ID

25737

Beschrijving

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

Trefwoorden

  1. 16-09-17 16-09-17 -
Houder van rechten

glaxoSmithKline

Geüploaded op

16 september 2017

DOI

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Licentie

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

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

12 Lead ECG Monitoring
Beschrijving

12 Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Actual Date
Beschrijving

12 Lead ECG Date

Datatype

date

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

12 Lead ECG Time

Datatype

time

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

Pulse Rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
PR
Beschrijving

PR

Datatype

integer

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

QRS

Datatype

integer

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

QT

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTc
Beschrijving

QTc

Datatype

integer

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

ECG normal

Datatype

boolean

Alias
UMLS CUI [1]
C0522054
Rhythms of Concern
Beschrijving

Rhythms of Concern

Datatype

integer

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

Continous ECG Monitoring

Alias
UMLS CUI-1
C0420200
Monitoring Start Date
Beschrijving

Monitoring Start Date

Datatype

date

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

Monitoring Start Time

Datatype

time

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

Monitoring Stop Date

Datatype

date

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

Monitoring End Time

Datatype

time

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

ECG normal

Datatype

boolean

Alias
UMLS CUI [1]
C0522054
Rhythms of Concern
Beschrijving

Rhythms of Concern

Datatype

integer

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

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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])
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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