0 Évaluations
ID

36118

Description

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 Form D. It can be filled in for the end of study.

Mots-clés

Versions (1)
  1. 15/04/2019 15/04/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

15 avril 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

    Anglais

    Form D

    1 Formulaires  
    1. StudyEvent: ODM
      1. Form D
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Description

    Panel ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    GSK Receipt Date
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Form D
    Description

    Form D

    Alias
    UMLS CUI-1
    C0011065 (Cessation of life)
    SNOMED
    419620001
    Certified Cause of Death
    Description

    Cause of Death

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0007465 (Cause of Death)
    SNOMED
    16100001
    LOINC
    LA10595-9
    Date of Death
    Description

    day month year Complete Adverse Event From.

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1148348 (Date of death)
    SNOMED
    399753006
    LOINC
    MTHU014693
    Was an autopsy done?
    Description

    Autopsy

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0004398 (Autopsy)
    SNOMED
    29240004
    LOINC
    LA20097-4
    UMLS CUI [1,2]
    C0884358 (Performed)
    SNOMED
    398166005
    LOINC
    LA19974-7
    If an autopsy was done, please summarize findings (include diagnosis)
    Description

    Autopsy findings

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0004398 (Autopsy)
    SNOMED
    29240004
    LOINC
    LA20097-4
    UMLS CUI [1,2]
    C0243095 (Finding)
    LOINC
    LA9042-8
    UMLS CUI [2,1]
    C0004398 (Autopsy)
    SNOMED
    29240004
    LOINC
    LA20097-4
    UMLS CUI [2,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Investigator's Signature
    Description

    Investigator's Signature

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date of signature
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Retour au début de la page

    Similar models

    Form D

    1 Formulaires
    1. StudyEvent: ODM
      1. Form D
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Date
    Item
    GSK Receipt Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Form D
    C0011065 (UMLS CUI-1)
    Cause of Death
    Item
    Certified Cause of Death
    text
    C0007465 (UMLS CUI [1])
    Date of Death
    Item
    Date of Death
    date
    C1148348 (UMLS CUI [1])
    Item
    Was an autopsy done?
    text
    C0004398 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Autopsy
    Code List
    Was an autopsy done?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Autopsy findings
    Item
    If an autopsy was done, please summarize findings (include diagnosis)
    text
    C0004398 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    C0004398 (UMLS CUI [2,1])
    C0011900 (UMLS CUI [2,2])
    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])
    Retour au début de la page 

    Aide

    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