ID

40741

Beschrijving

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Trefwoorden

Versies (3)
  1. 06-05-20 06-05-20 -
  2. 06-05-20 06-05-20 -
  3. 08-05-20 08-05-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

6 mei 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Engels

Vital Signs

1 Formulieren  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Vital Signs - Pre-Dose
Beschrijving

Vital Signs - Pre-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Vital Signs - Date and Time
Beschrijving

Vital Signs - Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Vital Signs - Semi-supine BP Systolic
Beschrijving

Vital Signs - Semi-supine BP Systolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522019
mm[Hg]
Vital Signs - Semi-supine BP Diastolic
Beschrijving

Vital Signs - Semi-supine BP Diastolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522019
mm[Hg]
Vital Signs - Semi-supine Hear Rate
Beschrijving

Vital Signs - Semi-supine Hear Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
beats/min
Vital Signs - Time
Beschrijving

Vital Signs - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Vital Signs - Erect BP Systolic
Beschrijving

Vital Signs - Erect BP Systolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect BP Diastolic
Beschrijving

Vital Signs - Erect BP Diastolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect Heart Rate
Beschrijving

Vital Signs - Erect Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522014
beats/min
Vital Signs - Pre-Dose (Mean)
Beschrijving

Vital Signs - Pre-Dose (Mean)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
UMLS CUI-3
C0444504
Vital Signs - Semi-supine BP Systolic (Mean)
Beschrijving

Vital Signs - Semi-supine BP Systolic (Mean)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522019
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Semi-supine BP Diastolic (Mean)
Beschrijving

Vital Signs - Semi-supine BP Diastolic (Mean)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522019
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Semi-supine Hear Rate (Mean)
Beschrijving

Vital Signs - Semi-supine Hear Rate (Mean)

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
UMLS CUI [3]
C0444504
beats/min
Vital Signs - Erect BP Systolic (Mean)
Beschrijving

Vital Signs - Erect BP Systolic (Mean)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522014
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Erect BP Diastolic (Mean)
Beschrijving

Vital Signs - Erect BP Diastolic (Mean)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522014
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Erect Heart Rate (Mean)
Beschrijving

Vital Signs - Erect Heart Rate (Mean)

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522014
UMLS CUI [3]
C0444504
beats/min
Vital Signs Post-Dose
Beschrijving

Vital Signs Post-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
Vital Signs (Post-Dose) - Study Time
Beschrijving

Vital Signs (Post-Dose) - Study Time

Datatype

integer

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0439568
UMLS CUI [2,2]
C0040223
Vital Signs (Post-Dose) - Date and Time
Beschrijving

Vital Signs (Post-Dose) - Date and Time

Datatype

datetime

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0011008
UMLS CUI [3,2]
C0040223
Vital Signs (Post-Dose) - Semi-supine systolic blood pressure
Beschrijving

Vital Signs (Post-Dose) - Semi-supine systolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0522019
mm[Hg]
Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure
Beschrijving

Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0522019
mm[Hg]
Vital Signs (Post-Dose) - Semi-supine heart rate
Beschrijving

Vital Signs (Post-Dose) - Semi-supine heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0018810
UMLS CUI [3,2]
C0522019
beats/min
Vital Signs (Post-Dose) - Time
Beschrijving

Vital Signs (Post-Dose) - Time

Datatype

time

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3]
C0040223
Vital Signs (Post-Dose) - Erect systolic blood pressure
Beschrijving

Vital Signs (Post-Dose) - Erect systolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0522014
mm[Hg]
Vital Signs (Post-Dose) - Erect diastolic blood pressure
Beschrijving

Vital Signs (Post-Dose) - Erect diastolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0522014
mm[Hg]
Vital Signs (Post-Dose) - Erect heart rate
Beschrijving

Vital Signs (Post-Dose) - Erect heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0018810
UMLS CUI [3,2]
C0522014
beats/min
Terug naar het begin van de pagina

Similar models

Vital Signs

1 Formulieren
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs - Pre-Dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Vital Signs - Date and Time
Item
Vital Signs - Date and Time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Vital Signs - Semi-supine BP Systolic
Item
Vital Signs - Semi-supine BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine BP Diastolic
Item
Vital Signs - Semi-supine BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine Hear Rate
Item
Vital Signs - Semi-supine Hear Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Time
Item
Vital Signs - Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vital Signs - Erect BP Systolic
Item
Vital Signs - Erect BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect BP Diastolic
Item
Vital Signs - Erect BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect Heart Rate
Item
Vital Signs - Erect Heart Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Item Group
Vital Signs - Pre-Dose (Mean)
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0444504 (UMLS CUI-3)
Vital Signs - Semi-supine BP Systolic (Mean)
Item
Vital Signs - Semi-supine BP Systolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Semi-supine BP Diastolic (Mean)
Item
Vital Signs - Semi-supine BP Diastolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Semi-supine Hear Rate (Mean)
Item
Vital Signs - Semi-supine Hear Rate (Mean)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Erect BP Systolic (Mean)
Item
Vital Signs - Erect BP Systolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Erect BP Diastolic (Mean)
Item
Vital Signs - Erect BP Diastolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Erect Heart Rate (Mean)
Item
Vital Signs - Erect Heart Rate (Mean)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Item Group
Vital Signs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Vital Signs (Post-Dose) - Study Time
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Vital Signs (Post-Dose) - Study Time
Code List
Vital Signs (Post-Dose) - Study Time
CL Item
+0.5 hrs (1)
CL Item
+1 hr (2)
CL Item
+1.5 hrs (3)
CL Item
+2 hrs (4)
CL Item
+3 hrs (5)
Vital Signs (Post-Dose) - Date and Time
Item
Vital Signs (Post-Dose) - Date and Time
datetime
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0011008 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Semi-supine systolic blood pressure
Item
Vital Signs (Post-Dose) - Semi-supine systolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0522019 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure
Item
Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0428883 (UMLS CUI [3,1])
C0522019 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Semi-supine heart rate
Item
Vital Signs (Post-Dose) - Semi-supine heart rate
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0018810 (UMLS CUI [3,1])
C0522019 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Time
Item
Vital Signs (Post-Dose) - Time
time
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Vital Signs (Post-Dose) - Erect systolic blood pressure
Item
Vital Signs (Post-Dose) - Erect systolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0522014 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Erect diastolic blood pressure
Item
Vital Signs (Post-Dose) - Erect diastolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0428883 (UMLS CUI [3,1])
C0522014 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Erect heart rate
Item
Vital Signs (Post-Dose) - Erect heart rate
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0018810 (UMLS CUI [3,1])
C0522014 (UMLS CUI [3,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial