ID

26348

Beschreibung

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver events

Stichworte

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  4. 23.10.17 23.10.17 -
  5. 11.01.18 11.01.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Liver events GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

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

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

[1] ALT (alanine aminotransferase)
Beschreibung

alanine aminotransferase

Datentyp

boolean

[2] AST (aspartate aminotransferase)
Beschreibung

aspartate aminotransferase

Datentyp

boolean

[3] Total bilirubin
Beschreibung

Total bilirubin

Datentyp

boolean

[4] Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

boolean

[OT] Other
Beschreibung

Other liver chemistry result

Datentyp

boolean

Liver events
Beschreibung

Liver events

2. Is the subject age 55 or older?
Beschreibung

subject age

Datentyp

boolean

3. If female, is the subject pregnant?
Beschreibung

If yes, ensure Pregnancy Notification Form has been completed.

Datentyp

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)?
Beschreibung

diagnostic imaging of liver or hepatobiliary system

Datentyp

boolean

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

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

Datentyp

boolean

5. Were any liver biopsies performed?
Beschreibung

If yes, complete Liver Biopsy form.

Datentyp

boolean

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

If yes, record on the appropriate Concomitant Medication form.

Datentyp

boolean

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

dietary change

Datentyp

boolean

Evaluation interval code
Beschreibung

[hidden]

Datentyp

text

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Ähnliche Modelle

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
subject pregnant
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
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