ID

40733

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Keywords

Versions (1)
  1. 5/5/20 5/5/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 5, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

English

Alcohol Breath Test, Randomisation, Drug Screening

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Alcohol Breath Test
Description

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Was an alcohol breath test carried out?
Description

Was an alcohol breath test carried out?

Data type

boolean

Alias
UMLS CUI [1]
C0202306
If no alcohol breath test was carried out, specify reason
Description

If no alcohol breath test was carried out, specify reason

Data type

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C2826287
Date of alcohol breath test
Description

Date of alcohol breath test

Data type

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Result of alcohol breath test
Description

Result of alcohol breath test

Data type

integer

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Has the patient been randomised to conduct a PK visit for this dose level?
Description

Has the patient been randomised to conduct a PK visit for this dose level?

Data type

boolean

Alias
UMLS CUI [1]
C0034656
UMLS CUI [2]
C0201734
UMLS CUI [3]
C0178602
Drug Screening (Urine)
Description

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Exact date and time of sampling
Description

Exact date and time of sampling

Data type

date

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2,1]
C0200354
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Were there any contra-indicated drugs detected?
Description

Were there any contra-indicated drugs detected?

Data type

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C3845816
Type of Drug
Description

Type of Drug

Data type

text

Alias
UMLS CUI [1]
C0457591
Drug Screening Comment
Description

Drug Screening Comment

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0947611
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Similar models

Alcohol Breath Test, Randomisation, Drug Screening

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Was an alcohol breath test carried out?
Item
Was an alcohol breath test carried out?
boolean
C0202306 (UMLS CUI [1])
If no alcohol breath test was carried out, specify reason
Item
If no alcohol breath test was carried out, specify reason
text
C0202306 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Date of alcohol breath test
Item
Date of alcohol breath test
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of alcohol breath test
integer
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of alcohol breath test
Code List
Result of alcohol breath test
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Has the patient been randomised to conduct a PK visit for this dose level?
Item
Has the patient been randomised to conduct a PK visit for this dose level?
boolean
C0034656 (UMLS CUI [1])
C0201734 (UMLS CUI [2])
C0178602 (UMLS CUI [3])
Item Group
Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Exact date and time of sampling
Item
Exact date and time of sampling
date
C0202274 (UMLS CUI [1])
C0200354 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Were there any contra-indicated drugs detected?
Item
Were there any contra-indicated drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])
Type of Drug
Item
Type of Drug
text
C0457591 (UMLS CUI [1])
Drug Screening Comment
Item
Drug Screening Comment
text
C0202274 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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