ID

36893

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 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.

Trefwoorden

  1. 02-09-17 02-09-17 -
  2. 19-06-19 19-06-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

19 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.

Itemgroep Commentaren voor :

Item Commentaren voor :

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

12 LEAD ECG Monitoring 2

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Beschrijving

Study Week

Datatype

integer

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

Study Day

Datatype

integer

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

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Study Time
Beschrijving

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.

Datatype

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
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
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611

Similar models

12 LEAD ECG Monitoring 2

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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])
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])
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])
Code List
ECG normal?
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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