ID
36226
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 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
Link
https://www.clinicaltrials.gov/ct2/show/NCT02140242
Keywords
Versions (3)
- 10/24/17 10/24/17 - Julian Varghese
- 4/23/19 4/23/19 - Sarah Riepenhausen
- 9/20/21 9/20/21 -
Copyright Holder
PD Dr. med. Christoph Röllig, MSc
Uploaded on
April 23, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242
Drop out Sheet and visit
- StudyEvent: ODMjoin
- Visit Registration/Randomization I
- Visit 1 - Medical History
- Visit 1 Baseline
- Visit 2 (Day 1 Induction I)
- Visit 7 (Day 15 Induction I)
- Visit Randomization II
- Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- Visit 8 (before Day 1 Induction II)
- Visit 9/10/11/12 (Day 2, 3, 4, 5 Induction II)
- Visit 13 (End of Study)
- Drop out Sheet and visit
- Adverse events and Death sheet
Description
Drop out Visit
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C0457454
Description
2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0034656
Description
Visit date
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Drop-Out Visit not done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1272696
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
Electrocardiography
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
ECG findings
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Pathological ECG findings
Data type
integer
Alias
- UMLS CUI [1]
- C1832603
Description
In case of any new pathological findings of clinical significance, please fill in AE.
Data type
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2826293
Description
Echocardiography
Alias
- UMLS CUI-1
- C0013516
Description
Echocardiography
Data type
integer
Alias
- UMLS CUI [1]
- C0013516
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
LVEF
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0428772
Description
In case of any change in valvular defects of clinical significance, please fill in AE.
Data type
boolean
Alias
- UMLS CUI [1]
- C2748945
Description
Tricuspid valve defect
Data type
boolean
Alias
- UMLS CUI [1]
- C0264882
Description
Tricuspid valve defect
Data type
integer
Alias
- UMLS CUI [1]
- C0264882
Description
Severity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0264882
Description
Pulmonary valve defect
Data type
boolean
Alias
- UMLS CUI [1]
- C0034087
Description
Pulmonary valve defect
Data type
integer
Alias
- UMLS CUI [1]
- C0034087
Description
Severity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0034087
Description
Mitral valve defect
Data type
boolean
Alias
- UMLS CUI [1]
- C0026265
Description
Mitral valve defect
Data type
integer
Alias
- UMLS CUI [1]
- C0026265
Description
Severity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0026265
Description
Aortic valve defect
Data type
boolean
Alias
- UMLS CUI [1]
- C1260873
Description
Aortic valve defect
Data type
integer
Alias
- UMLS CUI [1]
- C1260873
Description
Severity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C1260873
Description
Cardiac Enzymes
Alias
- UMLS CUI-1
- C0443763
Description
Cardiac Enzymes measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0201934
Description
Date of sampling
Data type
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
xxx , x
Data type
float
Alias
- UMLS CUI [1]
- C3272900
Description
Unit used
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Data type
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xxx , x
Data type
float
Alias
- UMLS CUI [1]
- C0523953
Description
Unit used
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Data type
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xxx , x
Data type
float
Alias
- UMLS CUI [1]
- C0920210
Description
Unit used
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Data type
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Neutropenia/Thrombopenia
Alias
- UMLS CUI-1
- C0027947
- UMLS CUI-2
- C0040034
Description
Neutropenia grade IV
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C1516728
Description
Preexisting neutropenia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2347662
Description
(after date V1, Induction I) < 0,5 Gpt/l or < 500 /μl
Data type
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C0574845
Description
Only if patient participates in Induction II
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2826663
Description
Ongoing adverse event, neutropenia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2826663
Description
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Data type
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2697886
Description
(only possible during Induction II)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C0277793
Description
< 0,5 Gpt/l or < 500 /μ
Data type
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C0574845
Description
Ongoing Adverse event , neutropenia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2826663
Description
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Data type
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2697886
Description
Thrombopenia grade IV
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C1516728
Description
Preexisting thrombopenia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2347662
Description
(after date V1, Induction I) < 0,5 Gpt/l or < 500 /μl
Data type
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C0574845
Description
Only if patient participates in Induction II
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2826663
Description
Ongoing adverse event, thrombopenia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2826663
Description
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Data type
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2697886
Description
(only possible during Induction II)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C0277793
Description
< 0,5 Gpt/l or < 500 /μ
Data type
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C0574845
Description
Ongoing Adverse event , thrombopenia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2826663
Description
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Data type
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2697886
Description
RBC transfusion units
Data type
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449961
Description
platelet transfusion units
Data type
integer
Alias
- UMLS CUI [1,1]
- C0086818
- UMLS CUI [1,2]
- C0449961
Description
G-CSF Administration
Alias
- UMLS CUI-1
- C0079459
Description
G-CSF administered
Data type
integer
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C1533734
Description
G-CSF start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0808070
Description
G-CSF end date
Data type
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0806020
Description
G-CSF ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0549178
Description
G-CSF administered
Data type
integer
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C1533734
Description
G-CSF start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0808070
Description
G-CSF end date
Data type
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0806020
Description
G-CSF ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0549178
Description
Response Assessment
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C1516048
Description
Examination of Bone Marrow
Alias
- UMLS CUI-1
- C0005957
Description
Bone marrow aspiration or biopsy date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005954
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0398523
- UMLS CUI [2,2]
- C0011008
Description
Percentage of blasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0587348
Description
Disease Response
Alias
- UMLS CUI-1
- C1704632
Description
Remission Assessment
Alias
- UMLS CUI-1
- C0544452
- UMLS CUI-2
- C1516048
Description
Examination of Bone Marrow
Alias
- UMLS CUI-1
- C0005957
Description
Remission Status
Alias
- UMLS CUI-1
- C1704632
Description
Cytogenetics (central)
Alias
- UMLS CUI-1
- C0010802
Description
Cytogenetic analysis
Data type
integer
Alias
- UMLS CUI [1]
- C0752095
Description
Number of analyzed metaphases
Data type
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0260877
- UMLS CUI [1,3]
- C0449788
Description
Karyotype
Data type
integer
Alias
- UMLS CUI [1,1]
- C1261273
- UMLS CUI [1,2]
- C0678257
Description
Karyotype characteristics
Data type
integer
Alias
- UMLS CUI [1,1]
- C1261273
- UMLS CUI [1,2]
- C0008625
Description
Complete
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205197
- UMLS CUI [1,2]
- C1511726
Description
Chromosome aberrations
Alias
- UMLS CUI-1
- C0008625
Description
High risk aberrations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C0684030
Description
Low risk aberrations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C3538919
Description
Other aberrations
Data type
text
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C0205394
Description
Further entry
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1705654
- UMLS CUI [1,2]
- C1517331
Similar models
Drop out Sheet and visit
- StudyEvent: ODMjoin
- Visit Registration/Randomization I
- Visit 1 - Medical History
- Visit 1 Baseline
- Visit 2 (Day 1 Induction I)
- Visit 7 (Day 15 Induction I)
- Visit Randomization II
- Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- Visit 8 (before Day 1 Induction II)
- Visit 9/10/11/12 (Day 2, 3, 4, 5 Induction II)
- Visit 13 (End of Study)
- Drop out Sheet and visit
- Adverse events and Death sheet
C0034656 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0600091 (UMLS CUI [2,2])
C1521902 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0264882 (UMLS CUI [1,2])
C0034087 (UMLS CUI [1,2])
C0026265 (UMLS CUI [1,2])
C1260873 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040034 (UMLS CUI-2)
C1516728 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C0277793 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C0277793 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C2826663 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C0449961 (UMLS CUI [1,2])
C0449961 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
(Comment:en)
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C0011008 (UMLS CUI [1,2])
C0398523 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C1516048 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0398523 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0260877 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0008625 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,2])
C0684030 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C3538919 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C0205394 (UMLS CUI-2)
(Comment:en)
C0205394 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])