ID

36908

Descripción

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the smoking history form. It has to be filled in at screening.

Palabras clave

  1. 31/8/17 31/8/17 -
  2. 21/6/19 21/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de junio 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.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

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

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Smoking History

  1. StudyEvent: ODM
    1. Smoking History
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Descripción

Identification number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Smoking History
Descripción

Smoking History

Alias
UMLS CUI-1
C1519384
Is the subject a smoker?
Descripción

If you tick yes, please complete the smoking history in the following items

Tipo de datos

text

Alias
UMLS CUI [1]
C1519386
Number of years subject has been smoking?
Descripción

Number of years smoking

Tipo de datos

integer

Unidades de medida
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
years
Average number of cigarettes smoked per day?
Descripción

Number of cigarettes smoked per day

Tipo de datos

integer

Alias
UMLS CUI [1]
C3694146
Please state type of tobacco product
Descripción

(eg. pipe, cigar, chewing tobacco or cigarette)

Tipo de datos

text

Alias
UMLS CUI [1]
C3166496

Similar models

Smoking History

  1. StudyEvent: ODM
    1. Smoking History
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Smoking History
C1519384 (UMLS CUI-1)
Item
Is the subject a smoker?
text
C1519386 (UMLS CUI [1])
Code List
Is the subject a smoker?
CL Item
Yes (Y)
CL Item
No (N)
Number of years smoking
Item
Number of years subject has been smoking?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of cigarettes smoked per day
Item
Average number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1])
Tobacco product
Item
Please state type of tobacco product
text
C3166496 (UMLS CUI [1])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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