Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Adverse event
Item
Adverse event
boolean
C0877248 (UMLS CUI [1])
AE line number
Item
Consecutively numbered AEs
integer
C2826275 (UMLS CUI [1])
Item
Adverse event
integer
C0877248 (UMLS CUI [1])
CL Item
Hematoma (specify Localization) (6)
CL Item
Hemorrhage (specify Organ) (8)
CL Item
Infection (specify Organ) (9)
CL Item
Mucositis (specify Organ) (10)
CL Item
Pain (specify Organ) (12)
CL Item
other (specify) (16)
Adverse Event
Item
Specify localization of hematoma
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify hemorrhaging organ
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify infected organ
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify organ with mucositis
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify site of pain
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify other adverse event
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse event Start date
Item
Date START
date
C2697888 (UMLS CUI [1])
Adverse event End Date
Item
Date END or Date of final Assessment AE
date
C2697886 (UMLS CUI [1])
Adverse event seriousness
Item
Serious?
boolean
C1710056 (UMLS CUI [1])
Item
SAE reported?
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
CL Item
not necassary according to protocoll (3)
Item
Actions taken regarding study medication?
integer
C2826626 (UMLS CUI [1])
Code List
Actions taken regarding study medication?
CL Item
Study drug interrupted (1)
CL Item
Study drug reduced (2)
CL Item
Study drug withdrawn (3)
CL Item
Unknown/ not applicable (4)
Item
Relatedness to study medication?
integer
C0015127 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Relatedness to study medication?
Item
max. CTCAE-Grade
integer
C3888020 (UMLS CUI [1])
Code List
max. CTCAE-Grade
CL Item
Life threatening (4)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Completely recovered (0)
CL Item
Recovered with sequelae (1)
CL Item
Not Recovered (3)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Death
Item
Death
boolean
C0011065 (UMLS CUI [1])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Reasons
integer
C0007465 (UMLS CUI [1])
CL Item
Adverse event (1)
CL Item
Death did NOT occur as a result of an AE (2)
Adverse event number
Item
Number of AE in database documentation
integer
C2826275 (UMLS CUI [1])
Cause of death description
Item
If death did NOT occur as a result of an AE Description
text
C0007465 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Death in aplasia
Item
Death in aplasia
boolean
C0243065 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Item
Last available bone marrow assessment before death
integer
C0005957 (UMLS CUI [1])
Code List
Last available bone marrow assessment before death
CL Item
another date (please fill in the next two entry masks) (3)
Date of aspiration or biopsy
Item
Date of aspiration or biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0349707 (UMLS CUI [2,2])
Item
Examination of Bone Marrow
integer
C0005957 (UMLS CUI [1])
Code List
Examination of Bone Marrow
CL Item
for early response assessment (1)
CL Item
for remission assessment (after completion Induction II) (2)
Item
Response
text
C1704632 (UMLS CUI [1])
CL Item
Good Response (early assessment, no peripheral blood count regeneration,blast count < 5%, aspirate with marrow spicules) (1)
CL Item
Refractory Disease (early assessment, no peripheral blood count regeneration,increase in bone marrow blast count compared to baseline or no change in bone marrow cellularity with unchanged blast count.) (3)
CL Item
Moderate Response (early assessment, no peripheral blood count regeneration, (2)
CL Item
5%, reduction in blast count and/or bone marrow cellularity) (blast count >)
Item
Remission
text
C0544452 (UMLS CUI [1])
CL Item
Morphological complete remission (CR) (1)
CL Item
Complete remission with incomplete recovery (CRi) (2)
CL Item
Cytogenetic complete remission (CRc) (3)
CL Item
Molecular complete remission (CRm) (4)
CL Item
Treatment failure (No CR)
CL Item
Morphologic relapse (6)
Investigators signature
Item
With my signature I hereby confirm, that all data are correct and complete.
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])