ID

40853

Beskrivning

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline 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

Nyckelord

Versioner (1)
  1. 2020-05-26 2020-05-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 maj 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

Engelsk

Laboratory Collections

1 Formulär  
  1. StudyEvent: ODM
    1. Laboratory Collections
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Clinical Chemistry & Haematology
Beskrivning

Clinical Chemistry & Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Clinical Chemistry & Haematology - Exact date and time of blood sampling
Beskrivning

Clinical Chemistry & Haematology - Exact date and time of blood sampling

Datatyp

datetime

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0018941
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C0011008
UMLS CUI [3,3]
C0040223
Clinical Chemistry & Haematology - Research Physicians Initial
Beskrivning

Clinical Chemistry & Haematology - Research Physicians Initial

Datatyp

text

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0018941
UMLS CUI [3,1]
C0031831
UMLS CUI [3,2]
C2986440
Clinical Chemistry & Haematology - Comments
Beskrivning

Clinical Chemistry & Haematology - Comments

Datatyp

text

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0018941
UMLS CUI [3]
C0947611
Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beskrivning

If YES, please record diagnosis on Baseline Signs and Symptoms page.

Datatyp

boolean

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0018941
UMLS CUI [3]
C0438215
Clinical Chemistry & Haematology - Abnormal values - Research Physician Initial
Beskrivning

Clinical Chemistry & Haematology - Abnormal values - Research Physician Initial

Datatyp

text

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0018941
UMLS CUI [3]
C0438215
UMLS CUI [4,1]
C0031831
UMLS CUI [4,2]
C2986440
Urinalysis
Beskrivning

Urinalysis

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

Exact date and time of urine sampling

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Urinalysis - Research Physicians Initial
Beskrivning

Urinalysis - Research Physicians Initial

Datatyp

text

Alias
UMLS CUI [1]
C0042014
UMLS CUI [2,1]
C0031831
UMLS CUI [2,2]
C2986440
Urinalysis - Comments
Beskrivning

Urinalysis - Comments

Datatyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0947611
Urinalysis - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beskrivning

If YES, please record diagnosis on Baseline Signs and Symptoms page.

Datatyp

boolean

Alias
UMLS CUI [1]
C0042014
UMLS CUI [2]
C0438215
Urinalysis - Abnormal values - Research Physician Initial
Beskrivning

Urinalysis - Abnormal values - Research Physician Initial

Datatyp

text

Alias
UMLS CUI [1]
C0042014
UMLS CUI [2]
C0438215
UMLS CUI [3,1]
C0031831
UMLS CUI [3,2]
C2986440
Drug Screening (Urine)
Beskrivning

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Drug Screening - Exact date and time of sampling
Beskrivning

Drug Screening - Exact date and time of sampling

Datatyp

datetime

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Drug Screening - Research Physicians Initial
Beskrivning

Drug Screening - Research Physicians Initial

Datatyp

text

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2,1]
C0031831
UMLS CUI [2,2]
C2986440
Drug Screening - Comments
Beskrivning

Drug Screening - Comments

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0947611
Drug Screening - Were there any contra-indicated drugs detected?
Beskrivning

If YES, please record all the relevant contra-indicated drugs below.

Datatyp

boolean

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2,1]
C1511790
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C4036061
Contra-indicated drugs
Beskrivning

Contra-indicated drugs

Alias
UMLS CUI-1
C1301624
UMLS CUI-2
C4036061
Type of drug
Beskrivning

Type of drug

Datatyp

text

Alias
UMLS CUI [1]
C0457591
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Alcohol Urine/ Breath Test
Beskrivning

Alcohol Urine/ Breath Test

Alias
UMLS CUI-1
C0202304
UMLS CUI-2
C0042036
UMLS CUI-3
C0202306
Average number of units per week
Beskrivning

Average number of units per week

Datatyp

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Exact date and time of alcohol urine/ breath test
Beskrivning

Exact date and time of alcohol urine/ breath test

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
UMLS CUI [2,1]
C0202306
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Alcohol Urine/ Breath Test Result
Beskrivning

If positive please withdraw from the study.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0456984
UMLS CUI [2,1]
C0202306
UMLS CUI [2,2]
C0456984
Research Physician’s Signatur
Beskrivning

Research Physician’s Signatur

Alias
UMLS CUI-1
C1519316
UMLS CUI-2
C0031831
Research Physician’s Signatur
Beskrivning

Research Physician’s Signatur

Datatyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
Research Physician’s Signature - Date
Beskrivning

Research Physician’s Signature - Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0011008
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Similar models

Laboratory Collections

1 Formulär
  1. StudyEvent: ODM
    1. Laboratory Collections
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Clinical Chemistry & Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Clinical Chemistry & Haematology - Exact date and time of blood sampling
Item
Clinical Chemistry & Haematology - Exact date and time of blood sampling
datetime
C0008000 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0005834 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C0040223 (UMLS CUI [3,3])
Clinical Chemistry & Haematology - Research Physicians Initial
Item
Clinical Chemistry & Haematology - Research Physicians Initial
text
C0008000 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0031831 (UMLS CUI [3,1])
C2986440 (UMLS CUI [3,2])
Clinical Chemistry & Haematology - Comments
Item
Clinical Chemistry & Haematology - Comments
text
C0008000 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Item
Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0008000 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0438215 (UMLS CUI [3])
Clinical Chemistry & Haematology - Abnormal values - Research Physician Initial
Item
Clinical Chemistry & Haematology - Abnormal values - Research Physician Initial
text
C0008000 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0438215 (UMLS CUI [3])
C0031831 (UMLS CUI [4,1])
C2986440 (UMLS CUI [4,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Exact date and time of urine sampling
Item
Exact date and time of urine sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urinalysis - Research Physicians Initial
Item
Urinalysis - Research Physicians Initial
text
C0042014 (UMLS CUI [1])
C0031831 (UMLS CUI [2,1])
C2986440 (UMLS CUI [2,2])
Urinalysis - Comments
Item
Urinalysis - Comments
text
C0042014 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urinalysis - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Item
Urinalysis - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0042014 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
Urinalysis - Abnormal values - Research Physician Initial
Item
Urinalysis - Abnormal values - Research Physician Initial
text
C0042014 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0031831 (UMLS CUI [3,1])
C2986440 (UMLS CUI [3,2])
Item Group
Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Drug Screening - Exact date and time of sampling
Item
Drug Screening - Exact date and time of sampling
datetime
C0202274 (UMLS CUI [1])
C0870078 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Drug Screening - Research Physicians Initial
Item
Drug Screening - Research Physicians Initial
text
C0202274 (UMLS CUI [1])
C0031831 (UMLS CUI [2,1])
C2986440 (UMLS CUI [2,2])
Drug Screening - Comments
Item
Drug Screening - Comments
text
C0202274 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Drug Screening - Were there any contra-indicated drugs detected?
Item
Drug Screening - Were there any contra-indicated drugs detected?
boolean
C0202274 (UMLS CUI [1])
C1511790 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C4036061 (UMLS CUI [2,3])
Item Group
Contra-indicated drugs
C1301624 (UMLS CUI-1)
C4036061 (UMLS CUI-2)
Type of drug
Item
Type of drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Alcohol Urine/ Breath Test
C0202304 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0202306 (UMLS CUI-3)
Average number of units per week
Item
Average number of units per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Exact date and time of alcohol urine/ breath test
Item
Exact date and time of alcohol urine/ breath test
datetime
C0202304 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0202306 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
Alcohol Urine/ Breath Test Result
integer
C0202304 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0202306 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
Alcohol Urine/ Breath Test Result
Code List
Alcohol Urine/ Breath Test Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Research Physician’s Signatur
C1519316 (UMLS CUI-1)
C0031831 (UMLS CUI-2)
Research Physician’s Signatur
Item
Research Physician’s Signatur
text
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Research Physician’s Signature - Date
Item
Research Physician’s Signature - Date
date
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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