ID

38109

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-09-18 2019-09-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 september 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

Vital Signs

1 Formulär  
  1. StudyEvent: ODM
    1. Vital Signs
Dosing Date and Time
Beskrivning

Dosing Date and Time

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

Vital Signs, Dosage, Date in time, Time

Datatyp

datetime

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

Predose

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

Vital signs, Pre-dose, Time

Datatyp

time

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

Systolic Pressure, Pre-dose

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439565
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, Pre-dose

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439565
mmHg
Heart rate
Beskrivning

Heart rate, Pre-dose

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439565
bpm
1 Hour post dose
Beskrivning

1 Hour post dose

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

Vital signs, Post-dose, 1 Hour, Time

Datatyp

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
Beskrivning

Systolic Pressure, Post-dose, 1 Hour

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, Post-dose, 1 Hour

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
mmHg
Heart rate
Beskrivning

Heart rate, Post-dose, 1 Hour

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
bpm
2 Hours post dose
Beskrivning

2 Hours post dose

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

Vital signs, 2 hours post-dose, Time

Datatyp

time

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

Systolic Pressure, 2 hours post-dose

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439572
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, 2 hours post-dose

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439572
mmHg
Heart rate
Beskrivning

Heart rate, 2 hours post-dose

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439572
bpm
4 Hours post dose
Beskrivning

4 Hours post dose

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

Vital signs, 4 Hours post dose, Time

Datatyp

time

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

Systolic Pressure, 4 Hours post dose

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439574
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, 4 Hours post dose

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439574
mmHg
Heart rate
Beskrivning

Heart rate, 4 Hours post dose

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439574
bpm
6 Hours post dose
Beskrivning

6 Hours post dose

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

Vital signs, Post-dose, 6 Hours, Time

Datatyp

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
Beskrivning

Systolic Pressure, Post-dose, 6 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292428
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, Post-dose, 6 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292428
mmHg
Heart rate
Beskrivning

Heart rate, Post-dose, 6 Hours

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292428
bpm
8 Hours post dose
Beskrivning

8 Hours post dose

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

Vital signs, Post-dose, 8 Hours, Time

Datatyp

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
Beskrivning

Systolic Pressure, Post-dose, 8 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, Post-dose, 8 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
mmHg
Heart rate
Beskrivning

Heart rate, Post-dose, 8 Hours

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
bpm
10 Hours post dose
Beskrivning

10 Hours post dose

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

Vital signs, Post-dose, 10 Hours, Time

Datatyp

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
Beskrivning

Systolic Pressure, Post-dose, 10 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442445
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, Post-dose, 10 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442445
mmHg
Heart rate
Beskrivning

Heart rate, Post-dose, 10 Hours

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442445
bpm
12 Hours post dose
Beskrivning

12 Hours post dose

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

Vital signs, Post-dose, 12 Hours, Time

Datatyp

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
Beskrivning

Systolic Pressure, Post-dose, 12 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, Post-dose, 12 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
mmHg
Heart rate
Beskrivning

Heart rate, Post-dose, 12 Hours

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
bpm
24 Hours post dose
Beskrivning

24 Hours post dose

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

Vital signs, Post-dose, 24 Hours, Time

Datatyp

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
Beskrivning

Systolic Pressure, Post-dose, 24 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
mmHg
Blood pressure - diastolic
Beskrivning

Diastolic blood pressure, Post-dose, 24 Hours

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
mmHg
Heart rate
Beskrivning

Heart rate, Post-dose, 24 Hours

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
bpm
Tillbaka till toppen

Similar models

Vital Signs

1 Formulär
  1. StudyEvent: ODM
    1. Vital Signs
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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