ID

13469

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

Versions (5)
  1. 3/4/15 3/4/15 -
  2. 3/9/15 3/9/15 -
  3. 4/22/15 4/22/15 -
  4. 12/8/15 12/8/15 -
  5. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Evaluation AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML)

English

Evaluation AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

1 forms  
Evaluation
Description

Evaluation

Alias
UMLS CUI-1
C0220825
Point in time
Description

Point in time

Data type

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
If in Maintenance: Month
Description

Maintenance Month

Data type

integer

Alias
UMLS CUI [1,1]
C0481504
UMLS CUI [1,2]
C0439231
If Follow-up: consecutive Follow-up number
Description

Follow up number

Data type

integer

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0750480
Status
Description

Status

Is the patient alive?
Description

Status of patient

Data type

boolean

Alias
UMLS CUI [1]
C1148433
Date of last information/death
Description

Date of last information/death

Data type

date

Alias
UMLS CUI-1
C0805839
Cause of death
Description

Cause of death

Data type

integer

Alias
UMLS CUI-1
C0007465
Specifiy if Cause of death = 2,4,5
Description

Specifiy if Cause of death = 2,4,5

Data type

text

Alias
UMLS CUI [1]
C1521902
Response after Induction Cycles or Consolidation or Maintenance or during Follow-up
Description

Response after Induction Cycles or Consolidation or Maintenance or during Follow-up

Date of evaluation
Description

Date of evaluation

Data type

date

Alias
UMLS CUI [1]
C2985720
Response
Description

Response

Data type

integer

Alias
UMLS CUI [1]
C1704632
Extramedullary Manifestatation
Description

Extramedullary Manifestatation

Data type

boolean

Alias
UMLS CUI [1]
C1868812
Please specify Extramedullary Manifestation
Description

Extramedullary Manifestatation location

Data type

text

Alias
UMLS CUI [1]
C1521902
Evaluation based on on following examinations
Description

Evaluation based on on following examinations

Bone marrow evaluation done (If yes specify on CRF "Bone marrow Evaluation"
Description

Bone marrow evaluation done

Data type

boolean

Alias
UMLS CUI [1]
C0005953
Blood count evaluation done? (If yes specify on CRF "Blood Count Evaluation"
Description

Blood count evaluation done

Data type

boolean

Alias
UMLS CUI [1]
C0005771
Signature
Description

Signature

Date
Description

Date

Data type

date

Alias
UMLS CUI-1
C0011008
Name of Investigator
Description

Name of Investigator

Data type

text

Alias
UMLS CUI-1
C0008961
Signature of investigator
Description

Signature of investigator

Data type

text

Alias
UMLS CUI-1
C2346576
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Similar models

Evaluation AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Evaluation
C0220825 (UMLS CUI-1)
Item
Point in time
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Point in time
Code List
Point in time
CL Item
Induction I (1)
C3179010 (UMLS CUI-1)
CL Item
Induction II (optional) (2)
C3179010 (UMLS CUI-1)
CL Item
Consolidation I (3)
C3179017 (UMLS CUI-1)
CL Item
Consolidation II (4)
C3179017 (UMLS CUI-1)
CL Item
Consolidation III (5)
C3179017 (UMLS CUI-1)
CL Item
Consolidation IV (6)
C3179017 (UMLS CUI-1)
CL Item
Maintenance (7)
C0481504 (UMLS CUI-1)
CL Item
Follow-up (8)
C1522577 (UMLS CUI-1)
Item
If in Maintenance: Month
integer
C0481504 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Maintenance Month
Code List
If in Maintenance: Month
CL Item
after 3 Months (3)
C1522577 (UMLS CUI-1)
C1442461 (UMLS CUI-2)
CL Item
after 6 Months (6)
C1522577 (UMLS CUI-1)
C0589124 (UMLS CUI-2)
CL Item
after 9 Months (9)
C1522577 (UMLS CUI-1)
CL Item
after 12 Months (12)
C1522577 (UMLS CUI-1)
Follow up number
Item
If Follow-up: consecutive Follow-up number
integer
C1522577 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item Group
Status
Status of patient
Item
Is the patient alive?
boolean
C1148433 (UMLS CUI [1])
Date of last information/death
Item
Date of last information/death
date
C0805839 (UMLS CUI-1)
Item
Cause of death
integer
C0007465 (UMLS CUI-1)
Cause of death
Code List
Cause of death
CL Item
Leukemia (1)
C0023418 (UMLS CUI-1)
CL Item
Infection (2)
C0009450 (UMLS CUI-1)
CL Item
Bleeding (3)
C0019080 (UMLS CUI-1)
CL Item
Secondary illness (4)
C0277555 (UMLS CUI-1)
CL Item
Other (5)
C0205394 (UMLS CUI-1)
CL Item
Unknown (6)
C0439673 (UMLS CUI-1)
Specifiy if Cause of death = 2,4,5
Item
Specifiy if Cause of death = 2,4,5
text
C1521902 (UMLS CUI [1])
Item Group
Response after Induction Cycles or Consolidation or Maintenance or during Follow-up
Date of evaluation
Item
Date of evaluation
date
C2985720 (UMLS CUI [1])
Item
Response
integer
C1704632 (UMLS CUI [1])
Response
Code List
Response
CL Item
CR (1)
C0677874 (UMLS CUI-1)
CL Item
CRi (2)
C3538993 (UMLS CUI-1)
CL Item
PR (3)
C1521726 (UMLS CUI-1)
CL Item
RD (4)
C3844738 (UMLS CUI-1)
CL Item
PD (5)
C1335499 (UMLS CUI-1)
CL Item
ED (6)
CL Item
HD (7)
Extramedullary Manifestatation
Item
Extramedullary Manifestatation
boolean
C1868812 (UMLS CUI [1])
Extramedullary Manifestatation location
Item
Please specify Extramedullary Manifestation
text
C1521902 (UMLS CUI [1])
Item Group
Evaluation based on on following examinations
Bone marrow evaluation done
Item
Bone marrow evaluation done (If yes specify on CRF "Bone marrow Evaluation"
boolean
C0005953 (UMLS CUI [1])
Blood count evaluation done
Item
Blood count evaluation done? (If yes specify on CRF "Blood Count Evaluation"
boolean
C0005771 (UMLS CUI [1])
Item Group
Signature
Date
Item
Date
date
C0011008 (UMLS CUI-1)
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI-1)
Signature of investigator
Item
Signature of investigator
text
C2346576 (UMLS CUI-1)
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