ID

26281

Description

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

Keywords

Versions (2)
  1. 10/15/17 10/15/17 -
  2. 6/18/19 6/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 15, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Vital Signs Week 1 Day 1 Ropinirole Restless Legs Syndrome 101468/201

English

Vital Signs Week 1 Day 1

1 forms  
Vital Signs Pre-dose
Description

Vital Signs Pre-dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Supine- Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Systolic Blood pressure Supine
Description

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood pressure Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
Standing-Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood pressure Standing
Description

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Diastolic Blood pressure Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
VITAL SIGNS
Description

VITAL SIGNS

+0.5 hr Supine -Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+0.5 hr Blood pressure Systolic Supine
Description

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+0.5 hr Blood pressure Diastolic Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+0.5 hr Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+0.5 hr Standing-Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+0.5 hr Blood pressure Systolic Standing
Description

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+0.5 hr Blood pressure Diastolic Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+0.5 hr Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+1 hr Supine -Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+1 hr Blood pressure Systolic Supine
Description

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+1 hr Blood pressure Diastolic Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+1 hr Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+1 hr Standing-Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+1 hr Blood pressure Systolic Standing
Description

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+1 hr Blood pressure Diastolic Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+1 hr Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+1.5 hrs Supine -Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+1.5 hrs Blood pressure Systolic Supine
Description

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+1.5 hrs Blood pressure Diastolic Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+1.5 hrs Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+1.5 hrs Standing-Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+1.5 hrs Blood pressure Systolic Standing
Description

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+1.5 hrs Blood pressure Diastolic Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+1.5 hrs Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+2 hrs Supine -Time
Description

time

Data type

time

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

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+2 hrs Blood pressure Diastolic Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+2 hrs Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+2 hrs Standing-Time
Description

time

Data type

time

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

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+2 hrs Blood pressure Diastolic Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+2 hrs Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+3 hrs Supine -Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+3 hrs Blood pressure Systolic Supine
Description

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+3 hrs Blood pressure Diastolic Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+3 hrs Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+3 hrs Standing-Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+3 hrs Blood pressure Systolic Standing
Description

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+3 hrs Blood pressure Diastolic Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+3 hrs Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+4 hrs Supine -Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+4 hrs Blood pressure Systolic Supine
Description

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+4 hrs Blood pressure Diastolic Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+4 hrs Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+4 hrs Standing-Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
+4 hrs Blood pressure Systolic Standing
Description

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+4 hrs Blood pressure Diastolic Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+4 hrs Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
+6 hrs Supine -Time
Description

time

Data type

time

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

Systolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
+6 hrs Blood pressure Diastolic Supine
Description

Diastolic Blood pressure Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
+6 hrs Pulse Supine
Description

Pulse Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
+6 hrs Standing-Time
Description

time

Data type

time

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

Systolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
+6 hrs Blood pressure Diastolic Standing
Description

Diastolic Blood pressure Standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
+6 hrs Pulse Standing
Description

Pulse Standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2143221
bpm
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Similar models

Vital Signs Week 1 Day 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital Signs Pre-dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
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])
Diastolic Blood pressure Supine
Item
Diastolic Blood pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
Diastolic Blood pressure Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Pulse Standing
Item
Pulse Standing
integer
C2143221 (UMLS CUI [1])
Item Group
VITAL SIGNS
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])
Diastolic Blood pressure Supine
Item
+0.5 hr Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+0.5 hr Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
+0.5 hr Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Supine
Item
+1 hr Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+1 hr Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
+1 hr Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Supine
Item
+1.5 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+1.5 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
+1.5 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
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])
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
+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])
Diastolic Blood pressure Supine
Item
+3 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+3 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
+3 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Supine
Item
+4 hrs Blood pressure Diastolic Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Pulse Supine
Item
+4 hrs Pulse Supine
integer
C0232117 (UMLS CUI [1,1])
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])
Diastolic Blood pressure Standing
Item
+4 hrs Blood pressure Diastolic Standing
integer
C0428883 (UMLS CUI [1,1])
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])
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])
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