ID

33502

Description

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Keywords

  1. 11/8/18 11/8/18 -
  2. 12/11/18 12/11/18 -
  3. 12/11/18 12/11/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 11, 2018

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.

Itemgroup comments for :

Item comments for :

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

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

Vital Signs Form

  1. StudyEvent: ODM
    1. Vital Signs Form
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Sitting Vitals Signs
Description

Sitting Vitals Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0277814
Actual date
Description

Actual date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual time
Description

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Height
Description

Height

Data type

float

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

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

Body Mass Index

Data type

text

Alias
UMLS CUI [1]
C1305855
Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

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

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Supine Orthostatic Vitals Signs
Description

Supine Orthostatic Vitals Signs

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

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

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

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Sitting Orthostatic Vitals Signs
Description

Sitting Orthostatic Vitals Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0277814
Actual time
Description

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

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

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Standing Orthostatic Vitals Signs
Description

Standing Orthostatic Vitals Signs

Alias
UMLS CUI-1
C0231472
UMLS CUI-2
C0518766
Actual time
Description

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

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

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm

Similar models

Vital Signs Form

  1. StudyEvent: ODM
    1. Vital Signs Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Sitting Vitals Signs
C0518766 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
Actual date
Item
Actual date
date
C0011008 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
text
C1305855 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Supine Orthostatic Vitals Signs
C0038846 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Sitting Orthostatic Vitals Signs
C0518766 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Standing Orthostatic Vitals Signs
C0231472 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])

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

Fields marked with * are required.

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