ID

28272

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 procedured report form - Repeating form (Scheduled visits)

Keywords

Versions (4)
  1. 10/4/17 10/4/17 -
  2. 10/13/17 10/13/17 -
  3. 10/23/17 10/23/17 -
  4. 1/1/18 1/1/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 1, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

English

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
GI procedures performed post-randomization form
Description

GI procedures performed post-randomization form

1. Date of procedure(s)
Description

Date of procedure

Data type

date

Alias
UMLS CUI [1]
C2584899
GI procedures entry
Description

GI procedures entry

2.a GI Procedure
Description

GI Procedure

Data type

text

Alias
UMLS CUI [1]
C0524722
If other GI endoscopic procedure, specify:
Description

Other GI endoscopic procedure specification

Data type

text

Alias
UMLS CUI [1]
C0393107
2.b Reason for GI procedure: [1] Routine screening study
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3842345
2.b Reason for GI procedure: [2] Procedure for surveillance for Barrett's esophagus
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1333324
2.b Reason for GI procedure: [3] Procedure for surveillance for family history of colorectal cancer
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3266797
2.b Reason for GI procedure: [4] Procedure that was prompted by blood in stool or evidence of GI bleeding (upper or lower)
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0017181
2.b Reason for GI procedure: [5] Procedure that was prompted by anemia
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0002871
2.b Reason for GI procedure: [6] Procedure that was prompted by difficulty swallowing
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C4084787
2.b Reason for GI procedure: [7] Procedure that was prompted by esophageal reflux
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0232483
2.b Reason for GI procedure: [8] Procedure that was prompted by diarrhoea
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0011991
2.b Reason for GI procedure: [9] Procedure that was prompted by abdominal pain
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0000737
2.b Reason for GI procedure: [UNK] Unknown
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3258099
2.b Reason for GI procedure: [OT] Procedure that was precipitated by other symptom or finding
Description

Tick all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1335151
2.b Reason for GI procedure: If Procedure that was precipitated by other symptom or finding, specify
Description

Tick all that apply

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C2348235
3. Was a cancer identified?
Description

cancer identified

Data type

text

Alias
UMLS CUI [1]
C0006826
4. Was a benign GI polyp(s) (1), a benign GI neoplasms(s) or a neoplasm(s) unable to be determined as benign or malignant identified?
Description

1=neoplastic or non-neoplastic

Data type

text

Alias
UMLS CUI [1]
C3843757
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Similar models

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
GI procedures performed post-randomization form
Date of procedure
Item
1. Date of procedure(s)
date
C2584899 (UMLS CUI [1])
Item Group
GI procedures entry
Item
2.a GI Procedure
text
C0524722 (UMLS CUI [1])
GI Procedure
Code List
2.a GI Procedure
CL Item
Upper endoscopy (1)
C0438280 (UMLS CUI-1)
(Comment:en)
CL Item
Capsule endoscopy (2)
C1721048 (UMLS CUI-1)
(Comment:en)
CL Item
Push enteroscopy (3)
C2936452 (UMLS CUI-1)
(Comment:en)
CL Item
Colonoscopy (4)
C0009378 (UMLS CUI-1)
(Comment:en)
CL Item
Sigmoidoscopy only (5)
C0037075 (UMLS CUI-1)
(Comment:en)
CL Item
Other GI endoscopic procedure (specify) (OT)
C0393107 (UMLS CUI-1)
(Comment:en)
Other GI endoscopic procedure specification
Item
If other GI endoscopic procedure, specify:
text
C0393107 (UMLS CUI [1])
Routine screening study
Item
2.b Reason for GI procedure: [1] Routine screening study
boolean
C3842345 (UMLS CUI [1])
surveillance for Barrett's esophagus
Item
2.b Reason for GI procedure: [2] Procedure for surveillance for Barrett's esophagus
boolean
C1333324 (UMLS CUI [1])
surveillance for family history of colorectal cancer
Item
2.b Reason for GI procedure: [3] Procedure for surveillance for family history of colorectal cancer
boolean
C3266797 (UMLS CUI [1])
blood in stool or evidence of GI bleeding
Item
2.b Reason for GI procedure: [4] Procedure that was prompted by blood in stool or evidence of GI bleeding (upper or lower)
boolean
C0017181 (UMLS CUI [1])
anemia
Item
2.b Reason for GI procedure: [5] Procedure that was prompted by anemia
boolean
C0002871 (UMLS CUI [1])
difficulty swallowing
Item
2.b Reason for GI procedure: [6] Procedure that was prompted by difficulty swallowing
boolean
C4084787 (UMLS CUI [1])
esophageal reflux
Item
2.b Reason for GI procedure: [7] Procedure that was prompted by esophageal reflux
boolean
C0232483 (UMLS CUI [1])
Diarrhea
Item
2.b Reason for GI procedure: [8] Procedure that was prompted by diarrhoea
boolean
C0011991 (UMLS CUI [1])
abdominal pain
Item
2.b Reason for GI procedure: [9] Procedure that was prompted by abdominal pain
boolean
C0000737 (UMLS CUI [1])
Reason for GI procedure unknown
Item
2.b Reason for GI procedure: [UNK] Unknown
boolean
C3258099 (UMLS CUI [1])
other symptom or finding
Item
2.b Reason for GI procedure: [OT] Procedure that was precipitated by other symptom or finding
boolean
C1335151 (UMLS CUI [1])
other symptom or finding specification
Item
2.b Reason for GI procedure: If Procedure that was precipitated by other symptom or finding, specify
text
C1515974 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
3. Was a cancer identified?
text
C0006826 (UMLS CUI [1])
cancer identified
Code List
3. Was a cancer identified?
CL Item
No (confirmed by procedure/pathology report) (N)
CL Item
Yes, please complete the cancer/GI neoplasm/polyp form and report as an AE/SAE as appropriate (Y)
CL Item
Unknown (U)
Item
4. Was a benign GI polyp(s) (1), a benign GI neoplasms(s) or a neoplasm(s) unable to be determined as benign or malignant identified?
text
C3843757 (UMLS CUI [1])
cancer identified
Code List
4. Was a benign GI polyp(s) (1), a benign GI neoplasms(s) or a neoplasm(s) unable to be determined as benign or malignant identified?
CL Item
No (confirmed by procedure/pathology report) (N)
CL Item
Yes, please complete the cancer/GI neoplasm/polyp form and report as an AE/SAE as appropriate (Y)
CL Item
Unknown (U)
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