ID

26356

Description

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

Mots-clés

Versions (5)
  1. 11/10/2017 11/10/2017 -
  2. 16/10/2017 16/10/2017 -
  3. 16/10/2017 16/10/2017 -
  4. 23/10/2017 23/10/2017 -
  5. 11/01/2018 11/01/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

16 octobre 2017

DOI

Pour une demande vous connecter.

Licence

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

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Liver events GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires  
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

Type de données

boolean

[2] AST (aspartate aminotransferase)
Description

aspartate aminotransferase

Type de données

boolean

[3] Total bilirubin
Description

Total bilirubin

Type de données

boolean

[4] Alkaline phosphatase
Description

Alkaline phosphatase

Type de données

boolean

[OT] Other
Description

Other liver chemistry result

Type de données

boolean

Liver events
Description

Liver events

2. Is the subject age 55 or older?
Description

subject age

Type de données

boolean

3. If female, is the subject pregnant?
Description

If yes, ensure Pregnancy Notification Form has been completed.

Type de données

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

Type de données

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.

Type de données

boolean

5. Were any liver biopsies performed?
Description

If yes, complete Liver Biopsy form.

Type de données

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.

Type de données

boolean

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

dietary change

Type de données

boolean

Evaluation interval code
Description

[hidden]

Type de données

text

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Similar models

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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