ID

36394

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 Form D form. It has to be filled in if the subject dies during the study.

Palabras clave

Versiones (2)
  1. 8/9/17 8/9/17 -
  2. 10/5/19 10/5/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 de mayo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Inglés

Form D

1 formularios  
  1. StudyEvent: ODM
    1. Form D
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
FORM D
Descripción

FORM D

Alias
UMLS CUI-1
C1306577
Certified cause of death
Descripción

Complete Adverse Event Form

Tipo de datos

text

Alias
UMLS CUI [1]
C0007465
Date of death
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy done?
Descripción

Autopsy performance

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1518965
If an autopsy was performed, please summarize findings (including diagnosis)
Descripción

Findings autopsy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0004398
Physician’s signature
Descripción

Physician signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Date of signature
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Form D

1 formularios
  1. StudyEvent: ODM
    1. Form D
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
FORM D
C1306577 (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])
C1518965 (UMLS CUI [1,2])
Autopsy performance
Code List
Was an autopsy done?
CL Item
Yes (Y)
CL Item
No (N)
Findings autopsy
Item
If an autopsy was performed, please summarize findings (including diagnosis)
text
C0243095 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Physician signature
Item
Physician’s signature
text
C1519316 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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