ID

14936

Description

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Event Recording. All events have to be reported to the study centre within two weeks after event. Clinical Trial Number: NCT01117441.

Keywords

Versions (1)
  1. 5/9/16 5/9/16 -
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May 9, 2016

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Creative Commons BY-NC-ND 3.0
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Event recording AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

English

Event recording AIEOP-BFM ALL 2009 NCT01117441

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Study ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient birth date
Description

Patient birth date

Data type

date

Alias
UMLS CUI [1]
C0421451
Hospital (GCCR)
Description

Hospital

Data type

text

Alias
UMLS CUI [1]
C0019994
Malignancy identification (GCCR)
Description

Malignancy identification

Data type

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1300638
Patient Identification number (GHOP - Society for Paediatric Oncology and Haematology)
Description

Patient Identification number

Data type

text

Alias
UMLS CUI [1]
C1300638
Relapse
Description

Relapse

Alias
UMLS CUI-1
C0035020
Date of relapse
Description

Date of relapse

Data type

date

Alias
UMLS CUI [1]
C0807712
Number of relapses
Description

Number of relapses

Data type

text

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0237753
Site of relapse
Description

Site of relapse

Data type

text

Alias
UMLS CUI [1,1]
C0205145
UMLS CUI [1,2]
C0035020
Site of relapse If other, specify:
Description

Site of relapse: specification

Data type

text

Alias
UMLS CUI [1,1]
C0205145
UMLS CUI [1,2]
C0035020
UMLS CUI [1,3]
C2348235
Second neoplasms
Description

Second neoplasms

Alias
UMLS CUI-1
C0085183
Date of second neoplasm
Description

Date of second neoplasm

Data type

date

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C2316983
Second neoplasms specification
Description

Second neoplasms specification

Data type

text

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C2348235
Second neoplasms: brain tumor If the second neoplasm is a "brain tumor", specify:
Description

Second neoplasms: brain tumor

Data type

text

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C0006118
Second neoplasms: brain tumor If the second neoplasm is a "brain tumor", specify:
Description

Second neoplasms: brain tumor: specification

Data type

text

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C0006118
UMLS CUI [1,3]
C2348235
Other second neoplasms If the second neoplasm is "other", specify:
Description

Other second neoplasms

Data type

text

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C0205394
Other second neoplasms If the second neoplasm is "other", specify:
Description

Other second neoplasms: specification

Data type

text

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Death
Description

Death

Alias
UMLS CUI-1
C0011065
Date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Autopsy performed?
Description

Autopsy

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Cause of death
Description

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
If cause of death is "Therapy complication before 1st CR", specify:
Description

Cause of death: therapy complication before 1st CR

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0009566
If cause of death is "ALL/ therapy complication before 1st CR (not decidable)", specify:
Description

Cause of death: ALL/ therapy complication

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0023449
UMLS CUI [2,1]
C0007465
UMLS CUI [2,2]
C0009566
If cause of death is "Therapy complication in 1st CR", specify:
Description

Cause of death: Therapy complication in 1st CR

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0677874
If cause of death is "SCT-associated complication", specify:
Description

Cause of death: SCT-associated complication

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0872278
UMLS CUI [1,3]
C0009566
If cause of death is "Other", specify:
Description

Cause of death: other

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C2348235
Therapy discontinuation
Description

Therapy discontinuation

Alias
UMLS CUI-1
C0457454
Date of discontinuation
Description

Date of discontinuation

Data type

date

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0011008
Discontinuation Point of time within the protocol
Description

Discontinuation: Protocol timepoint

Data type

text

Alias
UMLS CUI [1,1]
C1442880
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0457454
Reason for discontinuation
Description

Reason for discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0392360
Comments
Description

Comments

Alias
UMLS CUI-1
C0947611
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Identification and Signature
Description

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-2
C1519316
Doctor's name
Description

Doctor's name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0031831
Date of report
Description

Date of report

Data type

date

Alias
UMLS CUI [1]
C1302584
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Event recording AIEOP-BFM ALL 2009 NCT01117441

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
Patient Study ID
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient birth date
Item
Patient birth date
date
C0421451 (UMLS CUI [1])
Hospital
Item
Hospital (GCCR)
text
C0019994 (UMLS CUI [1])
Malignancy identification
Item
Malignancy identification (GCCR)
text
C0006826 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient Identification number
Item
Patient Identification number (GHOP - Society for Paediatric Oncology and Haematology)
text
C1300638 (UMLS CUI [1])
Item Group
Relapse
C0035020 (UMLS CUI-1)
Date of relapse
Item
Date of relapse
date
C0807712 (UMLS CUI [1])
Item
Number of relapses
text
C0035020 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of relapses
Code List
Number of relapses
CL Item
1st relapse (1st relapse)
CL Item
2nd relapse (2nd relapse)
CL Item
3rd relapse (3rd relapse)
CL Item
4th relapse (4th relapse)
Item
Site of relapse
text
C0205145 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
Site of relapse
Code List
Site of relapse
CL Item
Bone marrow (Bone marrow)
CL Item
CNS (CNS)
CL Item
Testicles (Testicles)
CL Item
Other (Other)
Site of relapse: specification
Item
Site of relapse If other, specify:
text
C0205145 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Second neoplasms
C0085183 (UMLS CUI-1)
Date of second neoplasm
Item
Date of second neoplasm
date
C0085183 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item
Second neoplasms specification
text
C0085183 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Second neoplasms specification
Code List
Second neoplasms specification
CL Item
ALL (ALL)
CL Item
AML (AML)
CL Item
MDS (MDS)
CL Item
B-ALL (B-ALL)
CL Item
Burkitt-Lymphoma (Burkitt-Lymphoma)
CL Item
pB-LBL (pB-LBL)
CL Item
T-LBL (T-LBL)
CL Item
ALCL (ALCL)
CL Item
M. Hodgkin (M. Hodgkin)
CL Item
Brain tumour (Brain tumour)
CL Item
Other solid tumour (Other solid tumour)
CL Item
Other (Other)
Second neoplasms: brain tumor
Item
Second neoplasms: brain tumor If the second neoplasm is a "brain tumor", specify:
text
C0085183 (UMLS CUI [1,1])
C0006118 (UMLS CUI [1,2])
Item
Second neoplasms: brain tumor If the second neoplasm is a "brain tumor", specify:
text
C0085183 (UMLS CUI [1,1])
C0006118 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Second neoplasms: brain tumor: specification
Code List
Second neoplasms: brain tumor If the second neoplasm is a "brain tumor", specify:
CL Item
malignant (malignant)
CL Item
benign (benign)
Other second neoplasms
Item
Other second neoplasms If the second neoplasm is "other", specify:
text
C0085183 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Other second neoplasms If the second neoplasm is "other", specify:
text
C0085183 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Other second neoplasms: specification
Code List
Other second neoplasms If the second neoplasm is "other", specify:
CL Item
malignant (malignant)
CL Item
benign (benign)
Item Group
Death
C0011065 (UMLS CUI-1)
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Autopsy
Item
Autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Item
Cause of death
text
C0007465 (UMLS CUI [1])
Cause of death
Code List
Cause of death
CL Item
ALL before chemotherapy (ALL before chemotherapy)
CL Item
ALL after chemotherapy, before 1st CR (ALL after chemotherapy, before 1st CR)
CL Item
Therapy complication before 1st CR (Therapy complication before 1st CR)
CL Item
ALL/ therapy complication before 1st CR (not decidable) (ALL/ therapy complication before 1st CR (not decidable))
CL Item
Therapy complication in 1st CR (except after SCT) (Therapy complication in 1st CR (except after SCT))
CL Item
SCT-associated complications (SCT-associated complications)
CL Item
relapseor other complication of therapy of relapse (relapseor other complication of therapy of relapse)
CL Item
Second neoplasm or complication of therapy of relapse  (Second neoplasm or complication of therapy of relapse )
CL Item
Other (Other)
Cause of death: therapy complication before 1st CR
Item
If cause of death is "Therapy complication before 1st CR", specify:
text
C0007465 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
Cause of death: ALL/ therapy complication
Item
If cause of death is "ALL/ therapy complication before 1st CR (not decidable)", specify:
text
C0007465 (UMLS CUI [1,1])
C0023449 (UMLS CUI [1,2])
C0007465 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
Cause of death: Therapy complication in 1st CR
Item
If cause of death is "Therapy complication in 1st CR", specify:
text
C0007465 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
Cause of death: SCT-associated complication
Item
If cause of death is "SCT-associated complication", specify:
text
C0007465 (UMLS CUI [1,1])
C0872278 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
Cause of death: other
Item
If cause of death is "Other", specify:
text
C0007465 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Therapy discontinuation
C0457454 (UMLS CUI-1)
Date of discontinuation
Item
Date of discontinuation
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Discontinuation: Protocol timepoint
Item
Discontinuation Point of time within the protocol
text
C1442880 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Reason for discontinuation
Item
Reason for discontinuation
text
C0457454 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Comments
C0947611 (UMLS CUI-1)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
Doctor's name
Item
Doctor's name
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
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