Hoehn and Yahr stage is to be obtained while 'Off'

Data type

integer

Alias
UMLS CUI [1]
C0451215
UMLS CUI [2]
C1518544
Pre-study Parkinson's Disease Medication
Description

Pre-study Parkinson's Disease Medication

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0013227
UMLS CUI-3
C0332152
UMLS CUI-4
C2347804
Pre-study Parkinson's Disease Medication - Drug Sequence Number
Description

Pre-study Parkinson's Disease Medication - Drug Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2348184
Pre-study Parkinson's Disease Medication - Drug Name
Description

Trade name preferred

Data type

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2]
C0013227
Pre-study Parkinson's Disease Medication - Total daily dose
Description

Pre-study Parkinson's Disease Medication - Total daily dose

Data type

float

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C2348070
UMLS CUI [2,2]
C0439810
Pre-study Parkinson's Disease Medication - Unit
Description

Pre-study Parkinson's Disease Medication - Unit

Data type

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2]
C1519795
Pre-study Parkinson's Disease Medication - Indication
Description

Pre-study Parkinson's Disease Medication - Indication

Data type

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2]
C3146298
Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown
Description

Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown

Data type

integer

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0808070
UMLS CUI [2,2]
C0439673
Pre-study Parkinson's Disease Medication - Start date/time
Description

Pre-study Parkinson's Disease Medication - Start date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2]
C0808070
UMLS CUI [3]
C1301880
Pre-study Parkinson's Disease Medication - Taken prior to study?
Description

Pre-study Parkinson's Disease Medication - Taken prior to study?

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2603343
UMLS CUI [2,4]
C0332152
Pre-study Parkinson's Disease Medication - Ongoing?
Description

Pre-study Parkinson's Disease Medication - Ongoing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2]
C0549178
Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown
Description

Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown

Data type

integer

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0806020
UMLS CUI [2,2]
C0439673
Pre-study Parkinson's Disease Medication - End date/time
Description

Pre-study Parkinson's Disease Medication - End date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0806020
UMLS CUI [2,2]
C1522314
Prior/ Current Concomitant Medications
Description

Prior/ Current Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-3
C1514463
UMLS CUI-5
C0521116
Concomitant Medication Sequence Number
Description

Concomitant Medication Sequence Number

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Concomitant Medication - Drug Name
Description

(Trade name preferred)

Data type

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C2360065
Concomitant Medication - Total daily dose
Description

Concomitant Medication - Total daily dose

Data type

float

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C2348070
UMLS CUI [2,2]
C0439810
Concomitant Medication - Unit
Description

Concomitant Medication - Unit

Data type

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1519795
Concomitant Medication - Indication
Description

Concomitant Medication - Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication - Start date - Complete Date Unknown
Description

Concomitant Medication - Start date - Complete Date Unknown

Data type

integer

Alias
UMLS CUI [1,1]
C2826734
UMLS CUI [1,2]
C0439673
Concomitant Medication - Start date/ time
Description

Concomitant Medication - Start date/ time

Data type

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C2347852
Concomitant Medication - Taken prior to sudy?
Description

Concomitant Medication - Taken prior to sudy?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant Medication - Ongoing?
Description

Concomitant Medication - Ongoing?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Concomitant Medication - End date - Complete Date unknown
Description

Concomitant Medication - End date - Complete Date unknown

Data type

integer

Alias
UMLS CUI [1,1]
C2826744
UMLS CUI [1,2]
C0439673
Concomitant Medication - End date/ time
Description

Concomitant Medication - End date/ time

Data type

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1522314
AE/ SAE related?
Description

AE/ SAE related?

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0869014
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0869014

Similar models

Screening - Medical History; PD Stage Prior Med; PR/ Conmeds

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
General Medical History - Cardiovascular Risk Factors
C0262926 (UMLS CUI-1)
C0850624 (UMLS CUI-2)
Item
Cardiovascular Risk Factor
integer
C0850624 (UMLS CUI [1])
Code List
Cardiovascular Risk Factor
CL Item
Angina Pectoris (1)
CL Item
Myocardial Infarction (2)
CL Item
Stroke  (3)
CL Item
Diabetes (4)
CL Item
Hypertension (5)
CL Item
Hyperlipidemia (6)
Item
Cardiovascular Risk Factor Status
integer
C0850624 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Cardiovascular Risk Factor Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item Group
Family history - Cardiovascular Risk Factors
C0241889 (UMLS CUI-1)
C0850624 (UMLS CUI-2)
Item
Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only; e.g. biological mother or father, biological brother or sister, biological son or daughter (half siblings are considered first degree relatives)?
text
C0241889 (UMLS CUI [1])
C1867743 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C1517194 (UMLS CUI [5])
C0026591 (UMLS CUI [6,1])
C0337465 (UMLS CUI [6,2])
C0015671 (UMLS CUI [7,1])
C0337465 (UMLS CUI [7,2])
C0337527 (UMLS CUI [8])
C0337514 (UMLS CUI [9])
C0037683 (UMLS CUI [10])
C0011011 (UMLS CUI [11])
Code List
Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only; e.g. biological mother or father, biological brother or sister, biological son or daughter (half siblings are considered first degree relatives)?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Item
Medical Condition
integer
C0012634 (UMLS CUI [1])
Code List
Medical Condition
CL Item
Blood and lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Ear and labyrinth disorders (3)
CL Item
Endocrine disorders (4)
CL Item
Eye disorders (5)
CL Item
Gastrointestinal disorders (6)
CL Item
Hepatobiliary disorders (7)
CL Item
Immune system disorders (8)
CL Item
Metabolism and nutrition disorders (9)
CL Item
Musculoskeletal and connective tissue disorders  (10)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (11)
CL Item
Nervous system disorders (12)
CL Item
Psychiatric disorders (13)
CL Item
Renal and urinary disorders (14)
CL Item
Reproductive system and breast disorders (15)
CL Item
Respiratory, thoracic and mediastinal disorders (16)
CL Item
Skin and subcutaneous tissue disorders (17)
CL Item
Vascular disorders (18)
CL Item
Infections and infestations (19)
CL Item
Congenital, familial and genetic disorders (20)
CL Item
General disorders and administration site conditions (21)
CL Item
Injury, poisoning and procedural complications (22)
CL Item
Investigations (23)
Item
Medical Condition Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Medical Condition Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item Group
Tobacco Use
C0543414 (UMLS CUI-1)
Item
What is the subject's tobacco use history?
integer
C0841002 (UMLS CUI [1])
Code List
What is the subject's tobacco use history?
CL Item
Never used tobacco (1)
CL Item
Current tobacco user (2)
CL Item
Former tobacco user (3)
Provide average tobacco used per week in units, using the measurement below
Item
Provide average tobacco used per week in units, using the measurement below
integer
C0543414 (UMLS CUI [1,1])
C0585296 (UMLS CUI [1,2])
Item Group
Parkinson's Disease History
C0030567 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
A modified Hoehn and Yahr stage is to be obtained while 'Off'
integer
C0451215 (UMLS CUI [1])
C1518544 (UMLS CUI [2])
Code List
A modified Hoehn and Yahr stage is to be obtained while 'Off'
CL Item
0 (1)
CL Item
1 (2)
CL Item
1.5 (3)
CL Item
2 (4)
CL Item
2.5 (5)
CL Item
3 (6)
CL Item
4 (7)
CL Item
5 (8)
Item Group
Pre-study Parkinson's Disease Medication
C0030567 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C2347804 (UMLS CUI-4)
Pre-study Parkinson's Disease Medication - Drug Sequence Number
Item
Pre-study Parkinson's Disease Medication - Drug Sequence Number
integer
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C2348184 (UMLS CUI [2,2])
Pre-study Parkinson's Disease Medication - Drug Name
Item
Pre-study Parkinson's Disease Medication - Drug Name
text
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2])
Pre-study Parkinson's Disease Medication - Total daily dose
Item
Pre-study Parkinson's Disease Medication - Total daily dose
float
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Pre-study Parkinson's Disease Medication - Unit
Item
Pre-study Parkinson's Disease Medication - Unit
text
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C1519795 (UMLS CUI [2])
Pre-study Parkinson's Disease Medication - Indication
Item
Pre-study Parkinson's Disease Medication - Indication
text
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C3146298 (UMLS CUI [2])
Item
Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown
integer
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0808070 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Code List
Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Pre-study Parkinson's Disease Medication - Start date/time
Item
Pre-study Parkinson's Disease Medication - Start date/time
datetime
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0808070 (UMLS CUI [2])
C1301880 (UMLS CUI [3])
Pre-study Parkinson's Disease Medication - Taken prior to study?
Item
Pre-study Parkinson's Disease Medication - Taken prior to study?
boolean
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0030567 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
Pre-study Parkinson's Disease Medication - Ongoing?
Item
Pre-study Parkinson's Disease Medication - Ongoing?
boolean
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0549178 (UMLS CUI [2])
Item
Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown
integer
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0806020 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Code List
Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Pre-study Parkinson's Disease Medication - End date/time
Item
Pre-study Parkinson's Disease Medication - End date/time
datetime
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0806020 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item Group
Prior/ Current Concomitant Medications
C2347852 (UMLS CUI-1)
C1514463 (UMLS CUI-3)
C0521116 (UMLS CUI-5)
Concomitant Medication Sequence Number
Item
Concomitant Medication Sequence Number
text
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication - Drug Name
Item
Concomitant Medication - Drug Name
text
C2347852 (UMLS CUI [1])
C2360065 (UMLS CUI [2])
Concomitant Medication - Total daily dose
Item
Concomitant Medication - Total daily dose
float
C2347852 (UMLS CUI [1])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Concomitant Medication - Unit
Item
Concomitant Medication - Unit
text
C2347852 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Concomitant Medication - Indication
Item
Concomitant Medication - Indication
text
C2826696 (UMLS CUI [1])
Item
Concomitant Medication - Start date - Complete Date Unknown
integer
C2826734 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
Concomitant Medication - Start date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Concomitant Medication - Start date/ time
Item
Concomitant Medication - Start date/ time
datetime
C2826734 (UMLS CUI [1])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Concomitant Medication - Taken prior to sudy?
Item
Concomitant Medication - Taken prior to sudy?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication - Ongoing?
Item
Concomitant Medication - Ongoing?
boolean
C2826666 (UMLS CUI [1])
Item
Concomitant Medication - End date - Complete Date unknown
integer
C2826744 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
Concomitant Medication - End date - Complete Date unknown
CL Item
Complete Date Unknown (1)
Concomitant Medication - End date/ time
Item
Concomitant Medication - End date/ time
datetime
C2826744 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
AE/ SAE related?
Item
AE/ SAE related?
boolean
C1518404 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0869014 (UMLS CUI [2,2])

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