ID

25734

Description

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

Keywords

Versions (1)
  1. 9/16/17 9/16/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 16, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

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

1 forms  
Physical Exam
Description

Physical Exam

Alias
UMLS CUI-1
C0031809
Exam Date
Description

Physical Examination Date

Data type

date

Alias
UMLS CUI [1]
C2826643
Exam Time
Description

Physical Examination Time

Data type

time

Alias
UMLS CUI [1]
C2826761
Height
Description

Body height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Are there any clinically relevant findings for this subject?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0037088
Body system
Description

Body system finding

Data type

text

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

Finding physical examination

Data type

text

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

Vital signs (Supine position)

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

Date vital signs

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Time vital signs

Data type

time

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

Systolic blood pressure supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Assessment - Tobacco history
Description

Assessment - Tobacco history

Alias
UMLS CUI-1
C1519384
Session day
Description

Examination day

Data type

partialDate

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

Session hour

Data type

partialDatetime

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

Session minute

Data type

partialDatetime

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

Start date assessment

Data type

date

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

Start time assessment

Data type

time

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

current or past smoker

Data type

boolean

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

smoke type

Data type

text

Alias
UMLS CUI [1]
C3166496
Smoke - Quantity
Description

tobacco use quantity

Data type

integer

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

tobacco use duration

Data type

durationDatetime

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

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Session day
Description

Examination day

Data type

partialDate

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

Session hour

Data type

partialDatetime

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

Session minute

Data type

partialDatetime

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

Start date assessment

Data type

date

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

Start time assessment

Data type

time

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

Alcohol breath test result

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
%
Back to the top of the page

Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial