ID

9922

Description

Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Keywords

  1. 3/5/15 3/5/15 -
  2. 3/9/15 3/9/15 -
  3. 4/23/15 4/23/15 -
  4. 12/15/15 12/15/15 -
  5. 9/17/21 9/17/21 -
Uploaded on

March 5, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Adverse Event AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

Adverse Event AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

Adverse Event
Description

Adverse Event

Point in time
Description

Point in time

Data type

integer

Alias
UMLS CUI-1
C1442880
UMLS CUI-2
C1302181
If Maintenance: Month
Description

Maintenance Month

Data type

integer

Alias
UMLS CUI-1
C0481504
UMLS CUI-2
C0439231
Desciption of Adverse Event
Description

Desciption of Adverse Event

Data type

text

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0678257
Adverse Event Term
Description

Adverse Event Term

Data type

text

Alias
UMLS CUI-1
C2826934
Serious Adverse Event
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI-1
C1519255
Grade of Adverse Event
Description

Grade of Adverse Event

Data type

integer

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0441800
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI-1
C1705586
Treatment/Action taken
Description

Treatment/Action taken

Data type

text

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0877248
Adverse Event Start Date
Description

Adverse Event Start Date

Data type

date

Alias
UMLS CUI-1
C2697888
Adverse Event End Date
Description

Adverse Event End Date

Data type

date

Alias
UMLS CUI-1
C2697886
Adverse Event related to
Description

Adverse Event related to

Cytarabine
Description

Cytarabine

Data type

integer

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0010711
Daunorubicin
Description

Daunorubicin

Data type

integer

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0011015
Dasatinib
Description

Dasatinib

Data type

integer

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1455147
Underlying Disease
Description

Underlying Disease

Data type

text

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0277554
Concomitant medication
Description

Concomitant medication

Data type

text

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
Other
Description

Other

Data type

integer

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
UMLS CUI-3
C0205394
Signature
Description

Signature

Date
Description

Date

Data type

date

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0011008
Name and Signature of Investigator
Description

Name and Signature of Investigator

Data type

text

Alias
UMLS CUI-1
C0027365
UMLS CUI-2
C1519316
UMLS CUI-3
C0031831

Similar models

Adverse Event AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event
Item
Point in time
integer
C1442880 (UMLS CUI-1)
C1302181 (UMLS CUI-2)
Code List
Point in time
CL Item
Diagnostic (0)
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)
CL Item
Maintenance (7)
Item
If Maintenance: Month
integer
C0481504 (UMLS CUI-1)
C0439231 (UMLS CUI-2)
Code List
If Maintenance: Month
CL Item
after 1 Month (1)
CL Item
after 2 Months (2)
CL Item
after 3 Months (3)
CL Item
after 4 Months (4)
CL Item
after 5 Months (5)
CL Item
after 6 Months (6)
CL Item
after 7 Months (7)
CL Item
after 8 Months (8)
CL Item
after 9Months (9)
CL Item
after 10 Months (10)
CL Item
after 11 Months (11)
CL Item
after 12 Months (12)
Desciption of Adverse Event
Item
Desciption of Adverse Event
text
C0877248 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
Adverse Event Term
Item
Adverse Event Term
text
C2826934 (UMLS CUI-1)
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI-1)
Item
Grade of Adverse Event
integer
C0877248 (UMLS CUI-1)
C0441800 (UMLS CUI-2)
Code List
Grade of Adverse Event
CL Item
Mild  (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life-Threatening (4)
CL Item
Death related to AE (5)
Item
Outcome
integer
C1705586 (UMLS CUI-1)
Code List
Outcome
CL Item
recovered (1)
CL Item
not yet recovered (2)
CL Item
recovered with sequelae (3)
CL Item
Death (4)
CL Item
unknown (5)
Treatment/Action taken
Item
Treatment/Action taken
text
C0087111 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI-1)
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI-1)
Item Group
Adverse Event related to
Item
Cytarabine
integer
C0877248 (UMLS CUI-1)
C0010711 (UMLS CUI-2)
Code List
Cytarabine
CL Item
definitely (1)
CL Item
probably (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not related (5)
CL Item
Medication not administered (6)
Item
Daunorubicin
integer
C0877248 (UMLS CUI-1)
C0011015 (UMLS CUI-2)
Code List
Daunorubicin
CL Item
definitely (1)
CL Item
probably (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not related (5)
CL Item
Medication not administered (6)
Item
Dasatinib
integer
C0877248 (UMLS CUI-1)
C1455147 (UMLS CUI-2)
Code List
Dasatinib
CL Item
definitely (1)
CL Item
probably (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not related (5)
CL Item
Medication not administered (6)
Item
Underlying Disease
text
C0877248 (UMLS CUI-1)
C0277554 (UMLS CUI-2)
Code List
Underlying Disease
CL Item
definitely (1)
CL Item
probably (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not related (5)
CL Item
Medication not administered (6)
Item
Concomitant medication
text
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Code List
Concomitant medication
CL Item
definitely (1)
CL Item
probably (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not related (5)
CL Item
Medication not administered (6)
Item
Other
integer
C0877248 (UMLS CUI-1)
(UMLS CUI-2)
C0205394 (UMLS CUI-3)
Code List
Other
CL Item
definitely (1)
CL Item
probably (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not related (5)
CL Item
Medication not administered (6)
Item Group
Signature
Date
Item
Date
date
C2346576 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Name and Signature of Investigator
Item
Name and Signature of Investigator
text
C0027365 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
C0031831 (UMLS CUI-3)

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