Liver events GSK study Chronic Coronary Heart Disease NCT00799903

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

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

[1] ALT (alanine aminotransferase)
Descrizione

alanine aminotransferase

Tipo di dati

boolean

[2] AST (aspartate aminotransferase)
Descrizione

aspartate aminotransferase

Tipo di dati

boolean

[3] Total bilirubin
Descrizione

Total bilirubin

Tipo di dati

boolean

[4] Alkaline phosphatase
Descrizione

Alkaline phosphatase

Tipo di dati

boolean

[OT] Other
Descrizione

Other liver chemistry result

Tipo di dati

boolean

Liver events
Descrizione

Liver events

2. Is the subject age 55 or older?
Descrizione

subject age

Tipo di dati

boolean

3. If female, is the subject pregnant?
Descrizione

If yes, ensure Pregnancy Notification Form has been completed.

Tipo di dati

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)?
Descrizione

diagnostic imaging of liver or hepatobiliary system

Tipo di dati

boolean

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

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

Tipo di dati

boolean

5. Were any liver biopsies performed?
Descrizione

If yes, complete Liver Biopsy form.

Tipo di dati

boolean

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

If yes, record on the appropriate Concomitant Medication form.

Tipo di dati

boolean

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

dietary change

Tipo di dati

boolean

Evaluation interval code
Descrizione

[hidden]

Tipo di dati

text

Similar models

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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