ID

15077

Description

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Initial survey. Please send this document within one month after diagnosis to the study centre. Clinical Trial Number: NCT01117441.

Keywords

Versions (1)
  1. 15/05/2016 15/05/2016 -
Uploaded on

15 de maio de 2016

DOI

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License

Creative Commons BY-NC-ND 3.0
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Initial survey AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

English

Initial survey 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 date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Informed consent
Description

Informed consent

Data type

text

Alias
UMLS CUI [1]
C0021430
Anamnesis
Description

Anamnesis

Alias
UMLS CUI-1
C0199182
Hospital stay during the last four weeks before diagnosis
Description

Hospital stay

Data type

boolean

Alias
UMLS CUI [1]
C3489408
Hospital stay: If "Yes", specify hospital:
Description

Hospital stay: Hospital

Data type

text

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C0019994
Hospital stay: If "Yes", specify date of hospitalisation:
Description

Hospital stay: Date of hospitalisation

Data type

date

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C0011008
Hospital stay: If "Yes", specify date of discharge:
Description

Hospital stay: Date of discharge

Data type

date

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C2361123
Birth weight
Description

Birth weight

Data type

float

Measurement units
  • g
Alias
UMLS CUI [1]
C0005612
g
Birth size
Description

Birth size

Data type

text

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0005901
UMLS CUI [1,2]
C2599577
cm
Gestational age
Description

Gestational age

Data type

text

Measurement units
  • Weeks of pregnancy
Alias
UMLS CUI [1]
C0017504
Weeks of pregnancy
Medical assisted reproduction
Description

Medical assisted reproduction

Data type

boolean

Alias
UMLS CUI [1]
C0493980
Number of siblings
Description

Number of siblings

Data type

float

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C0237753
Number of half siblings
Description

Number of half siblings

Data type

float

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0337505
Number of not biological siblings
Description

Number of not biological siblings

Data type

float

Alias
UMLS CUI [1,1]
C0337502
UMLS CUI [1,2]
C1518422
UMLS CUI [1,3]
C0237753
Multiple birth offspring
Description

Multiple birth offspring

Data type

text

Alias
UMLS CUI [1]
C0026753
Multiple birth offspring If "Yes", specify zygosity:
Description

Multiple birth offspring: zygosity

Data type

text

Alias
UMLS CUI [1,1]
C0026753
UMLS CUI [1,2]
C1710709
Fever > 38,5 °C
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Pathogen detection
Description

Pathogen detection

Data type

boolean

Alias
UMLS CUI [1]
C1740302
Pathogen detection If "Yes", specify:
Description

Pathogen detection: specification

Data type

text

Alias
UMLS CUI [1,1]
C1740302
UMLS CUI [1,2]
C2348235
CRP increase
Description

CRP increase

Data type

boolean

Alias
UMLS CUI [1,1]
C0201657
UMLS CUI [1,2]
C0442805
CRP measurement: If a positive CRP increase, specify:
Description

CRP measurement

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201657
mg/dL
Previous disease: Malignancies
Description

Malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Previous disease: Malignancies: If "Yes", specify:
Description

Malignancies: specification

Data type

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2348235
Previous disease: Immune deficiency
Description

Immune deficiency

Data type

boolean

Alias
UMLS CUI [1]
C1855771
Previous disease: Immune deficiency If "Yes", specify:
Description

Immune deficiency: specification

Data type

text

Alias
UMLS CUI [1,1]
C1855771
UMLS CUI [1,2]
C2348235
Previous disease: Haematological disease
Description

Haematological disease

Data type

boolean

Alias
UMLS CUI [1]
C0018939
Previous disease: Haematological disease If "Yes", specify:
Description

Haematological disease: specification

Data type

text

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C2348235
Previous disease: Chronic virus infection
Description

Chronic virus infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3829806
UMLS CUI [1,2]
C0042769
Previous disease: Chronic virus infection If "Yes", specify:
Description

Chronic virus infection: specification

Data type

text

Alias
UMLS CUI [1,1]
C3829806
UMLS CUI [1,2]
C0042769
UMLS CUI [1,3]
C2348235
Previous disease: Chromosomal aberration/ hereditary disease
Description

Chromosomal aberration/ hereditary disease

Data type

boolean

Alias
UMLS CUI [1]
C0008625
UMLS CUI [2]
C0019247
Previous disease: Chromosomal aberration/ hereditary disease If "Yes", specify:
Description

Chromosomal aberration/ hereditary disease: specification

Data type

text

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0019247
UMLS CUI [2,2]
C2348235
Previous disease: Metabolic disease
Description

Metabolic disease

Data type

boolean

Alias
UMLS CUI [1]
C0025517
Previous disease: Metabolic disease If "Yes", specify:
Description

Metabolic disease: specification

Data type

text

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C2348235
Previous disease: Autoimmune disease
Description

Autoimmune disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
Previous disease: Autoimmune disease If "Yes", specify:
Description

Autoimmune disease: specification

Data type

text

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C2348235
Previous disease: Cardiac disease
Description

Cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
Previous disease: Cardiac disease If "Yes", specify:
Description

Cardiac disease: specification

Data type

text

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2348235
Previous disease: Chronic disease
Description

Chronic disease

Data type

boolean

Alias
UMLS CUI [1]
C0008679
Previous disease: Chronic disease If "Yes", specify:
Description

Chronic disease: specification

Data type

text

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C2348235
Siblings suffering from malignancy
Description

Siblings suffering from malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0337502
UMLS CUI [1,2]
C0006826
Siblings suffering from malignancy If "Yes", specify:
Description

Siblings suffering from malignancy specification

Data type

text

Alias
UMLS CUI [1,1]
C0337502
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C2348235
Mother suffering from malignancy
Description

Mother suffering from malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0006826
Mother suffering from malignancy If "Yes", specify:
Description

Mother suffering from malignancy specification

Data type

text

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C2348235
Parents of mother suffering from malignancy
Description

Parents of mother suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0337471
UMLS CUI [1,2]
C2347083
UMLS CUI [1,3]
C0006826
Mother of mother suffering from malignancy If "Yes, mother's mother", specify:
Description

Mother of mother suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0337474
UMLS CUI [1,2]
C2347083
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Father of mother suffering from malignancy If "Yes, mother's father", specify:
Description

Father of mother suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0337475
UMLS CUI [1,2]
C2347083
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Siblings of mother suffering from malignancy
Description

Siblings of mother suffering from malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C2347083
UMLS CUI [1,3]
C0006826
Siblings of mother suffering from malignancy: If "Yes", specify:
Description

Siblings of mother suffering from malignancy specification

Data type

text

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C2347083
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Niece/nephew of mother suffering from malignancy
Description

Niece/nephew of mother suffering from malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C1553703
UMLS CUI [1,2]
C2347083
UMLS CUI [1,3]
C0006826
Niece/nephew of mother suffering from malignancy specification If "Yes", specify:
Description

Niece/nephew of mother suffering from malignancy specification

Data type

text

Alias
UMLS CUI [1,1]
C1553703
UMLS CUI [1,2]
C2347083
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Father suffering from malignancy
Description

Father suffering from malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0006826
Father suffering from malignancy If "Yes", specify:
Description

Father suffering from malignancy specification

Data type

text

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C2348235
Parents of father suffering from malignancy
Description

Parents of father suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0337471
UMLS CUI [1,2]
C2347452
UMLS CUI [1,3]
C0006826
Mother of father suffering from malignancy If "Yes, father's mother", specify:
Description

Mother of father suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0337474
UMLS CUI [1,2]
C2347452
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Father of father suffering from malignancy If "Yes, father's father", specify:
Description

Father of father suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0337475
UMLS CUI [1,2]
C2347452
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Siblings of father suffering from malignancy
Description

Siblings of father suffering from malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C2347452
UMLS CUI [1,3]
C0006826
Siblings of mother suffering from malignancy
Description

Siblings of mother suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C2347452
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Niece/nephew of father suffering from malignancy
Description

Niece/nephew of father suffering from malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C1553703
UMLS CUI [1,2]
C2347452
UMLS CUI [1,3]
C0006826
Niece/nephew of father suffering from malignancy If "Yes", specify:
Description

Niece/nephew of father suffering from malignancy

Data type

text

Alias
UMLS CUI [1,1]
C1553703
UMLS CUI [1,2]
C2347452
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2348235
Diagnosis
Description

Diagnosis

Alias
UMLS CUI-1
C0011900
Hospital admission date (in hospital of study centre)
Description

Hospital admission date

Data type

date

Alias
UMLS CUI [1]
C0806429
Leukopheresis performed?
Description

Leukopheresis

Data type

boolean

Alias
UMLS CUI [1]
C0023416
Leukopheresis: If "Yes", specify start date:
Description

Leukopheresis start date

Data type

date

Alias
UMLS CUI [1,1]
C0023416
UMLS CUI [1,2]
C0808070
Leukopheresis: If "Yes", specify end date:
Description

Leukopheresis end date

Data type

date

Alias
UMLS CUI [1,1]
C0023416
UMLS CUI [1,2]
C0806020
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Blood analysis
Description

Blood analysis

Alias
UMLS CUI-1
C0018941
Date of initial blood analysis (first hospital admission, before transfusion)
Description

Initial blood analysis: date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0018941
Initial blood analysis: leukocytes
Description

Initial blood analysis: leukocytes

Data type

float

Measurement units
  • /μl
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0018941
/μl
Inital blood analysis: blasts
Description

Inital blood analysis: blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0523113
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0018941
%
Initial blood analysis: platelets
Description

Initial blood analysis: platelets

Data type

float

Measurement units
  • /μl
Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0018941
/μl
Initial blood analysis: haemoglobin
Description

Initial blood analysis: haemoglobin

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0018941
g/dL
Date of blood analysis at diagnosis (usually at bone-marrow-puncture; if there was no BMP perfomed before therapy start, take blood analysis wich was relevant for diagnosis)
Description

Blood analysis at diagnosis: date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0018941
Blood analysis at diagnosis: leukocytes
Description

Blood analysis at diagnosis: leukocytes

Data type

float

Measurement units
  • /μl
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0018941
/μl
Blood analysis at diagnosis: blasts
Description

Blood analysis at diagnosis: blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0523113
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0018941
%
Date of blood analysis at therapy start (Day 1 of the pre phase)
Description

Blood analysis at therapy start: date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2114713
UMLS CUI [1,3]
C0018941
Blood analysis at therapy start: leukocytes
Description

Blood analysis at therapy start: leukocytes

Data type

float

Measurement units
  • /μl
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C2114713
UMLS CUI [1,3]
C0018941
/μl
Blood analysis at therapy start: blasts
Description

Blood analysis at therapy start: blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0523113
UMLS CUI [1,2]
C2114713
UMLS CUI [1,3]
C0018941
%
Initial CNS status
Description

Initial CNS status

Alias
UMLS CUI-1
C0449389
UMLS CUI-2
C0205265
Initial lumbar puncture: date
Description

Initial lumbar puncture: date

Data type

date

Alias
UMLS CUI [1,1]
C2584899
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0553794
Cerebrospinal fluid contaminated with blood (macroscopically)
Description

Cerebrospinal fluid contaminated with blood

Data type

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C2349974
UMLS CUI [1,3]
C0005767
Cerebrospinal fluid: Cell count performed? (with haemocytometer)
Description

Cerebrospinal fluid: cell count

Data type

boolean

Alias
UMLS CUI [1]
C1317024
Cerebrospinal fluid: If cell count performed, specify erythrocytes:
Description

Cerebrospinal fluid: erythrocytes

Data type

float

Measurement units
  • /μl
Alias
UMLS CUI [1]
C2026591
/μl
Cerebrospinal fluid: If cell count performed, specify nucleated cells:
Description

Cerebrospinal fluid: nucleated cells

Data type

float

Measurement units
  • /μl
Alias
UMLS CUI [1]
C2926229
/μl
Cytomorphological assessment of cytospin
Description

Cytomorphological assessment of cytospin compound

Data type

text

Alias
UMLS CUI [1,1]
C1271796
UMLS CUI [1,2]
C0543482
UMLS CUI [1,3]
C0010819
Cytomorphological blasts in cytospin compound?
Description

Blasts in cytospin compound

Data type

boolean

Alias
UMLS CUI [1,1]
C0523113
UMLS CUI [1,2]
C1271796
Initial diagnostic imaging of CNS
Description

Initial diagnostic imaging of CNS

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C3714787
Initial diagnostic imaging of CNS If performed, specify date of procedure:
Description

Initial diagnostic imaging of CNS: Date

Data type

date

Alias
UMLS CUI [1,1]
C2584899
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0205265
UMLS CUI [1,4]
C3714787
Cerebral mass or leptomeningeal involvement found in imaging
Description

Cerebral mass or leptomeningeal involvement

Data type

text

Alias
UMLS CUI [1]
C0742078
UMLS CUI [2]
C3160796
Examination of cranial nerves: cranial nerves dysfunction?
Description

Examination of cranial nerves

Data type

text

Alias
UMLS CUI [1]
C0558819
Examination of cranial nerves: If performed, specify date:
Description

Date of examination of cranial nerves

Data type

date

Alias
UMLS CUI [1,1]
C2826643
UMLS CUI [1,2]
C0558819
Treatment of CNS
Description

Treatment of CNS

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3714787
Multi-organ involvement
Description

Multi-organ involvement

Alias
UMLS CUI-1
C0457577
Liver size (palpatoric): performed?
Description

Liver size

Data type

boolean

Alias
UMLS CUI [1]
C0426688
Liver size (palpatoric) If performed, specify value: (in cm under costal arch in MCL)
Description

Liver size value

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0426688
UMLS CUI [1,2]
C1522609
cm
Spleen size (palpatoric): performed?
Description

Spleen size

Data type

boolean

Alias
UMLS CUI [1]
C0030250
Spleen size (palpatoric) If performed, specify value: (in cm under costal arch in MCL)
Description

Spleen size value

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0030250
UMLS CUI [1,2]
C1522609
cm
Involvement of mediastinum
Description

Involvement of mediastinum

Data type

text

Alias
UMLS CUI [1,1]
C0025066
UMLS CUI [1,2]
C1314939
Involvement of testicles
Description

Involvement of testicles

Data type

text

Alias
UMLS CUI [1,1]
C0039597
UMLS CUI [1,2]
C1314939
Prednisone response (on day 8 of cytoreductive pre-phase)
Description

Prednisone response (on day 8 of cytoreductive pre-phase)

Alias
UMLS CUI-1
C0032952
UMLS CUI-2
C0871261
Date (on day 8 of cytoreductive pre-phase)
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Leukocytes
Description

Leukocytes

Data type

float

Measurement units
  • /μl
Alias
UMLS CUI [1]
C0023508
/μl
Blasts (peripher)
Description

Blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0523113
%
Cumulative dose of prednisone (7 days)
Description

Cumulative dose of prednisone

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C2986497
mg
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-3
C1519316
Investigator's name
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0027365
Date of report
Description

Date of report

Data type

date

Alias
UMLS CUI [1]
C1302584
Investigator's signature
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Initial survey 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 date of birth
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Informed consent
Item
Informed consent
text
C0021430 (UMLS CUI [1])
Item Group
Anamnesis
C0199182 (UMLS CUI-1)
Hospital stay
Item
Hospital stay during the last four weeks before diagnosis
boolean
C3489408 (UMLS CUI [1])
Hospital stay: Hospital
Item
Hospital stay: If "Yes", specify hospital:
text
C3489408 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Hospital stay: Date of hospitalisation
Item
Hospital stay: If "Yes", specify date of hospitalisation:
date
C3489408 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hospital stay: Date of discharge
Item
Hospital stay: If "Yes", specify date of discharge:
date
C3489408 (UMLS CUI [1,1])
C2361123 (UMLS CUI [1,2])
Birth weight
Item
Birth weight
float
C0005612 (UMLS CUI [1])
Birth size
Item
Birth size
text
C0005901 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
Gestational age
Item
Gestational age
text
C0017504 (UMLS CUI [1])
Medical assisted reproduction
Item
Medical assisted reproduction
boolean
C0493980 (UMLS CUI [1])
Number of siblings
Item
Number of siblings
float
C0037047 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of half siblings
Item
Number of half siblings
float
C0237753 (UMLS CUI [1,1])
C0337505 (UMLS CUI [1,2])
Number of not biological siblings
Item
Number of not biological siblings
float
C0337502 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Multiple birth offspring
text
C0026753 (UMLS CUI [1])
Multiple birth offspring
Code List
Multiple birth offspring
CL Item
no (no)
CL Item
yes, twins (yes, twins)
CL Item
yes, multiples (yes, multiples)
Item
Multiple birth offspring If "Yes", specify zygosity:
text
C0026753 (UMLS CUI [1,1])
C1710709 (UMLS CUI [1,2])
Multiple birth offspring: zygosity
Code List
Multiple birth offspring If "Yes", specify zygosity:
CL Item
dizygotic (dizygotic)
CL Item
monozygotic (monozygotic)
Fever
Item
Fever > 38,5 °C
boolean
C0015967 (UMLS CUI [1])
Pathogen detection
Item
Pathogen detection
boolean
C1740302 (UMLS CUI [1])
Pathogen detection: specification
Item
Pathogen detection If "Yes", specify:
text
C1740302 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
CRP increase
Item
CRP increase
boolean
C0201657 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
CRP measurement
Item
CRP measurement: If a positive CRP increase, specify:
float
C0201657 (UMLS CUI [1])
Malignancies
Item
Previous disease: Malignancies
boolean
C0006826 (UMLS CUI [1])
Malignancies: specification
Item
Previous disease: Malignancies: If "Yes", specify:
text
C0006826 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Immune deficiency
Item
Previous disease: Immune deficiency
boolean
C1855771 (UMLS CUI [1])
Immune deficiency: specification
Item
Previous disease: Immune deficiency If "Yes", specify:
text
C1855771 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Haematological disease
Item
Previous disease: Haematological disease
boolean
C0018939 (UMLS CUI [1])
Haematological disease: specification
Item
Previous disease: Haematological disease If "Yes", specify:
text
C0018939 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Chronic virus infection
Item
Previous disease: Chronic virus infection
boolean
C3829806 (UMLS CUI [1,1])
C0042769 (UMLS CUI [1,2])
Chronic virus infection: specification
Item
Previous disease: Chronic virus infection If "Yes", specify:
text
C3829806 (UMLS CUI [1,1])
C0042769 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Chromosomal aberration/ hereditary disease
Item
Previous disease: Chromosomal aberration/ hereditary disease
boolean
C0008625 (UMLS CUI [1])
C0019247 (UMLS CUI [2])
Chromosomal aberration/ hereditary disease: specification
Item
Previous disease: Chromosomal aberration/ hereditary disease If "Yes", specify:
text
C0008625 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0019247 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Metabolic disease
Item
Previous disease: Metabolic disease
boolean
C0025517 (UMLS CUI [1])
Metabolic disease: specification
Item
Previous disease: Metabolic disease If "Yes", specify:
text
C0025517 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Autoimmune disease
Item
Previous disease: Autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Autoimmune disease: specification
Item
Previous disease: Autoimmune disease If "Yes", specify:
text
C0004364 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Cardiac disease
Item
Previous disease: Cardiac disease
boolean
C0018799 (UMLS CUI [1])
Cardiac disease: specification
Item
Previous disease: Cardiac disease If "Yes", specify:
text
C0018799 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Chronic disease
Item
Previous disease: Chronic disease
boolean
C0008679 (UMLS CUI [1])
Chronic disease: specification
Item
Previous disease: Chronic disease If "Yes", specify:
text
C0008679 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Siblings suffering from malignancy
Item
Siblings suffering from malignancy
boolean
C0337502 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Siblings suffering from malignancy specification
Item
Siblings suffering from malignancy If "Yes", specify:
text
C0337502 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Mother suffering from malignancy
Item
Mother suffering from malignancy
boolean
C0026591 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Mother suffering from malignancy specification
Item
Mother suffering from malignancy If "Yes", specify:
text
C0026591 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Parents of mother suffering from malignancy
text
C0337471 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Parents of mother suffering from malignancy
Code List
Parents of mother suffering from malignancy
CL Item
no (no)
CL Item
yes, mother's mother (yes, mother's mother)
CL Item
yes, mother's father (yes, mother's father)
Mother of mother suffering from malignancy
Item
Mother of mother suffering from malignancy If "Yes, mother's mother", specify:
text
C0337474 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Father of mother suffering from malignancy
Item
Father of mother suffering from malignancy If "Yes, mother's father", specify:
text
C0337475 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Siblings of mother suffering from malignancy
Item
Siblings of mother suffering from malignancy
boolean
C0037047 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Siblings of mother suffering from malignancy specification
Item
Siblings of mother suffering from malignancy: If "Yes", specify:
text
C0037047 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Niece/nephew of mother suffering from malignancy
Item
Niece/nephew of mother suffering from malignancy
boolean
C1553703 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Niece/nephew of mother suffering from malignancy specification
Item
Niece/nephew of mother suffering from malignancy specification If "Yes", specify:
text
C1553703 (UMLS CUI [1,1])
C2347083 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Father suffering from malignancy
Item
Father suffering from malignancy
boolean
C0015671 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Father suffering from malignancy specification
Item
Father suffering from malignancy If "Yes", specify:
text
C0015671 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Parents of father suffering from malignancy
text
C0337471 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Parents of father suffering from malignancy
Code List
Parents of father suffering from malignancy
CL Item
no (no)
CL Item
yes, father's mother (yes, father's mother)
CL Item
yes, father's father (yes, fathers father)
Mother of father suffering from malignancy
Item
Mother of father suffering from malignancy If "Yes, father's mother", specify:
text
C0337474 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Father of father suffering from malignancy
Item
Father of father suffering from malignancy If "Yes, father's father", specify:
text
C0337475 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Siblings of father suffering from malignancy
Item
Siblings of father suffering from malignancy
boolean
C0037047 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Siblings of mother suffering from malignancy
Item
Siblings of mother suffering from malignancy
text
C0037047 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Niece/nephew of father suffering from malignancy
Item
Niece/nephew of father suffering from malignancy
boolean
C1553703 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Niece/nephew of father suffering from malignancy
Item
Niece/nephew of father suffering from malignancy If "Yes", specify:
text
C1553703 (UMLS CUI [1,1])
C2347452 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Diagnosis
C0011900 (UMLS CUI-1)
Hospital admission date
Item
Hospital admission date (in hospital of study centre)
date
C0806429 (UMLS CUI [1])
Leukopheresis
Item
Leukopheresis performed?
boolean
C0023416 (UMLS CUI [1])
Leukopheresis start date
Item
Leukopheresis: If "Yes", specify start date:
date
C0023416 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Leukopheresis end date
Item
Leukopheresis: If "Yes", specify end date:
date
C0023416 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item Group
Blood analysis
C0018941 (UMLS CUI-1)
Initial blood analysis: date
Item
Date of initial blood analysis (first hospital admission, before transfusion)
date
C0011008 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Initial blood analysis: leukocytes
Item
Initial blood analysis: leukocytes
float
C0023508 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Inital blood analysis: blasts
Item
Inital blood analysis: blasts
float
C0523113 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Initial blood analysis: platelets
Item
Initial blood analysis: platelets
float
C0032181 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Initial blood analysis: haemoglobin
Item
Initial blood analysis: haemoglobin
float
C0518015 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Blood analysis at diagnosis: date
Item
Date of blood analysis at diagnosis (usually at bone-marrow-puncture; if there was no BMP perfomed before therapy start, take blood analysis wich was relevant for diagnosis)
date
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Blood analysis at diagnosis: leukocytes
Item
Blood analysis at diagnosis: leukocytes
float
C0023508 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Blood analysis at diagnosis: blasts
Item
Blood analysis at diagnosis: blasts
float
C0523113 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Blood analysis at therapy start: date
Item
Date of blood analysis at therapy start (Day 1 of the pre phase)
date
C0011008 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Blood analysis at therapy start: leukocytes
Item
Blood analysis at therapy start: leukocytes
float
C0023508 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Blood analysis at therapy start: blasts
Item
Blood analysis at therapy start: blasts
float
C0523113 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Item Group
Initial CNS status
C0449389 (UMLS CUI-1)
C0205265 (UMLS CUI-2)
Initial lumbar puncture: date
Item
Initial lumbar puncture: date
date
C2584899 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0553794 (UMLS CUI [1,3])
Cerebrospinal fluid contaminated with blood
Item
Cerebrospinal fluid contaminated with blood (macroscopically)
boolean
C0007806 (UMLS CUI [1,1])
C2349974 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
Cerebrospinal fluid: cell count
Item
Cerebrospinal fluid: Cell count performed? (with haemocytometer)
boolean
C1317024 (UMLS CUI [1])
Cerebrospinal fluid: erythrocytes
Item
Cerebrospinal fluid: If cell count performed, specify erythrocytes:
float
C2026591 (UMLS CUI [1])
Cerebrospinal fluid: nucleated cells
Item
Cerebrospinal fluid: If cell count performed, specify nucleated cells:
float
C2926229 (UMLS CUI [1])
Item
Cytomorphological assessment of cytospin
text
C1271796 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0010819 (UMLS CUI [1,3])
Cytomorphological assessment of cytospin
Code List
Cytomorphological assessment of cytospin
CL Item
performed: assessment in study centre (performed: assessment in study centre)
CL Item
performed: assessment locally only (please add all results) (performed: assessment locally only (please add all results))
CL Item
not performed: no cytospin compounds prepared (not performed: no cytospin compounds prepared)
CL Item
not performed: cytospin compounds not evaluable (not performed: cytospin compounds not evaluable)
Blasts in cytospin compound
Item
Cytomorphological blasts in cytospin compound?
boolean
C0523113 (UMLS CUI [1,1])
C1271796 (UMLS CUI [1,2])
Item
Initial diagnostic imaging of CNS
text
C0011923 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
Initial diagnostic imaging of CNS
Code List
Initial diagnostic imaging of CNS
CL Item
performed: MRI (performed: MRI)
CL Item
performed: CT (performed: CT)
CL Item
not performed (not performed)
Initial diagnostic imaging of CNS: Date
Item
Initial diagnostic imaging of CNS If performed, specify date of procedure:
date
C2584899 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C3714787 (UMLS CUI [1,4])
Item
Cerebral mass or leptomeningeal involvement found in imaging
text
C0742078 (UMLS CUI [1])
C3160796 (UMLS CUI [2])
Cerebral mass or leptomeningeal involvement
Code List
Cerebral mass or leptomeningeal involvement found in imaging
CL Item
yes (please add results and images on CD-ROM) (yes (please add results and images on CD-ROM))
CL Item
no (no)
Item
Examination of cranial nerves: cranial nerves dysfunction?
text
C0558819 (UMLS CUI [1])
Examination of cranial nerves
Code List
Examination of cranial nerves: cranial nerves dysfunction?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Examination of cranial nerves not performed (Examination of cranial nerves not performed)
Date of examination of cranial nerves
Item
Examination of cranial nerves: If performed, specify date:
date
C2826643 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
Item
Treatment of CNS
text
C0087111 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
Treatment of CNS
Code List
Treatment of CNS
CL Item
Like "CNS negative" (Like "CNS negative")
CL Item
Like "CNS negative" and additional MTX (i.th.) in protocol IA (Like "CNS negative" and additional MTX (i.th.) in protocol IA)
CL Item
Like "CNS positive" (Like "CNS positive")
Item Group
Multi-organ involvement
C0457577 (UMLS CUI-1)
Liver size
Item
Liver size (palpatoric): performed?
boolean
C0426688 (UMLS CUI [1])
Liver size value
Item
Liver size (palpatoric) If performed, specify value: (in cm under costal arch in MCL)
float
C0426688 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Spleen size
Item
Spleen size (palpatoric): performed?
boolean
C0030250 (UMLS CUI [1])
Spleen size value
Item
Spleen size (palpatoric) If performed, specify value: (in cm under costal arch in MCL)
float
C0030250 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Item
Involvement of mediastinum
text
C0025066 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Involvement of mediastinum
Code List
Involvement of mediastinum
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
No examination performed (No examination performed)
Item
Involvement of testicles
text
C0039597 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Involvement of testicles
Code List
Involvement of testicles
CL Item
Yes (Yes)
CL Item
No  (No )
CL Item
No examinatin performed (No examinatin performed)
Item Group
Prednisone response (on day 8 of cytoreductive pre-phase)
C0032952 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
Date
Item
Date (on day 8 of cytoreductive pre-phase)
date
C0011008 (UMLS CUI [1])
Leukocytes
Item
Leukocytes
float
C0023508 (UMLS CUI [1])
Blasts
Item
Blasts (peripher)
float
C0523113 (UMLS CUI [1])
Cumulative dose of prednisone
Item
Cumulative dose of prednisone (7 days)
float
C0032952 (UMLS CUI [1,1])
C2986497 (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-3)
Investigator's name
Item
Investigator's name
text
C2346576 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
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