ID

41018

Beschrijving

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Trefwoorden

Versies (1)
  1. 12-06-20 12-06-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 juni 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

Engels

Vital Signs

1 Formulieren  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Vital Signs (Screening)
Beschrijving

Vital Signs (Screening)

Alias
UMLS CUI-1
C0518766
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschrijving

Body mass index

Datatype

float

Maateenheden
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Vital Signs Date
Beschrijving

Vital Signs Date

Datatype

date

Alias
UMLS CUI [1]
C2826644
Vital Signs Actual Time
Beschrijving

Vital Signs Actual Time

Datatype

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure Semi-supine
Beschrijving

Systolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure Semi-supine
Beschrijving

Diastolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mm[Hg]
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs (Day 1-4)
Beschrijving

Vital Signs (Day 1-4)

Alias
UMLS CUI-1
C0518766
Vital Signs Date
Beschrijving

Vital Signs Date

Datatype

date

Alias
UMLS CUI [1]
C2826644
Vital Signs Actual Time
Beschrijving

Vital Signs Actual Time

Datatype

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure Semi-supine
Beschrijving

Systolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure Semi-supine
Beschrijving

Diastolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mm[Hg]
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs (Day 5)
Beschrijving

Vital Signs (Day 5)

Alias
UMLS CUI-1
C0518766
Vital Signs Date
Beschrijving

Vital Signs Date

Datatype

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Vital Signs Actual Time
Beschrijving

Vital Signs Actual Time

Datatype

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure Semi-supine
Beschrijving

Systolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure Semi-supine
Beschrijving

Diastolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mm[Hg]
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs (Unscheduled Assessments)
Beschrijving

Vital Signs (Unscheduled Assessments)

Alias
UMLS CUI-1
C0518766
Vital Signs Date
Beschrijving

Vital Signs Date

Datatype

date

Alias
UMLS CUI [1]
C2826644
Vital Signs Actual Time
Beschrijving

Vital Signs Actual Time

Datatype

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure Semi-supine
Beschrijving

Systolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure Semi-supine
Beschrijving

Diastolic Blood Pressure Semi-supine

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mm[Hg]
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Vital Signs

1 Formulieren
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Vital Signs (Screening)
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Vital Signs Actual Time
Item
Vital Signs Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure Semi-supine
Item
Systolic Blood Pressure Semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-supine
Item
Diastolic Blood Pressure Semi-supine
integer
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Day 1-4)
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Vital Signs Actual Time
Item
Vital Signs Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure Semi-supine
Item
Systolic Blood Pressure Semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-supine
Item
Diastolic Blood Pressure Semi-supine
integer
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Day 5)
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
8 hr (2)
CL Item
48 hr (3)
Vital Signs Actual Time
Item
Vital Signs Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure Semi-supine
Item
Systolic Blood Pressure Semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-supine
Item
Diastolic Blood Pressure Semi-supine
integer
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Unscheduled Assessments)
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Vital Signs Actual Time
Item
Vital Signs Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure Semi-supine
Item
Systolic Blood Pressure Semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-supine
Item
Diastolic Blood Pressure Semi-supine
integer
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
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