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ID
41373
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 (3)
- 9/6/20 9/6/20 -
- 9/14/20 9/14/20 -
- 10/29/20 10/29/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 14, 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
Check for Study Continuation; Physical Examination; Laboratory Tests
Similar models
Check for Study Continuation; Physical Examination; Laboratory Tests
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation (Visit 1)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 1?
Item
Did the patient return for Visit 1?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Check for Study Continuation (Visit 2)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 2?
Item
Did the patient return for Visit 2?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
The ONE most appropriate reason for not returning to visit 2
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
The ONE most appropriate reason for not returning to visit 2
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 3)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 3?
Item
Did the patient return for Visit 3?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
The ONE most appropriate reason for not returning to visit 3
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
The ONE most appropriate reason for not returning to visit 3
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 4)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 4?
Item
Did the patient return for Visit 4?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
The ONE most appropriate reason for not returning to visit 4
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
The ONE most appropriate reason for not returning to visit 4
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 5)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 5?
Item
Did the patient return for Visit 5?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
The ONE most appropriate reason for not returning to visit 5
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
The ONE most appropriate reason for not returning to visit 5
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 6)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 6?
Item
Did the patient return for Visit 6?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
The ONE most appropriate reason for not returning to visit 6
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
The ONE most appropriate reason for not returning to visit 6
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 7)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 7?
Item
Did the patient return for Visit 7?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 7
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Reason for not returning to visit 7
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (Please complete Concluding Visit section. Please complete Treatment conclusion.) (1)
CL Item
Visit not done but next administration still planned to be performed (Please continue with next visit.) (2)
Item Group
Check for Study Continuation (Visit 8)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 8?
Item
Did the patient return for Visit 8?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 8
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 9)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 9?
Item
Did the patient return for Visit 9?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 9
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 10)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 10?
Item
Did the patient return for Visit 10?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 10
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 11)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 11?
Item
Did the patient return for Visit 11?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 11
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 12)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 12?
Item
Did the patient return for Visit 12?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 12
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 13)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 13?
Item
Did the patient return for Visit 13?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 13
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 14)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 14?
Item
Did the patient return for Visit 14?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 14
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (Please complete Concluding Visit section. Please complete Treatment conclusion.) (1)
CL Item
Visit not done but next administration still planned to be performed (Please continue with next visit.) (2)
Item Group
Check for Study Continuation (Visit 15)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 15?
Item
Did the patient return for Visit 15?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 15
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 16)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 16?
Item
Did the patient return for Visit 16?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 16
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 17)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 17?
Item
Did the patient return for Visit 17?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 17
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 18)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 18?
Item
Did the patient return for Visit 18?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 18
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 19)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 19?
Item
Did the patient return for Visit 19?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 19
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (Please complete Concluding Visit section. Please complete Treatment conclusion.) (1)
CL Item
Visit not done but next administration still planned to be performed (Please continue with next visit.) (2)
Item Group
Check for Study Continuation (Visit 20)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 20?
Item
Did the patient return for Visit 20?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 20
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 21)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 21?
Item
Did the patient return for Visit 21?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 21
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 22)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 22?
Item
Did the patient return for Visit 22?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 22
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 23)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 23?
Item
Did the patient return for Visit 23?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 23
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 24)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 24?
Item
Did the patient return for Visit 24?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 24
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 25)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 25?
Item
Did the patient return for Visit 25?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 25
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 26)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 26?
Item
Did the patient return for Visit 26?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 26
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 27)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 27?
Item
Did the patient return for Visit 27?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Reason for not returning to visit 27
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Maximum delay for postponing study treatment for this visit has been reached (related dose should be cancelled, please continue with next visit) (1)
CL Item
Patient discontinued due to criteria for permanent stopping of study treatment (please complete Concluding Visit section, please complete Treatment conclusion.) (2)
Item Group
Check for Study Continuation (Visit 28)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Did the patient return for Visit 28?
Item
Did the patient return for Visit 28?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Check for Study Continuation (Follow-Up)
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0008976 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Did the patient return for the Follow-Up Visit?
Item
Did the patient return for the Follow-Up Visit?
boolean
C0545082 (UMLS CUI [1])
C0805733 (UMLS CUI [2])
C1522577 (UMLS CUI [3])
C0805733 (UMLS CUI [2])
C1522577 (UMLS CUI [3])
Item
Reason for not returning to follow-up visit
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2])
CL Item
Lost to follow-up (LFU)
CL Item
Consent withdrawal not due to a serious adverse event (Please complete the Study Conclusion section) (CWS)
CL Item
Serious adverse event (Please complete and submit SAE report) (SAE)
CL Item
Recurrence / Progressive disease (Please complete the Best overall response assessment section) (PD)
CL Item
Death (any cause) (Please complete the Study Conclusion section. Please complete the Death form.) (DEA)
CL Item
Other, specify (OTH)
Specify reason for not returning to follow-up visit
Item
Specify reason for not returning to follow-up visit
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
Has a complete physical examination been performed?
Item
Has a complete physical examination been performed?
boolean
C0031809 (UMLS CUI [1])
Item
If a complete physical examination has been performed, record result
integer
C0031809 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
Code List
If a complete physical examination has been performed, record result
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
SAE (Record in SAE section) (3)
CL Item
No changes since previous physical examination (4)
CL Item
Other, specify (5)
If other physical examination result, specify
Item
If other physical examination result, specify
text
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Physical Examination (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 28)
C0031809 (UMLS CUI-1)
Has a complete physical examination been performed?
Item
Has a complete physical examination been performed?
boolean
C0031809 (UMLS CUI [1])
Item
If a complete physical examination has been performed, record result
integer
C0031809 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
Code List
If a complete physical examination has been performed, record result
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Adverse event / SAE (Record in AE / SAE section.) (3)
CL Item
Suspicion of progression (Complete the Unscheduled Tumor Assessment section.) (4)
CL Item
No changes since previous physical examination (5)
CL Item
Other, specify (6)
If other physical examination result, specify
Item
If other physical examination result, specify
text
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Physical Examination (Follow-Up)
C0031809 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
Has a complete physical examination been performed?
Item
Has a complete physical examination been performed?
boolean
C0031809 (UMLS CUI [1])
Item
If a complete physical examination has been performed, record result
integer
C0031809 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
Code List
If a complete physical examination has been performed, record result
CL Item
SAE (Record in SAE section) (1)
CL Item
Suspicion of progression (Complete the Tumor Assessment pages) (2)
CL Item
No changes since previous physical examination (3)
CL Item
Other, specify (4)
If other physical examination result, specify
Item
If other physical examination result, specify
text
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Weight (Visit 1 - 6, 8 - 13, 15 - 18, 20 - 28, Follow-Up)
C0005910 (UMLS CUI-1)
Has the weight been recorded?
Item
Has the weight been recorded?
boolean
C0005910 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Laboratory Tests (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28)
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])
C0805701 (UMLS CUI [1,2])
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date of blood sample taken
Item
Date of blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28)
C0018941 (UMLS CUI-1)
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
Hepatic Function (Visit 1, 3, 6, 8, 10, 14 -18, 21, 23 - 28)
C0232741 (UMLS CUI-1)
Item
Hepatic Function Test
integer
C0232741 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
CL Item
Serum 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])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
Item Group
Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28)
C0005477 (UMLS CUI-1)
CL Item
LDH (1)
Biochemistry Result
Item
Biochemistry Result
text
C0005477 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
Item Group
Renal Function (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28)
C0232804 (UMLS CUI-1)
Item
Renal Function Test
integer
C0232804 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
CL Item
Creatinine (1)
Renal Function Result
Item
Renal Function Result
text
C0232804 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
Item Group
Humoral Immunity (Serum) (Visit 1, 3, 7, 14, 19, 21, 23 - 28, Follow-Up)
C0020967 (UMLS CUI-1)
C0229671 (UMLS CUI-2)
C0229671 (UMLS CUI-2)
Has a blood sample been taken for antibody testing?
Item
Has a blood sample been taken for antibody testing?
boolean
C0005834 (UMLS CUI [1,1])
C3833453 (UMLS CUI [1,2])
C3833453 (UMLS CUI [1,2])
Date of antibody testing for humoral Immunity (Serum)
Item
Date of antibody testing for humoral Immunity (Serum)
date
C3833453 (UMLS CUI [1])
C0020967 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
C0020967 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
Requisition number:
Item
Requisition number:
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
Cellular Immunity (PBMC) (Visit 1, 7, 14, 19, 21, 23 - 26, 28, Follow-Up)
C0020966 (UMLS CUI-1)
Has a blood sample been taken for Cellular (T-cell) analysis (PBMC)?
Item
Has a blood sample been taken for Cellular (T-cell) analysis (PBMC)?
boolean
C0005834 (UMLS CUI [1,1])
C0039194 (UMLS CUI [1,2])
C0936012 (UMLS CUI [1,3])
C0039194 (UMLS CUI [1,2])
C0936012 (UMLS CUI [1,3])
Date of T-cell analysis
Item
Date of T-cell analysis
date
C0039194 (UMLS CUI [1,1])
C0936012 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0936012 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Requisition number:
Item
Requisition number:
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
HCG Urine or Blood Pregnancy Test (Visit 7, 11, 15, 17, 20 - 27)
C0430056 (UMLS CUI-1)
Item
Has a urine or blood sample been taken for pregnancy test?
integer
C0200354 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C1277698 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0430056 (UMLS CUI [1,2])
C1277698 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
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 sample taken for pregnancy test
Item
Date sample taken for pregnancy test
date
C0005834 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
Negative (1)
CL Item
Positive (Please complete treatment conclusion) (2)
Did the patient reach Month 60 of Follow-up phase?
Item
Did the patient reach Month 60 of Follow-up phase?
boolean
C1522577 (UMLS CUI [1])