ID
44274
Beschrijving
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
Trefwoorden
Versies (3)
- 24-10-17 24-10-17 - Julian Varghese
- 23-04-19 23-04-19 - Sarah Riepenhausen
- 20-09-21 20-09-21 -
Houder van rechten
PD Dr. med. Christoph Röllig, MSc
Geüploaded op
20 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242
Visit 1 Baseline
- 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
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body surface
Datatype
float
Maateenheden
- m2
Alias
- UMLS CUI [1]
- C0005902
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
ECOG
Datatype
integer
Alias
- UMLS CUI [1]
- C1520224
Beschrijving
ECOG
Datatype
integer
Alias
- UMLS CUI [1]
- C1520224
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Physical Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
General Appearance
Datatype
integer
Alias
- UMLS CUI [1]
- C1148438
Beschrijving
General Appearance findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C2607943
Beschrijving
Nervous system
Datatype
integer
Alias
- UMLS CUI [1]
- C0027763
Beschrijving
Nervous system findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027763
- UMLS CUI [1,2]
- C2607943
Beschrijving
Lungs
Datatype
integer
Alias
- UMLS CUI [1]
- C2228454
Beschrijving
Examination of Lungs findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C2228454
- UMLS CUI [1,2]
- C2607943
Beschrijving
Heart
Datatype
integer
Alias
- UMLS CUI [1]
- C0562319
Beschrijving
Heart findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0562319
- UMLS CUI [1,2]
- C2607943
Beschrijving
Abdomen
Datatype
integer
Alias
- UMLS CUI [1]
- C0562238
Beschrijving
Abdominal findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0562238
- UMLS CUI [1,2]
- C2607943
Beschrijving
Head examination
Datatype
integer
Alias
- UMLS CUI [1]
- C2239107
Beschrijving
Head examination findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C2239107
- UMLS CUI [1,2]
- C2607943
Beschrijving
Neck and thyroid examination
Datatype
integer
Alias
- UMLS CUI [1]
- C2228463
- UMLS CUI [2]
- C2228489
Beschrijving
Neck and thyroid examination findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C2228463
- UMLS CUI [1,2]
- C2607943
- UMLS CUI [2,1]
- C2228489
- UMLS CUI [2,2]
- C2607943
Beschrijving
Skin examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0436149
Beschrijving
Skin examination findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0436149
- UMLS CUI [1,2]
- C2607943
Beschrijving
Extremities examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0436150
Beschrijving
Extremities examination findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0436150
- UMLS CUI [1,2]
- C2607943
Beschrijving
Signs of bleeding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3251812
- UMLS CUI [1,2]
- C0037088
Beschrijving
Signs of bleeding findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C3251812
- UMLS CUI [1,2]
- C2607943
Beschrijving
Lymph nodes examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0562297
Beschrijving
Lymph nodes examination findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0562297
- UMLS CUI [1,2]
- C2607943
Beschrijving
Lymph node size
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C1285847
- UMLS CUI [1,2]
- C0443228
- UMLS CUI [1,3]
- C1444754
Beschrijving
Lymph node size
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C1285847
- UMLS CUI [1,2]
- C0443228
- UMLS CUI [1,3]
- C0487742
Beschrijving
Full Blood Count
Alias
- UMLS CUI-1
- C0005771
Beschrijving
Full blood count
Datatype
integer
Alias
- UMLS CUI [1]
- C0005771
Beschrijving
Date of sampling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
Leukocytes
Datatype
integer
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Hemoglobin
Datatype
integer
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Platelets
Datatype
integer
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Neutrophiles
Datatype
integer
Alias
- UMLS CUI [1]
- C0200633
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Lymphocytes
Datatype
integer
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Monocytes
Datatype
integer
Alias
- UMLS CUI [1]
- C0200637
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Basophiles
Datatype
integer
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Eosinophiles
Datatype
integer
Alias
- UMLS CUI [1]
- C0750879
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Blast percentage
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C0587348
- UMLS CUI [1,2]
- C0229664
Beschrijving
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0022885
Beschrijving
Clinical Chemistry
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0022885
Beschrijving
Date of sampling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
xx . xxxx
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Units used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xx . xxxx
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Units used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xx . xxxx
Datatype
float
Alias
- UMLS CUI [1]
- C1278039
Beschrijving
Units used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xx . xxxx
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Units used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xx . xxxx
Datatype
float
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Units used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xx . xxxx
Datatype
float
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Units used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Coagulation
Alias
- UMLS CUI-1
- C0005790
Beschrijving
Coagulation
Datatype
integer
Alias
- UMLS CUI [1]
- C0005790
Beschrijving
Date of sampling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Beschrijving
PTT
Datatype
integer
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0030605
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
x . xx
Datatype
float
Alias
- UMLS CUI [1]
- C0525032
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xxx . xx
Datatype
float
Alias
- UMLS CUI [1]
- C0337428
Beschrijving
Units used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
ECG
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Electrocardiography
Datatype
integer
Alias
- UMLS CUI [1]
- C1623258
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
ECG findings
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Pathological ECG findings
Datatype
integer
Alias
- UMLS CUI [1]
- C0522055
Beschrijving
Significant ECG findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C2826293
Beschrijving
Echocardiography
Alias
- UMLS CUI-1
- C0013516
Beschrijving
Echocardiography
Datatype
integer
Alias
- UMLS CUI [1]
- C0013516
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
If LVEF < 50 % no participation in this trial possible
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0428772
Beschrijving
valvular defects
Datatype
boolean
Alias
- UMLS CUI [1]
- C2748945
Beschrijving
Tricuspid valve defect
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264882
Beschrijving
Tricuspid valve defect
Datatype
integer
Alias
- UMLS CUI [1]
- C0264882
Beschrijving
Severity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0264882
Beschrijving
Pulmonary valve defect
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034087
Beschrijving
Pulmonary valve defect
Datatype
integer
Alias
- UMLS CUI [1]
- C0034087
Beschrijving
Severity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0034087
Beschrijving
Mitral valve defect
Datatype
boolean
Alias
- UMLS CUI [1]
- C0026265
Beschrijving
Mitral valve defect
Datatype
integer
Alias
- UMLS CUI [1]
- C0026265
Beschrijving
Severity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C0026265
Beschrijving
Aortic valve defect
Datatype
boolean
Alias
- UMLS CUI [1]
- C1260873
Beschrijving
Aortic valve defect
Datatype
integer
Alias
- UMLS CUI [1]
- C1260873
Beschrijving
Severity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0457451
- UMLS CUI [1,2]
- C1260873
Beschrijving
Cardiac Enzymes
Alias
- UMLS CUI-1
- C0443763
Beschrijving
Cardiac Enzymes measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0201934
Beschrijving
Date of sampling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Beschrijving
xxx , x
Datatype
float
Alias
- UMLS CUI [1]
- C3272900
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xxx , x
Datatype
float
Alias
- UMLS CUI [1]
- C0523953
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
xxx , x
Datatype
float
Alias
- UMLS CUI [1]
- C0920210
Beschrijving
Unit used
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Significance
Datatype
integer
Alias
- UMLS CUI [1]
- C2826293
Similar models
Visit 1 Baseline
- 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
C0600091 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C2228489 (UMLS CUI [2])
C2607943 (UMLS CUI [1,2])
C2228489 (UMLS CUI [2,1])
C2607943 (UMLS CUI [2,2])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
C0443228 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C0443228 (UMLS CUI [1,2])
C0487742 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0229664 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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])