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Liver Event Form: General Data

1 forms  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Data type

text

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

DCI Name/Shortname
Description

DCI Name/Shortname

Data type

text

Status
Description

Status

Data type

text

Doc#
Description

Doc#

Data type

integer

Visit #
Description

Visit #

Data type

float

Liver Events Assessment
Description

Liver Events Assessment

Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Description

If YES, stop investigational product, complete date on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following test: -Blood sample for PK analysis, obtained within three half-lives (21 days) of last dose -Hepatitis A -Hepatitis B -Hepatitis C -Hepatitis E -Cytomegalovirus IgM antibody -EBV or if unavailabel, obtain heteropile antibody or monospot testing -CPK -LDH -Bilirubin fractionation, if bilirubin >=1.5xULN

Data type

boolean

Liver Event Description
Description

Liver Event Description

Date of assessment
Description

Date of assessment

Data type

date

AE/SAE reference number
Description

AE/SAE reference number

Data type

text

Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Description

check all that apply

Data type

text

Other, specify
Description

Other, specify

Data type

text

Is the subject age 55 or older?
Description

Is the subject age 55 or older?

Data type

boolean

If female, is the subject pregnant?
Description

If YES, ensure Pregnancy Notification Form has been completed.

Data type

text

Were any diagnostic tests of the liver or hepatobiliary system performed?
Description

Were any diagnostic tests of the liver or hepatobiliary system performed?

Data type

boolean

If Yes, were the results normal?
Description

If Yes, complete Liver Biopsy Form

Data type

boolean

Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Description

If Yes, record on the appropriate Concomitant Medication form

Data type

boolean

Did the subject fast or undergo significant dietary change in the past week?
Description

Did the subject fast or undergo significant dietary change in the past week?

Data type

boolean

Was a pharmacokinetic blood sample obtained?
Description

An unscheduled PK blood sample must be obtained within three half-lives

Data type

boolean

If Yes, date of sample taken
Description

If Yes, date of sample taken

Data type

date

If Yes, time of sample taken
Description

If Yes, time of sample taken

Data type

time

If Yes, date of last investigational product dose prior to PK sample
Description

If Yes, date of last investigational product dose prior to PK sample

Data type

date

If Yes, time of last investigational product dose prior to PK sample
Description

If Yes, time of last investigational product dose prior to PK sample

Data type

time

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Similar models

Liver Event Form: General Data

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Item Group
Liver Events Assessment
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
boolean
Item Group
Liver Event Description
Date of assessment
Item
Date of assessment
date
AE/SAE reference number
Item
AE/SAE reference number
text
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Other (4)
Other, specify
Item
Other, specify
text
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
Item
If female, is the subject pregnant?
text
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Were any diagnostic tests of the liver or hepatobiliary system performed?
Item
Were any diagnostic tests of the liver or hepatobiliary system performed?
boolean
If Yes, were the results normal?
Item
If Yes, were the results normal?
boolean
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
If Yes, date of sample taken
Item
If Yes, date of sample taken
date
If Yes, time of sample taken
Item
If Yes, time of sample taken
time
If Yes, date of last investigational product dose prior to PK sample
Item
If Yes, date of last investigational product dose prior to PK sample
date
If Yes, time of last investigational product dose prior to PK sample
Item
If Yes, time of last investigational product dose prior to PK sample
time
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