ID

25335

Description

Study part: Laboratory Collections Screening Screening. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 1. Study Recruitment Status: Completed Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/201. Clinical Study ID: 101468/201

Keywords

Versions (2)
  1. 9/1/17 9/1/17 -
  2. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 1, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Laboratory Collections Screening Screening Ropinirole Restless Legs Syndrome 101468/201

English

Laboratory Collections Screening Screening

1 forms  
CLINICAL CHEMISTRY AND HAEMATOLOGY
Description

CLINICAL CHEMISTRY AND HAEMATOLOGY

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Volunteer panel number
Description

identification number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Exact date and time of blood sampling:
Description

Date and time blood sampling

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Description

laboratory findings blood sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0005834
URINALYSIS
Description

URINALYSIS

Alias
UMLS CUI-1
C0042014
Exact date and time of urine sampling:
Description

date and time urinalysis

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042014
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Description

laboratory findings urinalysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0042014
DRUG SCREENING (URINE)
Description

DRUG SCREENING (URINE)

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

Date and time drug screening urine

Data type

datetime

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

contraindication drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
If yes, type of Drug
Description

drug

Data type

text

Alias
UMLS CUI [1]
C0013227
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
HIV AND HEPATITIS B & C
Description

HIV AND HEPATITIS B & C

Alias
UMLS CUI-1
C0019682
UMLS CUI-2
C0019163
UMLS CUI-3
C0019196
Exact date and time of blood sampling:
Description

Date and time

Data type

datetime

Alias
UMLS CUI [1]
C0011008
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
PREGNANCY TEST (FEMALES ONLY)
Description

PREGNANCY TEST (FEMALES ONLY)

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

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
If ‘No’, please specify reason
Description

reason

Data type

text

Alias
UMLS CUI [1]
C0392360
If ‘Yes’, Date and time of sample:
Description

date and time

Data type

datetime

Alias
UMLS CUI [1]
C0011008
Pregnancy test result
Description

Pregnancy test result

Data type

text

Alias
UMLS CUI [1]
C0427777
Dipstick urine HCG
Description

Dipstick urine HCG

Data type

text

Alias
UMLS CUI [1]
C1254846
Serum HCG
Description

Serum HCG

Data type

text

Alias
UMLS CUI [1]
C2348195
Other
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Laboratory name, if applicable
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C0022877
ALCOHOL TEST
Description

ALCOHOL TEST

Alias
UMLS CUI-1
C0202304
Exact date and time of test:
Description

Date and time

Data type

datetime

Alias
UMLS CUI [1]
C0011008
Alcohol test finding
Description

Alcohol test finding

Data type

text

Alias
UMLS CUI [1]
C0495718
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Similar models

Laboratory Collections Screening Screening

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CLINICAL CHEMISTRY AND HAEMATOLOGY
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date and time blood sampling
Item
Exact date and time of blood sampling:
datetime
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
laboratory findings blood sampling
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0022877 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
URINALYSIS
C0042014 (UMLS CUI-1)
date and time urinalysis
Item
Exact date and time of urine sampling:
datetime
C0011008 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
laboratory findings urinalysis
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0022877 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item Group
DRUG SCREENING (URINE)
C0202274 (UMLS CUI-1)
Date and time drug screening urine
Item
Exact date and time of sampling:
datetime
C0011008 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
contraindication drugs
Item
Were there any contra-indicated drugs detected?
boolean
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
drug
Item
If yes, type of Drug
text
C0013227 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
HIV AND HEPATITIS B & C
C0019682 (UMLS CUI-1)
C0019163 (UMLS CUI-2)
C0019196 (UMLS CUI-3)
Date and time
Item
Exact date and time of blood sampling:
datetime
C0011008 (UMLS CUI [1])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
PREGNANCY TEST (FEMALES ONLY)
C0032976 (UMLS CUI-1)
pregnancy test
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
reason
Item
If ‘No’, please specify reason
text
C0392360 (UMLS CUI [1])
date and time
Item
If ‘Yes’, Date and time of sample:
datetime
C0011008 (UMLS CUI [1])
Item
Pregnancy test result
text
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Dipstick urine HCG
text
C1254846 (UMLS CUI [1])
Pregnancy test result
Code List
Dipstick urine HCG
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Serum HCG
text
C2348195 (UMLS CUI [1])
Pregnancy test result
Code List
Serum HCG
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Other
Item
Other
text
C0205394 (UMLS CUI [1])
Laboratory name
Item
Laboratory name, if applicable
text
C0022877 (UMLS CUI [1])
Item Group
ALCOHOL TEST
C0202304 (UMLS CUI-1)
Date and time
Item
Exact date and time of test:
datetime
C0011008 (UMLS CUI [1])
Item
Alcohol test finding
text
C0495718 (UMLS CUI [1])
Pregnancy test result
Code List
Alcohol test finding
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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