ID

38109

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.09.19 18.09.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

18. September 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

Englisch

Vital Signs

1 Formulare  
  1. StudyEvent: ODM
    1. Vital Signs
Dosing Date and Time
Beschreibung

Dosing Date and Time

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

Vital Signs, Dosage, Date in time, Time

Datentyp

datetime

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

Predose

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

Vital signs, Pre-dose, Time

Datentyp

time

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

Systolic Pressure, Pre-dose

Datentyp

integer

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

Diastolic blood pressure, Pre-dose

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439565
mmHg
Heart rate
Beschreibung

Heart rate, Pre-dose

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439565
bpm
1 Hour post dose
Beschreibung

1 Hour post dose

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

Vital signs, Post-dose, 1 Hour, Time

Datentyp

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
Beschreibung

Systolic Pressure, Post-dose, 1 Hour

Datentyp

integer

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

Diastolic blood pressure, Post-dose, 1 Hour

Datentyp

integer

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

Heart rate, Post-dose, 1 Hour

Datentyp

integer

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

2 Hours post dose

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

Vital signs, 2 hours post-dose, Time

Datentyp

time

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

Systolic Pressure, 2 hours post-dose

Datentyp

integer

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

Diastolic blood pressure, 2 hours post-dose

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439572
mmHg
Heart rate
Beschreibung

Heart rate, 2 hours post-dose

Datentyp

integer

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

4 Hours post dose

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

Vital signs, 4 Hours post dose, Time

Datentyp

time

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

Systolic Pressure, 4 Hours post dose

Datentyp

integer

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

Diastolic blood pressure, 4 Hours post dose

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0439574
mmHg
Heart rate
Beschreibung

Heart rate, 4 Hours post dose

Datentyp

integer

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

6 Hours post dose

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

Vital signs, Post-dose, 6 Hours, Time

Datentyp

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
Beschreibung

Systolic Pressure, Post-dose, 6 Hours

Datentyp

integer

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

Diastolic blood pressure, Post-dose, 6 Hours

Datentyp

integer

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

Heart rate, Post-dose, 6 Hours

Datentyp

integer

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

8 Hours post dose

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

Vital signs, Post-dose, 8 Hours, Time

Datentyp

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
Beschreibung

Systolic Pressure, Post-dose, 8 Hours

Datentyp

integer

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

Diastolic blood pressure, Post-dose, 8 Hours

Datentyp

integer

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

Heart rate, Post-dose, 8 Hours

Datentyp

integer

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

10 Hours post dose

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

Vital signs, Post-dose, 10 Hours, Time

Datentyp

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
Beschreibung

Systolic Pressure, Post-dose, 10 Hours

Datentyp

integer

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

Diastolic blood pressure, Post-dose, 10 Hours

Datentyp

integer

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

Heart rate, Post-dose, 10 Hours

Datentyp

integer

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

12 Hours post dose

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

Vital signs, Post-dose, 12 Hours, Time

Datentyp

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
Beschreibung

Systolic Pressure, Post-dose, 12 Hours

Datentyp

integer

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

Diastolic blood pressure, Post-dose, 12 Hours

Datentyp

integer

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

Heart rate, Post-dose, 12 Hours

Datentyp

integer

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

24 Hours post dose

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

Vital signs, Post-dose, 24 Hours, Time

Datentyp

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
Beschreibung

Systolic Pressure, Post-dose, 24 Hours

Datentyp

integer

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

Diastolic blood pressure, Post-dose, 24 Hours

Datentyp

integer

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

Heart rate, Post-dose, 24 Hours

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
bpm
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Ähnliche Modelle

Vital Signs

1 Formulare
  1. StudyEvent: ODM
    1. Vital Signs
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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