ID
12687
Description
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)
Keywords
Versions (5)
- 3/2/15 3/2/15 -
- 3/8/15 3/8/15 -
- 4/22/15 4/22/15 -
- 12/9/15 12/9/15 -
- 2/11/16 2/11/16 -
Uploaded on
December 9, 2015
DOI
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License
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
Description
For Induction I only
Description
Administration of Hydroxyurea
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0806914
- UMLS CUI [1,2]
- C0020402
Description
How many days
Data type
integer
Alias
- UMLS CUI [1]
- C1948053
Description
Date of last administration
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Cycle
Alias
- UMLS CUI-1
- C0949634
Description
Cytarabine
Alias
- UMLS CUI-1
- C0010711
Description
Total Dose[mg]
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C2986497
- UMLS CUI [1,2]
- C0010711
Description
Dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0178602
Description
Reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0392360
Description
Daunorubicin
Alias
- UMLS CUI-1
- C0011015
Description
Total Dose [mg]
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI-1
- C2986497
Description
Dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0178602
Description
Reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0392360
Description
Dasatinib
Alias
- UMLS CUI-1
- C1455147
Description
Total Dose [mg]
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI-1
- C2986497
Description
Dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C3174092
Description
Reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299575
- UMLS CUI [1,2]
- C0392360
Description
Events
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Events
Data type
boolean
Alias
- UMLS CUI-1
- C0877248
Description
Fever Days
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Hospital nights
Data type
integer
Measurement units
- nights
Alias
- UMLS CUI [1]
- C0420512
Description
Inpatient Hospitalisation during Cycle
Alias
- UMLS CUI-1
- C0420512
- UMLS CUI-2
- C1276413
Description
Hospitalisation after Discharge
Data type
boolean
Alias
- UMLS CUI-1
- C0019993
Description
Number of Hospitalisations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0750480
Description
Date of first Hospitalisation
Data type
date
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0011008
Description
Duration of all Hospitalsations in this Cycle
Data type
integer
Measurement units
- Nights
Alias
- UMLS CUI-1
- C0019993
- UMLS CUI-2
- C1515051
Description
Reason(s) for Hospitalisation(s)
Data type
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Description
MUGA/Echo Scan
Description
Echocardiography
Data type
boolean
Alias
- UMLS CUI [1]
- C0013516
Description
Echocardiography date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0011008
Description
Ejection fraction
Data type
integer
Measurement units
- %
Alias
- UMLS CUI-1
- C0232174
Description
Abnormalities
Data type
text
Alias
- UMLS CUI-1
- C1704258
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Buccal Swab (For Induction I only)
Description
Pregnancy test (female Patients of child-bearing age only)
Alias
- UMLS CUI-1
- C0032976
Description
Supportive Care (Period: Start Cycle – Start next Cycle / End of Study)
Alias
- UMLS CUI-1
- C0344211
Description
Number of platelet concentrates Single Donor (HLA-ident)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005821
- UMLS CUI [1,2]
- C2362067
Description
Number of platelet concentrates Random / Pool
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005821
- UMLS CUI [1,2]
- C2713244
Description
Date of first Transfusion platelet concentrates
Data type
date
Alias
- UMLS CUI [1,1]
- C2362067
- UMLS CUI [1,2]
- C0808070
Description
Date of last Transfusion Platelet concentrate
Data type
date
Alias
- UMLS CUI [1,1]
- C2362067
- UMLS CUI [1,2]
- C0806020
Description
Number of Erythrocyte concentrates/Packed red blood cells
Data type
integer
Alias
- UMLS CUI [1,1]
- C2316467
- UMLS CUI [1,2]
- C0014792
- UMLS CUI [1,3]
- C0750480
Description
Date of first Transfusion Erythrocyte concentrate
Data type
date
Alias
- UMLS CUI [1,1]
- C2316467
- UMLS CUI [1,2]
- C0808070
Description
Date of last Transfusion Erythrocyte concentrate
Data type
date
Alias
- UMLS CUI [1,1]
- C2316467
- UMLS CUI [1,2]
- C0806020
Description
Hematological Regeneration
Description
Neutrophiles > 0.5 Giga/l
Data type
integer
Alias
- UMLS CUI [1,1]
- C1882078
- UMLS CUI [1,2]
- C0027950
Description
Neutrophiles > 0.5 Giga/l Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1882078
- UMLS CUI [1,2]
- C0027950
- UMLS CUI [1,3]
- C0011008
Description
Neutrophiles > 1.5 Giga/l
Data type
integer
Alias
- UMLS CUI [1,1]
- C1882078
- UMLS CUI [1,2]
- C0027950
Description
Neutrophiles > 1.5 Giga/l Date
Data type
date
Alias
- UMLS CUI-1
- C0027950
Description
Leukocytes > 1.0 Giga/l
Data type
text
Alias
- UMLS CUI [1,1]
- C0301944
- UMLS CUI [1,2]
- C0023516
Description
Leukocytes > 1.0 Giga/l Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0301944
- UMLS CUI [1,2]
- C0023516
- UMLS CUI [1,3]
- C0011008
Description
Platelets > 20 Giga/l
Data type
integer
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
Description
Platelets > 20 Giga/l Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
- UMLS CUI [1,3]
- C0011008
Description
Platelets > 50 Giga/l
Data type
integer
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
Description
Platelets > 50 Giga/l Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
- UMLS CUI [1,3]
- C0011008
Description
Platelets > 100 Giga/l
Data type
integer
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
Description
Platelets > 100 Giga/l Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0005821
- UMLS CUI [1,3]
- C0011008
Description
Further Therapy planned
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C1553904
Description
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])