ID

41496

Description

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Keywords

Versions (1)
  1. 10/28/20 10/28/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 28, 2020

DOI

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License

Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

English

Screening - Laboratory Tests (Annex Report 2 Final)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Laboratory Name
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C3258037
Lab Code
Description

(For GSK use only)

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Laboratory Assay
Description

Laboratory Assay

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1510438
Has a blood sample been taken?
Description

Has a blood sample been taken?

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Description

Date blood sample taken

Data type

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Haematology
Description

Haematology

Alias
UMLS CUI-1
C0018941
Haematology Test
Description

Haematology Test

Data type

integer

Alias
UMLS CUI [1]
C0018941
Haematology Result
Description

Haematology Result

Data type

text

Alias
UMLS CUI [1]
C0474523
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C0005477
Biochemistry Test
Description

Biochemistry Test

Data type

integer

Alias
UMLS CUI [1]
C1655775
Biochemistry Result
Description

Biochemistry Result

Data type

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1274040
Hepatic Function
Description

Hepatic Function

Alias
UMLS CUI-1
C0232741
Hepatic Function Test
Description

Hepatic Function Test

Data type

integer

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0022885
Hepatic Function Result
Description

Hepatic Function Result

Data type

text

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C1274040
Renal Function
Description

Renal Function

Alias
UMLS CUI-1
C0232804
Renal Function Test
Description

Renal Function Test

Data type

integer

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0022885
Renal Function Result
Description

Renal Function Result

Data type

text

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C1274040
HCG Urine or Blood Pregnancy Test
Description

HCG Urine or Blood Pregnancy Test

Alias
UMLS CUI-1
C0430056
UMLS CUI-2
C0430060
Has a urine or blood sample been taken for pregnancy test?
Description

Has a urine or blood sample been taken for pregnancy test?

Data type

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0032976
Date of pregnancy test
Description

Date of pregnancy test

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test result
Description

Pregnancy test result

Data type

integer

Alias
UMLS CUI [1]
C0427777
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Similar models

Screening - Laboratory Tests (Annex Report 2 Final)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Lab Code
Item
Lab Code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Item Group
Laboratory Assay
C0022877 (UMLS CUI-1)
C1510438 (UMLS CUI-2)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Haematology
C0018941 (UMLS CUI-1)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Haematology Test
CL Item
Hemoglobin (1)
CL Item
Platelets (2)
CL Item
White Blood Cells (3)
CL Item
Neutrophils (4)
CL Item
Lymphocytes (5)
Haematology Result
Item
Haematology Result
text
C0474523 (UMLS CUI [1])
Item Group
Biochemistry
C0005477 (UMLS CUI-1)
Item
Biochemistry Test
integer
C1655775 (UMLS CUI [1])
Biochemistry Test
Code List
Biochemistry Test
CL Item
LDH (1)
Biochemistry Result
Item
Biochemistry Result
text
C0005477 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Hepatic Function
C0232741 (UMLS CUI-1)
Item
Hepatic Function Test
integer
C0232741 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Hepatic Function Test
Code List
Hepatic Function Test
CL Item
Total bilirubin (1)
CL Item
Aspartate transaminase (ASAT) (2)
CL Item
Alanine transaminase (ALAT) (3)
CL Item
Alkaline phosphatase (4)
Hepatic Function Result
Item
Hepatic Function Result
text
C0232741 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Renal Function
C0232804 (UMLS CUI-1)
Item
Renal Function Test
integer
C0232804 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Renal Function Test
Code List
Renal Function Test
CL Item
Creatinine (1)
Renal Function Result
Item
Renal Function Result
text
C0232804 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
HCG Urine or Blood Pregnancy Test
C0430056 (UMLS CUI-1)
C0430060 (UMLS CUI-2)
Item
Has a urine or blood sample been taken for pregnancy test?
integer
C0005834 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Has a urine or blood sample been taken for pregnancy test?
Code List
Has a urine or blood sample been taken for pregnancy test?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (Not of childbearing potential or male) (3)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Negative (1)
CL Item
Positive (please complete screening conclusion) (2)
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