ID
36226
Beschreibung
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
Stichworte
Versionen (3)
- 24.10.17 24.10.17 - Julian Varghese
- 23.04.19 23.04.19 - Sarah Riepenhausen
- 20.09.21 20.09.21 -
Rechteinhaber
PD Dr. med. Christoph Röllig, MSc
Hochgeladen am
23. April 2019
DOI
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Lizenz
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
Beschreibung
Drop out Visit
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C0457454
Beschreibung
2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0034656
Beschreibung
Visit date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Drop-Out Visit not done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1272696
Beschreibung
ECG
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Electrocardiography
Datentyp
integer
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
ECG findings
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
Pathological ECG findings
Datentyp
integer
Alias
- UMLS CUI [1]
- C1832603
Beschreibung
In case of any new pathological findings of clinical significance, please fill in AE.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2826293
Beschreibung
Echocardiography
Alias
- UMLS CUI-1
- C0013516
Beschreibung
Echocardiography
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013516
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
LVEF
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0428772
Beschreibung
In case of any change in valvular defects of clinical significance, please fill in AE.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2748945
Beschreibung
Tricuspid valve defect
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264882
Beschreibung
Tricuspid valve defect
Datentyp
integer
Alias
- UMLS CUI [1]
- C0264882
Beschreibung
Severity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0264882
Beschreibung
Pulmonary valve defect
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0034087
Beschreibung
Pulmonary valve defect
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034087
Beschreibung
Severity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0034087
Beschreibung
Mitral valve defect
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0026265
Beschreibung
Mitral valve defect
Datentyp
integer
Alias
- UMLS CUI [1]
- C0026265
Beschreibung
Severity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0026265
Beschreibung
Aortic valve defect
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1260873
Beschreibung
Aortic valve defect
Datentyp
integer
Alias
- UMLS CUI [1]
- C1260873
Beschreibung
Severity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C1260873
Beschreibung
Cardiac Enzymes
Alias
- UMLS CUI-1
- C0443763
Beschreibung
Cardiac Enzymes measurement
Datentyp
integer
Alias
- UMLS CUI [1]
- C0201934
Beschreibung
Date of sampling
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Beschreibung
xxx , x
Datentyp
float
Alias
- UMLS CUI [1]
- C3272900
Beschreibung
Unit used
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Significance
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826293
Beschreibung
xxx , x
Datentyp
float
Alias
- UMLS CUI [1]
- C0523953
Beschreibung
Unit used
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Significance
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826293
Beschreibung
xxx , x
Datentyp
float
Alias
- UMLS CUI [1]
- C0920210
Beschreibung
Unit used
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Significance
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826293
Beschreibung
Neutropenia/Thrombopenia
Alias
- UMLS CUI-1
- C0027947
- UMLS CUI-2
- C0040034
Beschreibung
Neutropenia grade IV
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C1516728
Beschreibung
Preexisting neutropenia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2347662
Beschreibung
(after date V1, Induction I) < 0,5 Gpt/l or < 500 /μl
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C0574845
Beschreibung
Only if patient participates in Induction II
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2826663
Beschreibung
Ongoing adverse event, neutropenia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2826663
Beschreibung
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2697886
Beschreibung
(only possible during Induction II)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C0277793
Beschreibung
< 0,5 Gpt/l or < 500 /μ
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C0574845
Beschreibung
Ongoing Adverse event , neutropenia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2826663
Beschreibung
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0027947
- UMLS CUI [1,2]
- C2697886
Beschreibung
Thrombopenia grade IV
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C1516728
Beschreibung
Preexisting thrombopenia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2347662
Beschreibung
(after date V1, Induction I) < 0,5 Gpt/l or < 500 /μl
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C0574845
Beschreibung
Only if patient participates in Induction II
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2826663
Beschreibung
Ongoing adverse event, thrombopenia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2826663
Beschreibung
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2697886
Beschreibung
(only possible during Induction II)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C0277793
Beschreibung
< 0,5 Gpt/l or < 500 /μ
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C0574845
Beschreibung
Ongoing Adverse event , thrombopenia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2826663
Beschreibung
(before or at date of this visit) >= 0,5 Gpt/l or >= 500 /μl
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0040034
- UMLS CUI [1,2]
- C2697886
Beschreibung
RBC transfusion units
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449961
Beschreibung
platelet transfusion units
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0086818
- UMLS CUI [1,2]
- C0449961
Beschreibung
G-CSF Administration
Alias
- UMLS CUI-1
- C0079459
Beschreibung
G-CSF administered
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C1533734
Beschreibung
G-CSF start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0808070
Beschreibung
G-CSF end date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0806020
Beschreibung
G-CSF ongoing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0549178
Beschreibung
G-CSF administered
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C1533734
Beschreibung
G-CSF start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0808070
Beschreibung
G-CSF end date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0806020
Beschreibung
G-CSF ongoing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0549178
Beschreibung
Response Assessment
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C1516048
Beschreibung
Examination of Bone Marrow
Alias
- UMLS CUI-1
- C0005957
Beschreibung
Bone marrow aspiration or biopsy date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005954
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0398523
- UMLS CUI [2,2]
- C0011008
Beschreibung
Percentage of blasts
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0587348
Beschreibung
Disease Response
Alias
- UMLS CUI-1
- C1704632
Beschreibung
Remission Assessment
Alias
- UMLS CUI-1
- C0544452
- UMLS CUI-2
- C1516048
Beschreibung
Examination of Bone Marrow
Alias
- UMLS CUI-1
- C0005957
Beschreibung
Remission Status
Alias
- UMLS CUI-1
- C1704632
Beschreibung
Cytogenetics (central)
Alias
- UMLS CUI-1
- C0010802
Beschreibung
Cytogenetic analysis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0752095
Beschreibung
Number of analyzed metaphases
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0260877
- UMLS CUI [1,3]
- C0449788
Beschreibung
Karyotype
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1261273
- UMLS CUI [1,2]
- C0678257
Beschreibung
Karyotype characteristics
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1261273
- UMLS CUI [1,2]
- C0008625
Beschreibung
Complete
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205197
- UMLS CUI [1,2]
- C1511726
Beschreibung
Chromosome aberrations
Alias
- UMLS CUI-1
- C0008625
Beschreibung
High risk aberrations
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C0684030
Beschreibung
Low risk aberrations
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C3538919
Beschreibung
Other aberrations
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C0205394
Beschreibung
Further entry
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1705654
- UMLS CUI [1,2]
- C1517331
Ähnliche Modelle
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)
(Comment:en)
(Comment:en)
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])