ID

42186

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. 3/5/15 3/5/15 -
  2. 3/9/15 3/9/15 -
  3. 12/9/15 12/9/15 -
  4. 2/11/16 2/11/16 -
  5. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

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

English

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

1 forms  
Maintenance
Description

Maintenance

Alias
UMLS CUI-1
C0481504
Point in time
Description

Point in time

Data type

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Date of evaluation
Description

Date of evaluation

Data type

date

Alias
UMLS CUI [1]
C2985720
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Description

Body surface area

Data type

integer

Measurement units
  • sqm
Alias
UMLS CUI-1
C0005902
sqm
Body temperature
Description

Body temperature

Data type

integer

Measurement units
  • Degree Celcius
Alias
UMLS CUI [1]
C0005903
Degree Celcius
Blood pressure
Description

Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
General Condition (WHO / ECOG)
Description

General Condition (WHO / ECOG)

Data type

integer

Alias
UMLS CUI [1]
C1520224
Dasatinib intake during last month (since last visit)
Description

Dasatinib intake during last month (since last visit)

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1455147
Start Date Desatinib intake
Description

Start Date Desatinib intake

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1455147
End Date of Dasatinib intake
Description

End Date of Dasatinib intake

Data type

date

Alias
UMLS CUI-1
C0806020
UMLS CUI-2
C1455147
Daily dose
Description

Daily dose

Data type

integer

Alias
UMLS CUI-1
C2348070
Reason for change of dose
Description

Reason for change of dose

Data type

text

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C1272707
Date of last administration of Desatinib
Description

Date of last administration of Desatinib

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1455147
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Urinalysis done
Description

Urinalysis done

Data type

boolean

Alias
UMLS CUI-1
C0042014
Urinalysis date
Description

Urinalysis date

Data type

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0011008
Urine pH
Description

Urine pH

Data type

integer

Measurement units
  • pH
Alias
UMLS CUI [1]
C0042044 
pH
Urine protein
Description

Urine protein

Data type

integer

Alias
UMLS CUI [1]
C0262923
Urinalysis glucose
Description

Urinalysis glucose

Data type

integer

Alias
UMLS CUI [1]
C0004076
Pregnancy test done? (Female patients of childbearing age only)
Description

Pregnancy test date

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Pregnancy test result
Description

Pregnancy test result

Data type

integer

Alias
UMLS CUI-1
C0032976
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Did any Adverse Event occur last month?
Description

Adverse Event

Data type

boolean

Alias
UMLS CUI-1
C0877248
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Did the Patient take any Concomitant Medication?
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI-1
C2347852
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
C2826892
Signature of investigator
Description

Signature of investigator

Data type

text

Alias
UMLS CUI-1
C2346576
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Maintenance
C0481504 (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
after 1 Month (1)
C0439231 (UMLS CUI-1)
C0205447 (UMLS CUI-2)
CL Item
after 2 Month (2)
C0439231 (UMLS CUI-1)
C0205448 (UMLS CUI-2)
CL Item
after 3 Month (3)
C0439231 (UMLS CUI-1)
C0205449 (UMLS CUI-2)
CL Item
after 4 Month (4)
C0439231 (UMLS CUI-1)
C0205450 (UMLS CUI-2)
CL Item
after 5 Month (5)
C0439231 (UMLS CUI-1)
C0205451 (UMLS CUI-2)
CL Item
after 6 Month (6)
C0439231 (UMLS CUI-1)
C0205452 (UMLS CUI-2)
CL Item
after 7 Month (7)
C0439231 (UMLS CUI-1)
C0205453 (UMLS CUI-2)
CL Item
after 8 Month (8)
C0439231 (UMLS CUI-1)
C0205454 (UMLS CUI-2)
CL Item
after 9 Month (9)
C0439231 (UMLS CUI-1)
C0205455 (UMLS CUI-2)
CL Item
after 10 Month (10)
C0439231 (UMLS CUI-1)
C0205456 (UMLS CUI-2)
CL Item
after 11 Month (11)
C0439231 (UMLS CUI-1)
C0205457 (UMLS CUI-2)
CL Item
after 12 Month (12)
C0439231 (UMLS CUI-1)
C0205458 (UMLS CUI-2)
Date of evaluation
Item
Date of evaluation
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Body surface area
Item
Body surface area
integer
C0005902 (UMLS CUI-1)
Body temperature
Item
Body temperature
integer
C0005903 (UMLS CUI [1])
Blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0018810 (UMLS CUI [1])
General Condition (WHO / ECOG)
Item
General Condition (WHO / ECOG)
integer
C1520224 (UMLS CUI [1])
Item Group
Dasatinib intake during last month (since last visit)
C0013227 (UMLS CUI-1)
C1455147 (UMLS CUI-2)
Start Date Desatinib intake
Item
Start Date Desatinib intake
date
C0808070 (UMLS CUI [1,1])
C1455147 (UMLS CUI [1,2])
End Date of Dasatinib intake
Item
End Date of Dasatinib intake
date
C0806020 (UMLS CUI-1)
C1455147 (UMLS CUI-2)
Daily dose
Item
Daily dose
integer
C2348070 (UMLS CUI-1)
Reason for change of dose
Item
Reason for change of dose
text
C1299575 (UMLS CUI [1,1])
C1272707 (UMLS CUI [1,2])
Date of last administration of Desatinib
Item
Date of last administration of Desatinib
date
C0806020 (UMLS CUI [1,1])
C1455147 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Urinalysis done
Item
Urinalysis done
boolean
C0042014 (UMLS CUI-1)
Urinalysis date
Item
Urinalysis date
date
C0042014 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Urine pH
Item
Urine pH
integer
C0042044  (UMLS CUI [1])
Item
Urine protein
integer
C0262923 (UMLS CUI [1])
Urine protein
Code List
Urine protein
CL Item
normal (0)
C0262923 (UMLS CUI-1)
CL Item
+ (1)
C0427724 (UMLS CUI-1)
CL Item
++ (2)
C0427725 (UMLS CUI-1)
CL Item
+++ (3)
C0427726 (UMLS CUI-1)
CL Item
++++ (4)
C0427727 (UMLS CUI-1)
Item
Urinalysis glucose
integer
C0004076 (UMLS CUI [1])
Urinalysis glucose
Code List
Urinalysis glucose
CL Item
normal (0)
C0427744 (UMLS CUI-1)
CL Item
+ (1)
C0427746 (UMLS CUI-1)
CL Item
++ (2)
C0427747 (UMLS CUI-1)
CL Item
+++ (3)
C0427748 (UMLS CUI-1)
CL Item
++++ (4)
C0427749 (UMLS CUI-1)
Pregnancy test date
Item
Pregnancy test done? (Female patients of childbearing age only)
boolean
C0032976 (UMLS CUI [1])
Item
Pregnancy test result
integer
C0032976 (UMLS CUI-1)
Pregnancy test result
Code List
Pregnancy test result
CL Item
negative (0)
C0205160 (UMLS CUI-1)
CL Item
positive (End of Study) (1)
C1446409 (UMLS CUI-1)
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
Item
Did any Adverse Event occur last month?
boolean
C0877248 (UMLS CUI-1)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Did the Patient take any Concomitant Medication?
boolean
C2347852 (UMLS CUI-1)
Item Group
Signature
Date
Item
Date
date
C0011008 (UMLS CUI-1)
Name of Investigator
Item
Name of Investigator
text
C2826892 (UMLS CUI-1)
Signature of investigator
Item
Signature of investigator
text
C2346576 (UMLS CUI-1)
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