ID

42912

Beskrivning

Description of Form: Follow Up Form

Nyckelord

Versioner (3)
  1. 2015-11-09 2015-11-09 -
  2. 2015-12-28 2015-12-28 -
  3. 2021-09-17 2021-09-17 -
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17 september 2021

DOI

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Creative Commons BY-NC 3.0
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Follow Up Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

Engelsk

Follow Up Form

1 Formulär  
  1. StudyEvent: ODM
    1. Follow Up Form
Default Itemgroup
Beskrivning

Default Itemgroup

Date last known to be alive or death
Beskrivning

Date last contact

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0805839
dd/mm/yyyy
Patient status
Beskrivning

Patient status

Alias
UMLS CUI-1
C0449437
Survival status
Beskrivning

Survival status

Datatyp

integer

Alias
UMLS CUI [1]
C1148433
*Cause of death
Beskrivning

Cause of death

Datatyp

integer

Alias
UMLS CUI [1]
C0007465
Specify
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1]
C1521902
Remission Status
Beskrivning

Remission Status

Alias
UMLS CUI-1
C0544452
Remission status
Beskrivning

Remission status

Datatyp

integer

Alias
UMLS CUI [1]
C0544452
Date of relapse
Beskrivning

Date of Relapse

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Second malignancy (not previously reported)
Beskrivning

second malignancy

Datatyp

integer

Alias
UMLS CUI [1]
C0006826
Specify
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0006826
Date of diagnosis
Beskrivning

NewCancerDiagnosisDate

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
GvHD
Beskrivning

GvHD

Alias
UMLS CUI-1
C0018133
Acute GvHD (not previously reported)
Beskrivning

Acute GvHD

Datatyp

integer

Alias
UMLS CUI [1]
C0856825
Chronic GvHD (not previously reported)
Beskrivning

Chronic GvHD

Datatyp

integer

Alias
UMLS CUI [1]
C0867389
AML/MDS Treatment Given after End of Protocol
Beskrivning

AML/MDS Treatment Given after End of Protocol

Treatment given off protocol
Beskrivning

Treatment off protocol

Datatyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1518546
Specify
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1]
C1521902
Date of start treatment
Beskrivning

Date of start treatment

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Was CR(i) achieved after off protocol treatment
Beskrivning

Was CR(i) achieved after off protocol treatment

Datatyp

integer

Alias
UMLS CUI [1]
C1704632
Date CR(i)
Beskrivning

Date CR

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Comments
Beskrivning

Comments

Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Fill in this Page in Case of autoHSCT, alloHSCT or DLI (Given after End of Protocol)
Beskrivning

Fill in this Page in Case of autoHSCT, alloHSCT or DLI (Given after End of Protocol)

Conditioning Therapy
Beskrivning

Conditioning Therapy

Datatyp

integer

Alias
UMLS CUI [1]
C0376450
Specify
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1]
C1521902
Date of Transplant
Beskrivning

Date of Transplant

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0472699
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Source of stem cells (actually infused)
Beskrivning

Source of stem cells

Datatyp

integer

Alias
UMLS CUI [1,1]
C0449416
UMLS CUI [1,2]
C0038250
Number of nucleated cells infused
Beskrivning

Number of nucleated cells infused

Datatyp

float

Måttenheter
  • 10^8/kg
Alias
UMLS CUI [1,1]
C1180059
UMLS CUI [1,2]
C0750480
10^8/kg
Number of CD34+ cells infused
Beskrivning

Number of CD34+ cells infused

Datatyp

float

Måttenheter
  • 10^6/kg
Alias
UMLS CUI [1,1]
C0882849
UMLS CUI [1,2]
C0750480
10^6/kg
T-cell depletion
Beskrivning

T-Cell Depletion

Datatyp

boolean

Alias
UMLS CUI [1]
C0677960
Number of T-cells infused
Beskrivning

Number of T-cells infused

Datatyp

float

Måttenheter
  • 10^4/kg
Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0750480
10^4/kg
Donor
Beskrivning

Donor

Alias
UMLS CUI-1
C0013018
Donor sex
Beskrivning

Donor sex

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
Donor date of birth
Beskrivning

Donor date of birth

Datatyp

date

Alias
UMLS CUI [1,1]
C0421451
UMLS CUI [1,2]
C0013018
Relation with patient
Beskrivning

Donor Relation

Datatyp

integer

Alias
UMLS CUI [1]
C0369128
Comments 2
Beskrivning

Comments 2

Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Follow Up Form

1 Formulär
  1. StudyEvent: ODM
    1. Follow Up Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Date last contact
Item
Date last known to be alive or death
date
C0805839 (UMLS CUI [1])
Item Group
Patient status
C0449437 (UMLS CUI-1)
Item
Survival status
integer
C1148433 (UMLS CUI [1])
Survival status
Code List
Survival status
CL Item
alive  (0)
CL Item
dead* (1)
Item
*Cause of death
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
*Cause of death
CL Item
leukemia  (1)
C0023418 (UMLS CUI-1)
CL Item
pneumonia  (2)
C0032285 (UMLS CUI-1)
CL Item
other infection  (3)
C0009450 (UMLS CUI-1)
CL Item
hemorrhage (4)
C0019080 (UMLS CUI-1)
CL Item
veno-occlusive disease*  (5)
C0948441 (UMLS CUI-1)
CL Item
other* (8)
C0205394 (UMLS CUI-1)
Specify
Item
Specify
text
C1521902 (UMLS CUI [1])
Item Group
Remission Status
C0544452 (UMLS CUI-1)
Item
Remission status
integer
C0544452 (UMLS CUI [1])
Remission status
Code List
Remission status
CL Item
no CR(i)  (0)
C3844738 (UMLS CUI-1)
CL Item
CR  (1)
C0677874 (UMLS CUI-1)
CL Item
CRi (2)
C3538993 (UMLS CUI-1)
Date of Relapse
Item
Date of relapse
date
C0035020 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Second malignancy (not previously reported)
integer
C0006826 (UMLS CUI [1])
second malignancy
Code List
Second malignancy (not previously reported)
CL Item
no (0)
CL Item
yes* (please complete SPM form (22) and SAE form) (1)
Specify
Item
Specify
text
C1521902 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
NewCancerDiagnosisDate
Item
Date of diagnosis
date
C0006826 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
GvHD
C0018133 (UMLS CUI-1)
Item
Acute GvHD (not previously reported)
integer
C0856825 (UMLS CUI [1])
Acute GvHD
Code List
Acute GvHD (not previously reported)
CL Item
none  (0)
CL Item
Grade I  (1)
CL Item
Grade II (2)
CL Item
Grade III  (3)
CL Item
Grade IV (4)
CL Item
not applicable, no alloHSCT (8 )
Item
Chronic GvHD (not previously reported)
integer
C0867389 (UMLS CUI [1])
Chronic GvHD
Code List
Chronic GvHD (not previously reported)
CL Item
none (0)
CL Item
too early (3)
CL Item
limited (1)
CL Item
extensive (2)
CL Item
not applicable, no alloHSCT (8)
Item Group
AML/MDS Treatment Given after End of Protocol
Item
Treatment given off protocol
integer
C0087111 (UMLS CUI [1,1])
C1518546 (UMLS CUI [1,2])
Treatment off protocol
Code List
Treatment given off protocol
CL Item
no (leave boxes 15 to 20 empty)  (0)
C0445106 (UMLS CUI-1)
CL Item
chemotherapy only (1)
C3665472 (UMLS CUI-1)
CL Item
autoHSCT** (2)
C0194037 (UMLS CUI-1)
CL Item
alloHSCT**  (3)
C1705576 (UMLS CUI-1)
CL Item
DLI** (4)
C1512034 (UMLS CUI-1)
CL Item
other* (8)
C0205394 (UMLS CUI-1)
Specify
Item
Specify
text
C1521902 (UMLS CUI [1])
Date of start treatment
Item
Date of start treatment
date
C0087111 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Was CR(i) achieved after off protocol treatment
integer
C1704632 (UMLS CUI [1])
Was CR(i) achieved after off protocol treatment
Code List
Was CR(i) achieved after off protocol treatment
CL Item
no  (0)
C3844738 (UMLS CUI-1)
CL Item
yes, CR*  (1)
C0677874 (UMLS CUI-1)
CL Item
yes, CRi* (2)
C3538993 (UMLS CUI-1)
CL Item
achieved before  (3)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Date CR
Item
Date CR(i)
date
C0677874 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Comments
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Conditioning Therapy
integer
C0376450 (UMLS CUI [1])
Conditioning Therapy
Code List
Conditioning Therapy
CL Item
no conditioning  (0)
C0445106 (UMLS CUI-1)
CL Item
non-myelo ablative (1)
C1831742 (UMLS CUI-1)
CL Item
myelo ablative (2)
C1513784 (UMLS CUI-1)
CL Item
other* (8)
C0205394 (UMLS CUI-1)
Specify
Item
Specify
text
C1521902 (UMLS CUI [1])
Date of Transplant
Item
Date of Transplant
date
C0472699 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Source of stem cells (actually infused)
integer
C0449416 (UMLS CUI [1,1])
C0038250 (UMLS CUI [1,2])
Source of stem cells
Code List
Source of stem cells (actually infused)
CL Item
bone marrow  (1)
CL Item
peripheral blood (2)
CL Item
BM + PB (3)
CL Item
cord blood (4)
Number of nucleated cells infused
Item
Number of nucleated cells infused
float
C1180059 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Number of CD34+ cells infused
Item
Number of CD34+ cells infused
float
C0882849 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
T-Cell Depletion
Item
T-cell depletion
boolean
C0677960 (UMLS CUI [1])
Number of T-cells infused
Item
Number of T-cells infused
float
C0039194 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item Group
Donor
C0013018 (UMLS CUI-1)
Item
Donor sex
integer
C0079399 (UMLS CUI [1])
Donor sex
Code List
Donor sex
CL Item
male (1)
C0086582 (UMLS CUI-1)
CL Item
female (2)
C0086287 (UMLS CUI-1)
Donor date of birth
Item
Donor date of birth
date
C0421451 (UMLS CUI [1,1])
C0013018 (UMLS CUI [1,2])
Item
Relation with patient
integer
C0369128 (UMLS CUI [1])
Donor Relation
Code List
Relation with patient
CL Item
monozygotic twin (1)
C0041432 (UMLS CUI-1)
CL Item
HLA identical sibling (2)
C0037047 (UMLS CUI-1)
CL Item
HLA identical parent (3)
C0030551 (UMLS CUI-1)
CL Item
1-antigen-mismatched related donor (4)
M (UMLS CUI-1)
CL Item
2-or more-antigen mismatched related donor (haplo-identical) (5)
M (UMLS CUI-1)
CL Item
matched unrelated donor# (6)
M (UMLS CUI-1)
CL Item
mismatched unrelated donor## (7)
M (UMLS CUI-1)
CL Item
cord blood unit identified (8)
C0162371 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Item Group
Comments 2
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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