ID

28414

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: GI conditions of special interest Report form

Keywords

Versions (4)
  1. 10/9/17 10/9/17 -
  2. 10/16/17 10/16/17 -
  3. 10/23/17 10/23/17 -
  4. 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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GI conditions of special interest GSK study Chronic Coronary Heart Disease NCT00799903

English

GI conditions of special interest GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
GI conditions of special interest completed for all randomized subjects
Description

GI conditions of special interest completed for all randomized subjects

1. Crohn's disease
Description

Crohn's disease

Data type

text

Alias
UMLS CUI [1]
C0010346
Month of diagnosis: 1. Crohn's disease
Description

Month of diagnosis Crohn's disease

Data type

date

Alias
UMLS CUI [1,1]
C0010346
UMLS CUI [1,2]
C0332177
UMLS CUI [1,3]
C0011900
Year of diagnosis: 1.Crohn's disease
Description

Year of diagnosis Crohn's disease

Data type

date

Alias
UMLS CUI [1,1]
C0010346
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0439234
2. Celiac disease
Description

Celiac disease

Data type

text

Alias
UMLS CUI [1]
C0007570
Month of diagnosis: 2. Celiac disease
Description

Month of diagnosis Celiac disease

Data type

text

Alias
UMLS CUI [1,1]
C0007570
UMLS CUI [1,2]
C0332177
UMLS CUI [1,3]
C0011900
Year of diagnosis: 2. Celiac disease
Description

Year of diagnosis Celiac disease

Data type

integer

Alias
UMLS CUI [1,1]
C0007570
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0011900
3. Ulcerative colitis
Description

Ulcerative colitis

Data type

text

Alias
UMLS CUI [1]
C0009324
Month of diagnosis: 3. Ulcerative colitis
Description

Month of diagnosis Ulcerative colitis

Data type

text

Alias
UMLS CUI [1,1]
C0009324
UMLS CUI [1,2]
C0332177
UMLS CUI [1,3]
C0011900
Year of diagnosis: 3. Ulcerative colitis
Description

Year of diagnosis Ulcerative colitis

Data type

integer

Alias
UMLS CUI [1,1]
C0009324
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0011900
4. Familial adenomatous polyposis
Description

(FAP: Autosomal dominant inherited condition that occurs in approximately 1 in 8,000 people)

Data type

text

Alias
UMLS CUI [1]
C0032580
Month of diagnosis: 4. Familial adenomatous polyposis
Description

Month of diagnosis Familial adenomatous polyposis

Data type

text

Alias
UMLS CUI [1,1]
C0032580
UMLS CUI [1,2]
C0332177
UMLS CUI [1,3]
C0011900
Year of diagnosis: 4. Familial adenomatous polyposis
Description

Year of diagnosis Familial adenomatous polyposis

Data type

integer

Alias
UMLS CUI [1,1]
C0032580
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0011900
5. Peutz-Jegher's syndrome
Description

Peutz-Jegher's syndrome

Data type

text

Alias
UMLS CUI [1]
C0031269
Month of diagnosis: 5. Peutz-Jegher's syndrome
Description

Month of diagnosis Peutz-Jegher's syndrome

Data type

text

Alias
UMLS CUI [1,1]
C0031269
UMLS CUI [1,2]
C0332177
UMLS CUI [1,3]
C0011900
Year of diagnosis: 5. Peutz-Jegher's syndrome
Description

Year of diagnosis Peutz-Jegher's syndrome

Data type

integer

Alias
UMLS CUI [1,1]
C0031269
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0011900
6. Hereditary non polyposis colorectal cancer syndrome
Description

Hereditary non polyposis colorectal cancer syndrome

Data type

text

Alias
UMLS CUI [1]
C1112155
Month of diagnosis: 6. Hereditary non polyposis colorectal cancer syndrome
Description

Month of diagnosis Hereditary non polyposis colorectal cancer syndrome

Data type

text

Alias
UMLS CUI [1,1]
C0332177
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1112155
Year of diagnosis: 6. Hereditary non polyposis colorectal cancer syndrome
Description

Year of diagnosis Hereditary non polyposis colorectal cancer syndrome

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1112155
History of adenomatous polyps
Description

History of adenomatous polyps

7. History of adenomatous polyps of the small intestine or colon prior to randomization
Description

History of adenomatous polyps

Data type

text

Alias
UMLS CUI [1]
C0206677
Family history of intestinal cancer or adenomatous polyps
Description

Family history of intestinal cancer or adenomatous polyps

8. Family history of intestinal cancer
Description

Family history of intestinal cancer

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0346627
If family history of intestinal cancer exists, select one
Description

family history of intestinal cancer site

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0346627
9. Family history of adenomatous polyps
Description

Family history of adenomatous polyps

Data type

text

Alias
UMLS CUI [1,1]
C0206677
UMLS CUI [1,2]
C0205179
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Similar models

GI conditions of special interest GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
GI conditions of special interest completed for all randomized subjects
Item
1. Crohn's disease
text
C0010346 (UMLS CUI [1])
Crohn's disease
Code List
1. Crohn's disease
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Month of diagnosis Crohn's disease
Item
Month of diagnosis: 1. Crohn's disease
date
C0010346 (UMLS CUI [1,1])
C0332177 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Year of diagnosis Crohn's disease
Item
Year of diagnosis: 1.Crohn's disease
date
C0010346 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
Item
2. Celiac disease
text
C0007570 (UMLS CUI [1])
Crohn's disease
Code List
2. Celiac disease
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Month of diagnosis Celiac disease
Item
Month of diagnosis: 2. Celiac disease
text
C0007570 (UMLS CUI [1,1])
C0332177 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Year of diagnosis Celiac disease
Item
Year of diagnosis: 2. Celiac disease
integer
C0007570 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
3. Ulcerative colitis
text
C0009324 (UMLS CUI [1])
Crohn's disease
Code List
3. Ulcerative colitis
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Month of diagnosis Ulcerative colitis
Item
Month of diagnosis: 3. Ulcerative colitis
text
C0009324 (UMLS CUI [1,1])
C0332177 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Year of diagnosis Ulcerative colitis
Item
Year of diagnosis: 3. Ulcerative colitis
integer
C0009324 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
4. Familial adenomatous polyposis
text
C0032580 (UMLS CUI [1])
Crohn's disease
Code List
4. Familial adenomatous polyposis
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Month of diagnosis Familial adenomatous polyposis
Item
Month of diagnosis: 4. Familial adenomatous polyposis
text
C0032580 (UMLS CUI [1,1])
C0332177 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Year of diagnosis Familial adenomatous polyposis
Item
Year of diagnosis: 4. Familial adenomatous polyposis
integer
C0032580 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
5. Peutz-Jegher's syndrome
text
C0031269 (UMLS CUI [1])
Crohn's disease
Code List
5. Peutz-Jegher's syndrome
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Month of diagnosis Peutz-Jegher's syndrome
Item
Month of diagnosis: 5. Peutz-Jegher's syndrome
text
C0031269 (UMLS CUI [1,1])
C0332177 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Year of diagnosis Peutz-Jegher's syndrome
Item
Year of diagnosis: 5. Peutz-Jegher's syndrome
integer
C0031269 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
6. Hereditary non polyposis colorectal cancer syndrome
text
C1112155 (UMLS CUI [1])
Crohn's disease
Code List
6. Hereditary non polyposis colorectal cancer syndrome
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Month of diagnosis Hereditary non polyposis colorectal cancer syndrome
Item
Month of diagnosis: 6. Hereditary non polyposis colorectal cancer syndrome
text
C0332177 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1112155 (UMLS CUI [1,3])
Year of diagnosis Hereditary non polyposis colorectal cancer syndrome
Item
Year of diagnosis: 6. Hereditary non polyposis colorectal cancer syndrome
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1112155 (UMLS CUI [1,3])
Item Group
History of adenomatous polyps
Item
7. History of adenomatous polyps of the small intestine or colon prior to randomization
text
C0206677 (UMLS CUI [1])
Crohn's disease
Code List
7. History of adenomatous polyps of the small intestine or colon prior to randomization
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Item Group
Family history of intestinal cancer or adenomatous polyps
Item
8. Family history of intestinal cancer
text
C0241889 (UMLS CUI [1,1])
C0346627 (UMLS CUI [1,2])
Crohn's disease
Code List
8. Family history of intestinal cancer
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
Item
If family history of intestinal cancer exists, select one
text
C0241889 (UMLS CUI [1,1])
C0346627 (UMLS CUI [1,2])
family history of intestinal cancer site
Code List
If family history of intestinal cancer exists, select one
CL Item
Small intestine (HXSMINTC)
C0021852 (UMLS CUI-1)
(Comment:en)
CL Item
Colon (includes rectum) (Y)
C0009368 (UMLS CUI-1)
(Comment:en)
CL Item
Both small intestine and colon (including rectum) (HXINTCOL)
C0021852 (UMLS CUI-1)
C0009368 (UMLS CUI-2)
(Comment:en)
Item
9. Family history of adenomatous polyps
text
C0206677 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Crohn's disease
Code List
9. Family history of adenomatous polyps
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
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