Liver events GSK study Chronic Coronary Heart Disease NCT00799903

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

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

[1] ALT (alanine aminotransferase)
Description

alanine aminotransferase

Data type

boolean

[2] AST (aspartate aminotransferase)
Description

aspartate aminotransferase

Data type

boolean

[3] Total bilirubin
Description

Total bilirubin

Data type

boolean

[4] Alkaline phosphatase
Description

Alkaline phosphatase

Data type

boolean

[OT] Other
Description

Other liver chemistry result

Data type

boolean

Liver events
Description

Liver events

2. Is the subject age 55 or older?
Description

subject age

Data type

boolean

3. If female, is the subject pregnant?
Description

If yes, ensure Pregnancy Notification Form has been completed.

Data type

text

4. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Description

diagnostic imaging of liver or hepatobiliary system

Data type

boolean

4. If diagnostic imaging tests were performed, were the results normal?
Description

If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

Data type

boolean

5. Were any liver biopsies performed?
Description

If yes, complete Liver Biopsy form.

Data type

boolean

6. 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

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

dietary change

Data type

boolean

Evaluation interval code
Description

[hidden]

Data type

text

Similar models

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
1. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
alanine aminotransferase
Item
[1] ALT (alanine aminotransferase)
boolean
aspartate aminotransferase
Item
[2] AST (aspartate aminotransferase)
boolean
Total bilirubin
Item
[3] Total bilirubin
boolean
Alkaline phosphatase
Item
[4] Alkaline phosphatase
boolean
Other liver chemistry result
Item
[OT] Other
boolean
Item Group
Liver events
subject age
Item
2. Is the subject age 55 or older?
boolean
Item
3. If female, is the subject pregnant?
text
Code List
3. If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
diagnostic imaging of liver or hepatobiliary system
Item
4. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
diagnostic imaging of liver or hepatobiliary system results
Item
4. If diagnostic imaging tests were performed, were the results normal?
boolean
liver biopsies
Item
5. Were any liver biopsies performed?
boolean
complementary or alternative medicines, supplements, illicit drugs
Item
6. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
dietary change
Item
7. Did the subject fast or undergo significant dietary change in the past week?
boolean
Evaluation interval code
Item
Evaluation interval code
text