ID

34025

Beschrijving

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

Trefwoorden

Versies (2)
  1. 09-11-18 09-11-18 -
  2. 11-01-19 11-01-19 -
Houder van rechten

GSK group of companies

Geüploaded op

11 januari 2019

DOI

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Licentie

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

Engels

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Beschrijving

Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschrijving

Patient Number

Datatype

integer

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

Date of Visit/Assessment

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

Date below is the start of the study for this subject

Datatype

date

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

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?
Beschrijving

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

Datatype

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?
Beschrijving

Did the subject experience any adverse events during the study?

Datatype

boolean

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

Were any repeat ECGs performed?

Datatype

boolean

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

Did the subject have any abnormal ECGs during the study?

Datatype

boolean

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

Were any repeat vital signs recorded?

Datatype

boolean

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

Were any repeat PK taken?

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

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