ID

9920

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. 3/4/15 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

March 4, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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

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

Evaluation
Description

Evaluation

Point in time
Description

Point in time

Data type

integer

Alias
UMLS CUI-1
C1442880
If in Maintenance: Month
Description

Maintenance Month

Data type

integer

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

Follow up number

Data type

integer

Alias
UMLS CUI-1
C1704685
UMLS CUI-2
C0237753
Status
Description

Status

Is the patient alive?
Description

Status of patient

Data type

boolean

Alias
UMLS CUI-1
C3844896
Date of last information/death
Description

Date of last information/death

Data type

date

Alias
UMLS CUI-1
C1148348
UMLS CUI-2
C0011008
UMLS CUI-3
C1533716
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

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
C0220825
UMLS CUI-2
C0011008
Response
Description

Response

Data type

integer

Alias
UMLS CUI-1
C0023418
UMLS CUI-2
C0005955
Extramedullary Manifestatation
Description

Extramedullary Manifestatation

Data type

boolean

Alias
UMLS CUI-1
C1517060
UMLS CUI-2
C1280464
Please specify Extramedullary Manifestation
Description

Extramedullary Manifestatation location

Data type

text

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
C2238269
UMLS CUI-2
C1272695
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
UMLS CUI-2
C0022885
UMLS CUI-3
C0220825
UMLS CUI-4
C1272695
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

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Evaluation
Item
Point in time
integer
C1442880 (UMLS CUI-1)
Code List
Point in time
CL Item
Induction I (1)
CL Item
Induction II (optional) (2)
CL Item
Consolidation I (3)
CL Item
Consolidation II (4)
CL Item
Consolidation III (5)
CL Item
Consolidation IV (6)
CL Item
Maintenance (7)
CL Item
Follow-up (8)
Item
If in Maintenance: Month
integer
C0481504 (UMLS CUI-1)
C0439231 (UMLS CUI-2)
Code List
If in Maintenance: Month
CL Item
after 3 Months (3)
CL Item
after 6 Months (6)
CL Item
after 9 Months (9)
CL Item
after 12 Months (12)
Follow up number
Item
If Follow-up: consecutive Follow-up number
integer
C1704685 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item Group
Status
Status of patient
Item
Is the patient alive?
boolean
C3844896 (UMLS CUI-1)
Date of last information/death
Item
Date of last information/death
date
C1148348 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
Item
Cause of death
integer
C0007465 (UMLS CUI-1)
Code List
Cause of death
CL Item
Leukemia (1)
CL Item
Infection (2)
CL Item
Bleeding (3)
CL Item
Secondary illness (4)
CL Item
Other (5)
CL Item
Unknown (6)
Specifiy if Cause of death = 2,4,5
Item
Specifiy if Cause of death = 2,4,5
text
Item Group
Response after Induction Cycles or Consolidation or Maintenance or during Follow-up
Date of evaluation
Item
Date of evaluation
date
C0220825 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item
Response
integer
C0023418 (UMLS CUI-1)
C0005955 (UMLS CUI-2)
Code List
Response
CL Item
CR (1)
CL Item
CRi (2)
CL Item
PR (3)
CL Item
RD (4)
CL Item
PD (5)
CL Item
ED (6)
CL Item
HD (7)
Extramedullary Manifestatation
Item
Extramedullary Manifestatation
boolean
C1517060 (UMLS CUI-1)
C1280464 (UMLS CUI-2)
Extramedullary Manifestatation location
Item
Please specify Extramedullary Manifestation
text
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
C2238269 (UMLS CUI-1)
C1272695 (UMLS CUI-2)
Blood count evaluation done
Item
Blood count evaluation done? (If yes specify on CRF "Blood Count Evaluation"
boolean
C0005771 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1272695 (UMLS CUI-4)
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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