ID

28402

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

Keywords

Versions (5)
  1. 10/11/17 10/11/17 -
  2. 10/16/17 10/16/17 -
  3. 10/16/17 10/16/17 -
  4. 10/23/17 10/23/17 -
  5. 1/11/18 1/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 2018

DOI

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License

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

English

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
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

Alias
UMLS CUI [1]
C0201836
[2] AST (aspartate aminotransferase)
Description

aspartate aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201899
[3] Total bilirubin
Description

Total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
[4] Alkaline phosphatase
Description

Alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
[OT] Other
Description

Other liver chemistry result

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
Liver events
Description

Liver events

2. Is the subject age 55 or older?
Description

subject age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. If female, is the subject pregnant?
Description

If yes, ensure Pregnancy Notification Form has been completed.

Data type

text

Alias
UMLS CUI [1]
C0549206
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

Alias
UMLS CUI [1,1]
C1711359
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0023884
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

Alias
UMLS CUI [1,1]
C1711359
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C1254595
5. Were any liver biopsies performed?
Description

If yes, complete Liver Biopsy form.

Data type

boolean

Alias
UMLS CUI [1]
C0193388
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

Alias
UMLS CUI [1,1]
C0002346
UMLS CUI [1,2]
C0242295
UMLS CUI [1,3]
C0281875
7. Did the subject fast or undergo significant dietary change in the past week?
Description

dietary change

Data type

boolean

Alias
UMLS CUI [1]
C3671772
Evaluation interval code
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2985767
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Similar models

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
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
C0201836 (UMLS CUI [1])
aspartate aminotransferase
Item
[2] AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1])
Total bilirubin
Item
[3] Total bilirubin
boolean
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
[4] Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1])
Other liver chemistry result
Item
[OT] Other
boolean
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Liver events
subject age
Item
2. Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
3. If female, is the subject pregnant?
text
C0549206 (UMLS CUI [1])
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
C1711359 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
diagnostic imaging of liver or hepatobiliary system results
Item
4. If diagnostic imaging tests were performed, were the results normal?
boolean
C1711359 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1254595 (UMLS CUI [1,4])
liver biopsies
Item
5. Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
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
C0002346 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
dietary change
Item
7. Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1])
Evaluation interval code
Item
Evaluation interval code
text
C2985767 (UMLS CUI [1])
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