ID

34025

Descrição

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

Palavras-chave

Versões (2)
  1. 09/11/2018 09/11/2018 -
  2. 11/01/2019 11/01/2019 -
Titular dos direitos

GSK group of companies

Transferido a

11 de janeiro de 2019

DOI

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Licença

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

Inglês

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Descrição

Site

Tipo de dados

text

Alias
UMLS CUI [1]
C2825164
Patient
Descrição

Patient

Tipo de dados

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Descrição

Patient Number

Tipo de dados

integer

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

Date of Visit/Assessment

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

Date below is the start of the study for this subject

Tipo de dados

date

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

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?
Descrição

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

Tipo de dados

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?
Descrição

Did the subject experience any adverse events during the study?

Tipo de dados

boolean

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

Were any repeat ECGs performed?

Tipo de dados

boolean

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

Did the subject have any abnormal ECGs during the study?

Tipo de dados

boolean

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

Were any repeat vital signs recorded?

Tipo de dados

boolean

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

Were any repeat PK taken?

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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