ID
32636
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)
- 11/9/18 11/9/18 -
- 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
Logs and Repeats: Adverse Event
- StudyEvent: ODM
Description
Adverse Events
Description
Sequence Number
Data type
integer
Description
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Description
Modified Term
Data type
text
Description
Start Date
Data type
date
Description
Start Time
Data type
time
Description
Outcome
Data type
text
Description
if FATAL, Date of Death
Data type
date
Description
if FATAL, Time of Death
Data type
time
Description
Frequency
Data type
text
Description
Maximum Intensity
Data type
text
Description
Action Taken with Investigational Product(s) as a Result of the AE
Data type
text
Description
Did the subject withdraw from study as a result of this AE?
Data type
boolean
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Description
If YES, complete paper SAE form and fax to GSK Safety within 24 hr
Data type
boolean
Description
If YES, check all that apply
Data type
text
Description
If OTHER, specify
Data type
text
Description
Was the SAE caused by an activity related to study participation (e.g., procedures)?
Data type
boolean
Description
Serious Flag
Data type
text
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Logs and Repeats: Adverse Event
- StudyEvent: ODM