ID

25734

Beschreibung

Physical exam, Vital signs, Health assessment - 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

Stichworte

Versionen (1)
  1. 16.09.17 16.09.17 -
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glaxoSmithKline

Hochgeladen am

16. September 2017

DOI

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Physical exam, Vital signs, Health assessment - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

Englisch

Physical exam, Vital signs, Health assessment - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 Formulare  
Physical Exam
Beschreibung

Physical Exam

Alias
UMLS CUI-1
C0031809
Exam Date
Beschreibung

Physical Examination Date

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Exam Time
Beschreibung

Physical Examination Time

Datentyp

time

Alias
UMLS CUI [1]
C2826761
Height
Beschreibung

Body height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Are there any clinically relevant findings for this subject?
Beschreibung

If "Yes" selected, please record the body system involved and the exam findings need to be recorded on the Adverse Event Form.

Datentyp

boolean

Alias
UMLS CUI [1]
C0037088
Body system
Beschreibung

Body system finding

Datentyp

text

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C1704258
Findings
Beschreibung

Finding physical examination

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
Vital signs (Supine position)
Beschreibung

Vital signs (Supine position)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0038846
Actual Date
Beschreibung

Date vital signs

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beschreibung

Time vital signs

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic blood pressure
Beschreibung

Systolic blood pressure supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Assessment - Tobacco history
Beschreibung

Assessment - Tobacco history

Alias
UMLS CUI-1
C1519384
Session day
Beschreibung

Examination day

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439228
Session hour
Beschreibung

Session hour

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439227
Session minute
Beschreibung

Session minute

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439232
Start Date
Beschreibung

Start date assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0549072
Start time
Beschreibung

Start time assessment

Datentyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0549072
Is subject a current or past smoker?
Beschreibung

current or past smoker

Datentyp

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C0337671
Smoke - Type
Beschreibung

smoke type

Datentyp

text

Alias
UMLS CUI [1]
C3166496
Smoke - Quantity
Beschreibung

tobacco use quantity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0425291
UMLS CUI [1,2]
C1265611
Smoke - Duration
Beschreibung

tobacco use duration

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0449238
Alcohol breath test
Beschreibung

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Session day
Beschreibung

Examination day

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439228
Session hour
Beschreibung

Session hour

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439227
Session minute
Beschreibung

Session minute

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439232
Start Date
Beschreibung

Start date assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0549072
Start time
Beschreibung

Start time assessment

Datentyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0549072
Alcohol breath test result
Beschreibung

Alcohol breath test result

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
%
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Ähnliche Modelle

Physical exam, Vital signs, Health assessment - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Physical Exam
C0031809 (UMLS CUI-1)
Physical Examination Date
Item
Exam Date
date
C2826643 (UMLS CUI [1])
Physical Examination Time
Item
Exam Time
time
C2826761 (UMLS CUI [1])
Body height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body weight
Item
Weight
float
C0005910 (UMLS CUI [1])
clinical findings
Item
Are there any clinically relevant findings for this subject?
boolean
C0037088 (UMLS CUI [1])
Body system finding
Item
Body system
text
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Finding physical examination
Item
Findings
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item Group
Vital signs (Supine position)
C0518766 (UMLS CUI-1)
C0038846 (UMLS CUI-2)
Date vital signs
Item
Actual Date
date
C0011008 (UMLS CUI [1])
Time vital signs
Item
Actual Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic blood pressure supine
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure supine
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Assessment - Tobacco history
C1519384 (UMLS CUI-1)
Examination day
Item
Session day
partialDate
C1883016 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Session hour
Item
Session hour
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Session minute
Item
Session minute
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Start date assessment
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0549072 (UMLS CUI [1,2])
Start time assessment
Item
Start time
time
C1301880 (UMLS CUI [1,1])
C0549072 (UMLS CUI [1,2])
current or past smoker
Item
Is subject a current or past smoker?
boolean
C3241966 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
smoke type
Item
Smoke - Type
text
C3166496 (UMLS CUI [1])
tobacco use quantity
Item
Smoke - Quantity
integer
C0425291 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
tobacco use duration
Item
Smoke - Duration
durationDatetime
C0543414 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
Alcohol breath test
C0202306 (UMLS CUI-1)
Examination day
Item
Session day
partialDate
C1883016 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Session hour
Item
Session hour
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Session minute
Item
Session minute
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Start date assessment
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0549072 (UMLS CUI [1,2])
Start time assessment
Item
Start time
time
C1301880 (UMLS CUI [1,1])
C0549072 (UMLS CUI [1,2])
Alcohol breath test result
Item
Alcohol breath test result
float
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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