ID

41503

Beschrijving

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

Trefwoorden

Versies (3)
  1. 06-09-20 06-09-20 -
  2. 14-09-20 14-09-20 -
  3. 29-10-20 29-10-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 oktober 2020

DOI

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Licentie

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

Engels

Check for Study Continuation; Physical Examination; Laboratory Tests (Report Final and Annex Report 2 Final)

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation (Visit 1)
Beschrijving

Check for Study Continuation (Visit 1)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 1?
Beschrijving

Yes → Please complete the next pages. No → Please complete the Study Conclusion section.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 2)
Beschrijving

Check for Study Continuation (Visit 2)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 2?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
The ONE most appropriate reason for not returning to visit 2
Beschrijving

The ONE most appropriate reason for not returning to visit 2

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 3)
Beschrijving

Check for Study Continuation (Visit 3)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 3?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
The ONE most appropriate reason for not returning to visit 3
Beschrijving

The ONE most appropriate reason for not returning to visit 3

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 4)
Beschrijving

Check for Study Continuation (Visit 4)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 4?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
The ONE most appropriate reason for not returning to visit 4
Beschrijving

The ONE most appropriate reason for not returning to visit 4

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 5)
Beschrijving

Check for Study Continuation (Visit 5)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 5?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
The ONE most appropriate reason for not returning to visit 5
Beschrijving

The ONE most appropriate reason for not returning to visit 5

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 6)
Beschrijving

Check for Study Continuation (Visit 6)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 6?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
The ONE most appropriate reason for not returning to visit 6
Beschrijving

The ONE most appropriate reason for not returning to visit 6

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 7)
Beschrijving

Check for Study Continuation (Visit 7)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 7?
Beschrijving

Yes → Please complete the next pages. No → Please tick the reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 7
Beschrijving

Reason for not returning to visit 7

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 8)
Beschrijving

Check for Study Continuation (Visit 8)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 8?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 8
Beschrijving

Reason for not returning to visit 8

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 9)
Beschrijving

Check for Study Continuation (Visit 9)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 9?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 9
Beschrijving

Reason for not returning to visit 9

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 10)
Beschrijving

Check for Study Continuation (Visit 10)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 10?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 10
Beschrijving

Reason for not returning to visit 10

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 11)
Beschrijving

Check for Study Continuation (Visit 11)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 11?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 11
Beschrijving

Reason for not returning to visit 11

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 12)
Beschrijving

Check for Study Continuation (Visit 12)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 12?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 12
Beschrijving

Reason for not returning to visit 12

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 13)
Beschrijving

Check for Study Continuation (Visit 13)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 13?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 13
Beschrijving

Reason for not returning to visit 13

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 14)
Beschrijving

Check for Study Continuation (Visit 14)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 14?
Beschrijving

Yes → Please complete the next pages. No → Please tick the reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 14
Beschrijving

Reason for not returning to visit 14

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 15)
Beschrijving

Check for Study Continuation (Visit 15)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 15?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 15
Beschrijving

Reason for not returning to visit 15

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 16)
Beschrijving

Check for Study Continuation (Visit 16)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 16?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 16
Beschrijving

Reason for not returning to visit 16

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 17)
Beschrijving

Check for Study Continuation (Visit 17)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 17?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 17
Beschrijving

Reason for not returning to visit 17

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 18)
Beschrijving

Check for Study Continuation (Visit 18)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 18?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 18
Beschrijving

Reason for not returning to visit 18

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 19)
Beschrijving

Check for Study Continuation (Visit 19)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 19?
Beschrijving

Yes → Please complete the next pages. No → Please tick the reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 19
Beschrijving

Reason for not returning to visit 19

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 20)
Beschrijving

Check for Study Continuation (Visit 20)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 20?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 20
Beschrijving

Reason for not returning to visit 20

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 21)
Beschrijving

Check for Study Continuation (Visit 21)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 21?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit. + boolean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 21
Beschrijving

Reason for not returning to visit 21

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 22)
Beschrijving

Check for Study Continuation (Visit 22)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 22?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 22
Beschrijving

Reason for not returning to visit 22

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 23)
Beschrijving

Check for Study Continuation (Visit 23)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 23?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 23
Beschrijving

Reason for not returning to visit 23

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 24)
Beschrijving

Check for Study Continuation (Visit 24)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 24?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 24
Beschrijving

Reason for not returning to visit 24

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 25)
Beschrijving

Check for Study Continuation (Visit 25)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 25?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 25
Beschrijving

Reason for not returning to visit 25

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 26)
Beschrijving

Check for Study Continuation (Visit 26)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 26?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 26
Beschrijving

Reason for not returning to visit 26

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Visit 27)
Beschrijving

Check for Study Continuation (Visit 27)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 27?
Beschrijving

Yes → Please complete the next pages. No → Please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for not returning to visit 27
Beschrijving

Reason for not returning to visit 27

Datatype

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
ICF Addendum - Did the patient sign the addendum to ICF? (Annex Report 2 Final)
Beschrijving

Yes - Please complete the date patient signed addendum ICF and complete the visit 27 study procedures No - Please complete the visit 27 study procedures (all need to be done except ASCI administration and serological sampling), complete the treatment conclusion, the concluding visit (as not done) and the study conclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1510776
Date of ICF Addendum (Annex Report 2 Final)
Beschrijving

Date of ICF Addendum (Annex Report 2 Final)

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1510776
UMLS CUI [1,3]
C0011008
Check for Study Continuation (Visit 28)
Beschrijving

Check for Study Continuation (Visit 28)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the patient return for Visit 28?
Beschrijving

Yes → Please complete the next pages. No → Please complete the Treatment conclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Check for Study Continuation (Follow-Up)
Beschrijving

Check for Study Continuation (Follow-Up)

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C1522577
Did the patient return for the Follow-Up Visit?
Beschrijving

Yes → Please complete this visit No → Please specify the reason

Datatype

boolean

Alias
UMLS CUI [1]
C0545082
UMLS CUI [2]
C0805733
UMLS CUI [3]
C1522577
Reason for not returning to follow-up visit
Beschrijving

Reason for not returning to follow-up visit

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C1522577
Specify reason for not returning to follow-up visit
Beschrijving

Specify reason for not returning to follow-up visit

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C1522577
UMLS CUI [3]
C0205394
Physical Examination (Visit 1)
Beschrijving

Physical Examination (Visit 1)

Alias
UMLS CUI-1
C0031809
Has a complete physical examination been performed?
Beschrijving

Has a complete physical examination been performed?

Datatype

boolean

Alias
UMLS CUI [1]
C0031809
If a complete physical examination has been performed, record result
Beschrijving

Tick all that apply. At least one box must be ticked.

Datatype

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1274040
If other physical examination result, specify
Beschrijving

If other physical examination result, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Physical Examination (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 28)
Beschrijving

Physical Examination (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 28)

Alias
UMLS CUI-1
C0031809
Has a complete physical examination been performed?
Beschrijving

Has a complete physical examination been performed?

Datatype

boolean

Alias
UMLS CUI [1]
C0031809
If a complete physical examination has been performed, record result
Beschrijving

Tick all that apply. At least one box must be ticked.

Datatype

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1274040
If other physical examination result, specify
Beschrijving

If other physical examination result, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Physical Examination (Follow-Up)
Beschrijving

Physical Examination (Follow-Up)

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C1522577
Has a complete physical examination been performed?
Beschrijving

Has a complete physical examination been performed?

Datatype

boolean

Alias
UMLS CUI [1]
C0031809
If a complete physical examination has been performed, record result
Beschrijving

Tick all that apply. At least one box must be ticked.

Datatype

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1274040
If other physical examination result, specify
Beschrijving

If other physical examination result, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Weight (Visit 1 - 6, 8 - 13, 15 - 18, 20 - 28, Follow-Up)
Beschrijving

Weight (Visit 1 - 6, 8 - 13, 15 - 18, 20 - 28, Follow-Up)

Alias
UMLS CUI-1
C0005910
Has the weight been recorded?
Beschrijving

Has the weight been recorded?

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Laboratory Tests (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28)
Beschrijving

Laboratory Tests (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28)

Alias
UMLS CUI-1
C0022885
Laboratory Name
Beschrijving

Laboratory Name

Datatype

text

Alias
UMLS CUI [1]
C3258037
Lab Code
Beschrijving

Lab Code

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Has a blood sample been taken?
Beschrijving

Has a blood sample been taken?

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
Date of blood sample taken
Beschrijving

Date of blood sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28)
Beschrijving

Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28)

Alias
UMLS CUI-1
C0018941
Haematology Test
Beschrijving

Haematology Test

Datatype

integer

Alias
UMLS CUI [1]
C0018941
Haematology Result
Beschrijving

Haematology Result

Datatype

text

Alias
UMLS CUI [1]
C0474523
Hepatic Function (Visit 1, 3, 6, 8, 10, 14 -18, 21, 23 - 28)
Beschrijving

Hepatic Function (Visit 1, 3, 6, 8, 10, 14 -18, 21, 23 - 28)

Alias
UMLS CUI-1
C0232741
Hepatic Function Test
Beschrijving

Hepatic Function Test

Datatype

integer

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

Hepatic Function Result

Datatype

text

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0456984
Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28)
Beschrijving

Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28)

Alias
UMLS CUI-1
C0005477
Biochemistry Test
Beschrijving

Biochemistry Test

Datatype

integer

Alias
UMLS CUI [1]
C1655775
Biochemistry Result
Beschrijving

Biochemistry Result

Datatype

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0456984
Renal Function (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28)
Beschrijving

Renal Function (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28)

Alias
UMLS CUI-1
C0232804
Renal Function Test
Beschrijving

Renal Function Test

Datatype

integer

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

Renal Function Result

Datatype

text

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0456984
Humoral Immunity (Serum) (Visit 1, 3, 7, 14, 19, 21, 23 - 28, Follow-Up)
Beschrijving

Humoral Immunity (Serum) (Visit 1, 3, 7, 14, 19, 21, 23 - 28, Follow-Up)

Alias
UMLS CUI-1
C0020967
UMLS CUI-2
C0229671
Has a blood sample been taken for antibody testing?
Beschrijving

Has a blood sample been taken for antibody testing?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C3833453
Date of antibody testing for humoral Immunity (Serum)
Beschrijving

Date of antibody testing for humoral Immunity (Serum)

Datatype

date

Alias
UMLS CUI [1]
C3833453
UMLS CUI [2,1]
C0020967
UMLS CUI [2,2]
C0229671
Requisition number:
Beschrijving

Requisition number:

Datatype

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
Cellular Immunity (PBMC) (Visit 1, 7, 14, 19, 21, 23 - 26, 28, Follow-Up)
Beschrijving

Cellular Immunity (PBMC) (Visit 1, 7, 14, 19, 21, 23 - 26, 28, Follow-Up)

Alias
UMLS CUI-1
C0020966
Has a blood sample been taken for Cellular (T-cell) analysis (PBMC)?
Beschrijving

Has a blood sample been taken for Cellular (T-cell) analysis (PBMC)?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0039194
UMLS CUI [1,3]
C0936012
Date of T-cell analysis
Beschrijving

Date of T-cell analysis

Datatype

date

Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0936012
UMLS CUI [2]
C0011008
Requisition number:
Beschrijving

Requisition number:

Datatype

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
HCG Urine or Blood Pregnancy Test (Visit 7, 11, 15, 17, 20 - 27)
Beschrijving

HCG Urine or Blood Pregnancy Test (Visit 7, 11, 15, 17, 20 - 27)

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

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

Datatype

integer

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0430056
UMLS CUI [2,1]
C1277698
UMLS CUI [2,2]
C0032976
Date sample taken for pregnancy test
Beschrijving

Date sample taken for pregnancy test

Datatype

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0011008
Pregnancy test result
Beschrijving

Pregnancy test result

Datatype

integer

Alias
UMLS CUI [1]
C0427777
End of follow-up
Beschrijving

End of follow-up

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0806020
Did the patient reach Month 60 of Follow-up phase?
Beschrijving

Please note that the patient in Follow-Up needs to be contacted for maximum of 5 years (60 Months) after first study treatment administration. Yes → Please complete Study Conclusion section. No → Please schedule the next Follow-up visit.

Datatype

boolean

Alias
UMLS CUI [1]
C1522577
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Similar models

Check for Study Continuation; Physical Examination; Laboratory Tests (Report Final and Annex Report 2 Final)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
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)
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])
Item Group
Check for Study Continuation (Visit 2)
C0805733 (UMLS CUI-1)
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])
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])
The ONE most appropriate reason for not returning to visit 2
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)
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])
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])
The ONE most appropriate reason for not returning to visit 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)
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])
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])
The ONE most appropriate reason for not returning to visit 4
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)
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])
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])
The ONE most appropriate reason for not returning to visit 5
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)
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])
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])
The ONE most appropriate reason for not returning to visit 6
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)
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])
Item
Reason for not returning to visit 7
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
The ONE most appropriate reason for not returning to visit 7
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)
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])
Item
Reason for not returning to visit 8
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 8
Code List
Reason for not returning to visit 8
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)
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])
Item
Reason for not returning to visit 9
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 9
Code List
Reason for not returning to visit 9
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)
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])
Item
Reason for not returning to visit 10
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 10
Code List
Reason for not returning to visit 10
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)
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])
Item
Reason for not returning to visit 11
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 11
Code List
Reason for not returning to visit 11
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)
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])
Item
Reason for not returning to visit 12
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 12
Code List
Reason for not returning to visit 12
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)
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])
Item
Reason for not returning to visit 13
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 13
Code List
Reason for not returning to visit 13
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)
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])
Item
Reason for not returning to visit 14
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 14
Code List
Reason for not returning to visit 14
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)
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])
Item
Reason for not returning to visit 15
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 15
Code List
Reason for not returning to visit 15
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)
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])
Item
Reason for not returning to visit 16
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 16
Code List
Reason for not returning to visit 16
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)
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])
Item
Reason for not returning to visit 17
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 17
Code List
Reason for not returning to visit 17
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)
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])
Item
Reason for not returning to visit 18
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 18
Code List
Reason for not returning to visit 18
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)
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])
Item
Reason for not returning to visit 19
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 19
Code List
Reason for not returning to visit 19
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)
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])
Item
Reason for not returning to visit 20
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 20
Code List
Reason for not returning to visit 20
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)
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])
Item
Reason for not returning to visit 21
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 21
Code List
Reason for not returning to visit 21
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)
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])
Item
Reason for not returning to visit 22
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 22
Code List
Reason for not returning to visit 22
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)
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])
Item
Reason for not returning to visit 23
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 23
Code List
Reason for not returning to visit 23
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)
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])
Item
Reason for not returning to visit 24
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 24
Code List
Reason for not returning to visit 24
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)
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])
Item
Reason for not returning to visit 25
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 25
Code List
Reason for not returning to visit 25
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)
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])
Item
Reason for not returning to visit 26
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 26
Code List
Reason for not returning to visit 26
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)
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])
Item
Reason for not returning to visit 27
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for not returning to visit 27
Code List
Reason for not returning to visit 27
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)
ICF Addendum - Did the patient sign the addendum to ICF? (Annex Report 2 Final)
Item
ICF Addendum - Did the patient sign the addendum to ICF? (Annex Report 2 Final)
boolean
C0021430 (UMLS CUI [1,1])
C1510776 (UMLS CUI [1,2])
Date of ICF Addendum (Annex Report 2 Final)
Item
Date of ICF Addendum (Annex Report 2 Final)
date
C0021430 (UMLS CUI [1,1])
C1510776 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Check for Study Continuation (Visit 28)
C0805733 (UMLS CUI-1)
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])
Item Group
Check for Study Continuation (Follow-Up)
C0805733 (UMLS CUI-1)
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])
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])
Reason for not returning to follow-up visit
Code List
Reason for not returning to follow-up visit
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])
Item Group
Physical Examination (Visit 1)
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])
If a complete physical examination has been performed, record result
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])
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])
If a complete physical examination has been performed, record result
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])
Item Group
Physical Examination (Follow-Up)
C0031809 (UMLS CUI-1)
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])
If a complete physical examination has been performed, record result
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])
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])
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])
Item Group
Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28)
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
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])
Hepatic Function Test
Code List
Hepatic Function Test
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])
Item Group
Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28)
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])
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])
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])
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)
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])
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])
Requisition number:
Item
Requisition number:
text
C1514821 (UMLS CUI [1,1])
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])
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])
Requisition number:
Item
Requisition number:
text
C1514821 (UMLS CUI [1,1])
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])
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 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])
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 treatment conclusion) (2)
Item Group
End of follow-up
C1522577 (UMLS CUI-1)
C0806020 (UMLS CUI-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])
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