ID

26356

Beskrivning

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

Nyckelord

Versioner (5)
  1. 2017-10-11 2017-10-11 -
  2. 2017-10-16 2017-10-16 -
  3. 2017-10-16 2017-10-16 -
  4. 2017-10-23 2017-10-23 -
  5. 2018-01-11 2018-01-11 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 oktober 2017

DOI

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Licens

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

Engelsk

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

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

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

[1] ALT (alanine aminotransferase)
Beskrivning

alanine aminotransferase

Datatyp

boolean

[2] AST (aspartate aminotransferase)
Beskrivning

aspartate aminotransferase

Datatyp

boolean

[3] Total bilirubin
Beskrivning

Total bilirubin

Datatyp

boolean

[4] Alkaline phosphatase
Beskrivning

Alkaline phosphatase

Datatyp

boolean

[OT] Other
Beskrivning

Other liver chemistry result

Datatyp

boolean

Liver events
Beskrivning

Liver events

2. Is the subject age 55 or older?
Beskrivning

subject age

Datatyp

boolean

3. If female, is the subject pregnant?
Beskrivning

If yes, ensure Pregnancy Notification Form has been completed.

Datatyp

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)?
Beskrivning

diagnostic imaging of liver or hepatobiliary system

Datatyp

boolean

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

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

Datatyp

boolean

5. Were any liver biopsies performed?
Beskrivning

If yes, complete Liver Biopsy form.

Datatyp

boolean

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

If yes, record on the appropriate Concomitant Medication form.

Datatyp

boolean

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

dietary change

Datatyp

boolean

Evaluation interval code
Beskrivning

[hidden]

Datatyp

text

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Similar models

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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