ID

25737

Descripción

ECG Monitoring - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Palabras clave

Versiones (1)
  1. 16/9/17 16/9/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

16 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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ECG Monitoring - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

Inglés

ECG Monitoring - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 formularios  
12 Lead ECG Monitoring
Descripción

12 Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Actual Date
Descripción

12 Lead ECG Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Actual Time
Descripción

12 Lead ECG Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
Pulse Rate
Descripción

Pulse Rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
PR
Descripción

PR

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Descripción

QRS

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Descripción

QT

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTc
Descripción

QTc

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal
Descripción

ECG normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522054
Rhythms of Concern
Descripción

Rhythms of Concern

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0871269
Continous ECG Monitoring
Descripción

Continous ECG Monitoring

Alias
UMLS CUI-1
C0420200
Monitoring Start Date
Descripción

Monitoring Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0808070
Monitoring Start Time
Descripción

Monitoring Start Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C1301880
Monitoring Stop Date
Descripción

Monitoring Stop Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0806020
Monitoring End Time
Descripción

Monitoring End Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C1522314
ECG normal
Descripción

ECG normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522054
Rhythms of Concern
Descripción

Rhythms of Concern

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0871269
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Similar models

ECG Monitoring - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
12 Lead ECG Monitoring
C0430456 (UMLS CUI-1)
12 Lead ECG Date
Item
Actual Date
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 Lead ECG Time
Item
Actual Time
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Pulse Rate
Item
Pulse Rate
integer
C0232117 (UMLS CUI [1])
PR
Item
PR
integer
C0429087 (UMLS CUI [1])
QRS
Item
QRS
integer
C1880451 (UMLS CUI [1])
QT
Item
QT
integer
C1880452 (UMLS CUI [1])
QTc
Item
QTc
integer
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal
boolean
C0522054 (UMLS CUI [1])
Item
Rhythms of Concern
integer
C0420200 (UMLS CUI [1,1])
C0871269 (UMLS CUI [1,2])
12 Lead ECG Finding
Code List
Rhythms of Concern
CL Item
A Fib, controlled V rate (1)
CL Item
A Flutter, 2:1 conduction (2)
CL Item
A Flutter, controlled VR (3)
Item Group
Continous ECG Monitoring
C0420200 (UMLS CUI-1)
Monitoring Start Date
Item
Monitoring Start Date
date
C0420200 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Monitoring Start Time
Item
Monitoring Start Time
time
C0420200 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Monitoring Stop Date
Item
Monitoring Stop Date
date
C0420200 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Monitoring End Time
Item
Monitoring End Time
time
C0420200 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
ECG normal
Item
ECG normal
boolean
C0522054 (UMLS CUI [1])
Item
Rhythms of Concern
integer
C0420200 (UMLS CUI [1,1])
C0871269 (UMLS CUI [1,2])
12 Lead ECG Finding
Code List
Rhythms of Concern
CL Item
A Fib, controlled V rate (1)
CL Item
A Flutter, 2:1 conduction (2)
CL Item
A Flutter, controlled VR (3)
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