ID

32635

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

9 november 2018

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

Site
Beskrivning

Site

Datatyp

text

Patient
Beskrivning

Patient

Datatyp

text

Patient Number
Beskrivning

Patient Number

Datatyp

integer

Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

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

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

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

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

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

Did the subject experience any adverse events during the study?

Datatyp

boolean

Were any repeat ECGs performed?
Beskrivning

Were any repeat ECGs performed?

Datatyp

boolean

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

Did the subject have any abnormal ECGs during the study?

Datatyp

boolean

Were any repeat vital signs recorded?
Beskrivning

Were any repeat vital signs recorded?

Datatyp

boolean

Were any repeat PK taken?
Beskrivning

Were any repeat PK taken?

Datatyp

boolean

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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
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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