ID
28271
Beschreibung
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)
Stichworte
Versionen (6)
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- 13.10.17 13.10.17 -
- 23.10.17 23.10.17 -
- 01.01.18 01.01.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
1. Januar 2018
DOI
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Lizenz
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
Beschreibung
2. Type of cancer, GI neoplasm or GI polyp diagnosis
Beschreibung
3. New cancer or Recurrence or progression (2) of cancer details
Beschreibung
Date of diagnosis
Datentyp
date
Alias
- UMLS CUI [1]
- C2316983
Beschreibung
Source of information supporting diagnosis date
Datentyp
text
Alias
- UMLS CUI [1]
- C0683836
Beschreibung
Procedure specification
Datentyp
text
Alias
- UMLS CUI [1]
- C2348235
Beschreibung
Other source of information specification
Datentyp
text
Alias
- UMLS CUI [1]
- C0683836
Beschreibung
Site of Primary cancer
Datentyp
text
Alias
- UMLS CUI [1]
- C0449695
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschreibung
3Metastatic disease = cancer that has spread beyond primary organ (i.e. lymph nodes, contiguous structure, secondary location)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0027627
Beschreibung
metastatic disease location
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027627
Beschreibung
metastatic disease other location
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0027627
Beschreibung
Note: If there are multiple metastatic sites, please list them in the "Other location(s), specify" section
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0872338
- UMLS CUI [1,2]
- C2348235
Beschreibung
4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
Beschreibung
Date of procedure
Datentyp
date
Alias
- UMLS CUI [1]
- C2584899
Beschreibung
Location of polyp/neoplasm Small intestine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0153425
Beschreibung
Location of polyp/neoplasm Colon
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Beschreibung
Location of polyp/neoplasm Anus
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Beschreibung
Location of polyp/neoplasm Stomach
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
Beschreibung
Location of polyp/neoplasm Esophagus
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009376
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0014876
Beschreibung
Location of polyp/neoplasm Biliary system
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032584
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0854196
Beschreibung
Location of polyp/neoplasm Liver
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0450429
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0032584
Beschreibung
Location of polyp/neoplasm Pancreas
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030274
- UMLS CUI [1,2]
- C0032584
Beschreibung
Location of polyp/neoplasm Other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0032584
Beschreibung
Location of polyp/neoplasm Other specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschreibung
5. Required source documents sent
Beschreibung
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)
Datentyp
text
Alias
- UMLS CUI [1]
- C1301746
Beschreibung
required source documents sent date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
CEC Status
Beschreibung
[read-only] Item is not required
Datentyp
text
Alias
- UMLS CUI [1]
- C2826275
Beschreibung
[hidden] Item is not required
Datentyp
text
Alias
- UMLS CUI [1]
- C1444748
Beschreibung
[hidden]. Item is not required.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449438
Beschreibung
[hidden]
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0443172
Beschreibung
[hidden]. Item is not required.
Datentyp
text
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348585
Beschreibung
Copy Adverse Event term from corresponding SAE/AE form [hidden]. Item is not required.
Datentyp
text
Alias
- UMLS CUI [1]
- C2826934
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C0027627 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0014876 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,2])
C0854196 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C0032584 (UMLS CUI [1,3])
C0032584 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0032584 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
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C0443172 (UMLS CUI [1,2])
C2348585 (UMLS CUI [1,2])