ID

9961

Descripción

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)

Palabras clave

  1. 5/3/15 5/3/15 -
  2. 9/3/15 9/3/15 -
  3. 9/12/15 9/12/15 -
  4. 11/2/16 11/2/16 -
  5. 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
Subido en

9 de marzo de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0

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

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

Maintenance
Descripción

Maintenance

Point in time
Descripción

Point in time

Tipo de datos

integer

Alias
UMLS CUI-1
C1442880
Date of evaluation
Descripción

Date of evaluation

Tipo de datos

date

Alias
UMLS CUI-1
C0220825
Weight
Descripción

Weight

Tipo de datos

integer

Unidades de medida
  • kg
Alias
UMLS CUI-1
C0005910
kg
Body surface area
Descripción

Body surface area

Tipo de datos

integer

Unidades de medida
  • sqm
Alias
UMLS CUI-1
C0005902
sqm
Body tempature
Descripción

Body tempature

Tipo de datos

integer

Unidades de medida
  • Degree Celcius
Alias
UMLS CUI-1
C0005903
Degree Celcius
Blood pressure
Descripción

Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI-1
C0005823
mmHg
Pulse
Descripción

Pulse

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI-1
C0232117
bpm
General Condition (WHO / ECOG)
Descripción

General Condition (WHO / ECOG)

Tipo de datos

integer

Alias
UMLS CUI-1
C1520224
Dasatinib intake during last month (since last visit)
Descripción

Dasatinib intake during last month (since last visit)

Start Date Desatinib intake
Descripción

Start Date Desatinib intake

Tipo de datos

date

Alias
UMLS CUI-1
C0808070
UMLS CUI-2
C1455147
End Date of Dasatinib intake
Descripción

End Date of Dasatinib intake

Tipo de datos

date

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

Daily dose

Tipo de datos

integer

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

Reason for change of dose

Tipo de datos

text

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C0456081
UMLS CUI-3
C1272707
Date of last administration of Desatinib
Descripción

Date of last administration of Desatinib

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C1517741
UMLS CUI-3
C1533734
UMLS CUI-4
C1455147
Urinalysis
Descripción

Urinalysis

Urinalysis done
Descripción

Urinalysis done

Tipo de datos

boolean

Alias
UMLS CUI-1
C0042014
Urinalysis date
Descripción

Urinalysis date

Tipo de datos

date

Alias
UMLS CUI-1
C0042014
Urine pH
Descripción

Urine pH

Tipo de datos

integer

Unidades de medida
  • pH
Alias
UMLS CUI-1
C1826989
pH
Urine protein
Descripción

Urine protein

Tipo de datos

integer

Alias
UMLS CUI-1
C0262923
Urinalysis glucose
Descripción

Urinalysis glucose

Tipo de datos

integer

Alias
UMLS CUI-1
C2188680
Pregnancy test done? (Female patients of childbearing age only)
Descripción

Pregnancy test date

Tipo de datos

boolean

Alias
UMLS CUI-1
C0032976
Pregnancy test result
Descripción

Pregnancy test result

Tipo de datos

integer

Alias
UMLS CUI-1
C0032976
Adverse Event
Descripción

Adverse Event

Did any Adverse Event occur last month?
Descripción

Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI-1
C0877248
Concomitant Medication
Descripción

Concomitant Medication

Did the Patient take any Concomitant Medication?
Descripción

Concomitant medication

Tipo de datos

boolean

Alias
UMLS CUI-1
C2347852
Signature
Descripción

Signature

Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Name of Investigator
Descripción

Name of Investigator

Tipo de datos

text

Alias
UMLS CUI-1
C2826892
Signature of investigator
Descripción

Signature of investigator

Tipo de datos

text

Alias
UMLS CUI-1
C2346576

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Maintenance
Item
Point in time
integer
C1442880 (UMLS CUI-1)
Code List
Point in time
CL Item
after 1 Month (1)
CL Item
after 2 Month (2)
CL Item
after 3 Month (3)
CL Item
after 4 Month (4)
CL Item
after 5 Month (5)
CL Item
after 6 Month (6)
CL Item
after 7 Month (7)
CL Item
after 8 Month (8)
CL Item
after 9 Month (9)
CL Item
after 10 Month (10)
CL Item
after 11 Month (11)
CL Item
after 12 Month (12)
Date of evaluation
Item
Date of evaluation
date
C0220825 (UMLS CUI-1)
Weight
Item
Weight
integer
C0005910 (UMLS CUI-1)
Body surface area
Item
Body surface area
integer
C0005902 (UMLS CUI-1)
Body tempature
Item
Body tempature
integer
C0005903 (UMLS CUI-1)
Blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI-1)
Pulse
Item
Pulse
integer
C0232117 (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)
Start Date Desatinib intake
Item
Start Date Desatinib intake
date
C0808070 (UMLS CUI-1)
C1455147 (UMLS CUI-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
C0678766 (UMLS CUI-1)
C0456081 (UMLS CUI-2)
C1272707 (UMLS CUI-3)
Date of last administration of Desatinib
Item
Date of last administration of Desatinib
date
C0011008 (UMLS CUI-1)
C1517741 (UMLS CUI-2)
C1533734 (UMLS CUI-3)
C1455147 (UMLS CUI-4)
Item Group
Urinalysis
Urinalysis done
Item
Urinalysis done
boolean
C0042014 (UMLS CUI-1)
Urinalysis date
Item
Urinalysis date
date
C0042014 (UMLS CUI-1)
Urine pH
Item
Urine pH
integer
C1826989 (UMLS CUI-1)
Item
Urine protein
integer
C0262923 (UMLS CUI-1)
Code List
Urine protein
CL Item
normal (0)
CL Item
+ (1)
CL Item
++ (2)
CL Item
+++ (3)
CL Item
++++ (4)
Item
Urinalysis glucose
integer
C2188680 (UMLS CUI-1)
Code List
Urinalysis glucose
CL Item
normal (0)
CL Item
+ (1)
CL Item
++ (2)
CL Item
+++ (3)
CL Item
++++ (4)
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)
Code List
Pregnancy test result
CL Item
negative (0)
CL Item
positive (End of Study) (1)
Item Group
Adverse Event
Adverse Event
Item
Did any Adverse Event occur last month?
boolean
C0877248 (UMLS CUI-1)
Item Group
Concomitant Medication
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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