ID

36912

Beschrijving

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 and follow-up form.

Trefwoorden

Versies (2)
  1. 18-06-19 18-06-19 -
  2. 21-06-19 21-06-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

21 juni 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

Vital Signs and ECG Monitoring for Screening and Follow-up

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Beschrijving

Volunteer panel number

Datatype

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Study Visit
Beschrijving

Study Visit

Datatype

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0545082
12 LEAD ECG MONITORING
Beschrijving

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beschrijving

PR

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Beschrijving

QRS

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Beschrijving

QT

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Beschrijving

QTc

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Beschrijving

ECG normal

Datatype

text

Alias
UMLS CUI [1]
C0522054
Comment
Beschrijving

If the abnormality is clinically significant, please withdraw the subject

Datatype

text

Alias
UMLS CUI [1]
C0947611
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Body position for blood pressure measurement
Beschrijving

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.

Datatype

integer

Alias
UMLS CUI [1]
C1828063
Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood pressure
Beschrijving

Systolic Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Beschrijving

Diastolic Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Terug naar het begin van de pagina

Similar models

Vital Signs and ECG Monitoring for Screening and Follow-up

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Study Visit
integer
C0008972 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Study Visit
Code List
Study Visit
CL Item
Screening (1)
CL Item
Follow-up (2)
Item Group
12 LEAD ECG MONITORING
C0430456 (UMLS CUI-1)
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
Vital Signs
C0518766 (UMLS CUI-1)
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])
Terug naar het begin van de pagina 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial