ID

40853

Beschreibung

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

Stichworte

Versionen (1)
  1. 26.05.20 26.05.20 -
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GlaxoSmithKline

Hochgeladen am

26. Mai 2020

DOI

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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

Englisch

Laboratory Collections

1 Formulare  
  1. StudyEvent: ODM
    1. Laboratory Collections
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

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

Clinical Chemistry & Haematology

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

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

Datentyp

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
Beschreibung

Clinical Chemistry & Haematology - Research Physicians Initial

Datentyp

text

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

Clinical Chemistry & Haematology - Comments

Datentyp

text

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

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

Datentyp

boolean

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

Clinical Chemistry & Haematology - Abnormal values - Research Physician Initial

Datentyp

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
Beschreibung

Urinalysis

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

Exact date and time of urine sampling

Datentyp

datetime

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

Urinalysis - Research Physicians Initial

Datentyp

text

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

Urinalysis - Comments

Datentyp

text

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

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

Datentyp

boolean

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

Urinalysis - Abnormal values - Research Physician Initial

Datentyp

text

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

Drug Screening (Urine)

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

Drug Screening - Exact date and time of sampling

Datentyp

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
Beschreibung

Drug Screening - Research Physicians Initial

Datentyp

text

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

Drug Screening - Comments

Datentyp

text

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

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

Datentyp

boolean

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

Contra-indicated drugs

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

Type of drug

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Comment
Beschreibung

Comment

Datentyp

text

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

Alcohol Urine/ Breath Test

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

Average number of units per week

Datentyp

integer

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

Exact date and time of alcohol urine/ breath test

Datentyp

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
Beschreibung

If positive please withdraw from the study.

Datentyp

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
Beschreibung

Research Physician’s Signatur

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

Research Physician’s Signatur

Datentyp

text

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

Research Physician’s Signature - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0011008
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Ähnliche Modelle

Laboratory Collections

1 Formulare
  1. StudyEvent: ODM
    1. Laboratory Collections
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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