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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

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Versionen (1)
  1. 26.05.20 26.05.20 -
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GlaxoSmithKline

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26. Mai 2020

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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
    Zum Seitenanfang zurückkehren

    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])
    Zum Seitenanfang zurückkehren 

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