ID

36893

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: 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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the 12 LEAD ECG Monitoring 2 form. It has to be filled in for Day 2, Day 3, Day 4, Day 5, Day 7, Day 9, Day 10, Day 11, Day 13, Day 14, Day 16, Day 17 and Day 18.

Keywords

Versions (2)
  1. 9/2/17 9/2/17 -
  2. 6/19/19 6/19/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 19, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

12 LEAD ECG Monitoring 2

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Description

Study Week

Data type

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study Day
Description

Study Day

Data type

integer

Alias
UMLS CUI [1]
C2826182
12 LEAD ECG MONITORING
Description

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Study Time
Description

Note: Pre-dose only has to be measured for Day 2, Day 7, Day 9, Day 13, Day 16. Timing +24 hrs has to be measured prior to next dose.

Data type

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

00:00-23:59

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

text

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 2

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study Week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Study Week
Code List
Study Week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 2 (1)
CL Item
Day 3 (2)
CL Item
Day 4 (3)
CL Item
Day 5 (4)
CL Item
Day 7 (5)
CL Item
Day 9 (6)
CL Item
Day 10 (7)
CL Item
Day 11 (8)
CL Item
Day 13 (9)
CL Item
Day 14 (10)
CL Item
Day 16 (11)
CL Item
Day 17 (12)
CL Item
Day 18 (13)
Item Group
12 LEAD ECG MONITORING
C0430456 (UMLS CUI-1)
Item
Study Time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study Time
Code List
Study Time
CL Item
Pre-dose  (1)
CL Item
+2 hrs  (2)
CL Item
+6 hrs  (3)
CL Item
+16 hrs (4)
CL Item
+24 hrs (5)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
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])
Item
ECG normal?
text
C0522054 (UMLS CUI [1])
ECG normal
Code List
ECG normal?
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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