ID

42899

Descripción

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

Palabras clave

Versiones (2)
  1. 27/10/20 27/10/20 -
  2. 17/9/21 17/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de septiembre de 2021

DOI

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Licencia

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

Inglés

Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
MAGE-A3 Expression Test
Descripción

MAGE-A3 Expression Test

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
Has the fresh sample been sent?
Descripción

Has the fresh sample been sent?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2827486
If the fresh sample has been sent, record date of sending
Descripción

If the fresh sample has been sent, record date of sending

Tipo de datos

date

Alias
UMLS CUI [1]
C2827486
UMLS CUI [2]
C0011008
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Descripción

Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3]
C0242356
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Descripción

If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3]
C0421451
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Descripción

If a tumor sample has been received for MAGE-A3 expression, enter date of reception

Tipo de datos

date

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3,1]
C0544683
UMLS CUI [3,2]
C0011008
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Descripción

If a tumor sample has been received for MAGE-A3 expression, enter date of result

Tipo de datos

date

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3,1]
C1274040
UMLS CUI [3,2]
C0011008
MAGE-A3 expression test result
Descripción

MAGE-A3 expression test result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0962473
UMLS CUI [1,2]
C0017262
UMLS CUI [2]
C1274040
Tumor Sample (For Re-Test)
Descripción

Tumor Sample (For Re-Test)

Alias
UMLS CUI-1
C0475358
Has a new fresh biopsy been collected?
Descripción

Has a new fresh biopsy been collected?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C2827486
Date of biopsy (fresh biopsy):
Descripción

Date of biopsy (fresh biopsy):

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C2827486
Requisition number (fresh biopsy):
Descripción

Requisition number (fresh biopsy):

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C2827486
Tumor biopsy type (fresh biopsy):
Descripción

Tumor biopsy type (fresh biopsy):

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0332307
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C2827486
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Descripción

Has a new Formalin fixed Paraffin embedded (FFPE) been collected?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2711483
Date of biopsy (FFPE):
Descripción

Date of biopsy (FFPE):

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C2711483
Requisition number (FFPE):
Descripción

Requisition number (FFPE):

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C2711483
Tumor block or tumor slides (FFPE)?
Descripción

Tumor block or tumor slides (FFPE)?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2317347
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1705201
UMLS CUI [3]
C2711483
Number of tumor slides sent (FFPE)
Descripción

Number of tumor slides sent (FFPE)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1705201
UMLS CUI [1,3]
C0237753
UMLS CUI [2]
C2711483
Does the FFPE come from the same lesion as the fresh biopsy?
Descripción

Does the FFPE come from the same lesion as the fresh biopsy?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2711483
UMLS CUI [2,1]
C0677862
UMLS CUI [2,2]
C2827486
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0445247
FFPE sample type:
Descripción

FFPE sample type:

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2711483
UMLS CUI [1,2]
C0456204
MAGE-A3 Expression Re-Test
Descripción

MAGE-A3 Expression Re-Test

Alias
UMLS CUI-1
C0962473
UMLS CUI-2
C0017262
UMLS CUI-3
C0022885
Has the fresh sample been sent?
Descripción

Has the fresh sample been sent?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2827486
If the fresh sample has been sent, record date of sending
Descripción

If the fresh sample has been sent, record date of sending

Tipo de datos

date

Alias
UMLS CUI [1]
C2827486
UMLS CUI [2]
C0011008
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Descripción

Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3]
C0242356
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Descripción

If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3]
C0421451
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Descripción

If a tumor sample has been received for MAGE-A3 expression, enter date of reception

Tipo de datos

date

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3,1]
C0544683
UMLS CUI [3,2]
C0011008
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Descripción

If a tumor sample has been received for MAGE-A3 expression, enter date of result

Tipo de datos

date

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0017262
UMLS CUI [3,1]
C1274040
UMLS CUI [3,2]
C0011008
MAGE-A3 expression test result
Descripción

MAGE-A3 expression test result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0962473
UMLS CUI [1,2]
C0017262
UMLS CUI [2]
C1274040
Prior Surgery
Descripción

Prior Surgery

Alias
UMLS CUI-1
C0744961
Prior Surgery
Descripción

Prior Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0744961
Prior Surgery Type
Descripción

Prior Surgery Type

Alias
UMLS CUI-1
C0744961
UMLS CUI-2
C0332307
Prior Surgery Type
Descripción

Prior Surgery Type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0744961
UMLS CUI [1,2]
C0332307
Date of last surgery
Descripción

Date of last surgery

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
Prior Surgery
Descripción

Prior Surgery

Alias
UMLS CUI-1
C0744961
Has patient recovered from past surgery?
Descripción

Has patient recovered from past surgery?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826210
Prior Therapy
Descripción

Prior Therapy

Alias
UMLS CUI-1
C1514463
1) Prior adjuvant treatment with Interferon?
Descripción

1) Prior adjuvant treatment with Interferon?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1522673
UMLS CUI [2]
C0021747
Date of last dose (Interferon):
Descripción

Date of last dose (Interferon):

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0021747
Did the patient receive more than one treatment line?
Descripción

Did the patient receive more than one treatment line?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522541
2) Prior treatment with cancer vaccine?
Descripción

2) Prior treatment with cancer vaccine?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0042210
Date of last dose (cancer vaccine):
Descripción

Date of last dose (cancer vaccine):

Tipo de datos

date

Alias
UMLS CUI [1]
C1762893
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0042210
3) Prior treatment with anti-CTL-A4 based therapy?
Descripción

3) Prior treatment with anti-CTL-A4 based therapy?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C4289973
Date of last dose (anti-CTL-A4):
Descripción

Date of last dose (anti-CTL-A4):

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C4289973
4) Prior treatment with radiotherapy?
Descripción

4) Prior treatment with radiotherapy?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279134
Date of last dose (radiotherapy):
Descripción

Date of last dose (radiotherapy):

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0279134
5) Prior isolated limb perfusion?
Descripción

5) Prior isolated limb perfusion?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0396670
Date of last dose (isolated limb perfusion):
Descripción

Date of last dose (isolated limb perfusion):

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0396670
6) Prior treatment with systemic chemotherapy?
Descripción

6) Prior treatment with systemic chemotherapy?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1883256
Date of last dose (systemic chemotherapy):
Descripción

Date of last dose (systemic chemotherapy):

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1883256
7) Prior treatment with systemic immunosuppressants within 6 months?
Descripción

7) Prior treatment with systemic immunosuppressants within 6 months?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0021079
UMLS CUI [1,3]
C0205373
Prior treatment with systemic immunosuppressants
Descripción

Prior treatment with systemic immunosuppressants

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0021079
UMLS CUI-3
C0205373
Trade/ Generic Name
Descripción

Trade/ Generic Name

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Other immunosuppressant
Descripción

Other immunosuppressant

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205394
Max. daily dose
Descripción

Max. daily dose

Tipo de datos

float

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0806909
Unit
Descripción

Unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Immunosuppressant start date
Descripción

Immunosuppressant start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0808070
Immunosuppressant stop date
Descripción

Immunosuppressant stop date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0806020
Immunosuppressant ongoing?
Descripción

Immunosuppressant ongoing?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0549178
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Similar models

Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
MAGE-A3 Expression Test
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Has the fresh sample been sent?
Item
Has the fresh sample been sent?
boolean
C2827486 (UMLS CUI [1])
If the fresh sample has been sent, record date of sending
Item
If the fresh sample has been sent, record date of sending
date
C2827486 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Item
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
boolean
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0242356 (UMLS CUI [3])
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Item
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
date
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0421451 (UMLS CUI [3])
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Item
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
date
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0544683 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Item
If a tumor sample has been received for MAGE-A3 expression, enter date of result
date
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
Item
MAGE-A3 expression test result
integer
C0962473 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2])
MAGE-A3 expression test result
Code List
MAGE-A3 expression test result
CL Item
MAGE-A3 positive (1)
CL Item
MAGE-A3 negative (2)
CL Item
Sample not valid (3)
Item Group
Tumor Sample (For Re-Test)
C0475358 (UMLS CUI-1)
Has a new fresh biopsy been collected?
Item
Has a new fresh biopsy been collected?
boolean
C0005558 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
Date of biopsy (fresh biopsy):
Item
Date of biopsy (fresh biopsy):
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Requisition number (fresh biopsy):
Item
Requisition number (fresh biopsy):
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Item
Tumor biopsy type (fresh biopsy):
integer
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Tumor biopsy type:
Code List
Tumor biopsy type (fresh biopsy):
CL Item
Skin (1)
CL Item
Subcutaneous (2)
CL Item
Lymphnode (3)
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Item
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
boolean
C0475358 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
Date of biopsy (FFPE):
Item
Date of biopsy (FFPE):
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Requisition number (FFPE):
Item
Requisition number (FFPE):
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Item
Tumor block or tumor slides (FFPE)?
integer
C0475358 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2317347 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1705201 (UMLS CUI [2,2])
C2711483 (UMLS CUI [3])
Tumor block or tumor slides (FFPE)?
Code List
Tumor block or tumor slides (FFPE)?
CL Item
Tumor block (1)
CL Item
Tumor slides (2)
Number of tumor slides sent (FFPE)
Item
Number of tumor slides sent (FFPE)
integer
C0027651 (UMLS CUI [1,1])
C1705201 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2711483 (UMLS CUI [2])
Does the FFPE come from the same lesion as the fresh biopsy?
Item
Does the FFPE come from the same lesion as the fresh biopsy?
boolean
C2711483 (UMLS CUI [1])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
Item
FFPE sample type:
integer
C2711483 (UMLS CUI [1,1])
C0456204 (UMLS CUI [1,2])
FFPE sample type:
Code List
FFPE sample type:
CL Item
Skin (1)
CL Item
Subcutaneous (2)
CL Item
Lymphnode (3)
Item Group
MAGE-A3 Expression Re-Test
C0962473 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Has the fresh sample been sent?
Item
Has the fresh sample been sent?
boolean
C2827486 (UMLS CUI [1])
If the fresh sample has been sent, record date of sending
Item
If the fresh sample has been sent, record date of sending
date
C2827486 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
Item
Has a tumor sample been received for MAGE-A3 expression? (Derived from R&D Database)
boolean
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0242356 (UMLS CUI [3])
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
Item
If a tumor sample has been received for MAGE-A3 expression, enter date of patient's birth
boolean
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0421451 (UMLS CUI [3])
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
Item
If a tumor sample has been received for MAGE-A3 expression, enter date of reception
date
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0544683 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
If a tumor sample has been received for MAGE-A3 expression, enter date of result
Item
If a tumor sample has been received for MAGE-A3 expression, enter date of result
date
C0475358 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
Item
MAGE-A3 expression test result
integer
C0962473 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2])
MAGE-A3 expression test result
Code List
MAGE-A3 expression test result
CL Item
MAGE-A3 positive  (1)
CL Item
MAGE-A3 negative  (2)
CL Item
Sample not valid (3)
Item Group
Prior Surgery
C0744961 (UMLS CUI-1)
Prior Surgery
Item
Prior Surgery
boolean
C0744961 (UMLS CUI [1])
Item Group
Prior Surgery Type
C0744961 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Prior Surgery Type
integer
C0744961 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Prior Surgery Type
Code List
Prior Surgery Type
CL Item
Excision/wide excision of primary (1)
CL Item
Sentinel lymph node biopsy (2)
CL Item
Lymphadenectomy (3)
CL Item
Excision of local recurrence (4)
CL Item
Excision of satellite or in-transit metastases (5)
CL Item
Excision of distant metastases (6)
CL Item
Other, specify (7)
Date of last surgery
Item
Date of last surgery
date
C0543467 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Item Group
Prior Surgery
C0744961 (UMLS CUI-1)
Has patient recovered from past surgery?
Item
Has patient recovered from past surgery?
boolean
C0543467 (UMLS CUI [1,1])
C2826210 (UMLS CUI [1,2])
Item Group
Prior Therapy
C1514463 (UMLS CUI-1)
1) Prior adjuvant treatment with Interferon?
Item
1) Prior adjuvant treatment with Interferon?
boolean
C0087111 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0021747 (UMLS CUI [2])
Date of last dose (Interferon):
Item
Date of last dose (Interferon):
date
C1762893 (UMLS CUI [1,1])
C0021747 (UMLS CUI [1,2])
Did the patient receive more than one treatment line?
Item
Did the patient receive more than one treatment line?
boolean
C1522541 (UMLS CUI [1])
2) Prior treatment with cancer vaccine?
Item
2) Prior treatment with cancer vaccine?
boolean
C1514463 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
Date of last dose (cancer vaccine):
Item
Date of last dose (cancer vaccine):
date
C1762893 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
3) Prior treatment with anti-CTL-A4 based therapy?
Item
3) Prior treatment with anti-CTL-A4 based therapy?
boolean
C1514463 (UMLS CUI [1,1])
C4289973 (UMLS CUI [1,2])
Date of last dose (anti-CTL-A4):
Item
Date of last dose (anti-CTL-A4):
date
C1762893 (UMLS CUI [1,1])
C4289973 (UMLS CUI [1,2])
4) Prior treatment with radiotherapy?
Item
4) Prior treatment with radiotherapy?
boolean
C0279134 (UMLS CUI [1])
Date of last dose (radiotherapy):
Item
Date of last dose (radiotherapy):
date
C1762893 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
5) Prior isolated limb perfusion?
Item
5) Prior isolated limb perfusion?
boolean
C0396670 (UMLS CUI [1])
Date of last dose (isolated limb perfusion):
Item
Date of last dose (isolated limb perfusion):
date
C1762893 (UMLS CUI [1,1])
C0396670 (UMLS CUI [1,2])
6) Prior treatment with systemic chemotherapy?
Item
6) Prior treatment with systemic chemotherapy?
boolean
C1514463 (UMLS CUI [1,1])
C1883256 (UMLS CUI [1,2])
Date of last dose (systemic chemotherapy):
Item
Date of last dose (systemic chemotherapy):
date
C1762893 (UMLS CUI [1,1])
C1883256 (UMLS CUI [1,2])
7) Prior treatment with systemic immunosuppressants within 6 months?
Item
7) Prior treatment with systemic immunosuppressants within 6 months?
boolean
C1514463 (UMLS CUI [1,1])
C0021079 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Item Group
Prior treatment with systemic immunosuppressants
C1514463 (UMLS CUI-1)
C0021079 (UMLS CUI-2)
C0205373 (UMLS CUI-3)
Item
Trade/ Generic Name
integer
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Trade/ Generic Name
Code List
Trade/ Generic Name
CL Item
Adalimumab (1)
CL Item
Anti-lymphocytes Immunoglobulin (2)
CL Item
Azathioprine (3)
CL Item
Basiliximab (4)
CL Item
Bethamethasone (5)
CL Item
Ciclosporine (6)
CL Item
Cortisone (7)
CL Item
Dexamethasone (8)
CL Item
Etanercept (9)
CL Item
Everolimus (10)
CL Item
Infliximab (11)
CL Item
Leflunomide (12)
CL Item
Methylprednisolone (13)
CL Item
Muronomab (14)
CL Item
Mycophenolate (15)
CL Item
Prednisone/prednisolone (16)
CL Item
Sirolimus (17)
CL Item
Tacrolimus (18)
CL Item
Triamcinolone (19)
Other immunosuppressant
Item
Other immunosuppressant
text
C0021081 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Max. daily dose
Item
Max. daily dose
float
C2348070 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Immunosuppressant start date
Item
Immunosuppressant start date
date
C0021081 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Immunosuppressant stop date
Item
Immunosuppressant stop date
date
C0021081 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Immunosuppressant ongoing?
Item
Immunosuppressant ongoing?
boolean
C0021081 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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