ID

42900

Description

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: https://www.clinicaltrials.gov/ct2/show/NCT02140242 Copyright Holder: PD Dr. med. Christoph Röllig, MSc Source:PD Dr. med. Christoph Röllig, MSc Universitätsklinikum Dresden

Link

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

Keywords

Versions (2)
  1. 3/7/18 3/7/18 -
  2. 9/17/21 9/17/21 -
Copyright Holder

Technische Universität Dresden,Dr. Röllig

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0
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26496_Daunorubicin Acute Myeloid Leukemia NCT02140242

English

Visit 1 - Medical History

12 forms  
AML First Diagnosis
Description

AML First Diagnosis

Alias
UMLS CUI-1
C0023467
UMLS CUI-2
C3172269
Randomization number
Description

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

Data type

integer

Alias
UMLS CUI [1]
C2986235
Date of first diagnosis
Description

Date of first diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
Type of Diagnosis
Description

Type of Diagnosis

Data type

integer

Alias
UMLS CUI [1]
C1550351
History of malignancy
Description

History of malignancy

Data type

boolean

Alias
UMLS CUI [1]
C2735088
Chemotherapy in anamnesis
Description

History of Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0262926
Radiation in anamnesis
Description

History of therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0262926
FAB Classification: (local) not done or failed
Description

FAB Classification (local) not done or failed

Data type

boolean

Alias
UMLS CUI [1]
C2984084
FAB Classification (local)
Description

FAB Classification (local)

Data type

integer

Alias
UMLS CUI [1]
C2984084
If FAB Classification is M5a or M5b, please mark M5 first.
Description

FAB Classification (local)

Data type

integer

Alias
UMLS CUI [1]
C2984084
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
Description

WHO subtype group

Data type

integer

Alias
UMLS CUI [1]
C1301142
FAB Classification (central) not done or failed
Description

FAB Classification (central) not done or failed

Data type

boolean

Alias
UMLS CUI [1]
C2984084
FAB Classification (central)
Description

FAB Classification (central)

Data type

integer

Alias
UMLS CUI [1]
C2984084
If FAB Classification is M5a or M5b, please mark M5 first.
Description

FAB Classification (central)

Data type

integer

Alias
UMLS CUI [1]
C2984084
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
Description

WHO subtype group

Data type

integer

Alias
UMLS CUI [1]
C1301142
Medical History of neoplastic diseases
Description

Medical History of neoplastic diseases

Alias
UMLS CUI-1
C2735088
Which type of malignancy?
Description

Type of malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332307
year of diagnosis
Description

year of diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0439234
Further entry?
Description

Further entry?

Data type

boolean

Alias
UMLS CUI [1,1]
C1705654
UMLS CUI [1,2]
C1517331
Year of chemotherapy
Description

Year of chemotherapy

Data type

partialDate

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0439234
Scheme
Description

Chemotherapy regimen

Data type

text

Alias
UMLS CUI [1]
C0392920
Further entry?
Description

Further entry?

Data type

boolean

Alias
UMLS CUI [1,1]
C1705654
UMLS CUI [1,2]
C1517331
Year of radiation
Description

Year of therapeutic radiology procedure

Data type

partialDate

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0439234
Dose
Description

Radiation dose

Data type

integer

Alias
UMLS CUI [1]
C2919490
Units used
Description

Units used

Data type

integer

Alias
UMLS CUI [1]
C1519795
Molecular Genetics
Description

Molecular Genetics

Alias
UMLS CUI-1
C0086345
Molecular genetics not done or failed
Description

Molecular genetics

Data type

boolean

Alias
UMLS CUI [1,1]
C0086345
UMLS CUI [1,2]
C1272696
UMLS CUI [2,1]
C0086345
UMLS CUI [2,2]
C0231175
RUNX1-RUNX1 T1
Description

RUNX1-RUNX1 T1

Data type

integer

Alias
UMLS CUI [1]
C1851466
CBF/MYH11
Description

CBF/MYH11

Data type

integer

Alias
UMLS CUI [1]
C3276534
Bcr-Abl 1
Description

Bcr-Abl 1

Data type

integer

Alias
UMLS CUI [1]
C1835417
NPM1-Mut
Description

NPM1-Mut

Data type

integer

Alias
UMLS CUI [1]
C2826175
CEBPA-Mut
Description

CEBPA-Mut

Data type

integer

Alias
UMLS CUI [1]
C1511473
FLT3-ITD-Mut
Description

FLT3-ITD-Mut

Data type

integer

Alias
UMLS CUI [1]
C2348499
FLT3-ITD/wt ratio
Description

FLT3-ITD/wt ratio

Data type

integer

Alias
UMLS CUI [1,1]
C2348499
UMLS CUI [1,2]
C0216388
UMLS CUI [1,3]
C0456603
If other, please specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Extramedullary Manifestations
Description

Extramedullary Manifestations

Data type

integer

Alias
UMLS CUI [1]
C1868812
Extramedullary Manifestations If yes or suspected, location
Description

Extramedullary Manifestations

Data type

text

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C1515974
Relevant Pre-existing Illnesses and Comorbidities
Description

Relevant Pre-existing Illnesses and Comorbidities

Alias
UMLS CUI-1
C0521987
UMLS CUI-2
C0009488
Any relevant pre-existing illnesses and comorbidities?
Description

pre-existing illnesses and comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2]
C0009488
Pre-existing illnesses and comorbidities
Description

Pre-existing illnesses and comorbidities

Alias
UMLS CUI-1
C0521987
UMLS CUI-2
C0009488
Illness
Description

Illness

Data type

text

Alias
UMLS CUI [1]
C0012634
Onset (month/year)
Description

In case the month of onset is unknown, please fill in 06 (June).

Data type

partialDate

Alias
UMLS CUI [1]
C0574845
Ongoing
Description

Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Severity
Description

severity

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0457451
further row
Description

further row

Data type

boolean

Alias
UMLS CUI [1,1]
C1705654
UMLS CUI [1,2]
C1517331
Examination of Bone Marrow
Description

Examination of Bone Marrow

Alias
UMLS CUI-1
C0005957
Examination of Bone Marrow
Description

Examination of Bone Marrow

Data type

integer

Alias
UMLS CUI [1]
C0005957
Date of aspiration or biopsy
Description

Bone Marrow biopsy date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005954
Percentage of blasts (Local)
Description

Percentage of blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0587348
%
Bone Marrow assessment
Description

Bone Marrow assessment

Data type

integer

Alias
UMLS CUI [1]
C0005957
Percentage of blasts (central, assessed by cytology)
Description

In case the percentage of blasts was assessed by both - cytology and histology,please document only cytology result.

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0587348
UMLS CUI [1,2]
C1305671
%
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Similar models

Visit 1 - Medical History

12 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
AML First Diagnosis
C0023467 (UMLS CUI-1)
C3172269 (UMLS CUI-2)
Randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
Date of first diagnosis
Item
Date of first diagnosis
date
C2316983 (UMLS CUI [1])
Item
Type of Diagnosis
integer
C1550351 (UMLS CUI [1])
Type of Diagnosis
Code List
Type of Diagnosis
CL Item
De novo (1)
C1515568 (UMLS CUI-1)
C0023467 (UMLS CUI-2)
(Comment:en)
CL Item
AML after MDS (2)
C0280449 (UMLS CUI-1)
C3463824 (UMLS CUI-2)
(Comment:en)
CL Item
AML after MPN-/OMF (3)
C0280449 (UMLS CUI-1)
C0027022 (UMLS CUI-2)
C0948968 (UMLS CUI-3)
(Comment:en)
History of malignancy
Item
History of malignancy
boolean
C2735088 (UMLS CUI [1])
History of Chemotherapy
Item
Chemotherapy in anamnesis
boolean
C0392920 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
History of therapeutic radiology procedure
Item
Radiation in anamnesis
boolean
C1522449 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
FAB Classification (local) not done or failed
Item
FAB Classification: (local) not done or failed
boolean
C2984084 (UMLS CUI [1])
Item
FAB Classification (local)
integer
C2984084 (UMLS CUI [1])
FAB Classification (local)
Code List
FAB Classification (local)
CL Item
M0 (1)
CL Item
M1 (2)
CL Item
M2 (3)
CL Item
M4 (4)
CL Item
M4Eo (5)
CL Item
M5 (6)
CL Item
M6 (7)
CL Item
M7 (8)
CL Item
RAEB-t (9)
Item
If FAB Classification is M5a or M5b, please mark M5 first.
integer
C2984084 (UMLS CUI [1])
FAB Classification (local)
Code List
If FAB Classification is M5a or M5b, please mark M5 first.
CL Item
M5a (1)
CL Item
M5b (2)
Item
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
integer
C1301142 (UMLS CUI [1])
WHO subtype group
Code List
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
CL Item
AML with minimal differentiation (1)
CL Item
AML without maturation (2)
CL Item
AML with maturation (3)
CL Item
AML myelomonocytic leukemia (4)
CL Item
AML monocytic leukemia (5)
CL Item
AML erythroid leukemia (6)
CL Item
AML megakaryoblastic leukemia (7)
CL Item
AML basophilic leukemia (8)
CL Item
AML panmyelosis with fibrosis (9)
FAB Classification (central) not done or failed
Item
FAB Classification (central) not done or failed
boolean
C2984084 (UMLS CUI [1])
Item
FAB Classification (central)
integer
C2984084 (UMLS CUI [1])
FAB Classification (local)
Code List
FAB Classification (central)
CL Item
M0 (1)
CL Item
M1 (2)
CL Item
M2 (3)
CL Item
M4 (4)
CL Item
M4Eo (5)
CL Item
M5 (6)
CL Item
M6 (7)
CL Item
M7 (8)
CL Item
RAEB-t (9)
Item
If FAB Classification is M5a or M5b, please mark M5 first.
integer
C2984084 (UMLS CUI [1])
FAB Classification (local)
Code List
If FAB Classification is M5a or M5b, please mark M5 first.
CL Item
M5a (1)
CL Item
M5b (2)
Item
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
integer
C1301142 (UMLS CUI [1])
WHO subtype group
Code List
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
CL Item
AML with minimal differentiation (1)
CL Item
AML without maturation (2)
CL Item
AML with maturation (3)
CL Item
AML myelomonocytic leukemia (4)
CL Item
AML monocytic leukemia (5)
CL Item
AML erythroid leukemia (6)
CL Item
AML megakaryoblastic leukemia (7)
CL Item
AML basophilic leukemia (8)
CL Item
AML panmyelosis with fibrosis (9)
Item Group
Medical History of neoplastic diseases
C2735088 (UMLS CUI-1)
Type of malignancy
Item
Which type of malignancy?
text
C0006826 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
year of diagnosis
Item
year of diagnosis
partialDate
C2316983 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Further entry?
Item
Further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Year of chemotherapy
Item
Year of chemotherapy
partialDate
C0392920 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Chemotherapy regimen
Item
Scheme
text
C0392920 (UMLS CUI [1])
Further entry?
Item
Further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Year of therapeutic radiology procedure
Item
Year of radiation
partialDate
C1522449 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Radiation dose
Item
Dose
integer
C2919490 (UMLS CUI [1])
Item
Units used
integer
C1519795 (UMLS CUI [1])
Units used
Code List
Units used
CL Item
Gy (1)
CL Item
GBq (2)
Item Group
Molecular Genetics
C0086345 (UMLS CUI-1)
Molecular genetics
Item
Molecular genetics not done or failed
boolean
C0086345 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0086345 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Item
RUNX1-RUNX1 T1
integer
C1851466 (UMLS CUI [1])
RUNX1-RUNX1 T1
Code List
RUNX1-RUNX1 T1
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
Item
CBF/MYH11
integer
C3276534 (UMLS CUI [1])
RUNX1-RUNX1 T1
Code List
CBF/MYH11
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
Item
Bcr-Abl 1
integer
C1835417 (UMLS CUI [1])
RUNX1-RUNX1 T1
Code List
Bcr-Abl 1
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
Item
NPM1-Mut
integer
C2826175 (UMLS CUI [1])
RUNX1-RUNX1 T1
Code List
NPM1-Mut
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
Item
CEBPA-Mut
integer
C1511473 (UMLS CUI [1])
RUNX1-RUNX1 T1
Code List
CEBPA-Mut
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
Item
FLT3-ITD-Mut
integer
C2348499 (UMLS CUI [1])
RUNX1-RUNX1 T1
Code List
FLT3-ITD-Mut
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
Item
FLT3-ITD/wt ratio
integer
C2348499 (UMLS CUI [1,1])
C0216388 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
RUNX1-RUNX1 T1
Code List
FLT3-ITD/wt ratio
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Item
Extramedullary Manifestations
integer
C1868812 (UMLS CUI [1])
Extramedullary Manifestations
Code List
Extramedullary Manifestations
CL Item
Not done (1)
CL Item
No signs (2)
CL Item
Yes, histologically proven (3)
CL Item
Suspected (4)
Extramedullary Manifestations
Item
Extramedullary Manifestations If yes or suspected, location
text
C1868812 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Item Group
Relevant Pre-existing Illnesses and Comorbidities
C0521987 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
pre-existing illnesses and comorbidities
Item
Any relevant pre-existing illnesses and comorbidities?
boolean
C0521987 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
Item Group
Pre-existing illnesses and comorbidities
C0521987 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Illness
Item
Illness
text
C0012634 (UMLS CUI [1])
Date of onset
Item
Onset (month/year)
partialDate
C0574845 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1])
Item
Severity
integer
C1516728 (UMLS CUI [1,1])
C0457451 (UMLS CUI [1,2])
severity
Code List
Severity
CL Item
CTCAE grade 1(mild) (1)
CL Item
CTCAE grade 2(moderate) (2)
CL Item
CTCAE grade 3(severe) (3)
CL Item
CTCAE grade 4(life threatening or disabeling) (4)
CL Item
not assessable (0)
further row
Item
further row
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Item Group
Examination of Bone Marrow
C0005957 (UMLS CUI-1)
Item
Examination of Bone Marrow
integer
C0005957 (UMLS CUI [1])
Examination of Bone Marrow
Code List
Examination of Bone Marrow
CL Item
Done (1)
CL Item
Not done, sufficient amount of blasts in peripheral blood (2)
Bone Marrow biopsy date
Item
Date of aspiration or biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
Percentage of blasts
Item
Percentage of blasts (Local)
float
C0587348 (UMLS CUI [1])
Item
Bone Marrow assessment
integer
C0005957 (UMLS CUI [1])
Bone Marrow assessment
Code List
Bone Marrow assessment
CL Item
assessed by cytology (1)
CL Item
assessed by histology (2)
Percentage of blasts
Item
Percentage of blasts (central, assessed by cytology)
float
C0587348 (UMLS CUI [1,1])
C1305671 (UMLS CUI [1,2])
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