ID

34025

Description

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

Mots-clés

Versions (2)
  1. 09/11/2018 09/11/2018 -
  2. 11/01/2019 11/01/2019 -
Détendeur de droits

GSK group of companies

Téléchargé le

11 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

Anglais

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Type de données

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Type de données

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Type de données

integer

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

Date of Visit/Assessment

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

Date below is the start of the study for this subject

Type de données

date

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

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?
Description

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

Type de données

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?
Description

Did the subject experience any adverse events during the study?

Type de données

boolean

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

Were any repeat ECGs performed?

Type de données

boolean

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

Did the subject have any abnormal ECGs during the study?

Type de données

boolean

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

Were any repeat vital signs recorded?

Type de données

boolean

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

Were any repeat PK taken?

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0205341
Retour au début de la page

Similar models

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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