ID
9945
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
March 8, 2015
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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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
- 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
- C0011008
Description
Cycle
Description
Cytarabine
Alias
- UMLS CUI-1
- C0010711
Description
Total Dose[mg]
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI-1
- C0010711
- UMLS CUI-2
- C2986497
Description
Dose
Data type
integer
Alias
- UMLS CUI-1
- C3174092
- UMLS CUI-2
- C1521801
Description
Reason
Data type
text
Alias
- UMLS CUI-1
- C0392360
Description
Daunorubicin
Alias
- UMLS CUI-1
- C0011015
Description
Total Dose [mg]
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI-1
- C2986497
- UMLS CUI-2
- C1521826
Description
Dose
Data type
integer
Alias
- UMLS CUI-1
- C3174092
- UMLS CUI-2
- C1521801
Description
Reason
Data type
integer
Alias
- UMLS CUI-1
- C0392360
Description
Dasatinib
Alias
- UMLS CUI-1
- C1455147
Description
Total Dose [mg]
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI-1
- C2986497
- UMLS CUI-2
- C1521826
Description
Dose
Data type
integer
Alias
- UMLS CUI-1
- C3174092
- UMLS CUI-2
- C1521801
Description
Reason
Data type
integer
Alias
- UMLS CUI-1
- C0392360
Description
Events
Alias
- UMLS CUI-1
- C0441471
Description
Adverse Events
Data type
boolean
Alias
- UMLS CUI-1
- C0877248
Description
Fever Days
Data type
integer
Alias
- UMLS CUI-1
- C0237753
- UMLS CUI-2
- C0015967
- UMLS CUI-3
- C0439228
Description
Hospital nights
Data type
integer
Measurement units
- nights
Alias
- UMLS CUI-1
- C0439583
- UMLS CUI-2
- C0420512
- UMLS CUI-3
- C0019994
Description
Inpatient Hospitalisation during Cycle
Alias
- UMLS CUI-1
- C0420512
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C3665472
Description
Hospitalisation after Discharge
Data type
boolean
Alias
- UMLS CUI-1
- C0019993
- UMLS CUI-2
- C0030685
Description
Number of Hospitalisations
Data type
integer
Alias
- UMLS CUI-1
- C0237753
- UMLS CUI-2
- C0019993
Description
Date of first Hospitalisation
Data type
date
Alias
- UMLS CUI-1
- C0011008
- UMLS CUI-2
- C0019993
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
Description
MUGA/Echo Scan
Description
Echocardiography
Data type
boolean
Alias
- UMLS CUI-1
- C0013516
Description
Echocardiography date
Data type
date
Alias
- UMLS CUI-1
- C0013516
- UMLS CUI-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
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
- C0237753
- UMLS CUI-2
- C2362067
- UMLS CUI-3
- C0205171
- UMLS CUI-4
- C0013018
Description
Number of platelet concentrates Random / Pool
Data type
integer
Alias
- UMLS CUI-1
- C0237753
- UMLS CUI-2
- C2362067
- UMLS CUI-3
- C0398309
Description
Date of first Transfusion platelet concentrates
Data type
integer
Alias
- UMLS CUI-1
- C0011008
- UMLS CUI-2
- C0205435
- UMLS CUI-3
- C0455012
- UMLS CUI-4
- C2362067
Description
Date of last Transfusion Platelet concentrate
Data type
date
Alias
- UMLS CUI-1
- C0011008
- UMLS CUI-2
- C1517741
- UMLS CUI-3
- C0455012
- UMLS CUI-4
- C2362067
Description
Number of Erythrocyte concentrates/Packed red blood cells
Data type
integer
Alias
- UMLS CUI-1
- C0237753
- UMLS CUI-2
- C2316467
Description
Date of first Transfusion Erythrocyte concentrate
Data type
date
Alias
- UMLS CUI-1
- C0011008
- UMLS CUI-2
- C0205435
- UMLS CUI-3
- C0199962
Description
Date of last Transfusion Erythrocyte concentrate
Data type
date
Alias
- UMLS CUI-1
- C0011008
- UMLS CUI-2
- C1517741
- UMLS CUI-3
- C0199962
Description
Hematological Regeneration
Description
Neutrophiles > 0.5 Giga/l
Data type
integer
Alias
- UMLS CUI-1
- C0858017
- UMLS CUI-2
- C0449438
Description
Neutrophiles > 0.5 Giga/l Date
Data type
date
Alias
- UMLS CUI-1
- C0858017
- UMLS CUI-2
- C0449438
- UMLS CUI-3
- C0011008
Description
Neutrophiles > 1.5 Giga/l
Data type
integer
Alias
- UMLS CUI-1
- C0858017
- UMLS CUI-2
- C0449438
Description
Neutrophiles > 1.5 Giga/l Date
Data type
date
Alias
- UMLS CUI-1
- C0858017
- UMLS CUI-2
- C0449438
- UMLS CUI-3
- C0011008
Description
Leukocytes > 1.0 Giga/l
Data type
text
Alias
- UMLS CUI-1
- C0023516
- UMLS CUI-2
- C0449438
Description
Leukocytes > 1.0 Giga/l Date
Data type
date
Alias
- UMLS CUI-1
- C0023516
- UMLS CUI-2
- C0449438
- UMLS CUI-3
- C0011008
Description
Platelets > 20 Giga/l
Data type
integer
Alias
- UMLS CUI-1
- C0005821
- UMLS CUI-2
- C0449438
Description
Platelets > 20 Giga/l Date
Data type
date
Alias
- UMLS CUI-1
- C0005821
- UMLS CUI-2
- C0449438
- UMLS CUI-3
- C0011008
Description
Platelets > 50 Giga/l
Data type
integer
Alias
- UMLS CUI-1
- C0005821
- UMLS CUI-2
- C0449438
Description
Platelets > 50 Giga/l Date
Data type
date
Alias
- UMLS CUI-1
- C0005821
- UMLS CUI-2
- C0449438
- UMLS CUI-3
- C0011008
Description
Platelets > 100 Giga/l
Data type
integer
Alias
- UMLS CUI-1
- C0005821
- UMLS CUI-2
- C0449438
Description
Platelets > 100 Giga/l Date
Data type
date
Alias
- UMLS CUI-1
- C0005821
- UMLS CUI-2
- C0449438
- UMLS CUI-3
- C0011008
Description
Further Therapy planned
Data type
boolean
Alias
- UMLS CUI-1
- C1517331
- UMLS CUI-2
- C0087111
Description
Signature
Similar models
Cycle AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)
- StudyEvent: ODM
C2986497 (UMLS CUI-2)
C1521826 (UMLS CUI-2)
C1521826 (UMLS CUI-2)
C0015967 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
C0420512 (UMLS CUI-2)
C0019994 (UMLS CUI-3)
C0347984 (UMLS CUI-2)
C3665472 (UMLS CUI-3)
C0030685 (UMLS CUI-2)
C0019993 (UMLS CUI-2)
C0019993 (UMLS CUI-2)
C1515051 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
C3813133 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
C1274040 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0022885 (UMLS CUI-4)
C2362067 (UMLS CUI-2)
C0205171 (UMLS CUI-3)
C0013018 (UMLS CUI-4)
C2362067 (UMLS CUI-2)
C0398309 (UMLS CUI-3)
C0205435 (UMLS CUI-2)
C0455012 (UMLS CUI-3)
C2362067 (UMLS CUI-4)
C1517741 (UMLS CUI-2)
C0455012 (UMLS CUI-3)
C2362067 (UMLS CUI-4)
C2316467 (UMLS CUI-2)
C0205435 (UMLS CUI-2)
C0199962 (UMLS CUI-3)
C1517741 (UMLS CUI-2)
C0199962 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0087111 (UMLS CUI-2)