ID

25714

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

Keywords

  1. 9/12/17 9/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 12, 2017

DOI

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License

Creative Commons BY-NC 3.0

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final examination physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

final examination physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Description

focus panel

Data type

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Treatment
Description

treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Has there been any change from the last examination (screening)?
Description

If Yes, Record below. Any clinically relevant worsening since the last examination must be recorded on the Adverse Event page.

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Recording of changes in physical examination
Description

changes from last physical examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172

Similar models

final examination physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Has there been any change from the last examination (screening)?
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Code List
Has there been any change from the last examination (screening)?
CL Item
Yes (Yes)
CL Item
No (No)
changes from last physical examination
Item
Recording of changes in physical examination
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])

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