Information: Detta är inte den senaste versionen av datamodellen. Du hittar en versionsöversikt till vänster under versioner. Den senaste versionen hittar du här.
Information:
Fel:
ID
25368
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-09-02 2017-09-02 -
- 2019-06-19 2019-06-19 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 september 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
12 LEAD ECG Monitoring Week 1 Day 1 Ropinirole Restless Legs Syndrome 101468/201
12 LEAD ECG Monitoring Week 1 Day 1
- StudyEvent: ODM
Similar models
12 LEAD ECG Monitoring Week 1 Day 1
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])