ID

9930

Beschrijving

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)

Trefwoorden

  1. 05-03-15 05-03-15 -
  2. 09-03-15 09-03-15 -
  3. 09-12-15 09-12-15 -
  4. 11-02-16 11-02-16 -
  5. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
Geüploaded op

5 maart 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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

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

Maintenance
Beschrijving

Maintenance

Point in time
Beschrijving

Point in time

Datatype

integer

Alias
UMLS CUI-1
C1442880
UMLS CUI-2
C1302181
Date of evaluation
Beschrijving

Date of evaluation

Datatype

date

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0011008
Weight
Beschrijving

Weight

Datatype

integer

Maateenheden
  • kg
Alias
UMLS CUI-1
C0005910
kg
Body surface area
Beschrijving

Body surface area

Datatype

integer

Maateenheden
  • sqm
Alias
UMLS CUI-1
C0005902
sqm
Body tempature
Beschrijving

Body tempature

Datatype

integer

Maateenheden
  • Degree Celcius
Alias
UMLS CUI-1
C0005903
Degree Celcius
Blood pressure
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI-1
C0005823
mmHg
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI-1
C0232117
bpm
General Condition (WHO / ECOG)
Beschrijving

General Condition (WHO / ECOG)

Datatype

integer

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

Dasatinib intake during last month (since last visit)

Start Date Desatinib intake
Beschrijving

Start Date Desatinib intake

Datatype

date

Alias
UMLS CUI-1
C0808070
UMLS CUI-2
C1455147
UMLS CUI-3
C0802004
End Date of Dasatinib intake
Beschrijving

End Date of Dasatinib intake

Datatype

date

Alias
UMLS CUI-1
C0806020
UMLS CUI-2
C1533734
UMLS CUI-3
C1455147
Daily dose
Beschrijving

Daily dose

Datatype

integer

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

Reason for change of dose

Datatype

text

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

Date of last administration of Desatinib

Datatype

date

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

Urinalysis

Urinalysis done
Beschrijving

Urinalysis done

Datatype

boolean

Alias
UMLS CUI-1
C0042014
Urinalysis date
Beschrijving

Urinalysis date

Datatype

date

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0011008
Urine pH
Beschrijving

Urine pH

Datatype

integer

Maateenheden
  • pH
Alias
UMLS CUI-1
C1826989
pH
Urine protein
Beschrijving

Urine protein

Datatype

integer

Alias
UMLS CUI-1
C0262923
Urinalysis glucose
Beschrijving

Urinalysis glucose

Datatype

integer

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

Pregnancy test date

Datatype

boolean

Alias
UMLS CUI-1
C0032976
Pregnancy test result
Beschrijving

Pregnancy test result

Datatype

integer

Alias
UMLS CUI-1
C1522602
UMLS CUI-2
C1274040
UMLS CUI-3
C0032961
UMLS CUI-4
C0022885
Adverse Event
Beschrijving

Adverse Event

Did any Adverse Event occur last month?
Beschrijving

Adverse Event

Datatype

boolean

Alias
UMLS CUI-1
C0877248
Concomitant Medication
Beschrijving

Concomitant Medication

Did the Patient take any Concomitant Medication?
Beschrijving

Concomitant medication

Datatype

boolean

Alias
UMLS CUI-1
C2347852
Signature
Beschrijving

Signature

Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0011008
Name and Signature of Investigator
Beschrijving

Name and Signature of Investigator

Datatype

text

Alias
UMLS CUI-1
C0027365
UMLS CUI-2
C1519316
UMLS CUI-3
C0031831

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Maintenance
Item
Point in time
integer
C1442880 (UMLS CUI-1)
C1302181 (UMLS CUI-2)
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)
C0011008 (UMLS CUI-2)
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)
C0802004 (UMLS CUI-3)
End Date of Dasatinib intake
Item
End Date of Dasatinib intake
date
C0806020 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
C1455147 (UMLS CUI-3)
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)
C0011008 (UMLS CUI-2)
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
C1522602 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0022885 (UMLS CUI-4)
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
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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