0 Beoordelingen
ID

35516

Beschrijving

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Trefwoorden

Versies (1)
  1. 06-03-19 06-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

6 maart 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

    Engels

    Study Medication and Compliance Record

    1 Formulieren  
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Beschrijving

    Study Coordinating Center, Identification number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Beschrijving

    Person Initials

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2986440
    Study Medication Record
    Beschrijving

    Study Medication Record

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C2734539
    Study Med. Week No.
    Beschrijving

    Experimental drug, Week, Numbers

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0439230
    UMLS CUI [1,3]
    C0237753
    Is this a Dose Reduction?
    Beschrijving

    if ’No’, continue if ’Yes’, please complete theDose Reductions due to AE on page 64. Do not continue on this page for this visit.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    Dose Level (Specify 1 - 8)
    Beschrijving

    Experimental drug, Dosage, Level

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0441889
    Date First Dose
    Beschrijving

    Experimental drug, Medication dose, Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [1,3]
    C0808070
    Date Last Dose
    Beschrijving

    Experimental drug, Date last dose

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1762893
    Number of tablets dispensed
    Beschrijving

    Experimental Drug, Dispensed Amount

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0805077
    Number of tablets returned
    Beschrijving

    Experimental drug, Returned Amount

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C2699071
    Interruption of ≥ 2 consecutive days?
    Beschrijving

    Experimental drug, Interruption

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1512900
    Medication Labels
    Beschrijving

    Experimental Drug, Drug Labeling

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0013191
    Dose Reduction Due to Adverse Experiences
    Beschrijving

    Dose Reduction Due to Adverse Experiences

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1707814
    UMLS CUI-3
    C0877248
    Study Med. Week No.
    Beschrijving

    Experimental drug, Dose Reduced, Adverse Event, Week, Numbers

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0439230
    UMLS CUI [1,5]
    C0237753
    Dose Level (Specify 1 - 8)
    Beschrijving

    Experimental drug, Dose Reduced, Adverse Event, Dosage, Level

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0178602
    UMLS CUI [1,5]
    C0441889
    Date First Dose
    Beschrijving

    Experimental drug, Dose Reduced, Adverse Event, Medication dose, Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C3174092
    UMLS CUI [1,5]
    C0808070
    Date Last Dose
    Beschrijving

    Experimental drug, Dose Reduced, Adverse Event, Date last dose

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C1762893
    Number of tablets dispensed
    Beschrijving

    Experimental Drug, Dose Reduced, Adverse Event, Dispensed Amount

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0805077
    Number of tablets returned
    Beschrijving

    Experimental drug, Dose Reduced, Adverse Event, Returned Amount

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C2699071
    Interruption of ≥ 2 consecutive days?
    Beschrijving

    Experimental drug, Dose Reduced, Adverse Event, Interruption

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C1512900
    Medication Labels
    Beschrijving

    Experimental Drug, Dose Reduced, Adverse Event, Drug Labeling

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0013191
    Terug naar het begin van de pagina

    Similar models

    Study Medication and Compliance Record

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Centre Number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Clinical Trial Subject Unique Identifier
    Item
    Patient Number
    integer
    C2348585 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Study Medication Record
    C0304229 (UMLS CUI-1)
    C2734539 (UMLS CUI-2)
    Item
    Study Med. Week No.
    text
    C0304229 (UMLS CUI [1,1])
    C0439230 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Experimental drug, Week, Numbers
    Code List
    Study Med. Week No.
    CL Item
    Wk 1 (Days 1-2) (1)
    CL Item
    Wk 1 (Days 3-7) (2)
    CL Item
    Wk 2 (3)
    CL Item
    Wk 3 (4)
    CL Item
    Wk 4 (5)
    CL Item
    Wk 5 (6)
    CL Item
    Wk 6 (7)
    CL Item
    Wk 7 (8)
    CL Item
    Wk 8 (9)
    CL Item
    Wk 9 (10)
    CL Item
    Wk 10 (11)
    CL Item
    Wk 11 (12)
    CL Item
    Wk 12 (13)
    Experimental drug, Dose Reduced
    Item
    Is this a Dose Reduction?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    Experimental drug, Dosage, Level
    Item
    Dose Level (Specify 1 - 8)
    integer
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0441889 (UMLS CUI [1,3])
    Experimental drug, Medication dose, Start Date
    Item
    Date First Dose
    date
    C0304229 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Experimental drug, Date last dose
    Item
    Date Last Dose
    date
    C0304229 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    Experimental Drug, Dispensed Amount
    Item
    Number of tablets dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0805077 (UMLS CUI [1,2])
    Experimental drug, Returned Amount
    Item
    Number of tablets returned
    integer
    C2699071 (UMLS CUI [1,1])
    C2699071 (UMLS CUI [1,2])
    Experimental drug, Interruption
    Item
    Interruption of ≥ 2 consecutive days?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1512900 (UMLS CUI [1,2])
    Experimental Drug, Drug Labeling
    Item
    Medication Labels
    text
    C0304229 (UMLS CUI [1,1])
    C0013191 (UMLS CUI [1,2])
    Item Group
    Dose Reduction Due to Adverse Experiences
    C0304229 (UMLS CUI-1)
    C1707814 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Experimental drug, Dose Reduced, Adverse Event, Week, Numbers
    Item
    Study Med. Week No.
    text
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0439230 (UMLS CUI [1,4])
    C0237753 (UMLS CUI [1,5])
    Experimental drug, Dose Reduced, Adverse Event, Dosage, Level
    Item
    Dose Level (Specify 1 - 8)
    integer
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0178602 (UMLS CUI [1,4])
    C0441889 (UMLS CUI [1,5])
    Experimental drug, Dose Reduced, Adverse Event, Medication dose, Start Date
    Item
    Date First Dose
    date
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C3174092 (UMLS CUI [1,4])
    C0808070 (UMLS CUI [1,5])
    Experimental drug, Dose Reduced, Adverse Event, Date last dose
    Item
    Date Last Dose
    date
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C1762893 (UMLS CUI [1,4])
    Experimental Drug, Dose Reduced, Adverse Event, Dispensed Amount
    Item
    Number of tablets dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0805077 (UMLS CUI [1,4])
    Experimental drug, Dose Reduced, Adverse Event, Returned Amount
    Item
    Number of tablets returned
    integer
    C2699071 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C2699071 (UMLS CUI [1,4])
    Experimental drug, Dose Reduced, Adverse Event, Interruption
    Item
    Interruption of ≥ 2 consecutive days?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C1512900 (UMLS CUI [1,4])
    Experimental Drug, Dose Reduced, Adverse Event, Drug Labeling
    Item
    Medication Labels
    text
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0013191 (UMLS CUI [1,4])
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial