ID

38109

Description

Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Keywords

Versions (1)
  1. 9/18/19 9/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 18, 2019

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.

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

English

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
Dosing Date and Time
Description

Dosing Date and Time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date/time
Description

Vital Signs, Dosage, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Predose
Description

Predose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Actual time
Description

Vital signs, Pre-dose, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, Pre-dose

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439565
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, Pre-dose

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439565
mmHg
Heart rate
Description

Heart rate, Pre-dose

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439565
bpm
1 Hour post dose
Description

1 Hour post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
UMLS CUI-3
C1442450
Actual time
Description

Vital signs, Post-dose, 1 Hour, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, Post-dose, 1 Hour

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, Post-dose, 1 Hour

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
mmHg
Heart rate
Description

Heart rate, Post-dose, 1 Hour

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
bpm
2 Hours post dose
Description

2 Hours post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439572
Actual time
Description

Vital signs, 2 hours post-dose, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, 2 hours post-dose

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439572
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, 2 hours post-dose

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439572
mmHg
Heart rate
Description

Heart rate, 2 hours post-dose

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439572
bpm
4 Hours post dose
Description

4 Hours post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439574
Actual time
Description

Vital signs, 4 Hours post dose, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, 4 Hours post dose

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439574
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, 4 Hours post dose

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439574
mmHg
Heart rate
Description

Heart rate, 4 Hours post dose

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439574
bpm
6 Hours post dose
Description

6 Hours post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
UMLS CUI-3
C1292428
Actual time
Description

Vital signs, Post-dose, 6 Hours, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292428
UMLS CUI [1,4]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, Post-dose, 6 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292428
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, Post-dose, 6 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292428
mmHg
Heart rate
Description

Heart rate, Post-dose, 6 Hours

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292428
bpm
8 Hours post dose
Description

8 Hours post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
UMLS CUI-3
C1292429
Actual time
Description

Vital signs, Post-dose, 8 Hours, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, Post-dose, 8 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, Post-dose, 8 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
mmHg
Heart rate
Description

Heart rate, Post-dose, 8 Hours

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
bpm
10 Hours post dose
Description

10 Hours post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
UMLS CUI-3
C1442445
Actual time
Description

Vital signs, Post-dose, 10 Hours, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442445
UMLS CUI [1,4]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, Post-dose, 10 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442445
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, Post-dose, 10 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442445
mmHg
Heart rate
Description

Heart rate, Post-dose, 10 Hours

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442445
bpm
12 Hours post dose
Description

12 Hours post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
UMLS CUI-3
C1292430
Actual time
Description

Vital signs, Post-dose, 12 Hours, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, Post-dose, 12 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, Post-dose, 12 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
mmHg
Heart rate
Description

Heart rate, Post-dose, 12 Hours

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
bpm
24 Hours post dose
Description

24 Hours post dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
UMLS CUI-3
C1442770
Actual time
Description

Vital signs, Post-dose, 24 Hours, Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0040223
Blood pressure - systolic
Description

Systolic Pressure, Post-dose, 24 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
mmHg
Blood pressure - diastolic
Description

Diastolic blood pressure, Post-dose, 24 Hours

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
mmHg
Heart rate
Description

Heart rate, Post-dose, 24 Hours

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
bpm
Back to the top of the page

Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosing Date and Time
C0518766 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Vital Signs, Dosage, Date in time, Time
Item
Dosing date/time
datetime
C0518766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Predose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Vital signs, Pre-dose, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic Pressure, Pre-dose
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Diastolic blood pressure, Pre-dose
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Heart rate, Pre-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Item Group
1 Hour post dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1442450 (UMLS CUI-3)
Vital signs, Post-dose, 1 Hour, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Post-dose, 1 Hour
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
Diastolic blood pressure, Post-dose, 1 Hour
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
Heart rate, Post-dose, 1 Hour
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
Item Group
2 Hours post dose
C0518766 (UMLS CUI-1)
C0439572 (UMLS CUI-2)
Vital signs, 2 hours post-dose, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic Pressure, 2 hours post-dose
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
Diastolic blood pressure, 2 hours post-dose
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
Heart rate, 2 hours post-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
Item Group
4 Hours post dose
C0518766 (UMLS CUI-1)
C0439574 (UMLS CUI-2)
Vital signs, 4 Hours post dose, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic Pressure, 4 Hours post dose
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
Diastolic blood pressure, 4 Hours post dose
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
Heart rate, 4 Hours post dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
Item Group
6 Hours post dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1292428 (UMLS CUI-3)
Vital signs, Post-dose, 6 Hours, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292428 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Post-dose, 6 Hours
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292428 (UMLS CUI [1,3])
Diastolic blood pressure, Post-dose, 6 Hours
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292428 (UMLS CUI [1,3])
Heart rate, Post-dose, 6 Hours
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292428 (UMLS CUI [1,3])
Item Group
8 Hours post dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1292429 (UMLS CUI-3)
Vital signs, Post-dose, 8 Hours, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Post-dose, 8 Hours
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
Diastolic blood pressure, Post-dose, 8 Hours
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
Heart rate, Post-dose, 8 Hours
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
Item Group
10 Hours post dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1442445 (UMLS CUI-3)
Vital signs, Post-dose, 10 Hours, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442445 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Post-dose, 10 Hours
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442445 (UMLS CUI [1,3])
Diastolic blood pressure, Post-dose, 10 Hours
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442445 (UMLS CUI [1,3])
Heart rate, Post-dose, 10 Hours
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442445 (UMLS CUI [1,3])
Item Group
12 Hours post dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1292430 (UMLS CUI-3)
Vital signs, Post-dose, 12 Hours, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Post-dose, 12 Hours
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
Diastolic blood pressure, Post-dose, 12 Hours
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
Heart rate, Post-dose, 12 Hours
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
Item Group
24 Hours post dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1442770 (UMLS CUI-3)
Vital signs, Post-dose, 24 Hours, Time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Post-dose, 24 Hours
Item
Blood pressure - systolic
integer
C0871470 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
Diastolic blood pressure, Post-dose, 24 Hours
Item
Blood pressure - diastolic
integer
C0428883 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
Heart rate, Post-dose, 24 Hours
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
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