ID
32675
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 (1)
- 11/12/18 11/12/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 12, 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
Serious Adverse Event Form
- StudyEvent: ODM
Description
Serious Adverse Event (SAE)
Description
Section 1
Description
Diagnosis only (if known) Otherwise Sign/Symptom e.g., Anaphylaxis
Data type
text
Description
Start Date
Data type
date
Description
Start Time
Data type
time
Description
Outcome
Data type
text
Description
If FATAL, record date of death
Data type
date
Description
End Time
Data type
time
Description
Maximum Intensity
Data type
text
Description
Action Taken with Investigational Product(s) as a Result of the SAE
Data type
text
Description
Complete Study Conclusion page anf check Adverse Event as a reason for withdrawal.
Data type
boolean
Description
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Data type
boolean
Description
Section 2 - Seriousness
Description
check YES for all that apply
Data type
text
Description
Results in death
Data type
boolean
Description
Is life-threatening
Data type
boolean
Description
Requires hospitalisation or prolongation of existing hospitalisation
Data type
boolean
Description
Results in disability/incapacity
Data type
boolean
Description
Congenital anomaly/birth defect
Data type
boolean
Description
Other, specify
Data type
text
Description
Section 3 - Demography Data
Description
Section 4
Description
Section 5 - Possible Causes of SAE
Description
check all that apply
Data type
integer
Description
If MEDICAL CONDITIONS, specify
Data type
text
Description
If OTHER, specify
Data type
text
Description
Section 6 - Relevant Medical Conditions
Description
specify all relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Data type
text
Description
Date of Onset
Data type
date
Description
Condition present at Time of the SAE
Data type
boolean
Description
If NO, Date of Last Occurrence
Data type
date
Description
Section 7 - Relevant Risk Factors
Description
Record other relevant risk factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Data type
text
Description
Section 8 - Relevant Concomitant Medications
Description
Trade name preferred e.g., Zantac
Data type
text
Description
Dose
Data type
float
Description
Unit
Data type
text
Description
Frequency
Data type
text
Description
Route
Data type
text
Description
Taken Prior to Study
Data type
boolean
Description
Start Date
Data type
date
Description
Stop Date
Data type
date
Description
Ongoing Medication
Data type
boolean
Description
e.g., Gastric ulcer
Data type
text
Description
Section 9 - Investigational Product
Description
Section 10 - Relevant Assessment
Description
Section 11 - Narrative Remarks
Description
Administrative data
Similar models
Serious Adverse Event Form
- StudyEvent: ODM
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