ID

28267

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 Report Form - Repeating form (Scheduled visits)

Stichworte

Versionen (4)
  1. 04.10.17 04.10.17 -
  2. 13.10.17 13.10.17 -
  3. 23.10.17 23.10.17 -
  4. 01.01.18 01.01.18 -
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GlaxoSmithKline

Hochgeladen am

1. Januar 2018

DOI

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Cancer Report Form Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

Cancer Report Form Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
1. Diagnosis of a new, recurrence of, or metastatic cancer
Beschreibung

1. Diagnosis of a new, recurrence of, or metastatic cancer

Diagnosis of a new, recurrence of, or metastatic cancer
Beschreibung

Cancer diagnosis

Datentyp

integer

Alias
UMLS CUI [1]
C0920688
2. New cancer details
Beschreibung

2. New cancer details

Date of diagnosis
Beschreibung

Date of diagnosis new cancer

Datentyp

date

Alias
UMLS CUI [1,1]
C0205314
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0011900
UMLS CUI [1,4]
C0011008
Site
Beschreibung

Site new cancer

Datentyp

integer

Other site
Beschreibung

Other site new cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2945843
Other site, specify
Beschreibung

Other site new cancer specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C2348235
Was the pathology report obtained for the source documentation?
Beschreibung

pathology report new cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0807321
3. Recurrence of cancer details
Beschreibung

3. Recurrence of cancer details

Date of recurrence
Beschreibung

Date of recurrence

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0277556
Site
Beschreibung

Site recurrence

Datentyp

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0277556
Other site
Beschreibung

Other site recurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0277556
Other site, specify
Beschreibung

Other site recurrence specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0277556
UMLS CUI [1,3]
C2348235
Was the pathology report obtained for the source documentation?
Beschreibung

pathology report recurrence

Datentyp

boolean

Alias
UMLS CUI [1]
C0807321
Was the pathology report for primary diagnosis obtained for the source documentation?
Beschreibung

pathology report primary diagnosis recurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302656
UMLS CUI [1,2]
C0807321
UMLS CUI [1,3]
C4291713
4. Metastatic cancer details
Beschreibung

4. Metastatic cancer details

Date of diagnosis of metastasis
Beschreibung

Date of diagnosis of metastasis

Datentyp

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0027627
Site
Beschreibung

Site of metastasis

Datentyp

integer

Alias
UMLS CUI [1]
C0807944
Other site
Beschreibung

Other site metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0807944
Other site, specify
Beschreibung

Other site specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Was the pathology report obtained for the source documentation?
Beschreibung

pathology report metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0807321
Date of diagnosis of primary site
Beschreibung

Date of diagnosis primary site

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Primary site
Beschreibung

Primary site metastasis

Datentyp

integer

Alias
UMLS CUI [1]
C0807944
Other primary site
Beschreibung

Other primary site

Datentyp

boolean

Alias
UMLS CUI [1]
C0475447
Other primary site, specify
Beschreibung

Other primary site specification

Datentyp

text

Alias
UMLS CUI [1]
C0475447
Was the pathology report for primary diagnosis obtained for the source documentation?
Beschreibung

pathology report primary diagnosis metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302656
UMLS CUI [1,2]
C0807321
UMLS CUI [1,3]
C4291713
5. Was the subject hospitalised related to this diagnosis?
Beschreibung

5. Was the subject hospitalised related to this diagnosis?

Was the subject hospitalised related to this diagnosis?
Beschreibung

Hospitalisation related to diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0392360
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Ähnliche Modelle

Cancer Report Form Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
1. Diagnosis of a new, recurrence of, or metastatic cancer
Item
Diagnosis of a new, recurrence of, or metastatic cancer
integer
C0920688 (UMLS CUI [1])
Cancer diagnosis
Code List
Diagnosis of a new, recurrence of, or metastatic cancer
CL Item
New cancer (1)
C0205314 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Recurrence of cancer (2)
C0920420 (UMLS CUI-1)
(Comment:en)
CL Item
Metastatic cancer (3)
C0027627 (UMLS CUI-1)
(Comment:en)
Item Group
2. New cancer details
Date of diagnosis new cancer
Item
Date of diagnosis
date
C0205314 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Site
integer
Site new cancer
Code List
Site
CL Item
Benign neoplasm (1)
C0086692 (UMLS CUI-1)
(Comment:en)
CL Item
Bile duct cancer (2)
C0005400 (UMLS CUI-1)
(Comment:en)
CL Item
Bladder cancer (3)
C0005684 (UMLS CUI-1)
(Comment:en)
CL Item
Bowel cancer (4)
C0699790 (UMLS CUI-1)
(Comment:en)
CL Item
Breast cancer (5)
C0678222 (UMLS CUI-1)
(Comment:en)
CL Item
Cervical cancer (6)
C0007847 (UMLS CUI-1)
(Comment:en)
CL Item
Endometrial cancer (7)
C0476089 (UMLS CUI-1)
(Comment:en)
CL Item
Esophageal cancer (8)
C0014859 (UMLS CUI-1)
(Comment:en)
CL Item
Fallopian tube cancer (9)
C0015560 (UMLS CUI-1)
(Comment:en)
CL Item
Gallbladder cancer (10)
C0016976 (UMLS CUI-1)
(Comment:en)
CL Item
Gastric cancer (11)
C0006826 (UMLS CUI-1)
C0038351 (UMLS CUI-2)
(Comment:en)
CL Item
Hodgkin's disease (12)
C0024305 (UMLS CUI-1)
(Comment:en)
CL Item
Leukemia (13)
C0023418 (UMLS CUI-1)
(Comment:en)
CL Item
Lip cancer (14)
C0023759 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Liver cancer (15)
C0006826 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
(Comment:en)
CL Item
Lung cancer (16)
C0242379 (UMLS CUI-1)
(Comment:en)
CL Item
Lymphoma (17)
C0024299 (UMLS CUI-1)
(Comment:en)
CL Item
Multiple myeloma (18)
C0026764 (UMLS CUI-1)
(Comment:en)
CL Item
Myelodysplastic syndrome (19)
C3463824 (UMLS CUI-1)
(Comment:en)
CL Item
Non-melanoma skin cancer (20)
C0006826 (UMLS CUI-1)
C0699893 (UMLS CUI-2)
(Comment:en)
CL Item
Oral cancer (21)
C0442027 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Ovarian cancer (22)
C0029925 (UMLS CUI-1)
(Comment:en)
CL Item
Pancreatic cancer (23)
C0235974 (UMLS CUI-1)
(Comment:en)
CL Item
Penile cancer (24)
C0581395 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Pharyngeal cancer (25)
C0031354 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Prostate cancer (26)
C0600139 (UMLS CUI-1)
(Comment:en)
CL Item
Renal cancer (27)
C1378703 (UMLS CUI-1)
(Comment:en)
CL Item
Scrotum cancer (28)
C0036471 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Skin melanoma (29)
C0151779 (UMLS CUI-1)
(Comment:en)
CL Item
Testicular cancer (30)
C0153594 (UMLS CUI-1)
(Comment:en)
CL Item
Vaginal cancer (31)
C0269208 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Vulval cancer (32)
C1699561 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
Other site new cancer
Item
Other site
boolean
C0006826 (UMLS CUI [1,1])
C2945843 (UMLS CUI [1,2])
Other site new cancer specification
Item
Other site, specify
text
C0751623 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
pathology report new cancer
Item
Was the pathology report obtained for the source documentation?
boolean
C0807321 (UMLS CUI [1])
Item Group
3. Recurrence of cancer details
Date of recurrence
Item
Date of recurrence
date
C0012634 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Site new cancer
Code List
Site
CL Item
Benign neoplasm (1)
C0086692 (UMLS CUI-1)
(Comment:en)
CL Item
Bile duct cancer (2)
C0005400 (UMLS CUI-1)
(Comment:en)
CL Item
Bladder cancer (3)
C0005684 (UMLS CUI-1)
(Comment:en)
CL Item
Bowel cancer (4)
C0699790 (UMLS CUI-1)
(Comment:en)
CL Item
Breast cancer (5)
C0678222 (UMLS CUI-1)
(Comment:en)
CL Item
Cervical cancer (6)
C0007847 (UMLS CUI-1)
(Comment:en)
CL Item
Endometrial cancer (7)
C0476089 (UMLS CUI-1)
(Comment:en)
CL Item
Esophageal cancer (8)
C0014859 (UMLS CUI-1)
(Comment:en)
CL Item
Fallopian tube cancer (9)
C0015560 (UMLS CUI-1)
(Comment:en)
CL Item
Gallbladder cancer (10)
C0016976 (UMLS CUI-1)
(Comment:en)
CL Item
Gastric cancer (11)
C0006826 (UMLS CUI-1)
C0038351 (UMLS CUI-2)
(Comment:en)
CL Item
Hodgkin's disease (12)
C0024305 (UMLS CUI-1)
(Comment:en)
CL Item
Leukemia (13)
C0023418 (UMLS CUI-1)
(Comment:en)
CL Item
Lip cancer (14)
C0023759 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Liver cancer (15)
C0006826 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
(Comment:en)
CL Item
Lung cancer (16)
C0242379 (UMLS CUI-1)
(Comment:en)
CL Item
Lymphoma (17)
C0024299 (UMLS CUI-1)
(Comment:en)
CL Item
Multiple myeloma (18)
C0026764 (UMLS CUI-1)
(Comment:en)
CL Item
Myelodysplastic syndrome (19)
C3463824 (UMLS CUI-1)
(Comment:en)
CL Item
Non-melanoma skin cancer (20)
C0006826 (UMLS CUI-1)
C0699893 (UMLS CUI-2)
(Comment:en)
CL Item
Oral cancer (21)
C0442027 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Ovarian cancer (22)
C0029925 (UMLS CUI-1)
(Comment:en)
CL Item
Pancreatic cancer (23)
C0235974 (UMLS CUI-1)
(Comment:en)
CL Item
Penile cancer (24)
C0581395 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Pharyngeal cancer (25)
C0031354 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Prostate cancer (26)
C0600139 (UMLS CUI-1)
(Comment:en)
CL Item
Renal cancer (27)
C1378703 (UMLS CUI-1)
(Comment:en)
CL Item
Scrotum cancer (28)
C0036471 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Skin melanoma (29)
C0151779 (UMLS CUI-1)
(Comment:en)
CL Item
Testicular cancer (30)
C0153594 (UMLS CUI-1)
(Comment:en)
CL Item
Vaginal cancer (31)
C0269208 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Vulval cancer (32)
C1699561 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
Other site recurrence
Item
Other site
boolean
C1515974 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Other site recurrence specification
Item
Other site, specify
text
C1515974 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
pathology report recurrence
Item
Was the pathology report obtained for the source documentation?
boolean
C0807321 (UMLS CUI [1])
pathology report primary diagnosis recurrence
Item
Was the pathology report for primary diagnosis obtained for the source documentation?
boolean
C1302656 (UMLS CUI [1,1])
C0807321 (UMLS CUI [1,2])
C4291713 (UMLS CUI [1,3])
Item Group
4. Metastatic cancer details
Date of diagnosis of metastasis
Item
Date of diagnosis of metastasis
date
C2316983 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Item
Site
integer
C0807944 (UMLS CUI [1])
Site new cancer
Code List
Site
CL Item
Benign neoplasm (1)
C0086692 (UMLS CUI-1)
(Comment:en)
CL Item
Bile duct cancer (2)
C0005400 (UMLS CUI-1)
(Comment:en)
CL Item
Bladder cancer (3)
C0005684 (UMLS CUI-1)
(Comment:en)
CL Item
Bowel cancer (4)
C0699790 (UMLS CUI-1)
(Comment:en)
CL Item
Breast cancer (5)
C0678222 (UMLS CUI-1)
(Comment:en)
CL Item
Cervical cancer (6)
C0007847 (UMLS CUI-1)
(Comment:en)
CL Item
Endometrial cancer (7)
C0476089 (UMLS CUI-1)
(Comment:en)
CL Item
Esophageal cancer (8)
C0014859 (UMLS CUI-1)
(Comment:en)
CL Item
Fallopian tube cancer (9)
C0015560 (UMLS CUI-1)
(Comment:en)
CL Item
Gallbladder cancer (10)
C0016976 (UMLS CUI-1)
(Comment:en)
CL Item
Gastric cancer (11)
C0006826 (UMLS CUI-1)
C0038351 (UMLS CUI-2)
(Comment:en)
CL Item
Hodgkin's disease (12)
C0024305 (UMLS CUI-1)
(Comment:en)
CL Item
Leukemia (13)
C0023418 (UMLS CUI-1)
(Comment:en)
CL Item
Lip cancer (14)
C0023759 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Liver cancer (15)
C0006826 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
(Comment:en)
CL Item
Lung cancer (16)
C0242379 (UMLS CUI-1)
(Comment:en)
CL Item
Lymphoma (17)
C0024299 (UMLS CUI-1)
(Comment:en)
CL Item
Multiple myeloma (18)
C0026764 (UMLS CUI-1)
(Comment:en)
CL Item
Myelodysplastic syndrome (19)
C3463824 (UMLS CUI-1)
(Comment:en)
CL Item
Non-melanoma skin cancer (20)
C0006826 (UMLS CUI-1)
C0699893 (UMLS CUI-2)
(Comment:en)
CL Item
Oral cancer (21)
C0442027 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Ovarian cancer (22)
C0029925 (UMLS CUI-1)
(Comment:en)
CL Item
Pancreatic cancer (23)
C0235974 (UMLS CUI-1)
(Comment:en)
CL Item
Penile cancer (24)
C0581395 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Pharyngeal cancer (25)
C0031354 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Prostate cancer (26)
C0600139 (UMLS CUI-1)
(Comment:en)
CL Item
Renal cancer (27)
C1378703 (UMLS CUI-1)
(Comment:en)
CL Item
Scrotum cancer (28)
C0036471 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Skin melanoma (29)
C0151779 (UMLS CUI-1)
(Comment:en)
CL Item
Testicular cancer (30)
C0153594 (UMLS CUI-1)
(Comment:en)
CL Item
Vaginal cancer (31)
C0269208 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Vulval cancer (32)
C1699561 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
Other site metastasis
Item
Other site
boolean
C0807944 (UMLS CUI [1])
Other site specification
Item
Other site, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
pathology report metastasis
Item
Was the pathology report obtained for the source documentation?
boolean
C0807321 (UMLS CUI [1])
Date of diagnosis primary site
Item
Date of diagnosis of primary site
date
C2316983 (UMLS CUI [1])
Item
Primary site
integer
C0807944 (UMLS CUI [1])
Site new cancer
Code List
Primary site
CL Item
Benign neoplasm (1)
C0086692 (UMLS CUI-1)
(Comment:en)
CL Item
Bile duct cancer (2)
C0005400 (UMLS CUI-1)
(Comment:en)
CL Item
Bladder cancer (3)
C0005684 (UMLS CUI-1)
(Comment:en)
CL Item
Bowel cancer (4)
C0699790 (UMLS CUI-1)
(Comment:en)
CL Item
Breast cancer (5)
C0678222 (UMLS CUI-1)
(Comment:en)
CL Item
Cervical cancer (6)
C0007847 (UMLS CUI-1)
(Comment:en)
CL Item
Endometrial cancer (7)
C0476089 (UMLS CUI-1)
(Comment:en)
CL Item
Esophageal cancer (8)
C0014859 (UMLS CUI-1)
(Comment:en)
CL Item
Fallopian tube cancer (9)
C0015560 (UMLS CUI-1)
(Comment:en)
CL Item
Gallbladder cancer (10)
C0016976 (UMLS CUI-1)
(Comment:en)
CL Item
Gastric cancer (11)
C0006826 (UMLS CUI-1)
C0038351 (UMLS CUI-2)
(Comment:en)
CL Item
Hodgkin's disease (12)
C0024305 (UMLS CUI-1)
(Comment:en)
CL Item
Leukemia (13)
C0023418 (UMLS CUI-1)
(Comment:en)
CL Item
Lip cancer (14)
C0023759 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Liver cancer (15)
C0006826 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
(Comment:en)
CL Item
Lung cancer (16)
C0242379 (UMLS CUI-1)
(Comment:en)
CL Item
Lymphoma (17)
C0024299 (UMLS CUI-1)
(Comment:en)
CL Item
Multiple myeloma (18)
C0026764 (UMLS CUI-1)
(Comment:en)
CL Item
Myelodysplastic syndrome (19)
C3463824 (UMLS CUI-1)
(Comment:en)
CL Item
Non-melanoma skin cancer (20)
C0006826 (UMLS CUI-1)
C0699893 (UMLS CUI-2)
(Comment:en)
CL Item
Oral cancer (21)
C0442027 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Ovarian cancer (22)
C0029925 (UMLS CUI-1)
(Comment:en)
CL Item
Pancreatic cancer (23)
C0235974 (UMLS CUI-1)
(Comment:en)
CL Item
Penile cancer (24)
C0581395 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Pharyngeal cancer (25)
C0031354 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Prostate cancer (26)
C0600139 (UMLS CUI-1)
(Comment:en)
CL Item
Renal cancer (27)
C1378703 (UMLS CUI-1)
(Comment:en)
CL Item
Scrotum cancer (28)
C0036471 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Skin melanoma (29)
C0151779 (UMLS CUI-1)
(Comment:en)
CL Item
Testicular cancer (30)
C0153594 (UMLS CUI-1)
(Comment:en)
CL Item
Vaginal cancer (31)
C0269208 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
CL Item
Vulval cancer (32)
C1699561 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
(Comment:en)
Other primary site
Item
Other primary site
boolean
C0475447 (UMLS CUI [1])
Other primary site specification
Item
Other primary site, specify
text
C0475447 (UMLS CUI [1])
pathology report primary diagnosis metastasis
Item
Was the pathology report for primary diagnosis obtained for the source documentation?
boolean
C1302656 (UMLS CUI [1,1])
C0807321 (UMLS CUI [1,2])
C4291713 (UMLS CUI [1,3])
Item Group
5. Was the subject hospitalised related to this diagnosis?
Hospitalisation related to diagnosis
Item
Was the subject hospitalised related to this diagnosis?
boolean
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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