ID

34025

Beskrivning

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Nyckelord

Versioner (2)
  1. 2018-11-09 2018-11-09 -
  2. 2019-01-11 2019-01-11 -
Rättsinnehavare

GSK group of companies

Uppladdad den

11 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

Engelsk

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beskrivning

Patient Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date below is the start of the study for this subject
Beskrivning

Date below is the start of the study for this subject

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0008976
Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Beskrivning

Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C1516048
Were any concomitant medications taken by the subject during the study?
Beskrivning

Were any concomitant medications taken by the subject during the study?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject experience any adverse events during the study?
Beskrivning

Did the subject experience any adverse events during the study?

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Were any repeat ECGs performed?
Beskrivning

Were any repeat ECGs performed?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Did the subject have any abnormal ECGs during the study?
Beskrivning

Did the subject have any abnormal ECGs during the study?

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat vital signs recorded?
Beskrivning

Were any repeat vital signs recorded?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0031809
Were any repeat PK taken?
Beskrivning

Were any repeat PK taken?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0205341
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Similar models

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date below is the start of the study for this subject
Item
Date below is the start of the study for this subject
date
C0808070 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item Group
Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1516048 (UMLS CUI-3)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Did the subject experience any adverse events during the study?
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Did the subject have any abnormal ECGs during the study?
Item
Did the subject have any abnormal ECGs during the study?
boolean
C0522055 (UMLS CUI [1])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Were any repeat PK taken?
Item
Were any repeat PK taken?
boolean
C0031327 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Tillbaka till toppen 

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