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ID
9895
Beschreibung
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)
Stichworte
Versionen (5)
- 02.03.15 02.03.15 -
- 08.03.15 08.03.15 -
- 22.04.15 22.04.15 -
- 09.12.15 09.12.15 -
- 11.02.16 11.02.16 -
Hochgeladen am
2. März 2015
DOI
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Lizenz
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
Ähnliche Modelle
Cycle AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
CL Item
Induction I (1)
CL Item
Induction II (optional) (2)
CL Item
Consolid. I (3)
CL Item
Consolid. II (4)
CL Item
Consolid. III (5)
CL Item
Consolid. IV (6)
Weight
Item
Weight [kg]
integer
C0005910 (UMLS CUI-1)
Body surface area
Item
Body surface area
integer
C0005902 (UMLS CUI-1)
Temperature
Item
Temperature
integer
C0039476 (UMLS CUI-1)
Blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI-1)
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI-1)
General Condition (WHO / ECOG)
Item
General Condition (WHO / ECOG)
integer
C1520224 (UMLS CUI-1)
Administration of Hydroxyurea
Item
Administration of Hydroxyurea before start of Induction I?
boolean
How many days
Item
If yes, how many days before start of Induction I?
integer
C1948053 (UMLS CUI-1)
Date of last administration
Item
Date of last administration
date
C0011008 (UMLS CUI-1)
Start of Cycle
Item
Start of Cycle
date
C0011008 (UMLS CUI-1)
Total Dose[mg]
Item
Total Dose[mg]
integer
C2986497 (UMLS CUI-1)
C1521826 (UMLS CUI-2)
C1521826 (UMLS CUI-2)
CL Item
complete scheduled Dose (1 )
CL Item
Withdrawal of consent (2 )
CL Item
Dose reduced >10% (3 )
CL Item
Dose reduced and delayed (4 )
CL Item
not administered (5 )
CL Item
discontinued and administered again (6 )
CL Item
completed prematurely (7 )
CL Item
Other (please specify) (8 )
CL Item
Toxicity (please specify) (1 )
CL Item
Withdrawal of consent (2 )
CL Item
Other (please specify) (3 )
Total Dose [mg]
Item
Total Dose [mg]
integer
C2986497 (UMLS CUI-1)
C1521826 (UMLS CUI-2)
C1521826 (UMLS CUI-2)
CL Item
complete scheduled Dose (1 )
CL Item
complete Dose, but delayed (2 )
CL Item
Dose reduced >10% (3 )
CL Item
Dose reduced und delayed (4 )
CL Item
not administered (5 )
CL Item
discontinued and administered again (6 )
CL Item
completed prematurely (7 )
CL Item
Other (please specify) (8 )
CL Item
Toxicity (please specify) (1 )
CL Item
Withdrawal of consent (2 )
CL Item
Other (please specify) (3 )
Total Dose [mg]
Item
Total Dose [mg]
integer
C2986497 (UMLS CUI-1)
C1521826 (UMLS CUI-2)
C1521826 (UMLS CUI-2)
CL Item
complete scheduled Dose (1 )
CL Item
complete Dose, but delayed (2 )
CL Item
Dose reduced >10% (3 )
CL Item
Dose reduced und delayed (4 )
CL Item
not administered (5 )
CL Item
discontinued and administered again (6 )
CL Item
completed prematurely (7 )
CL Item
Other (please specify) (8 )
CL Item
Toxicity (please specify) (1 )
CL Item
Withdrawal of consent (2 )
CL Item
Other (please specify) (3 )
Adverse Events
Item
Did any Adverse Events occur? If Yes, please document on CRF Adverse Event (7)
boolean
C0877248 (UMLS CUI-1)
Fever Days
Item
Number of Days with Fever higher than 38.5°C
integer
C0237753 (UMLS CUI-1)
C0015967 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
C0015967 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Hospital nights
Item
Number of Nights in Hospital (until discharge or start of next Cycle)
integer
C0439583 (UMLS CUI-1)
C0420512 (UMLS CUI-2)
C0019994 (UMLS CUI-3)
C0420512 (UMLS CUI-2)
C0019994 (UMLS CUI-3)
Item Group
Inpatient Hospitalisation during Cycle
C0420512 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C3665472 (UMLS CUI-3)
C0347984 (UMLS CUI-2)
C3665472 (UMLS CUI-3)
Hospitalisation after Discharge
Item
Was the Patient hospitalised again after discharge in this Cycle?
boolean
C0019993 (UMLS CUI-1)
C0030685 (UMLS CUI-2)
C0030685 (UMLS CUI-2)
Number of Hospitalisations
Item
Number of Hospitalisations
integer
C0237753 (UMLS CUI-1)
C0019993 (UMLS CUI-2)
C0019993 (UMLS CUI-2)
Date of first Hospitalisation
Item
Date of first Hospitalisation
date
C0011008 (UMLS CUI-1)
C0019993 (UMLS CUI-2)
C0019993 (UMLS CUI-2)
Duration of all Hospitalsations in this Cycle
Item
Duration of all Hospitalsations in this Cycle
integer
C0019993 (UMLS CUI-1)
C1515051 (UMLS CUI-2)
C1515051 (UMLS CUI-2)
Reason(s) for Hospitalisation(s)
Item
Reason(s) for Hospitalisation(s)
text
Echocardiography
Item
Echocardiography
boolean
C0013516 (UMLS CUI-1)
Echocardiography date
Item
Echocardiography date
date
C0013516 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
Ejection fraction
Item
Ejection fraction
integer
C0232174 (UMLS CUI-1)
Abnormalities
Item
Abnormalities
text
C1704258 (UMLS CUI-1)
Intake of Medication
Item
Intake of Medication? (If Yes, specify on CRF "Concomitant Medication"
boolean
C2826668 (UMLS CUI-1)
Buccal Swab
Item
Buccal Swab
boolean
C3813133 (UMLS CUI-1)
Date of Buccal Swab
Item
Date of Buccal Swab
date
C0011008 (UMLS CUI-1)
C3813133 (UMLS CUI-2)
C3813133 (UMLS CUI-2)
Item Group
Pregnancy test (female Patients of child-bearing age only)
C0032976 (UMLS CUI-1)
Pregnancy test date
Item
Pregnancy test date
date
C0032976 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
Item
Pregnancy test result
integer
C1522602 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0022885 (UMLS CUI-4)
C1274040 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0022885 (UMLS CUI-4)
CL Item
negative (0)
CL Item
positive (1 )
Item Group
Supportive Care (Period: Start Cycle – Start next Cycle / End of Study)
C0344211 (UMLS CUI-1)
Number of platelet concentrates Single Donor (HLA-ident)
Item
Number of platelet concentrates Single Donor (HLA-ident)
integer
C0237753 (UMLS CUI-1)
C2362067 (UMLS CUI-2)
C0205171 (UMLS CUI-3)
C0013018 (UMLS CUI-4)
C2362067 (UMLS CUI-2)
C0205171 (UMLS CUI-3)
C0013018 (UMLS CUI-4)
Number of platelet concentrates Random / Pool
Item
Number of platelet concentrates Random / Pool
integer
C0237753 (UMLS CUI-1)
C2362067 (UMLS CUI-2)
C0398309 (UMLS CUI-3)
C2362067 (UMLS CUI-2)
C0398309 (UMLS CUI-3)
Date of first Transfusion platelet concentrates
Item
Date of first Transfusion platelet concentrates
integer
C0011008 (UMLS CUI-1)
C0205435 (UMLS CUI-2)
C0455012 (UMLS CUI-3)
C2362067 (UMLS CUI-4)
C0205435 (UMLS CUI-2)
C0455012 (UMLS CUI-3)
C2362067 (UMLS CUI-4)
Date of last Transfusion Platelet concentrate
Item
Date of last Transfusion Platelet concentrate
date
C0011008 (UMLS CUI-1)
C1517741 (UMLS CUI-2)
C0455012 (UMLS CUI-3)
C2362067 (UMLS CUI-4)
C1517741 (UMLS CUI-2)
C0455012 (UMLS CUI-3)
C2362067 (UMLS CUI-4)
Number of Erythrocyte concentrates/Packed red blood cells
Item
Number of Erythrocyte concentrates/Packed red blood cells
integer
C0237753 (UMLS CUI-1)
C2316467 (UMLS CUI-2)
C2316467 (UMLS CUI-2)
Date of first Transfusion Erythrocyte concentrate
Item
Date of first Transfusion Erythrocyte concentrate
date
C0011008 (UMLS CUI-1)
C0205435 (UMLS CUI-2)
C0199962 (UMLS CUI-3)
C0205435 (UMLS CUI-2)
C0199962 (UMLS CUI-3)
Date of last Transfusion Erythrocyte concentrate
Item
Date of last Transfusion Erythrocyte concentrate
date
C0011008 (UMLS CUI-1)
C1517741 (UMLS CUI-2)
C0199962 (UMLS CUI-3)
C1517741 (UMLS CUI-2)
C0199962 (UMLS CUI-3)
Item
Neutrophiles > 0.5 Giga/l
integer
C0858017 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Neutrophiles > 0.5 Giga/l Date
Item
Neutrophiles > 0.5 Giga/l Date
date
C0858017 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
Item
Neutrophiles > 1.5 Giga/l
integer
C0858017 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Neutrophiles > 1.5 Giga/l Date
Item
Neutrophiles > 1.5 Giga/l Date
date
C0858017 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
Item
Leukocytes > 1.0 Giga/l
text
C0023516 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Leukocytes > 1.0 Giga/l Date
Item
Leukocytes > 1.0 Giga/l Date
date
C0023516 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
Item
Platelets > 20 Giga/l
integer
C0005821 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Platelets > 20 Giga/l Date
Item
Platelets > 20 Giga/l Date
date
C0005821 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
Item
Platelets > 50 Giga/l
integer
C0005821 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Platelets > 50 Giga/l Date
Item
Platelets > 50 Giga/l Date
date
C0005821 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
Item
Platelets > 100 Giga/l
integer
C0005821 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Platelets > 100 Giga/l Date
Item
Platelets > 100 Giga/l Date
date
C0005821 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
Further Therapy planned
Item
Further Therapy planned
boolean
C1517331 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI-1)
Name and Signature of Investigator
Item
Name and Signature of Investigator
text
C0027365 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
C0031831 (UMLS CUI-3)
C1519316 (UMLS CUI-2)
C0031831 (UMLS CUI-3)