ID
42817
Beschrijving
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
Trefwoorden
Versies (4)
- 22-02-18 22-02-18 -
- 24-02-18 24-02-18 -
- 25-02-18 25-02-18 -
- 17-09-21 17-09-21 -
Houder van rechten
gsk
Geüploaded op
17 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
PREGNANCY INFORMATION
Beschrijving
PREGNANCY INFORMATION
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
If 'Yes' record details on Pregnancy Notification Form.
Datatype
text
Alias
- UMLS CUI [1]
- C3828490
Beschrijving
If 'Yes' record details on Pregnancy Notification Form.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0919624
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008972
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Beschrijving
John Hopkins RLS Quality of Life questionnaire
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0679830
- UMLS CUI [1,4]
- C0035258
Beschrijving
MEDICAL OUTCOMES STUDY SLEEP SCALE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0449820
- UMLS CUI [1,2]
- C0037313
Beschrijving
Profile of mood states
Datatype
text
Alias
- UMLS CUI [1]
- C0451394
Beschrijving
Hospital anxiety and depression scale
Datatype
text
Alias
- UMLS CUI [1]
- C3539657
Beschrijving
Pittsburgh Sleep quality index
Datatype
text
Alias
- UMLS CUI [1]
- C0424563
Beschrijving
Patient global improvement scale
Datatype
text
Alias
- UMLS CUI [1]
- C0451125
Beschrijving
PATIENT SATISFACTION QUESTION
Datatype
text
Alias
- UMLS CUI [1]
- C3476649
Beschrijving
Serious Adverse Event
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
If yes, please give the total number of SAE's:
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beschrijving
elimination criteria
Datatype
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
elimination criteria
Datatype
text
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
withdrawn
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Beschrijving
If Yes, please specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Beschrijving
If Serious adverse event, please specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
If Non-serious adverse event, please specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Protocol violation
Datatype
text
Alias
- UMLS CUI [1]
- C1709750
Beschrijving
If Other, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Beschrijving
reason for withdrawal
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Beschrijving
Date of last contact
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Beschrijving
subject condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beschrijving
Investigators signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigators signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Beschrijving
RLS Symptoms on the first day of the patient
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0035258
Beschrijving
From 07:00 on the morning to 06:59 of the next morning.
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
time medication intake
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1512806
Beschrijving
Symptoms RLS
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0035258
Beschrijving
time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
time fall sleep
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C3830397
Beschrijving
time wake up
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1170730
Beschrijving
site
Datatype
integer
Alias
- UMLS CUI [1]
- C1515974
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
RLS Symptoms on the first day of the patient
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0035258
Beschrijving
From 07:00 on the morning to 06:59 of the next morning.
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
time medication intake
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1512806
Beschrijving
Symptoms RLS
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0035258
Beschrijving
time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
time fall sleep
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C3830397
Beschrijving
time wake up
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1170730
Beschrijving
site
Datatype
integer
Alias
- UMLS CUI [1]
- C1515974
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
Beschrijving
time frame
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332168
Beschrijving
symptom severity
Datatype
text
Alias
- UMLS CUI [1]
- C1319166
Beschrijving
symptom Beginning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0439659
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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)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
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])