ID

9955

Beskrivning

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)

Nyckelord

  1. 2015-03-04 2015-03-04 -
  2. 2015-03-09 2015-03-09 -
  3. 2015-04-22 2015-04-22 -
  4. 2015-12-08 2015-12-08 -
  5. 2016-02-11 2016-02-11 -
Uppladdad den

9 mars 2015

DOI

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Licens

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
Beskrivning

Evaluation

Point in time
Beskrivning

Point in time

Datatyp

integer

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

Maintenance Month

Datatyp

integer

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

Follow up number

Datatyp

integer

Alias
UMLS CUI-1
C1704685
Status
Beskrivning

Status

Is the patient alive?
Beskrivning

Status of patient

Datatyp

boolean

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

Date of last information/death

Datatyp

date

Alias
UMLS CUI-1
C1148348
UMLS CUI-2
C0011008
UMLS CUI-3
C1533716
Cause of death
Beskrivning

Cause of death

Datatyp

integer

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

Specifiy if Cause of death = 2,4,5

Datatyp

text

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

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

Date of evaluation
Beskrivning

Date of evaluation

Datatyp

date

Alias
UMLS CUI-1
C0220825
Response
Beskrivning

Response

Datatyp

integer

Alias
UMLS CUI-1
C1704632
Extramedullary Manifestatation
Beskrivning

Extramedullary Manifestatation

Datatyp

boolean

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

Extramedullary Manifestatation location

Datatyp

text

Evaluation based on on following examinations
Beskrivning

Evaluation based on on following examinations

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

Bone marrow evaluation done

Datatyp

boolean

Alias
UMLS CUI-1
C2238269
UMLS CUI-2
C1272695
Blood count evaluation done? (If yes specify on CRF "Blood Count Evaluation"
Beskrivning

Blood count evaluation done

Datatyp

boolean

Alias
UMLS CUI-1
C0005771
UMLS CUI-2
C0022885
UMLS CUI-3
C0220825
UMLS CUI-4
C1272695
Signature
Beskrivning

Signature

Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI-1
C0011008
Name of Investigator
Beskrivning

Name of Investigator

Datatyp

text

Alias
UMLS CUI-1
C0008961
Signature of investigator
Beskrivning

Signature of investigator

Datatyp

text

Alias
UMLS CUI-1
C2346576

Similar models

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

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
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)
Item
Response
integer
C1704632 (UMLS CUI-1)
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
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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