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Information:
Fel:
ID
26281
Beskrivning
Study part: Vital Signs Week 1 Day 1. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 1. 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: 101468/201. Clinical Study ID: 101468/201
Nyckelord
Versioner (2)
- 2017-10-15 2017-10-15 -
- 2019-06-18 2019-06-18 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 oktober 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Vital Signs Week 1 Day 1 Ropinirole Restless Legs Syndrome 101468/201
Similar models
Vital Signs Week 1 Day 1
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Time
Item
Supine- Time
time
C0040223 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
Systolic Blood pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
Diastolic Blood pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Time
Item
Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
Systolic Blood pressure Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
Diastolic Blood pressure Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+0.5 hr Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+0.5 hr Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+0.5 hr Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+0.5 hr Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
time
Item
+0.5 hr Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+0.5 hr Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+0.5 hr Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+0.5 hr Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+1 hr Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+1 hr Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+1 hr Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+1 hr Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
time
Item
+1 hr Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+1 hr Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+1 hr Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+1 hr Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+1.5 hrs Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+1.5 hrs Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+1.5 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+1.5 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
time
Item
+1.5 hrs Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+1.5 hrs Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+1.5 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+1.5 hrs Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+2 hrs Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+2 hrs Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+2 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+2 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
time
Item
+2 hrs Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+2 hrs Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+2 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+2 hrs Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+3 hrs Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+3 hrs Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+3 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+3 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
time
Item
+3 hrs Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+3 hrs Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+3 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+3 hrs Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+4 hrs Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+4 hrs Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+4 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+4 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
time
Item
+4 hrs Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+4 hrs Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+4 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+4 hrs Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+6 hrs Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+6 hrs Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+6 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+6 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
time
Item
+6 hrs Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+6 hrs Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+6 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+6 hrs Pulse Standing
integer
C2143221 (UMLS CUI [1])