ID

28402

Beschrijving

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

Trefwoorden

Versies (5)
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  5. 11-01-18 11-01-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 januari 2018

DOI

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Licentie

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

Engels

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

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

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

[1] ALT (alanine aminotransferase)
Beschrijving

alanine aminotransferase

Datatype

boolean

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

aspartate aminotransferase

Datatype

boolean

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

Total bilirubin

Datatype

boolean

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

Alkaline phosphatase

Datatype

boolean

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

Other liver chemistry result

Datatype

boolean

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

Liver events

2. Is the subject age 55 or older?
Beschrijving

subject age

Datatype

boolean

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

If yes, ensure Pregnancy Notification Form has been completed.

Datatype

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)?
Beschrijving

diagnostic imaging of liver or hepatobiliary system

Datatype

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?
Beschrijving

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

Datatype

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?
Beschrijving

If yes, complete Liver Biopsy form.

Datatype

boolean

Alias
UMLS CUI [1]
C0193388
6. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beschrijving

If yes, record on the appropriate Concomitant Medication form.

Datatype

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?
Beschrijving

dietary change

Datatype

boolean

Alias
UMLS CUI [1]
C3671772
Evaluation interval code
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C2985767
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Similar models

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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