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.

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

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License

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Form D

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

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
GSK Receipt Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Form D
Description

Form D

Alias
UMLS CUI-1
C0011065
Certified Cause of Death
Description

Cause of Death

Data type

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Description

day month year Complete Adverse Event From.

Data type

date

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

Autopsy

Data type

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0884358
If an autopsy was done, please summarize findings (include diagnosis)
Description

Autopsy findings

Data type

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
UMLS CUI [2,1]
C0004398
UMLS CUI [2,2]
C0011900
Investigator's Signature
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Description

day month year

Data type

date

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

Form D

1 forms
  1. StudyEvent: ODM
    1. Form D
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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