ID
28271
Descripción
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)
Palabras clave
Versiones (6)
- 2/10/17 2/10/17 -
- 4/10/17 4/10/17 -
- 4/10/17 4/10/17 -
- 13/10/17 13/10/17 -
- 23/10/17 23/10/17 -
- 1/1/18 1/1/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
1 de enero de 2018
DOI
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Licencia
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
Descripción
2. Type of cancer, GI neoplasm or GI polyp diagnosis
Descripción
3. New cancer or Recurrence or progression (2) of cancer details
Descripción
Date of diagnosis
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2316983
Descripción
Source of information supporting diagnosis date
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0683836
Descripción
Procedure specification
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348235
Descripción
Other source of information specification
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0683836
Descripción
Site of Primary cancer
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0449695
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Descripción
3Metastatic disease = cancer that has spread beyond primary organ (i.e. lymph nodes, contiguous structure, secondary location)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0027627
Descripción
metastatic disease location
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0027627
Descripción
metastatic disease other location
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0027627
Descripción
Note: If there are multiple metastatic sites, please list them in the "Other location(s), specify" section
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0872338
- UMLS CUI [1,2]
- C2348235
Descripción
4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
Descripción
Date of procedure
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2584899
Descripción
Location of polyp/neoplasm Small intestine
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0153425
Descripción
Location of polyp/neoplasm Colon
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Descripción
Location of polyp/neoplasm Anus
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Descripción
Location of polyp/neoplasm Stomach
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Descripción
Location of polyp/neoplasm Esophagus
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0014876
Descripción
Location of polyp/neoplasm Biliary system
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0032584
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0854196
Descripción
Location of polyp/neoplasm Liver
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0032584
Descripción
Location of polyp/neoplasm Pancreas
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0030274
- UMLS CUI [1,2]
- C0032584
Descripción
Location of polyp/neoplasm Other
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0032584
Descripción
Location of polyp/neoplasm Other specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Descripción
5. Required source documents sent
Descripción
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)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1301746
Descripción
required source documents sent date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
CEC Status
Descripción
[read-only] Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826275
Descripción
[hidden] Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1444748
Descripción
[hidden]. Item is not required.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0449438
Descripción
[hidden]
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0443172
Descripción
[hidden]. Item is not required.
Tipo de datos
text
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348585
Descripción
Copy Adverse Event term from corresponding SAE/AE form [hidden]. Item is not required.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826934
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