ID
12687
Beskrivning
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel™) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)
Nyckelord
Versioner (5)
- 2015-03-02 2015-03-02 -
- 2015-03-08 2015-03-08 -
- 2015-04-22 2015-04-22 -
- 2015-12-09 2015-12-09 -
- 2016-02-11 2016-02-11 -
Uppladdad den
9 december 2015
DOI
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Licens
Creative Commons BY-NC 3.0
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Cycle AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)
Cycle AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)
- StudyEvent: ODM
Beskrivning
For Induction I only
Beskrivning
Administration of Hydroxyurea
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0806914
- UMLS CUI [1,2]
- C0020402
Beskrivning
How many days
Datatyp
integer
Alias
- UMLS CUI [1]
- C1948053
Beskrivning
Date of last administration
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Cycle
Alias
- UMLS CUI-1
- C0949634
Beskrivning
Cytarabine
Alias
- UMLS CUI-1
- C0010711
Beskrivning
Total Dose[mg]
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C2986497
- UMLS CUI [1,2]
- C0010711
Beskrivning
Dose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0178602
Beskrivning
Reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0392360
Beskrivning
Daunorubicin
Alias
- UMLS CUI-1
- C0011015
Beskrivning
Total Dose [mg]
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI-1
- C2986497
Beskrivning
Dose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0178602
Beskrivning
Reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0392360
Beskrivning
Dasatinib
Alias
- UMLS CUI-1
- C1455147
Beskrivning
Total Dose [mg]
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI-1
- C2986497
Beskrivning
Dose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C3174092
Beskrivning
Reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0392360
Beskrivning
Events
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Adverse Events
Datatyp
boolean
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Fever Days
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Hospital nights
Datatyp
integer
Måttenheter
- nights
Alias
- UMLS CUI [1]
- C0420512
Beskrivning
Inpatient Hospitalisation during Cycle
Alias
- UMLS CUI-1
- C0420512
- UMLS CUI-2
- C1276413
Beskrivning
Hospitalisation after Discharge
Datatyp
boolean
Alias
- UMLS CUI-1
- C0019993
Beskrivning
Number of Hospitalisations
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0750480
Beskrivning
Date of first Hospitalisation
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0011008
Beskrivning
Duration of all Hospitalsations in this Cycle
Datatyp
integer
Måttenheter
- Nights
Alias
- UMLS CUI-1
- C0019993
- UMLS CUI-2
- C1515051
Beskrivning
Reason(s) for Hospitalisation(s)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Beskrivning
MUGA/Echo Scan
Beskrivning
Echocardiography
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013516
Beskrivning
Echocardiography date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0011008
Beskrivning
Ejection fraction
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI-1
- C0232174
Beskrivning
Abnormalities
Datatyp
text
Alias
- UMLS CUI-1
- C1704258
Beskrivning
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Buccal Swab (For Induction I only)
Beskrivning
Pregnancy test (female Patients of child-bearing age only)
Alias
- UMLS CUI-1
- C0032976
Beskrivning
Supportive Care (Period: Start Cycle – Start next Cycle / End of Study)
Alias
- UMLS CUI-1
- C0344211
Beskrivning
Number of platelet concentrates Single Donor (HLA-ident)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005821
- UMLS CUI [1,2]
- C2362067
Beskrivning
Number of platelet concentrates Random / Pool
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005821
- UMLS CUI [1,2]
- C2713244
Beskrivning
Date of first Transfusion platelet concentrates
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2362067
- UMLS CUI [1,2]
- C0808070
Beskrivning
Date of last Transfusion Platelet concentrate
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2362067
- UMLS CUI [1,2]
- C0806020
Beskrivning
Number of Erythrocyte concentrates/Packed red blood cells
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2316467
- UMLS CUI [1,2]
- C0014792
- UMLS CUI [1,3]
- C0750480
Beskrivning
Date of first Transfusion Erythrocyte concentrate
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2316467
- UMLS CUI [1,2]
- C0808070
Beskrivning
Date of last Transfusion Erythrocyte concentrate
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2316467
- UMLS CUI [1,2]
- C0806020
Beskrivning
Hematological Regeneration
Beskrivning
Neutrophiles > 0.5 Giga/l
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1882078
- UMLS CUI [1,2]
- C0027950
Beskrivning
Neutrophiles > 0.5 Giga/l Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1882078
- UMLS CUI [1,2]
- C0027950
- UMLS CUI [1,3]
- C0011008
Beskrivning
Neutrophiles > 1.5 Giga/l
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1882078
- UMLS CUI [1,2]
- C0027950
Beskrivning
Neutrophiles > 1.5 Giga/l Date
Datatyp
date
Alias
- UMLS CUI-1
- C0027950
Beskrivning
Leukocytes > 1.0 Giga/l
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0301944
- UMLS CUI [1,2]
- C0023516
Beskrivning
Leukocytes > 1.0 Giga/l Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0301944
- UMLS CUI [1,2]
- C0023516
- UMLS CUI [1,3]
- C0011008
Beskrivning
Platelets > 20 Giga/l
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
Beskrivning
Platelets > 20 Giga/l Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
- UMLS CUI [1,3]
- C0011008
Beskrivning
Platelets > 50 Giga/l
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
Beskrivning
Platelets > 50 Giga/l Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
- UMLS CUI [1,3]
- C0011008
Beskrivning
Platelets > 100 Giga/l
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
Beskrivning
Platelets > 100 Giga/l Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
- UMLS CUI [1,3]
- C0011008
Beskrivning
Further Therapy planned
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C1553904
Beskrivning
Signature
Similar models
Cycle AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)
- StudyEvent: ODM
C0020402 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0949634 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
C0205307 (UMLS CUI-2)
C1707492 (UMLS CUI-2)
C0392756 (UMLS CUI-2)
C0392756 (UMLS CUI-2)
C0205421 (UMLS CUI-3)
C1548562 (UMLS CUI-2)
C0443239 (UMLS CUI-2)
C0205197 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
C1707492 (UMLS CUI-2)
C0205307 (UMLS CUI-2)
C1707492 (UMLS CUI-2)
C0392756 (UMLS CUI-2)
C0392756 (UMLS CUI-2)
C0205421 (UMLS CUI-3)
C1548562 (UMLS CUI-2)
C0443239 (UMLS CUI-2)
C0205197 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
C1707492 (UMLS CUI-2)
C0205307 (UMLS CUI-2)
C1707492 (UMLS CUI-2)
C0392756 (UMLS CUI-2)
C0392756 (UMLS CUI-2)
C0205421 (UMLS CUI-3)
C1548562 (UMLS CUI-2)
C0443239 (UMLS CUI-2)
C0205197 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
C1707492 (UMLS CUI-2)
C1276413 (UMLS CUI-2)
C0750480 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1515051 (UMLS CUI-2)
C0392360 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2362067 (UMLS CUI [1,2])
C2713244 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0014792 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0027950 (UMLS CUI [1,2])
C0027950 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0027950 (UMLS CUI [1,2])
C0023516 (UMLS CUI [1,2])
C0023516 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005821 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005821 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005821 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1553904 (UMLS CUI [1,2])