ID

26105

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

October 9, 2017

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

Month of diagnosis: 1. Crohn's disease
Description

Month of diagnosis Crohn's disease

Data type

text

Year of diagnosis: 1.Crohn's disease
Description

Year of diagnosis Crohn's disease

Data type

integer

2. Celiac disease
Description

Celiac disease

Data type

text

Month of diagnosis: 2. Celiac disease
Description

Month of diagnosis Celiac disease

Data type

text

Year of diagnosis: 2. Celiac disease
Description

Year of diagnosis Celiac disease

Data type

integer

3. Ulcerative colitis
Description

Ulcerative colitis

Data type

text

Month of diagnosis: 3. Ulcerative colitis
Description

Month of diagnosis Ulcerative colitis

Data type

text

Year of diagnosis: 3. Ulcerative colitis
Description

Year of diagnosis Ulcerative colitis

Data type

integer

4. Familial adenomatous polyposis
Description

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

Data type

text

Month of diagnosis: 4. Familial adenomatous polyposis
Description

Month of diagnosis Familial adenomatous polyposis

Data type

text

Year of diagnosis: 4. Familial adenomatous polyposis
Description

Year of diagnosis Familial adenomatous polyposis

Data type

integer

5. Peutz-Jegher's syndrome
Description

Peutz-Jegher's syndrome

Data type

text

Month of diagnosis: 5. Peutz-Jegher's syndrome
Description

Month of diagnosis Peutz-Jegher's syndrome

Data type

text

Year of diagnosis: 5. Peutz-Jegher's syndrome
Description

Year of diagnosis Peutz-Jegher's syndrome

Data type

integer

6. Hereditary non polyposis colorectal cancer syndrome
Description

Hereditary non polyposis colorectal cancer syndrome

Data type

text

Month of diagnosis: 6. Hereditary non polyposis colorectal cancer syndrome
Description

Month of diagnosis Hereditary non polyposis colorectal cancer syndrome

Data type

text

Year of diagnosis: 6. Hereditary non polyposis colorectal cancer syndrome
Description

Year of diagnosis Hereditary non polyposis colorectal cancer syndrome

Data type

integer

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

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

If family history of intestinal cancer exists, select one
Description

family history of intestinal cancer site

Data type

text

9. Family history of adenomatous polyps
Description

Family history of adenomatous polyps

Data type

text

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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
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
text
Year of diagnosis Crohn's disease
Item
Year of diagnosis: 1.Crohn's disease
integer
Item
2. Celiac disease
text
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
Year of diagnosis Celiac disease
Item
Year of diagnosis: 2. Celiac disease
integer
Item
3. Ulcerative colitis
text
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
Year of diagnosis Ulcerative colitis
Item
Year of diagnosis: 3. Ulcerative colitis
integer
Item
4. Familial adenomatous polyposis
text
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
Year of diagnosis Familial adenomatous polyposis
Item
Year of diagnosis: 4. Familial adenomatous polyposis
integer
Item
5. Peutz-Jegher's syndrome
text
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
Year of diagnosis Peutz-Jegher's syndrome
Item
Year of diagnosis: 5. Peutz-Jegher's syndrome
integer
Item
6. Hereditary non polyposis colorectal cancer syndrome
text
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
Year of diagnosis Hereditary non polyposis colorectal cancer syndrome
Item
Year of diagnosis: 6. Hereditary non polyposis colorectal cancer syndrome
integer
Item Group
History of adenomatous polyps
Item
7. History of adenomatous polyps of the small intestine or colon prior to randomization
text
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
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
family history of intestinal cancer site
Code List
If family history of intestinal cancer exists, select one
CL Item
Small intestine (HXSMINTC)
CL Item
Colon (includes rectum) (Y)
CL Item
Both small intestine and colon (including rectum) (HXINTCOL)
Item
9. Family history of adenomatous polyps
text
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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