ID

36226

Beskrivning

Randomized Comparison Between Two Dose Levels of Daunorubicin and Between One Versus Two Cycles of Induction Therapy for Adult Patients With Acute Myeloid Leukemia <=60 Years. See further details on: https://www.clinicaltrials.gov/ct2/show/NCT02140242 Principal Investigator: PD Dr. med. Christoph Röllig, MSc Source:PD Dr. med. Christoph Röllig, MSc Universitätsklinikum Dresden

Länk

https://www.clinicaltrials.gov/ct2/show/NCT02140242

Nyckelord

Versioner (3)
  1. 2017-10-24 2017-10-24 - Julian Varghese
  2. 2019-04-23 2019-04-23 - Sarah Riepenhausen
  3. 2021-09-20 2021-09-20 -
Rättsinnehavare

PD Dr. med. Christoph Röllig, MSc

Uppladdad den

23 april 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242

Engelsk

Drop out Sheet and visit

12 Formulär  
Drop-Out Sheet
Beskrivning

Drop-Out Sheet

Alias
UMLS CUI-1
C0457454
UMLS CUI-2
C3890410
Randomization number
Beskrivning

2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Study Drop-out?
Beskrivning

Study Drop-out only possible until visit 13. If patient dies after visit 13, please mark „No“.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0457454
Date of premature study termination
Beskrivning

Date of discontinuation

Datatyp

date

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0011008
Reason
Beskrivning

Reason for discontinuation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0392360
Please document reason and circumstances of the patient‘s withdrawal
Beskrivning

Consent withdrawal reason

Datatyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Number of (S)AE in database documentation
Beskrivning

Number of (S)AE

Datatyp

integer

Alias
UMLS CUI [1]
C2826275
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0600091
Violation inclusion/exclusion criteria, please specify
Beskrivning

Specify protocol violation

Datatyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Specify Investigators decision
Beskrivning

Specify Investigators decision

Datatyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0679006
Specify other reason
Beskrivning

Specify other reason

Datatyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
Drop out Visit
Beskrivning

Drop out Visit

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C0457454
Randomization number
Beskrivning

2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Date of visit
Beskrivning

Visit date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Drop-Out Visit not done
Beskrivning

Drop-Out Visit not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1272696
ECG
Beskrivning

ECG

Alias
UMLS CUI-1
C1623258
Electrocardiography
Beskrivning

Electrocardiography

Datatyp

integer

Alias
UMLS CUI [1]
C1623258
Date of assessment
Beskrivning

Date of assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
ECG findings
Beskrivning

ECG findings

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Pathological ECG findings
Beskrivning

Pathological ECG findings

Datatyp

integer

Alias
UMLS CUI [1]
C1832603
Significant ECG findings
Beskrivning

In case of any new pathological findings of clinical significance, please fill in AE.

Datatyp

text

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2826293
Echocardiography
Beskrivning

Echocardiography

Alias
UMLS CUI-1
C0013516
Echocardiography
Beskrivning

Echocardiography

Datatyp

integer

Alias
UMLS CUI [1]
C0013516
Date of assessment
Beskrivning

Date of assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
LV ejection fraction
Beskrivning

LVEF

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0428772
%
Any valvular defects?
Beskrivning

In case of any change in valvular defects of clinical significance, please fill in AE.

Datatyp

boolean

Alias
UMLS CUI [1]
C2748945
Tricuspid valve defect
Beskrivning

Tricuspid valve defect

Datatyp

boolean

Alias
UMLS CUI [1]
C0264882
Tricuspid valve type of defect
Beskrivning

Tricuspid valve defect

Datatyp

integer

Alias
UMLS CUI [1]
C0264882
Degree of Tricuspid valve defect
Beskrivning

Severity

Datatyp

integer

Alias
UMLS CUI [1,1]
C0457451
UMLS CUI [1,2]
C0264882
Pulmonary valve defect
Beskrivning

Pulmonary valve defect

Datatyp

boolean

Alias
UMLS CUI [1]
C0034087
Pulmonary valve type of defect
Beskrivning

Pulmonary valve defect

Datatyp

integer

Alias
UMLS CUI [1]
C0034087
Degree of pulmonary valve defect
Beskrivning

Severity

Datatyp

integer

Alias
UMLS CUI [1,1]
C0457451
UMLS CUI [1,2]
C0034087
Mitral valve defect
Beskrivning

Mitral valve defect

Datatyp

boolean

Alias
UMLS CUI [1]
C0026265
Mitral valve type of defect
Beskrivning

Mitral valve defect

Datatyp

integer

Alias
UMLS CUI [1]
C0026265
Degree of mitral valve defect
Beskrivning

Severity

Datatyp

integer

Alias
UMLS CUI [1,1]
C0457451
UMLS CUI [1,2]
C0026265
Aortic valve defect
Beskrivning

Aortic valve defect

Datatyp

boolean

Alias
UMLS CUI [1]
C1260873
Aortic valve type of defect
Beskrivning

Aortic valve defect

Datatyp

integer

Alias
UMLS CUI [1]
C1260873
Degree of aortic valve defect
Beskrivning

Severity

Datatyp

integer

Alias
UMLS CUI [1,1]
C0457451
UMLS CUI [1,2]
C1260873
Cardiac Enzymes
Beskrivning

Cardiac Enzymes

Alias
UMLS CUI-1
C0443763
Cardiac Enzymes
Beskrivning

Cardiac Enzymes measurement

Datatyp

integer

Alias
UMLS CUI [1]
C0201934
Date of sampling
Beskrivning

Date of sampling

Datatyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
NT-proBNP value
Beskrivning

xxx , x

Datatyp

float

Alias
UMLS CUI [1]
C3272900
Unit for NT-proBNP
Beskrivning

Unit used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Troponin T value
Beskrivning

xxx , x

Datatyp

float

Alias
UMLS CUI [1]
C0523953
Unit for TnT
Beskrivning

Unit used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Troponin I value
Beskrivning

xxx , x

Datatyp

float

Alias
UMLS CUI [1]
C0920210
Unit for TnI
Beskrivning

Unit used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Neutropenia/Thrombopenia
Beskrivning

Neutropenia/Thrombopenia

Alias
UMLS CUI-1
C0027947
UMLS CUI-2
C0040034
Neutropenia grade IV
Beskrivning

Neutropenia grade IV

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C1516728
1st neutropenia preexisting at V1?
Beskrivning

Preexisting neutropenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C2347662
Date of 1st onset neutropenia
Beskrivning

(after date V1, Induction I) < 0,5 Gpt/l or < 500 /μl

Datatyp

date

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C0574845
1st neutropenia ongoing at start administration Cytarabin /Induction II??
Beskrivning

Only if patient participates in Induction II

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C2826663
1st neutropenia ongoing at this visit ?
Beskrivning

Ongoing adverse event, neutropenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C2826663
End date 1st neutropenia
Beskrivning

(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl

Datatyp

date

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C2697886
Second onset neutropenia?
Beskrivning

(only possible during Induction II)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C0277793
Date of 2nd onset neutropenia
Beskrivning

< 0,5 Gpt/l or < 500 /μ

Datatyp

date

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C0574845
2nd neutropenia ongoing at this visit ?
Beskrivning

Ongoing Adverse event , neutropenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C2826663
End date 2nd neutropenia
Beskrivning

(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl

Datatyp

date

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C2697886
Thrombopenia grade IV
Beskrivning

Thrombopenia grade IV

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C1516728
1st thrombopenia preexisting at V1?
Beskrivning

Preexisting thrombopenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C2347662
Date of 1st onset thrombopenia
Beskrivning

(after date V1, Induction I) < 0,5 Gpt/l or < 500 /μl

Datatyp

date

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0574845
1st thrombopenia ongoing at start administration Cytarabin /Induction II??
Beskrivning

Only if patient participates in Induction II

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C2826663
1st thrombopenia ongoing at this visit ?
Beskrivning

Ongoing adverse event, thrombopenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C2826663
End date 1st thrombopenia
Beskrivning

(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl

Datatyp

date

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C2697886
Second onset thrombopenia?
Beskrivning

(only possible during Induction II)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0277793
Date of 2nd onset thrombopenia
Beskrivning

< 0,5 Gpt/l or < 500 /μ

Datatyp

date

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0574845
2nd thrombopenia ongoing at this visit ?
Beskrivning

Ongoing Adverse event , thrombopenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C2826663
End date 2nd thrombopenia
Beskrivning

(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl

Datatyp

date

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C2697886
Number of RBC transfusion units from start trial until this visit
Beskrivning

RBC transfusion units

Datatyp

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0449961
Number of platelet transfusion units from start trial until this visit
Beskrivning

platelet transfusion units

Datatyp

integer

Alias
UMLS CUI [1,1]
C0086818
UMLS CUI [1,2]
C0449961
G-CSF Administration
Beskrivning

G-CSF Administration

Alias
UMLS CUI-1
C0079459
G-CSF administered during trial?
Beskrivning

G-CSF administered

Datatyp

integer

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C1533734
Start date 1st administration G-CSF
Beskrivning

G-CSF start date

Datatyp

date

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0808070
End date 1st administration G-CSF
Beskrivning

G-CSF end date

Datatyp

date

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0806020
1st administration ongoing at this visit
Beskrivning

G-CSF ongoing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0549178
2nd administration of G-CSF?
Beskrivning

G-CSF administered

Datatyp

integer

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C1533734
Start date 2nd administration G-CSF
Beskrivning

G-CSF start date

Datatyp

date

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0808070
End date 2nd administration G-CSF
Beskrivning

G-CSF end date

Datatyp

date

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0806020
2nd administration ongoing at this visit
Beskrivning

G-CSF ongoing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0549178
Response Assessment
Beskrivning

Response Assessment

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C1516048
Response Assessment
Beskrivning

Response Assessment

Datatyp

integer

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C1516048
Examination of Bone Marrow
Beskrivning

Examination of Bone Marrow

Alias
UMLS CUI-1
C0005957
Date of aspiration or biopsy
Beskrivning

Bone marrow aspiration or biopsy date

Datatyp

date

Alias
UMLS CUI [1,1]
C0005954
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0398523
UMLS CUI [2,2]
C0011008
Percentage of blasts
Beskrivning

Percentage of blasts

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0587348
%
Disease Response
Beskrivning

Disease Response

Alias
UMLS CUI-1
C1704632
Response
Beskrivning

Remission Status

Datatyp

text

Alias
UMLS CUI [1]
C1704632
Remission Assessment
Beskrivning

Remission Assessment

Alias
UMLS CUI-1
C0544452
UMLS CUI-2
C1516048
Remission Assessment
Beskrivning

Please document the first Remission assessment after Drop Out

Datatyp

integer

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C1516048
Examination of Bone Marrow
Beskrivning

Examination of Bone Marrow

Alias
UMLS CUI-1
C0005957
Date of aspiration or biopsy
Beskrivning

Bone marrow aspiration or biopsy date

Datatyp

date

Alias
UMLS CUI [1,1]
C0005954
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0398523
UMLS CUI [2,2]
C0011008
Remission Status
Beskrivning

Remission Status

Alias
UMLS CUI-1
C1704632
Remission Status
Beskrivning

Remission Status

Datatyp

integer

Alias
UMLS CUI [1]
C1704632
Cytogenetics (central)
Beskrivning

Cytogenetics (central)

Alias
UMLS CUI-1
C0010802
Cytogenetic analysis
Beskrivning

Cytogenetic analysis

Datatyp

integer

Alias
UMLS CUI [1]
C0752095
Total number of analyzed metaphases
Beskrivning

Number of analyzed metaphases

Datatyp

integer

Alias
UMLS CUI [1,1]
C1621812
UMLS CUI [1,2]
C0260877
UMLS CUI [1,3]
C0449788
Karyotype
Beskrivning

Karyotype

Datatyp

integer

Alias
UMLS CUI [1,1]
C1261273
UMLS CUI [1,2]
C0678257
If karyotype is not normal, which characteristics apply?
Beskrivning

Karyotype characteristics

Datatyp

integer

Alias
UMLS CUI [1,1]
C1261273
UMLS CUI [1,2]
C0008625
Have you marked all karyotype characteristics?
Beskrivning

Complete

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205197
UMLS CUI [1,2]
C1511726
Chromosome aberrations
Beskrivning

Chromosome aberrations

Alias
UMLS CUI-1
C0008625
High risk aberrations
Beskrivning

High risk aberrations

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C0684030
Low risk aberrations
Beskrivning

Low risk aberrations

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C3538919
Other aberrations, please specify
Beskrivning

Other aberrations

Datatyp

text

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C0205394
Further entry
Beskrivning

Further entry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705654
UMLS CUI [1,2]
C1517331
Tillbaka till toppen

Similar models

Drop out Sheet and visit

12 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Drop-Out Sheet
C0457454 (UMLS CUI-1)
C3890410 (UMLS CUI-2)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Study Drop-out
Item
Study Drop-out?
boolean
C2348568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Date of discontinuation
Item
Date of premature study termination
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason
integer
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for discontinuation
Code List
Reason
CL Item
Patient withdrew consent (1)
CL Item
(Serious) adverse event (2)
CL Item
Neither aspirate nor biopsy of BM done (at Visit 7) (4)
CL Item
No assessment of extracted bone marrow possible (at Visit 7) (5)
CL Item
Patient is lacking compliance (6)
CL Item
Violation inclusion/exclusion criteria (7)
CL Item
Investigator‘s decision (8)
CL Item
Death (Please fill in Death sheet) (9)
CL Item
Other reasons (10)
CL Item
Suboptimal responder (blast > = 5% at Visit 7) (3)
Consent withdrawal reason
Item
Please document reason and circumstances of the patient‘s withdrawal
text
C2349954 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Number of (S)AE
Item
Number of (S)AE in database documentation
integer
C2826275 (UMLS CUI [1])
C1519255 (UMLS CUI [2,1])
C0600091 (UMLS CUI [2,2])
Specify protocol violation
Item
Violation inclusion/exclusion criteria, please specify
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify Investigators decision
Item
Specify Investigators decision
text
C0008961 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Specify other reason
Item
Specify other reason
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Drop out Visit
C0545082 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Drop-Out Visit not done
Item
Drop-Out Visit not done
boolean
C0457454 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Electrocardiography
integer
C1623258 (UMLS CUI [1])
Full blood count
Code List
Electrocardiography
CL Item
Not done (1)
CL Item
Failed (2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item
ECG findings
integer
C0438154 (UMLS CUI [1])
ECG findings
Code List
ECG findings
CL Item
no pathological findings (1)
CL Item
new pathological findings (2)
Item
Pathological ECG findings
integer
C1832603 (UMLS CUI [1])
Pathological ECG findings
Code List
Pathological ECG findings
CL Item
clinically NOT significant findings (1)
CL Item
clinically significant findings (2)
Significant ECG findings
Item
Significant ECG findings
text
C1832603 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Item Group
Echocardiography
C0013516 (UMLS CUI-1)
Item
Echocardiography
integer
C0013516 (UMLS CUI [1])
Full blood count
Code List
Echocardiography
CL Item
Not done (1)
CL Item
Failed (2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
LVEF
Item
LV ejection fraction
integer
C0428772 (UMLS CUI [1])
valvular defects
Item
Any valvular defects?
boolean
C2748945 (UMLS CUI [1])
Tricuspid valve defect
Item
Tricuspid valve defect
boolean
C0264882 (UMLS CUI [1])
Item
Tricuspid valve type of defect
integer
C0264882 (UMLS CUI [1])
Tricuspid valve defect
Code List
Tricuspid valve type of defect
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of Tricuspid valve defect
integer
C0457451 (UMLS CUI [1,1])
C0264882 (UMLS CUI [1,2])
Severity
Code List
Degree of Tricuspid valve defect
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Pulmonary valve defect
Item
Pulmonary valve defect
boolean
C0034087 (UMLS CUI [1])
Item
Pulmonary valve type of defect
integer
C0034087 (UMLS CUI [1])
Tricuspid valve defect
Code List
Pulmonary valve type of defect
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of pulmonary valve defect
integer
C0457451 (UMLS CUI [1,1])
C0034087 (UMLS CUI [1,2])
Severity
Code List
Degree of pulmonary valve defect
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Mitral valve defect
Item
Mitral valve defect
boolean
C0026265 (UMLS CUI [1])
Item
Mitral valve type of defect
integer
C0026265 (UMLS CUI [1])
Tricuspid valve defect
Code List
Mitral valve type of defect
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of mitral valve defect
integer
C0457451 (UMLS CUI [1,1])
C0026265 (UMLS CUI [1,2])
Severity
Code List
Degree of mitral valve defect
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Aortic valve defect
Item
Aortic valve defect
boolean
C1260873 (UMLS CUI [1])
Item
Aortic valve type of defect
integer
C1260873 (UMLS CUI [1])
Tricuspid valve defect
Code List
Aortic valve type of defect
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of aortic valve defect
integer
C0457451 (UMLS CUI [1,1])
C1260873 (UMLS CUI [1,2])
Severity
Code List
Degree of aortic valve defect
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item Group
Cardiac Enzymes
C0443763 (UMLS CUI-1)
Item
Cardiac Enzymes
integer
C0201934 (UMLS CUI [1])
Full blood count
Code List
Cardiac Enzymes
CL Item
Not done (1)
CL Item
Failed (2)
Date of sampling
Item
Date of sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
NT-proBNP
Item
NT-proBNP value
float
C3272900 (UMLS CUI [1])
Item
Unit for NT-proBNP
integer
C1519795 (UMLS CUI [1])
Unit used
Code List
Unit for NT-proBNP
CL Item
pg/ml (1)
CL Item
pmol/l (2)
CL Item
ng/ml (μg/l) (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnT
Item
Troponin T value
float
C0523953 (UMLS CUI [1])
Item
Unit for TnT
integer
C1519795 (UMLS CUI [1])
Unit used
Code List
Unit for TnT
CL Item
μg/l (1)
CL Item
pg/ml (2)
CL Item
ng/ml (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnI
Item
Troponin I value
float
C0920210 (UMLS CUI [1])
Item
Unit for TnI
integer
C1519795 (UMLS CUI [1])
Unit used
Code List
Unit for TnI
CL Item
μg/l (1)
CL Item
pg/ml (2)
CL Item
ng/ml (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Item Group
Neutropenia/Thrombopenia
C0027947 (UMLS CUI-1)
C0040034 (UMLS CUI-2)
Neutropenia grade IV
Item
Neutropenia grade IV
boolean
C0027947 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Preexisting neutropenia
Item
1st neutropenia preexisting at V1?
boolean
C0027947 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Neutropenia onset date
Item
Date of 1st onset neutropenia
date
C0027947 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing adverse event, neutropenia
Item
1st neutropenia ongoing at start administration Cytarabin /Induction II??
boolean
C0027947 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Ongoing adverse event, neutropenia
Item
1st neutropenia ongoing at this visit ?
boolean
C0027947 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, neutropenia
Item
End date 1st neutropenia
date
C0027947 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Second onset neutropenia
Item
Second onset neutropenia?
boolean
C0027947 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
Neutropenia onset date
Item
Date of 2nd onset neutropenia
date
C0027947 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing Adverse event , neutropenia
Item
2nd neutropenia ongoing at this visit ?
boolean
C0027947 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, neutropenia
Item
End date 2nd neutropenia
date
C0027947 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Thrombopenia grade IV
Item
Thrombopenia grade IV
boolean
C0040034 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Preexisting thrombopenia
Item
1st thrombopenia preexisting at V1?
boolean
C0040034 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
thrombopenia onset date
Item
Date of 1st onset thrombopenia
date
C0040034 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing adverse event, Thrombopenia
Item
1st thrombopenia ongoing at start administration Cytarabin /Induction II??
boolean
C0040034 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Ongoing adverse event, thrombopenia
Item
1st thrombopenia ongoing at this visit ?
boolean
C0040034 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, thrombopenia
Item
End date 1st thrombopenia
date
C0040034 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Second onset thrombopenia
Item
Second onset thrombopenia?
boolean
C0040034 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
Thrombopenia onset date
Item
Date of 2nd onset thrombopenia
date
C0040034 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing Adverse event , thrombopenia
Item
2nd thrombopenia ongoing at this visit ?
boolean
C0040034 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, thrombopenia
Item
End date 2nd thrombopenia
date
C0040034 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
RBC transfusion units
Item
Number of RBC transfusion units from start trial until this visit
integer
C0086252 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
platelet transfusion units
Item
Number of platelet transfusion units from start trial until this visit
integer
C0086818 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
Item Group
G-CSF Administration
C0079459 (UMLS CUI-1)
Item
G-CSF administered during trial?
integer
C0079459 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
G-CSF administered
Code List
G-CSF administered during trial?
CL Item
Unknown (1)
CL Item
No (2)
CL Item
Yes (3)
G-CSF start date
Item
Start date 1st administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
G-CSF end date
Item
End date 1st administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
G-CSF ongoing
Item
1st administration ongoing at this visit
boolean
C0079459 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
2nd administration of G-CSF?
integer
C0079459 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
G-CSF administered
Code List
2nd administration of G-CSF?
CL Item
Unknown (1)
CL Item
No (2)
CL Item
Yes (3)
G-CSF start date
Item
Start date 2nd administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
G-CSF end date
Item
End date 2nd administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
G-CSF ongoing
Item
2nd administration ongoing at this visit
boolean
C0079459 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Response Assessment
C0521982 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Item
Response Assessment
integer
C0521982 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Remission Assessment
Code List
Response Assessment
CL Item
Done (1)
C1272695 (UMLS CUI-1)
(Comment:en)
CL Item
Not done (2)
C1272696 (UMLS CUI-1)
(Comment:en)
CL Item
Failed (3)
C1272705 (UMLS CUI-1)
(Comment:en)
Item Group
Examination of Bone Marrow
C0005957 (UMLS CUI-1)
Bone marrow aspiration or biopsy date
Item
Date of aspiration or biopsy
date
C0005954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0398523 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Percentage of blasts
Item
Percentage of blasts
float
C0587348 (UMLS CUI [1])
Item Group
Disease Response
C1704632 (UMLS CUI-1)
Item
Response
text
C1704632 (UMLS CUI [1])
Disease Response
Code List
Response
CL Item
Good Response (blast count < 5%, aspirate with marrow spicules) (1)
(Comment:en)
CL Item
Refractory Disease ( increase in bone marrow blast count compared to baseline or no change in (3)
(Comment:en)
CL Item
Moderate Response (blast count > = 5%, reduction in blast count and/or bone marrow cellularity) (2)
(Comment:en)
CL Item
bone marrow cellularity with unchanged blast count.) (bone marrow cellularity with unchanged blast count.))
Item Group
Remission Assessment
C0544452 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Item
Remission Assessment
integer
C0544452 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Remission Assessment
Code List
Remission Assessment
CL Item
Done (1)
CL Item
Neither aspirate nor biopsy done (2)
Item Group
Examination of Bone Marrow
C0005957 (UMLS CUI-1)
Bone marrow aspiration or biopsy date
Item
Date of aspiration or biopsy
date
C0005954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0398523 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item Group
Remission Status
C1704632 (UMLS CUI-1)
Item
Remission Status
integer
C1704632 (UMLS CUI [1])
Remission Status
Code List
Remission Status
CL Item
Morphological complete remission (CR) (1)
CL Item
Complete remission with incomplete recovery (CRi) (2)
CL Item
Cytogenetic complete remission (CRc) (3)
CL Item
Molecular complete remission (CRm) (4)
CL Item
No CR = Treatment failure (5)
Item Group
Cytogenetics (central)
C0010802 (UMLS CUI-1)
Item
Cytogenetic analysis
integer
C0752095 (UMLS CUI [1])
Cytogenetic analysis
Code List
Cytogenetic analysis
CL Item
Not done (1)
CL Item
Failed (e.g. technical problems, EDTA conditioned) (2)
CL Item
Failure (bad morphology, no proliferation) (3)
CL Item
Done (4)
Number of analyzed metaphases
Item
Total number of analyzed metaphases
integer
C1621812 (UMLS CUI [1,1])
C0260877 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item
Karyotype
integer
C1261273 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Karyotype
Code List
Karyotype
CL Item
Normal karyotype (1)
CL Item
Abnormal karyotype (2)
Item
If karyotype is not normal, which characteristics apply?
integer
C1261273 (UMLS CUI [1,1])
C0008625 (UMLS CUI [1,2])
Karyotype characteristics
Code List
If karyotype is not normal, which characteristics apply?
CL Item
high risk aberrations (1)
CL Item
low risk aberrations (2)
Complete
Item
Have you marked all karyotype characteristics?
boolean
C0205197 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Item Group
Chromosome aberrations
C0008625 (UMLS CUI-1)
Item
High risk aberrations
integer
C0008625 (UMLS CUI [1,1])
C0684030 (UMLS CUI [1,2])
High risk aberrations
Code List
High risk aberrations
CL Item
-5 (1)
C0439075 (UMLS CUI-1)
(Comment:en)
CL Item
-7 (2)
C3846158 (UMLS CUI-1)
(Comment:en)
CL Item
abnl(17p) (3)
C0796349 (UMLS CUI-1)
(Comment:en)
CL Item
del(5q) (4)
C1521461 (UMLS CUI-1)
(Comment:en)
CL Item
inv(3)(q21q26.2) (5)
C1515666 (UMLS CUI-1)
(Comment:en)
CL Item
t(3;3)(q21;q26.2) (6)
C1515764 (UMLS CUI-1)
(Comment:en)
CL Item
t(6;9) (q23;q34) (7)
C1515781 (UMLS CUI-1)
(Comment:en)
CL Item
t(v;11)(v;q23) (8)
C1515810 (UMLS CUI-1)
(Comment:en)
CL Item
complex karyotype (≥ 3 aberrations) (9)
C3273253 (UMLS CUI-1)
(Comment:en)
Item
Low risk aberrations
integer
C0008625 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
Low risk aberrations
Code List
Low risk aberrations
CL Item
inv(16) (1)
C3897144 (UMLS CUI-1)
(Comment:en)
CL Item
t(8;21) (2)
C3897139 (UMLS CUI-1)
(Comment:en)
CL Item
t(16;16) (3)
C4287945 (UMLS CUI-1)
(Comment:en)
CL Item
other aberrations (4)
C0008625 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
Other aberrations
Item
Other aberrations, please specify
text
C0008625 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Further entry
Item
Further entry
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
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