ID

25426

Beschreibung

Study part: Vital Signs Week 1 Day 2. 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

Stichworte

Versionen (2)
  1. 03.09.17 03.09.17 -
  2. 18.06.19 18.06.19 -
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GlaxoSmithKline

Hochgeladen am

3. September 2017

DOI

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Vital Signs Week 1 Day 2 Ropinirole Restless Legs Syndrome 101468/201

Englisch

Vital Signs Week 1 Day 2

1 Formulare  
VITAL SIGNS
Beschreibung

VITAL SIGNS

Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Pre-dose Supine -Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Pre-dose Blood pressure Systolic Supine
Beschreibung

Systolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Pre-dose Blood pressure Diastolic Supine
Beschreibung

Diastolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Pre-dose Pulse Supine
Beschreibung

Pulse Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
Pre-dose Standing-Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Pre-dose Blood pressure Systolic Standing
Beschreibung

Systolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Pre-dose Blood pressure Diastolic Standing
Beschreibung

Diastolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Pre-dose Pulse Standing
Beschreibung

Pulse Standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+2 hrs Supine -Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
+2 hrs Blood pressure Systolic Supine
Beschreibung

Systolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+2 hrs Blood pressure Diastolic Supine
Beschreibung

Diastolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+2 hrs Pulse Supine
Beschreibung

Pulse Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+2 hrs Standing-Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
+2 hrs Blood pressure Systolic Standing
Beschreibung

Systolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+2 hrs Blood pressure Diastolic Standing
Beschreibung

Diastolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+2 hrs Pulse Standing
Beschreibung

Pulse Standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+6 hrs Supine -Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
+6 hrs Blood pressure Systolic Supine
Beschreibung

Systolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+6 hrs Blood pressure Diastolic Supine
Beschreibung

Diastolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+6 hrs Pulse Supine
Beschreibung

Pulse Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+6 hrs Standing-Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
+6 hrs Blood pressure Systolic Standing
Beschreibung

Systolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+6 hrs Blood pressure Diastolic Standing
Beschreibung

Diastolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+6 hrs Pulse Standing
Beschreibung

Pulse Standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+16 hrs Supine -Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
+16 hrs Blood pressure Systolic Supine
Beschreibung

Systolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+16 hrs Blood pressure Diastolic Supine
Beschreibung

Diastolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+16 hrs Pulse Supine
Beschreibung

Pulse Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+16 hrs Standing-Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
+16 hrs Blood pressure Systolic Standing
Beschreibung

Systolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+16 hrs Blood pressure Diastolic Standing
Beschreibung

Diastolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+16 hrs Pulse Standing
Beschreibung

Pulse Standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+24 hrs (prior to next dose) Supine -Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
+24 hrs (prior to next dose) Blood pressure Systolic Supine
Beschreibung

Systolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+24 hrs (prior to next dose) Blood pressure Diastolic Supine
Beschreibung

Diastolic Blood pressure Supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+24 hrs (prior to next dose) Pulse Supine
Beschreibung

Pulse Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+24 hrs (prior to next dose) Standing-Time
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
+24 hrs (prior to next dose) Blood pressure Systolic Standing
Beschreibung

Systolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+24 hrs (prior to next dose) Blood pressure Diastolic Standing
Beschreibung

Diastolic Blood pressure Standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+24 hrs (prior to next dose) Pulse Standing
Beschreibung

Pulse Standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
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Ähnliche Modelle

Vital Signs Week 1 Day 2

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
VITAL SIGNS
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
time
Item
Pre-dose Supine -Time
time
C0040223 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
Pre-dose Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
Pre-dose Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
Pre-dose Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
time
Item
Pre-dose Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
Pre-dose Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
Pre-dose Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
Pre-dose 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])
Diastolic Blood pressure Supine
Item
+2 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+2 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
+2 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+2 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])
Diastolic Blood pressure Supine
Item
+6 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+6 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
+6 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+6 hrs Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+16 hrs Supine -Time
time
C0040223 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+16 hrs Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+16 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+16 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
time
Item
+16 hrs Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+16 hrs Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+16 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+16 hrs Pulse Standing
integer
C2143221 (UMLS CUI [1])
time
Item
+24 hrs (prior to next dose) Supine -Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Supine
Item
+24 hrs (prior to next dose) Blood pressure Systolic Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure Supine
Item
+24 hrs (prior to next dose) Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+24 hrs (prior to next dose) Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
time
Item
+24 hrs (prior to next dose) Standing-Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure Standing
Item
+24 hrs (prior to next dose) Blood pressure Systolic Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Standing
Item
+24 hrs (prior to next dose) Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
+24 hrs (prior to next dose) Pulse Standing
integer
C2143221 (UMLS CUI [1])
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