ID
28271
Beschrijving
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)
Trefwoorden
Versies (6)
- 02-10-17 02-10-17 -
- 04-10-17 04-10-17 -
- 04-10-17 04-10-17 -
- 13-10-17 13-10-17 -
- 23-10-17 23-10-17 -
- 01-01-18 01-01-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 januari 2018
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
2. Type of cancer, GI neoplasm or GI polyp diagnosis
Beschrijving
3. New cancer or Recurrence or progression (2) of cancer details
Beschrijving
Date of diagnosis
Datatype
date
Alias
- UMLS CUI [1]
- C2316983
Beschrijving
Source of information supporting diagnosis date
Datatype
text
Alias
- UMLS CUI [1]
- C0683836
Beschrijving
Procedure specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Other source of information specification
Datatype
text
Alias
- UMLS CUI [1]
- C0683836
Beschrijving
Site of Primary cancer
Datatype
text
Alias
- UMLS CUI [1]
- C0449695
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschrijving
3Metastatic disease = cancer that has spread beyond primary organ (i.e. lymph nodes, contiguous structure, secondary location)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027627
Beschrijving
metastatic disease location
Datatype
integer
Alias
- UMLS CUI [1]
- C0027627
Beschrijving
metastatic disease other location
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0027627
Beschrijving
Note: If there are multiple metastatic sites, please list them in the "Other location(s), specify" section
Datatype
text
Alias
- UMLS CUI [1,1]
- C0872338
- UMLS CUI [1,2]
- C2348235
Beschrijving
4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
Beschrijving
Date of procedure
Datatype
date
Alias
- UMLS CUI [1]
- C2584899
Beschrijving
Location of polyp/neoplasm Small intestine
Datatype
boolean
Alias
- UMLS CUI [1]
- C0153425
Beschrijving
Location of polyp/neoplasm Colon
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Beschrijving
Location of polyp/neoplasm Anus
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Beschrijving
Location of polyp/neoplasm Stomach
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Beschrijving
Location of polyp/neoplasm Esophagus
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0014876
Beschrijving
Location of polyp/neoplasm Biliary system
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032584
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0854196
Beschrijving
Location of polyp/neoplasm Liver
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0032584
Beschrijving
Location of polyp/neoplasm Pancreas
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030274
- UMLS CUI [1,2]
- C0032584
Beschrijving
Location of polyp/neoplasm Other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0032584
Beschrijving
Location of polyp/neoplasm Other specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschrijving
5. Required source documents sent
Beschrijving
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)
Datatype
text
Alias
- UMLS CUI [1]
- C1301746
Beschrijving
required source documents sent date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
CEC Status
Beschrijving
[read-only] Item is not required
Datatype
text
Alias
- UMLS CUI [1]
- C2826275
Beschrijving
[hidden] Item is not required
Datatype
text
Alias
- UMLS CUI [1]
- C1444748
Beschrijving
[hidden]. Item is not required.
Datatype
integer
Alias
- UMLS CUI [1]
- C0449438
Beschrijving
[hidden]
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0443172
Beschrijving
[hidden]. Item is not required.
Datatype
text
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348585
Beschrijving
Copy Adverse Event term from corresponding SAE/AE form [hidden]. Item is not required.
Datatype
text
Alias
- UMLS CUI [1]
- C2826934
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