ID

32635

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

Keywords

Versions (2)
  1. 11/9/18 11/9/18 -
  2. 1/11/19 1/11/19 -
Copyright Holder

GSK group of companies

Uploaded on

November 9, 2018

DOI

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License

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

English

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 forms  
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Patient
Description

Patient

Data type

text

Patient Number
Description

Patient Number

Data type

integer

Date of Visit/Assessment
Description

Date of Visit/Assessment

Date below is the start of the study for this subject
Description

Date below is the start of the study for this subject

Data type

date

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

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

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

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

Data type

boolean

Did the subject experience any adverse events during the study?
Description

Did the subject experience any adverse events during the study?

Data type

boolean

Were any repeat ECGs performed?
Description

Were any repeat ECGs performed?

Data type

boolean

Did the subject have any abnormal ECGs during the study?
Description

Did the subject have any abnormal ECGs during the study?

Data type

boolean

Were any repeat vital signs recorded?
Description

Were any repeat vital signs recorded?

Data type

boolean

Were any repeat PK taken?
Description

Were any repeat PK taken?

Data type

boolean

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Similar models

Logs and Repeats: Adverse Event and Concomitant Medication Questions

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Patient
Item
Patient
text
Patient Number
Item
Patient Number
integer
Item Group
Date of Visit/Assessment
Date below is the start of the study for this subject
Item
Date below is the start of the study for this subject
date
Item Group
Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
Did the subject experience any adverse events during the study?
Item
Did the subject experience any adverse events during the study?
boolean
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
Did the subject have any abnormal ECGs during the study?
Item
Did the subject have any abnormal ECGs during the study?
boolean
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
Were any repeat PK taken?
Item
Were any repeat PK taken?
boolean
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