ID
44274
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
Lien
https://www.clinicaltrials.gov/ct2/show/NCT02140242
Mots-clés
Versions (3)
- 24/10/2017 24/10/2017 - Julian Varghese
- 23/04/2019 23/04/2019 - Sarah Riepenhausen
- 20/09/2021 20/09/2021 -
Détendeur de droits
PD Dr. med. Christoph Röllig, MSc
Téléchargé le
20 septembre 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242
Visit 7 (Day 15 Induction I)
- 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
Full Blood Count
Alias
- UMLS CUI-1
- C0005771
Description
Full blood count
Type de données
integer
Alias
- UMLS CUI [1]
- C0005771
Description
Date of sampling
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Leukocytes
Type de données
integer
Alias
- UMLS CUI [1]
- C0023508
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Hemoglobin
Type de données
integer
Alias
- UMLS CUI [1]
- C0518015
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Platelets
Type de données
integer
Alias
- UMLS CUI [1]
- C0032181
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Neutrophiles
Type de données
integer
Alias
- UMLS CUI [1]
- C0200633
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Lymphocytes
Type de données
integer
Alias
- UMLS CUI [1]
- C0200635
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Monocytes
Type de données
integer
Alias
- UMLS CUI [1]
- C0200637
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Basophiles
Type de données
integer
Alias
- UMLS CUI [1]
- C0200641
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Eosinophiles
Type de données
integer
Alias
- UMLS CUI [1]
- C0750879
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Blast percentage
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1,1]
- C0587348
- UMLS CUI [1,2]
- C0229664
Description
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0022885
Description
Clinical Chemistry
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0022885
Description
Date of sampling
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
xx . xxxx
Type de données
float
Alias
- UMLS CUI [1]
- C0201899
Description
Units used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xx . xxxx
Type de données
float
Alias
- UMLS CUI [1]
- C0201836
Description
Units used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xx . xxxx
Type de données
float
Alias
- UMLS CUI [1]
- C1278039
Description
Units used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xx . xxxx
Type de données
float
Alias
- UMLS CUI [1]
- C0201976
Description
Units used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xx . xxxx
Type de données
float
Alias
- UMLS CUI [1]
- C0337443
Description
Units used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xx . xxxx
Type de données
float
Alias
- UMLS CUI [1]
- C0202194
Description
Units used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Coagulation
Alias
- UMLS CUI-1
- C0005790
Description
Coagulation
Type de données
integer
Alias
- UMLS CUI [1]
- C0005790
Description
Date of sampling
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
PTT
Type de données
integer
Unités de mesure
- sec
Alias
- UMLS CUI [1]
- C0030605
Description
If value is „of clinical significance“: "Please check, whether an AE has occured“
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
x . xx
Type de données
float
Alias
- UMLS CUI [1]
- C0525032
Description
If value is „of clinical significance“: "Please check, whether an AE has occured“
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xxx . xx
Type de données
float
Alias
- UMLS CUI [1]
- C0337428
Description
Units used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
If value is „of clinical significance“: "Please check, whether an AE has occured“
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Cardiac Enzymes
Alias
- UMLS CUI-1
- C0443763
Description
Cardiac Enzymes measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C0201934
Description
Date of sampling
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
xxx , x
Type de données
float
Alias
- UMLS CUI [1]
- C3272900
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xxx , x
Type de données
float
Alias
- UMLS CUI [1]
- C0523953
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
xxx , x
Type de données
float
Alias
- UMLS CUI [1]
- C0920210
Description
Unit used
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Significance
Type de données
integer
Alias
- UMLS CUI [1]
- C2826293
Description
Response Assessment
Alias
- UMLS CUI-1
- C1704632
Description
Examination of Bone Marrow
Alias
- UMLS CUI-1
- C0005957
Description
Bone Marrow biopsy date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Description
If blasts (local assessment) < 5 % patient proceeds to Randomization/ Induction II, otherwise complete documentation Visit 7 and fill in Drop-Out Sheet
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0587348
Description
Bone Marrow assessment
Type de données
integer
Alias
- UMLS CUI [1]
- C0005957
Description
In case the percentage of blasts was assessed by both - cytology and histology,please document only cytology result.
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1,1]
- C0587348
- UMLS CUI [1,2]
- C1305671
Description
Disease Response
Alias
- UMLS CUI-1
- C1704632
Description
Molecular Genetics
Alias
- UMLS CUI-1
- C0086345
Description
Molecular genetics
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0086345
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [2,1]
- C0086345
- UMLS CUI [2,2]
- C0231175
Description
RUNX1-RUNX1 T1
Type de données
integer
Alias
- UMLS CUI [1]
- C1851466
Description
CBF/MYH11
Type de données
integer
Alias
- UMLS CUI [1]
- C3276534
Description
Bcr-Abl 1
Type de données
integer
Alias
- UMLS CUI [1]
- C1835417
Description
NPM1-Mut
Type de données
integer
Alias
- UMLS CUI [1]
- C2826175
Description
CEBPA-Mut
Type de données
integer
Alias
- UMLS CUI [1]
- C1511473
Description
FLT3-ITD-Mut
Type de données
integer
Alias
- UMLS CUI [1]
- C2348499
Description
FLT3-ITD/wt ratio
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348499
- UMLS CUI [1,2]
- C0216388
- UMLS CUI [1,3]
- C0456603
Description
Other
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0026882
- UMLS CUI [1,2]
- C0205394
Description
Other
Type de données
text
Alias
- UMLS CUI [1,1]
- C0026882
- UMLS CUI [1,2]
- C0205394
Description
Success assessment
Alias
- UMLS CUI-1
- C1516048
- UMLS CUI-2
- C0679864
Similar models
Visit 7 (Day 15 Induction I)
- 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])
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])
C0011008 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
C1305671 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0086345 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0216388 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0679864 (UMLS CUI [1,2])