ID

37905

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. 8/29/19 8/29/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 29, 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

Logs and Repeats

1 forms  
  1. StudyEvent: ODM
    1. Logs and Repeats
Date of Visit/Assessment
Description

Date of Visit/Assessment

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

Date of visit, Assessment Date

Data type

date

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

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?
Description

Concomitant Agent

Data type

boolean

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

Adverse Event

Data type

boolean

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

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

Data type

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?
Description

Urinalysis, Sampling, Repeat

Data type

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?
Description

12 lead ECG, Repeat

Data type

boolean

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

12 lead ECG, Abnormality

Data type

boolean

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

Vital signs, Repeat

Data type

boolean

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

Pharmacokinetic aspects, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Back to the top of the page

Similar models

Logs and Repeats

1 forms
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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