0 Bewertungen
ID

21094

Beschreibung

Documentation Part: Treatment Phase Day 22 An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Stichworte

Versionen (4)
  1. 04.03.17 04.03.17 -
  2. 04.03.17 04.03.17 -
  3. 08.03.17 08.03.17 -
  4. 10.04.17 10.04.17 -
Hochgeladen am

10. April 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    Englisch

    Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    1 Formulare  
    Subject information
    Beschreibung

    Subject information

    Alias
    UMLS CUI-1
    C2707520
    Subject identifier
    Beschreibung

    Subject identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit date
    Beschreibung

    Visit date

    Alias
    UMLS CUI-1
    C1320303
    Visit date
    Beschreibung

    Visit date

    Datentyp

    date

    Maßeinheiten
    • Day Month Year
    Alias
    UMLS CUI [1]
    C1320303
    Day Month Year
    Vital signs
    Beschreibung

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Beschreibung

    Date

    Datentyp

    date

    Maßeinheiten
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Day Month Year
    Planned Relative Time
    Beschreibung

    Planned Relative Time

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439564
    Planned Absolute time
    Beschreibung

    Planned Absolute time

    Datentyp

    integer

    Maßeinheiten
    • min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1552097
    min
    Actual time
    Beschreibung

    Actual time

    Datentyp

    time

    Maßeinheiten
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Systolic Blood Pressure
    Beschreibung

    Systolic Blood Pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Beschreibung

    Diastolic Blood Pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0428883
    mmHg
    Subject position
    Beschreibung

    Subject position

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1262869
    Heart Rate
    Beschreibung

    Heart Rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0018810
    beats/min
    12-Lead-ECG
    Beschreibung

    12-Lead-ECG

    Alias
    UMLS CUI-1
    C0430456
    Start date of ECG
    Beschreibung

    Start date of ECG

    Datentyp

    date

    Maßeinheiten
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0013798
    Day Month Year
    Planned Relative Time
    Beschreibung

    Planned Relative Time

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0439564
    Start Time of ECG
    Beschreibung

    Start Time of ECG

    Datentyp

    time

    Maßeinheiten
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0013798
    Hr : Min
    Ventricular Rate
    Beschreibung

    Ventricular Rate

    Datentyp

    integer

    Maßeinheiten
    • Beats/min
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C2189285
    Beats/min
    PR Interval
    Beschreibung

    PR Interval

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    QRS Duration
    Beschreibung

    QRS Duration

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Beschreibung

    Uncorrected QT Interval

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    QTc Invertal
    Beschreibung

    QTc Invertal

    Datentyp

    integer

    Maßeinheiten
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0860814
    msec
    Result of the ECG
    Beschreibung

    Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Invesatigational product
    Beschreibung

    Invesatigational product

    Alias
    UMLS CUI-1
    C3898691
    Planned timepoint
    Beschreibung

    Planned timepoint

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348792
    Date of dose
    Beschreibung

    Date of dose

    Datentyp

    date

    Maßeinheiten
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0011008
    Day Month Year
    Time of dose
    Beschreibung

    Time of dose

    Datentyp

    time

    Maßeinheiten
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Treatment confirmation
    Beschreibung

    Treatment confirmation

    Alias
    UMLS CUI-1
    C0750484
    UMLS CUI-2
    C0087111
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Beschreibung

    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If No, record reason(s)
    Beschreibung

    If No, record reason(s)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0750484
    UMLS CUI [1,3]
    C0087111
    Ambulatory blood pressure monitoring
    Beschreibung

    Ambulatory blood pressure monitoring

    Alias
    UMLS CUI-1
    C0026426
    UMLS CUI-2
    C0439841
    Start date
    Beschreibung

    Start date

    Datentyp

    date

    Maßeinheiten
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Day Month Year
    Start time
    Beschreibung

    Start time

    Datentyp

    time

    Maßeinheiten
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Hr : Min
    Stop time
    Beschreibung

    Stop time

    Datentyp

    time

    Maßeinheiten
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Hr : Min
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Subject information
    C2707520 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Visit date
    C1320303 (UMLS CUI-1)
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0518766 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (1)
    CL Item
    Unscheduled (2)
    Planned Absolute time
    Item
    Planned Absolute time
    integer
    C0518766 (UMLS CUI [1,1])
    C1552097 (UMLS CUI [1,2])
    Actual time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0518766 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0518766 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    Item
    Subject position
    text
    C0518766 (UMLS CUI [1,1])
    C1262869 (UMLS CUI [1,2])
    Subject position
    Code List
    Subject position
    CL Item
    Supine (1)
    CL Item
    Standing (3)
    Heart Rate
    Item
    Heart Rate
    integer
    C0518766 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Item Group
    12-Lead-ECG
    C0430456 (UMLS CUI-1)
    Start date of ECG
    Item
    Start date of ECG
    date
    C0808070 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0430456 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (1)
    CL Item
    Unscheduled (2)
    Start Time of ECG
    Item
    Start Time of ECG
    time
    C1301880 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Ventricular Rate
    Item
    Ventricular Rate
    integer
    C0430456 (UMLS CUI [1,1])
    C2189285 (UMLS CUI [1,2])
    PR Interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    QRS Duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    QTc Invertal
    Item
    QTc Invertal
    integer
    C0430456 (UMLS CUI [1,1])
    C0860814 (UMLS CUI [1,2])
    Result of the ECG
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Item Group
    Invesatigational product
    C3898691 (UMLS CUI-1)
    Planned timepoint
    Item
    Planned timepoint
    text
    C2348792 (UMLS CUI [1])
    Date of dose
    Item
    Date of dose
    date
    C0013227 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of dose
    Item
    Time of dose
    time
    C0013227 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Treatment confirmation
    C0750484 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    text
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Code List
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    If No, record reason(s)
    Item
    If No, record reason(s)
    text
    C0392360 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    Item Group
    Ambulatory blood pressure monitoring
    C0026426 (UMLS CUI-1)
    C0439841 (UMLS CUI-2)
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
    Start time
    Item
    Start time
    time
    C1301880 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
    Stop time
    Item
    Stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
    Zum Seitenanfang zurückkehren 

    Hilfe

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video