ID
29110
Description
Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage
Keywords
Versions (4)
- 2/22/18 2/22/18 -
- 2/24/18 2/24/18 -
- 2/25/18 2/25/18 -
- 9/17/21 9/17/21 -
Copyright Holder
gsk
Uploaded on
February 25, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
PREGNANCY INFORMATION
Description
PREGNANCY INFORMATION
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
If 'Yes' record details on Pregnancy Notification Form.
Data type
text
Alias
- UMLS CUI [1]
- C3828490
Description
If 'Yes' record details on Pregnancy Notification Form.
Data type
text
Alias
- UMLS CUI [1,1]
- C0919624
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008972
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Description
John Hopkins RLS Quality of Life questionnaire
Data type
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0679830
- UMLS CUI [1,4]
- C0035258
Description
MEDICAL OUTCOMES STUDY SLEEP SCALE
Data type
integer
Alias
- UMLS CUI [1,1]
- C0449820
- UMLS CUI [1,2]
- C0037313
Description
Profile of mood states
Data type
text
Alias
- UMLS CUI [1]
- C0451394
Description
Hospital anxiety and depression scale
Data type
text
Alias
- UMLS CUI [1]
- C3539657
Description
Pittsburgh Sleep quality index
Data type
text
Alias
- UMLS CUI [1]
- C0424563
Description
Patient global improvement scale
Data type
text
Alias
- UMLS CUI [1]
- C0451125
Description
PATIENT SATISFACTION QUESTION
Data type
text
Alias
- UMLS CUI [1]
- C3476649
Description
Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
If yes, please give the total number of SAE's:
Data type
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Description
elimination criteria
Data type
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
elimination criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
withdrawn
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Description
If Yes, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Description
If Serious adverse event, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
If Non-serious adverse event, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Protocol violation
Data type
text
Alias
- UMLS CUI [1]
- C1709750
Description
If Other, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Description
reason for withdrawal
Data type
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Description
Date of last contact
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Description
subject condition
Data type
integer
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Description
Investigators signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigators signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Description
RLS Symptoms on the first day of the patient
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0035258
Description
From 07:00 on the morning to 06:59 of the next morning.
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
medication
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
time medication intake
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1512806
Description
Symptoms RLS
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0035258
Description
time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
time fall sleep
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C3830397
Description
time wake up
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1170730
Description
site
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
RLS Symptoms on the first day of the patient
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0035258
Description
From 07:00 on the morning to 06:59 of the next morning.
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
medication
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
time medication intake
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1512806
Description
Symptoms RLS
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0035258
Description
time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
time fall sleep
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C3830397
Description
time wake up
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1170730
Description
site
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Description
time frame
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
symptom severity
Data type
text
Alias
- UMLS CUI [1]
- C1319166
Description
symptom Beginning
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Similar models
PREGNANCY INFORMATION
C0030695 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0034380 (UMLS CUI [1,2])
C0679830 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
C0037313 (UMLS CUI [1,2])
(Comment:en)
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C1519255 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1705415 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C0035258 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C3830397 (UMLS CUI [1,2])
C1170730 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0035258 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C3830397 (UMLS CUI [1,2])
C1170730 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])