ID

25368

Description

Study part: 12 LEAD ECG Monitoring 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. 9/2/17 9/2/17 -
  2. 6/19/19 6/19/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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12 LEAD ECG Monitoring Week 1 Day 1 Ropinirole Restless Legs Syndrome 101468/201

English

12 LEAD ECG Monitoring Week 1 Day 1

1 forms  
12 LEAD ECG MONITORING
Description

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Pre-dose- Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
+0.5 hr - Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
+1 hr - Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
+1.5 hrs - Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
+2 hrs - Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
+3 hrs - Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
+4 hrs - Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
+6 hrs - Actual Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

12 LEAD ECG Monitoring Week 1 Day 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12 LEAD ECG MONITORING
C0430456 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Time
Item
Pre-dose- Actual Time
time
C0040223 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
+0.5 hr - Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
+1 hr - Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
+1.5 hrs - Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
+2 hrs - Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
+3 hrs - Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
+4 hrs - Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
+6 hrs - Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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