0 Evaluaciones
ID

36088

Descripción

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Baseline Sign and Symptom form. It has to be filled in for screening.

Palabras clave

Versiones (2)
  1. 15/4/19 15/4/19 -
  2. 15/4/19 15/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Inglés

    Baseline Sign and Symptom

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Descripción

    Subject No.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Descripción

    Panel ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    No event
    Descripción

    No event

    If no baseline events experienced, please mark box and sign form below.
    Descripción

    No baseline event experienced

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3846032
    UMLS CUI [1,2]
    C1442488
    Adverse Event
    Descripción

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Baseline Sign/Symptom
    Descripción

    Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to the subject: "How do you feel?" Provide the diagnosis NOT symptoms where possible. (One Baseline event per column)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    Onset Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985916
    Onset Time
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C0877248
    End Date
    Descripción

    day month year (If ongoing, please leave blank)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0877248
    End Time
    Descripción

    00:00-23:59 (If ongoing, please leave blank)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0877248
    Outcome of AE
    Descripción

    If subject died, please inform GSK within 24 hours and complete form D

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Event Course
    Descripción

    Event Course

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    If event course is intermittent, please note No. of Episodes
    Descripción

    No. of Episodes

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4086638
    Intensity of AE
    Descripción

    MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Relationship to Study Procedures performed prior to randomisation
    Descripción

    NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1510821
    Corrective Therapy
    Descripción

    If you tick yes, please record on Prior Medication form.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was the subject withdrawn due to this event?
    Descripción

    Subject withdrawn

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0422727
    Investigator's Signature:
    Descripción

    Investigator's Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Volver a la parte superior de la página

    Similar models

    Baseline Sign and Symptom

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    No event
    No baseline event experienced
    Item
    If no baseline events experienced, please mark box and sign form below.
    boolean
    C3846032 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Baseline Sign/Symptom
    Item
    Baseline Sign/Symptom
    text
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Onset Date
    Item
    Onset Date
    date
    C2985916 (UMLS CUI [1])
    Onset Time
    Item
    Onset Time
    time
    C0449244 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    End Time
    Item
    End Time
    time
    C1522314 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Outcome of AE
    integer
    C1705586 (UMLS CUI [1])
    Outcome of AE
    Code List
    Outcome of AE
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (2)
    Item
    Event Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Event Course
    Code List
    Event Course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    No. of Episodes
    Item
    If event course is intermittent, please note No. of Episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Intensity of AE
    integer
    C1710066 (UMLS CUI [1])
    Intensity of AE
    Code List
    Intensity of AE
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Relationship to Study Procedures performed prior to randomisation
    integer
    C0877248 (UMLS CUI [1,1])
    C1510821 (UMLS CUI [1,2])
    Relationship to Study Procedures
    Code List
    Relationship to Study Procedures performed prior to randomisation
    CL Item
    Not related (1)
    CL Item
    Unlikely (2)
    CL Item
    Suspected (reasonable possibility) (3)
    CL Item
    Probable (4)
    Item
    Corrective Therapy
    text
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Corrective Therapy
    Code List
    Corrective Therapy
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was the subject withdrawn due to this event?
    text
    C0422727 (UMLS CUI [1])
    Subject withdrawn
    Code List
    Was the subject withdrawn due to this event?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Investigator's Signature
    Item
    Investigator's Signature:
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Volver a la parte superior de la página 

    Ayuda

    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