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)
  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

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

Adverse Events
Description

Adverse Events

Sequence Number
Description

Sequence Number

Data type

integer

Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Event Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Modified Term
Description

Modified Term

Data type

text

Start Date
Description

Start Date

Data type

date

Start Time
Description

Start Time

Data type

time

Outcome
Description

Outcome

Data type

text

End Date
Description

if FATAL, Date of Death

Data type

date

End Time
Description

if FATAL, Time of Death

Data type

time

Frequency
Description

Frequency

Data type

text

Maximum Intensity
Description

Maximum Intensity

Data type

text

Action Taken with Investigational Product(s) as a Result of the AE
Description

Action Taken with Investigational Product(s) as a Result of the AE

Data type

text

Did the subject withdraw from study as a result of this AE?
Description

Did the subject withdraw from study as a result of this AE?

Data type

boolean

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Data type

boolean

Does the AE meet the definition of serious?
Description

If YES, complete paper SAE form and fax to GSK Safety within 24 hr

Data type

boolean

If YES, check all that apply
Description

If YES, check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

text

Was the SAE caused by an activity related to study participation (e.g., procedures)?
Description

Was the SAE caused by an activity related to study participation (e.g., procedures)?

Data type

boolean

Serious Flag
Description

Serious Flag

Data type

text

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Similar models

Logs and Repeats: Adverse Event

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
Adverse Events
Sequence Number
Item
Sequence Number
integer
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
Modified Term
Item
Modified Term
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not reslved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
End Time
Item
End Time
time
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Does the AE meet the definition of serious?
Item
Does the AE meet the definition of serious?
boolean
Item
If YES, check all that apply
text
If YES, check all that apply
Code List
If YES, check all that apply
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other (6)
If OTHER, specify
Item
If OTHER, specify
text
Was the SAE caused by an activity related to study participation (e.g., procedures)?
Item
Was the SAE caused by an activity related to study participation (e.g., procedures)?
boolean
Serious Flag
Item
Serious Flag
text
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