ID

26700

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)

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GlaxoSmithKline

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23 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903

Engels

Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
1. Involvement of gastrointestinal system
Beschrijving

1. Involvement of gastrointestinal system

Does the cancer or polyp(s)/neoplasm(s) involve the gastrointestinal system (esophagus, stomach, small intestine, colon, anus, liver, biliary system/gall bladder or pancreas)?
Beschrijving

if yes, source documents must be sent to CEC

Datatype

integer

2. Type of cancer, GI neoplasm or GI polyp diagnosis
Beschrijving

2. Type of cancer, GI neoplasm or GI polyp diagnosis

Type of cancer, GI neoplasm or GI polyp diagnosis
Beschrijving

Type of cancer, GI neoplasm or GI polyp diagnosis

Datatype

integer

3. New cancer or Recurrence or progression (2) of cancer details
Beschrijving

3. New cancer or Recurrence or progression (2) of cancer details

Date of diagnosis
Beschrijving

Date of diagnosis

Datatype

date

Source of information supporting the diagnosis date
Beschrijving

Source of information supporting diagnosis date

Datatype

text

Please specify procedure
Beschrijving

Procedure specification

Datatype

text

Other, specify
Beschrijving

Other source of information specification

Datatype

text

Site of Primary cancer
Beschrijving

Site of Primary cancer

Datatype

text

Other site, specify
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

Was metastatic (3) disease present?
Beschrijving

3Metastatic disease = cancer that has spread beyond primary organ (i.e. lymph nodes, contiguous structure, secondary location)

Datatype

boolean

If yes, Locations(s) if known
Beschrijving

metastatic disease location

Datatype

integer

Other location
Beschrijving

metastatic disease other location

Datatype

boolean

Other location(s), specify
Beschrijving

Note: If there are multiple metastatic sites, please list them in the "Other location(s), specify" section

Datatype

text

4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
Beschrijving

4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant

Date of procedure
Beschrijving

Date of procedure

Datatype

date

Location of polyp(s)/neoplasm(s): Small intestine
Beschrijving

Location of polyp/neoplasm Small intestine

Datatype

boolean

Location of polyp(s)/neoplasm(s): Colon
Beschrijving

Location of polyp/neoplasm Colon

Datatype

boolean

Location of polyp(s)/neoplasm(s): Anus
Beschrijving

Location of polyp/neoplasm Anus

Datatype

boolean

Location of polyp(s)/neoplasm(s): Stomach
Beschrijving

Location of polyp/neoplasm Stomach

Datatype

boolean

Location of polyp(s)/neoplasm(s): Esophagus
Beschrijving

Location of polyp/neoplasm Esophagus

Datatype

boolean

Location of polyp(s)/neoplasm(s): Biliary system
Beschrijving

Location of polyp/neoplasm Biliary system

Datatype

boolean

Location of polyp(s)/neoplasm(s): Liver
Beschrijving

Location of polyp/neoplasm Liver

Datatype

boolean

Location of polyp(s)/neoplasm(s): Pancreas
Beschrijving

Location of polyp/neoplasm Pancreas

Datatype

boolean

Location of polyp(s)/neoplasm(s): Other
Beschrijving

Location of polyp/neoplasm Other

Datatype

boolean

Other, specify
Beschrijving

Location of polyp/neoplasm Other specification

Datatype

text

5. Required source documents sent
Beschrijving

5. Required source documents sent

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

If yes, date sent:
Beschrijving

required source documents sent date

Datatype

date

CEC Status
Beschrijving

CEC Status

6. Event number
Beschrijving

[read-only] Item is not required

Datatype

text

7. Trigger number
Beschrijving

[hidden] Item is not required

Datatype

text

8. CEC Status
Beschrijving

[hidden]. Item is not required.

Datatype

integer

9. Date of status change
Beschrijving

[hidden]

Datatype

date

10. CEC Coordinator comments
Beschrijving

[hidden]. Item is not required.

Datatype

text

11. Adverse event reference identifier
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

12. Adverse event term
Beschrijving

Copy Adverse Event term from corresponding SAE/AE form [hidden]. Item is not required.

Datatype

text

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Similar models

Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
1. Involvement of gastrointestinal system
Item
Does the cancer or polyp(s)/neoplasm(s) involve the gastrointestinal system (esophagus, stomach, small intestine, colon, anus, liver, biliary system/gall bladder or pancreas)?
integer
Involvement of gastrointestinal system
Code List
Does the cancer or polyp(s)/neoplasm(s) involve the gastrointestinal system (esophagus, stomach, small intestine, colon, anus, liver, biliary system/gall bladder or pancreas)?
CL Item
Primary gastrointestinal cancer or benign polyp(s)/neoplasm(s) (local only) (1)
CL Item
Primary gastrointestinal cancer with metastasis or spread, including lymph nodes (2)
CL Item
Non-gastrointestinal primary cancer or unknown type of primary cancer, with metastasis or spread to the gastrointestinal system (3)
CL Item
No, not known to involve the gastrointestinal tract (4)
Item Group
2. Type of cancer, GI neoplasm or GI polyp diagnosis
Item
Type of cancer, GI neoplasm or GI polyp diagnosis
integer
Type of cancer, GI neoplasm or GI polyp diagnosis
Code List
Type of cancer, GI neoplasm or GI polyp diagnosis
CL Item
New cancer (1)
CL Item
Recurrence or progression of cancer (4)
CL Item
GI Polyp(s) or GI neoplasm(s) (benign or unknown) (6)
Item Group
3. New cancer or Recurrence or progression (2) of cancer details
Date of diagnosis
Item
Date of diagnosis
date
Item
Source of information supporting the diagnosis date
text
Source of information supporting diagnosis date
Code List
Source of information supporting the diagnosis date
CL Item
Date of diagnostic procedure(s) - Please specify procedure (1)
CL Item
Date of pathology (2)
CL Item
Date of signs or symptoms (3)
CL Item
Date of death (if applicable e.g. first diagnosed on autopsy) (4)
CL Item
Other, specify (OT)
Procedure specification
Item
Please specify procedure
text
Other source of information specification
Item
Other, specify
text
Item
Site of Primary cancer
text
Site of Primary cancer
Code List
Site of Primary cancer
CL Item
Cancer of the anus (101)
CL Item
Benign non-gastrointestinal neoplasm (123)
CL Item
Bile duct cancer (2)
CL Item
Bladder cancer (3)
CL Item
Bone cancer (3b)
CL Item
Bowel cancer - region unknown (4b)
CL Item
Brain cancer (3c)
CL Item
Breast cancer (5)
CL Item
Cervical cancer (6)
CL Item
Colon cancer (102)
CL Item
Colorectal cancer (103)
CL Item
Endometrium (104)
CL Item
Esophageal cancer (105)
CL Item
Fallopian tube cancer (106)
CL Item
Gastric cancer (11)
CL Item
Gallbladder cancer (10)
CL Item
Gastrointestinal carcinoid tumor (107)
CL Item
Gastrointestinal stromal tumor (GIST) (108)
CL Item
Hodgkin's disease with gastrointestinal involvement (110)
CL Item
Hodgkin's diasease with no gastrointestinal involvement (109)
CL Item
Larynx cancer (111)
CL Item
Leukemia (13)
CL Item
Lip cancer (14)
CL Item
Liver cancer (15)
CL Item
Lung cancer (16)
CL Item
Lymphoma gastric origin (112)
CL Item
Lymphoma small intestinal origin (113)
CL Item
Lymphoma other gastrointestinal (114)
CL Item
Lymphoma non-gastrointestinal (115)
CL Item
Mesothelioma (116a)
CL Item
Multiple myeloma (18)
CL Item
Myelodysplastic syndrome (19)
CL Item
Oral cancer (21)
CL Item
Ovarian cancer (22)
CL Item
Pancreatic cancer (23)
CL Item
Penile cancer (24)
CL Item
Pharyngeal cancer (25)
CL Item
Prostate cance (26)
CL Item
Rectal cancer (117)
CL Item
Renal cancer (27)
CL Item
Scrotum cancer (28)
CL Item
Skin cancer, melanoma (29a)
CL Item
Skin cancer non-melanoma (29b)
CL Item
Small Intestinal adenocarcinoma (118)
CL Item
Small intestinal carcinoid tumors (120)
CL Item
Small Intestinal sarcoma (119)
CL Item
Small intestinal cancer other, specify (121)
CL Item
Spinal cord (125)
CL Item
Testicular cancer (30)
CL Item
Thyroid cancer (122)
CL Item
Unknown primary cancer (126)
CL Item
Uterine, other site (127)
CL Item
Vaginal cancer (31)
CL Item
Vulval cancer (32)
CL Item
Other gastrointestinal cancer, specify (129A)
CL Item
Other cancer site, specify (129)
Other site specification
Item
Other site, specify
text
metastatic disease
Item
Was metastatic (3) disease present?
boolean
Item
If yes, Locations(s) if known
integer
metastatic disease location
Code List
If yes, Locations(s) if known
CL Item
Anus (1)
CL Item
Bile duct (2)
CL Item
Bladder (3)
CL Item
Bone (4)
CL Item
Bone marrow (5)
CL Item
Bowel - region unknown (6)
CL Item
Brain (7)
CL Item
Breast (8)
CL Item
Cervix (9)
CL Item
Colon (10)
CL Item
Endometrium (11)
CL Item
Esophagus (12)
CL Item
Eye (13)
CL Item
Fallopian tube (14)
CL Item
Gall bladder (15)
CL Item
Kidney (16)
CL Item
Larynx (17)
CL Item
Lip (18)
CL Item
Liver (19)
CL Item
Lung (20)
CL Item
Lymph node(s) (21)
CL Item
Mouth (22)
CL Item
Ovary (23)
CL Item
Pancreas (24)
CL Item
Penis (25)
CL Item
Pharynx (26)
CL Item
Prostate (27)
CL Item
Rectum (28)
CL Item
Scrotum (29)
CL Item
Skin (30)
CL Item
Small intestine (31)
CL Item
Spinal cord (32)
CL Item
Stomach (33)
CL Item
Testes (34)
CL Item
Thyroid (35)
CL Item
Vagina (36)
CL Item
Vulva (37)
metastatic disease other location
Item
Other location
boolean
metastatic disease other location specification
Item
Other location(s), specify
text
Item Group
4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
Date of procedure
Item
Date of procedure
date
Location of polyp/neoplasm Small intestine
Item
Location of polyp(s)/neoplasm(s): Small intestine
boolean
Location of polyp/neoplasm Colon
Item
Location of polyp(s)/neoplasm(s): Colon
boolean
Location of polyp/neoplasm Anus
Item
Location of polyp(s)/neoplasm(s): Anus
boolean
Location of polyp/neoplasm Stomach
Item
Location of polyp(s)/neoplasm(s): Stomach
boolean
Location of polyp/neoplasm Esophagus
Item
Location of polyp(s)/neoplasm(s): Esophagus
boolean
Location of polyp/neoplasm Biliary system
Item
Location of polyp(s)/neoplasm(s): Biliary system
boolean
Location of polyp/neoplasm Liver
Item
Location of polyp(s)/neoplasm(s): Liver
boolean
Location of polyp/neoplasm Pancreas
Item
Location of polyp(s)/neoplasm(s): Pancreas
boolean
Location of polyp/neoplasm Other
Item
Location of polyp(s)/neoplasm(s): Other
boolean
Location of polyp/neoplasm Other specification
Item
Other, specify
text
Item Group
5. Required source documents sent
Item
Required source documents sent
text
Required source documents sent
Code List
Required source documents sent
CL Item
Yes (Y)
CL Item
Not available (NV)
CL Item
Source documents not required - case does not require adjudication (i.e. non-GI cancer/neoplasm) (NR)
required source documents sent date
Item
If yes, date sent:
date
Item Group
CEC Status
Event number
Item
6. Event number
text
Trigger number
Item
7. Trigger number
text
Item
8. CEC Status
integer
CEC Status
Code List
8. CEC Status
CL Item
New (1)
CL Item
Coordinator Screen check (2)
CL Item
Hold (3)
CL Item
Ready for review (4)
CL Item
In Phase I review (5)
CL Item
Queried (InForm) (6)
CL Item
Additional documents required (7)
CL Item
In Phase II committee (8)
CL Item
Data change (9)
CL Item
Re-Review (10)
CL Item
Completed event (11)
CL Item
No event to adjudicate (12)
CL Item
QC Random sample (13)
CL Item
In Translation (14)
Date of status change
Item
9. Date of status change
date
CEC Coordinator comments
Item
10. CEC Coordinator comments
text
Adverse event reference identifier
Item
11. Adverse event reference identifier
text
Adverse event term
Item
12. Adverse event term
text
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