ID

37905

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. 29.08.19 29.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. August 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

Logs and Repeats

1 Formulare  
  1. StudyEvent: ODM
    1. Logs and Repeats
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschreibung

Date of visit, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Beschreibung

Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C0220825
Were any concomitant medications taken by the subject during the study?
Beschreibung

Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any adverse events during the study?
Beschreibung

Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Were any repeat hematology or clinical chemistry samples taken?
Beschreibung

Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0870078
UMLS CUI [2,3]
C0205341
Were any repeat urinalysis samples taken?
Beschreibung

Urinalysis, Sampling, Repeat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Were any repeat/unscheduled 12-Lead ECGs performed?
Beschreibung

12 lead ECG, Repeat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205341
Were there 12-Lead ECGs, Holter or Telemetry abnormalities recorded?
Beschreibung

12 lead ECG, Abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
Were any repeat/unscheduled vital signs recorded?
Beschreibung

Vital signs, Repeat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat/unscheduled PKs samples taken?
Beschreibung

Pharmacokinetic aspects, Sampling, Repeat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
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Ähnliche Modelle

Logs and Repeats

1 Formulare
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Concomitant Agent
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Adverse Event
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat
Item
Were any repeat hematology or clinical chemistry samples taken?
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Urinalysis, Sampling, Repeat
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
12 lead ECG, Repeat
Item
Were any repeat/unscheduled 12-Lead ECGs performed?
boolean
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Item
Were there 12-Lead ECGs, Holter or Telemetry abnormalities recorded?
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Vital signs, Repeat
Item
Were any repeat/unscheduled vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic aspects, Sampling, Repeat
Item
Were any repeat/unscheduled PKs samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
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