ID
28271
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: Cancer / GI Neoplasm / Polyp Report Form (CNP) - Repeating form (Scheduled visits)
Keywords
Versions (6)
- 10/2/17 10/2/17 -
- 10/4/17 10/4/17 -
- 10/4/17 10/4/17 -
- 10/13/17 10/13/17 -
- 10/23/17 10/23/17 -
- 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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Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903
Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903
Description
2. Type of cancer, GI neoplasm or GI polyp diagnosis
Description
3. New cancer or Recurrence or progression (2) of cancer details
Description
Date of diagnosis
Data type
date
Alias
- UMLS CUI [1]
- C2316983
Description
Source of information supporting diagnosis date
Data type
text
Alias
- UMLS CUI [1]
- C0683836
Description
Procedure specification
Data type
text
Alias
- UMLS CUI [1]
- C2348235
Description
Other source of information specification
Data type
text
Alias
- UMLS CUI [1]
- C0683836
Description
Site of Primary cancer
Data type
text
Alias
- UMLS CUI [1]
- C0449695
Description
Only complete specify box if no primary cancer site has been selected OR if 'Other gastrointestinal cancer, specify' OR 'Other cancer site, specify' OR 'Small intestinal cancer other, specify' is selected from the site list, otherwise leave blank
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
3Metastatic disease = cancer that has spread beyond primary organ (i.e. lymph nodes, contiguous structure, secondary location)
Data type
boolean
Alias
- UMLS CUI [1]
- C0027627
Description
metastatic disease location
Data type
integer
Alias
- UMLS CUI [1]
- C0027627
Description
metastatic disease other location
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0027627
Description
Note: If there are multiple metastatic sites, please list them in the "Other location(s), specify" section
Data type
text
Alias
- UMLS CUI [1,1]
- C0872338
- UMLS CUI [1,2]
- C2348235
Description
4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
Description
Date of procedure
Data type
date
Alias
- UMLS CUI [1]
- C2584899
Description
Location of polyp/neoplasm Small intestine
Data type
boolean
Alias
- UMLS CUI [1]
- C0153425
Description
Location of polyp/neoplasm Colon
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Description
Location of polyp/neoplasm Anus
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Description
Location of polyp/neoplasm Stomach
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Description
Location of polyp/neoplasm Esophagus
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0014876
Description
Location of polyp/neoplasm Biliary system
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032584
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0854196
Description
Location of polyp/neoplasm Liver
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0032584
Description
Location of polyp/neoplasm Pancreas
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030274
- UMLS CUI [1,2]
- C0032584
Description
Location of polyp/neoplasm Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0032584
Description
Location of polyp/neoplasm Other specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
5. Required source documents sent
Description
Source documents to send (source documents are required if you answered Yes to question 1): Pathology Report Operative Report Imaging study report Oncology/surgical consult notes Endoscopy Report (upper and lower) GI capsule study report Hospital Discharge Summary (if applicable)
Data type
text
Alias
- UMLS CUI [1]
- C1301746
Description
required source documents sent date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
CEC Status
Description
[read-only] Item is not required
Data type
text
Alias
- UMLS CUI [1]
- C2826275
Description
[hidden] Item is not required
Data type
text
Alias
- UMLS CUI [1]
- C1444748
Description
[hidden]. Item is not required.
Data type
integer
Alias
- UMLS CUI [1]
- C0449438
Description
[hidden]
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0443172
Description
[hidden]. Item is not required.
Data type
text
Description
Use AE Sequence number from the corresponding SAE/AE form (the last item on the form, in the "Non- Clinical" section) [hidden]. Item is not required.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348585
Description
Copy Adverse Event term from corresponding SAE/AE form [hidden]. Item is not required.
Data type
text
Alias
- UMLS CUI [1]
- C2826934
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