ID

42822

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

Versioner (5)
  1. 2015-03-05 2015-03-05 -
  2. 2015-03-09 2015-03-09 -
  3. 2015-04-23 2015-04-23 -
  4. 2015-12-15 2015-12-15 -
  5. 2021-09-17 2021-09-17 -
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17 september 2021

DOI

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

Engelsk

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

1 Formulär  
Adverse Event
Beskrivning

Adverse Event

Point in time
Beskrivning

Point in time

Datatyp

integer

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

Maintenance Month

Datatyp

integer

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

Description of Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Adverse Event Term
Beskrivning

Adverse Event Term

Datatyp

text

Alias
UMLS CUI-1
C2826934
Serious Adverse Event
Beskrivning

Serious Adverse Event

Datatyp

boolean

Alias
UMLS CUI-1
C1519255
Grade of Adverse Event
Beskrivning

Grade of Adverse Event

Datatyp

integer

Alias
UMLS CUI-1
C2985911
Outcome
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI-1
C1705586
Treatment/Action taken
Beskrivning

Treatment/Action taken

Datatyp

text

Alias
UMLS CUI-1
C0087111
Adverse Event Start Date
Beskrivning

Adverse Event Start Date

Datatyp

date

Alias
UMLS CUI-1
C2697888
Adverse Event End Date
Beskrivning

Adverse Event End Date

Datatyp

date

Alias
UMLS CUI-1
C2697886
Adverse Event related to
Beskrivning

Adverse Event related to

Cytarabine
Beskrivning

Cytarabine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0010711
Daunorubicin
Beskrivning

Daunorubicin

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011015
Dasatinib
Beskrivning

Dasatinib

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1455147
Underlying Disease
Beskrivning

Underlying Disease

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0277554
Concomitant medication
Beskrivning

Concomitant medication

Datatyp

integer

Alias
UMLS CUI [1]
C2347852
Other
Beskrivning

Other

Datatyp

integer

Alias
UMLS CUI [1]
C0205394
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
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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Adverse Event
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
Diagnostic (0)
C0086143 (UMLS CUI-1)
CL Item
Induction I (1)
C3179010 (UMLS CUI-1)
CL Item
Induction II (optional) (2)
C3179010 (UMLS CUI-1)
CL Item
Consolid. I (3)
C3179017 (UMLS CUI-1)
CL Item
Consolid. II (4)
C3179017 (UMLS CUI-1)
CL Item
Consolid. III (5)
C3179017 (UMLS CUI-1)
CL Item
Consolid. IV (6)
C3179017 (UMLS CUI-1)
CL Item
Maintenance (7)
C0481504 (UMLS CUI-1)
Item
If Maintenance: Month
integer
C0481504 (UMLS CUI-1)
C0439231 (UMLS CUI-2)
Maintenance Month
Code List
If Maintenance: Month
CL Item
after 1 Month (1)
C0439231 (UMLS CUI-1)
C0205447 (UMLS CUI-2)
CL Item
after 2 Months (2)
C0439231 (UMLS CUI-1)
C0205448 (UMLS CUI-2)
CL Item
after 3 Months (3)
C0439231 (UMLS CUI-1)
C0205449 (UMLS CUI-2)
CL Item
after 4 Months (4)
C0439231 (UMLS CUI-1)
C0205450 (UMLS CUI-2)
CL Item
after 5 Months (5)
C0439231 (UMLS CUI-1)
C0205451 (UMLS CUI-2)
CL Item
after 6 Months (6)
C0439231 (UMLS CUI-1)
C0205452 (UMLS CUI-2)
CL Item
after 7 Months (7)
C0439231 (UMLS CUI-1)
C0205453 (UMLS CUI-2)
CL Item
after 8 Months (8)
C0439231 (UMLS CUI-1)
C0205454 (UMLS CUI-2)
CL Item
after 9Months (9)
C0439231 (UMLS CUI-1)
C0205455 (UMLS CUI-2)
CL Item
after 10 Months (10)
C0439231 (UMLS CUI-1)
C0205456 (UMLS CUI-2)
CL Item
after 11 Months (11)
C0439231 (UMLS CUI-1)
C0205457 (UMLS CUI-2)
CL Item
after 12 Months (12)
C0439231 (UMLS CUI-1)
C0205458 (UMLS CUI-2)
Description of Adverse Event
Item
Description of Adverse Event
text
C0877248 (UMLS CUI [1])
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
C2985911 (UMLS CUI-1)
Grade of Adverse Event
Code List
Grade of Adverse Event
CL Item
Mild  (1)
C2945599 (UMLS CUI-1)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
CL Item
Life-Threatening (4)
C2826244 (UMLS CUI-1)
CL Item
Death related to AE (5)
C0877248 (UMLS CUI-1)
C0011065 (UMLS CUI-2)
Item
Outcome
integer
C1705586 (UMLS CUI-1)
Outcome
Code List
Outcome
CL Item
recovered (1)
C2826210 (UMLS CUI-1)
CL Item
not yet recovered (2)
C1709277 (UMLS CUI-1)
CL Item
recovered with sequelae (3)
C1709862 (UMLS CUI-1)
CL Item
Death (4)
C0011065 (UMLS CUI-1)
CL Item
unknown (5)
C0439673 (UMLS CUI-1)
Treatment/Action taken
Item
Treatment/Action taken
text
C0087111 (UMLS CUI-1)
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 [1,1])
C0010711 (UMLS CUI [1,2])
Cytarabine
Code List
Cytarabine
CL Item
definitely (1)
C1704787 (UMLS CUI-1)
CL Item
probably (2)
C0750492 (UMLS CUI-1)
CL Item
possible (3)
C0332149 (UMLS CUI-1)
CL Item
unlikely (4)
C0750558 (UMLS CUI-1)
CL Item
not related (5)
C1546988 (UMLS CUI-1)
CL Item
Medication not administered (6)
C0445106 (UMLS CUI-1)
C0806914 (UMLS CUI-2)
Item
Daunorubicin
integer
C0877248 (UMLS CUI [1,1])
C0011015 (UMLS CUI [1,2])
Cytarabine
Code List
Daunorubicin
CL Item
definitely (1)
C1704787 (UMLS CUI-1)
CL Item
probably (2)
C0750492 (UMLS CUI-1)
CL Item
possible (3)
C0332149 (UMLS CUI-1)
CL Item
unlikely (4)
C0750558 (UMLS CUI-1)
CL Item
not related (5)
C1546988 (UMLS CUI-1)
CL Item
Medication not administered (6)
C0445106 (UMLS CUI-1)
C0806914 (UMLS CUI-2)
Item
Dasatinib
integer
C0877248 (UMLS CUI [1,1])
C1455147 (UMLS CUI [1,2])
Cytarabine
Code List
Dasatinib
CL Item
definitely (1)
C1704787 (UMLS CUI-1)
CL Item
probably (2)
C0750492 (UMLS CUI-1)
CL Item
possible (3)
C0332149 (UMLS CUI-1)
CL Item
unlikely (4)
C0750558 (UMLS CUI-1)
CL Item
not related (5)
C1546988 (UMLS CUI-1)
CL Item
Medication not administered (6)
C0445106 (UMLS CUI-1)
C0806914 (UMLS CUI-2)
Item
Underlying Disease
integer
C0877248 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])
Outcome
Code List
Underlying Disease
CL Item
recovered (1)
C2826210 (UMLS CUI-1)
CL Item
not yet recovered (2)
C1709277 (UMLS CUI-1)
CL Item
recovered with sequelae (3)
C1709862 (UMLS CUI-1)
CL Item
Death (4)
C0011065 (UMLS CUI-1)
CL Item
unknown (5)
C0439673 (UMLS CUI-1)
Item
Concomitant medication
integer
C2347852 (UMLS CUI [1])
Cytarabine
Code List
Concomitant medication
CL Item
definitely (1)
C1704787 (UMLS CUI-1)
CL Item
probably (2)
C0750492 (UMLS CUI-1)
CL Item
possible (3)
C0332149 (UMLS CUI-1)
CL Item
unlikely (4)
C0750558 (UMLS CUI-1)
CL Item
not related (5)
C1546988 (UMLS CUI-1)
CL Item
Medication not administered (6)
C0445106 (UMLS CUI-1)
C0806914 (UMLS CUI-2)
Item
Other
integer
C0205394 (UMLS CUI [1])
Outcome
Code List
Other
CL Item
recovered (1)
C2826210 (UMLS CUI-1)
CL Item
not yet recovered (2)
C1709277 (UMLS CUI-1)
CL Item
recovered with sequelae (3)
C1709862 (UMLS CUI-1)
CL Item
Death (4)
C0011065 (UMLS CUI-1)
CL Item
unknown (5)
C0439673 (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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