ID

36876

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 Unscheduled Vital Signs and ECG Monitoring for Screening form. It has to be filled in if there is an unscheduled measurement of vital sings and/or ECG at Screening.

Keywords

Versions (1)
  1. 6/18/19 6/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 18, 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

Unscheduled Vital Signs and ECG Monitoring for Screening

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Description

Volunteer panel number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Unscheduled 12 Lead ECG Monitoring
Description

Unscheduled 12 Lead ECG Monitoring

Alias
UMLS CUI-1
C3854240
UMLS CUI-2
C0430456
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
Comment
Description

If the abnormality is clinically significant, please withdraw the subject.

Data type

text

Alias
UMLS CUI [1]
C0947611
Unscheduled Vital Signs
Description

Unscheduled Vital Signs

Alias
UMLS CUI-1
C3854240
UMLS CUI-2
C0518766
Body position for blood pressure measurement
Description

Supine pulse and blood pressure will be made after the subject has been resting supine for a period of at least 10 minutes. Standing pulse and blood pressure will be made after the subject has been standing for 1 minute after the supine measurements.

Data type

integer

Alias
UMLS CUI [1]
C1828063
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
Systolic Blood pressure
Description

Systolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Description

Diastolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
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Similar models

Unscheduled Vital Signs and ECG Monitoring for Screening

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer panel number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Unscheduled 12 Lead ECG Monitoring
C3854240 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
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)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Unscheduled Vital Signs
C3854240 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
Item
Body position for blood pressure measurement
integer
C1828063 (UMLS CUI [1])
Body position for blood pressure measurement
Code List
Body position for blood pressure measurement
CL Item
Supine (1)
CL Item
Standing (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
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