ID

25687

Beschrijving

Study part: Vital Signs. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. Phase: phase 3. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

Trefwoorden

Versies (2)
  1. 09-09-17 09-09-17 -
  2. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

9 september 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Vital Signs (VS) Ropinirole Restless Legs Syndrom NCT00355641

Engels

Vital Signs

1 Formulieren  
  1. StudyEvent: ODM
    1. Vital Signs
VITAL SIGNS
Beschrijving

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Dosing date/time
Beschrijving

date and time

Datatype

datetime

Alias
UMLS CUI [1]
C1717740
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
PRE-DOSE
Beschrijving

PRE-DOSE

Alias
UMLS CUI-1
C0439565
2. Actual date/time
Beschrijving

date and time

Datatype

datetime

Alias
UMLS CUI [1]
C1717740
3. Blood pressure - Semi-supine
Beschrijving

Blood pressure supine

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
4. Heart rate - Semi-supine
Beschrijving

Heart rate supine

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
5. Blood pressure - Standing
Beschrijving

Blood pressure - Standing

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0580945
mmHg
6. Heart rate - Standing
Beschrijving

Heart rate - Standing

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
2 HOURS POST-DOSE
Beschrijving

2 HOURS POST-DOSE

Alias
UMLS CUI-1
C0439568
7. Actual date/time
Beschrijving

date and time

Datatype

datetime

Alias
UMLS CUI [1]
C1717740
8. Blood pressure - Semi-supine
Beschrijving

Blood pressure supine

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
9. Heart rate - Semi-supine
Beschrijving

Heart rate supine

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
10. Blood pressure - Standing
Beschrijving

Blood pressure - Standing

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0580945
mmHg
11. Heart rate - Standing
Beschrijving

Heart rate - Standing

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
4 HOURS POST-DOSE
Beschrijving

4 HOURS POST-DOSE

Alias
UMLS CUI-1
C0439568
12. Actual date/time
Beschrijving

date and time

Datatype

datetime

Alias
UMLS CUI [1]
C1717740
13. Blood pressure - Semi-supine
Beschrijving

Blood pressure supine

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
14. Heart rate - Semi-supine
Beschrijving

Heart rate supine

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
15. Blood pressure - Standing
Beschrijving

Blood pressure - Standing

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0580945
mmHg
16. Heart rate - Standing
Beschrijving

Heart rate - Standing

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
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Similar models

Vital Signs

1 Formulieren
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
date and time
Item
Dosing date/time
datetime
C1717740 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
PRE-DOSE
C0439565 (UMLS CUI-1)
date and time
Item
2. Actual date/time
datetime
C1717740 (UMLS CUI [1])
Blood pressure supine
Item
3. Blood pressure - Semi-supine
text
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate supine
Item
4. Heart rate - Semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Blood pressure - Standing
Item
5. Blood pressure - Standing
text
C0580945 (UMLS CUI [1])
Heart rate - Standing
Item
6. Heart rate - Standing
integer
C2029905 (UMLS CUI [1])
Item Group
2 HOURS POST-DOSE
C0439568 (UMLS CUI-1)
date and time
Item
7. Actual date/time
datetime
C1717740 (UMLS CUI [1])
Blood pressure supine
Item
8. Blood pressure - Semi-supine
text
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate supine
Item
9. Heart rate - Semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Blood pressure - Standing
Item
10. Blood pressure - Standing
text
C0580945 (UMLS CUI [1])
Heart rate - Standing
Item
11. Heart rate - Standing
integer
C2029905 (UMLS CUI [1])
Item Group
4 HOURS POST-DOSE
C0439568 (UMLS CUI-1)
date and time
Item
12. Actual date/time
datetime
C1717740 (UMLS CUI [1])
Blood pressure supine
Item
13. Blood pressure - Semi-supine
text
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate supine
Item
14. Heart rate - Semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Blood pressure - Standing
Item
15. Blood pressure - Standing
text
C0580945 (UMLS CUI [1])
Heart rate - Standing
Item
16. Heart rate - Standing
integer
C2029905 (UMLS CUI [1])
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