ID

43573

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 for internal use, not to be databased

Keywords

Versions (3)
  1. 9/12/17 9/12/17 -
  2. 9/12/17 9/12/17 -
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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visit period 1,2,3 & 4 baseline/adverse event checklist PK and tolerability of ropinirole as 5 new formulations 101468/197

English

visit period 1,2,3 & 4 baseline/adverse event checklist PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms  
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
Number of Visit
Description

visit number

Data type

text

Alias
UMLS CUI [1]
C1549755
Treatment
Description

treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
baseline/adverse event checklist
Description

baseline/adverse event checklist

Alias
UMLS CUI-1
C0877248
Time relative to start of dose
Description

time relative to start of dose

Data type

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3174092
Actual Date and Time
Description

date and time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Any Events?
Description

adverse events

Data type

text

Alias
UMLS CUI [1]
C0877248
Initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
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Similar models

visit period 1,2,3 & 4 baseline/adverse event checklist PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms
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])
Item
Number of Visit
text
C1549755 (UMLS CUI [1])
visit number
Code List
Number of Visit
CL Item
Period 1 Day 1-2 (Period 1 Day 1-2)
CL Item
Period 2 Day 1-2 (Period 2 Day 1-2)
CL Item
Period 3 Day 1-2 (Period 3 Day 1-2)
CL Item
Period 4 Day 1-2 (Period 4 Day 1-2)
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
baseline/adverse event checklist
C0877248 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0040223 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
time relative to start of dose
Code List
Time relative to start of dose
CL Item
pre (Day 1) (pre)
CL Item
+1h (Day 1) (+1h)
CL Item
+4hrs (Day 1) (+4hrs)
CL Item
+12 hrs (Day 1) (+12hrs)
CL Item
+24 hrs (Day 2) (+24 hrs)
CL Item
+36 hrs (Day 2) (+36 hrs)
date and time
Item
Actual Date and Time
datetime
C1264639 (UMLS CUI [1])
Item
Any Events?
text
C0877248 (UMLS CUI [1])
adverse events
Code List
Any Events?
CL Item
Yes (Yes)
CL Item
No (No)
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
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