ID

15177

Beschrijving

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Study Protocol IB. Clinical Trial Number: NCT01117441.

Trefwoorden

Versies (1)
  1. 21-05-16 21-05-16 -
Geüploaded op

21 mei 2016

DOI

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Creative Commons BY-NC-ND 3.0
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Protocol IB AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

Engels

Protocol IB AIEOP-BFM ALL 2009 NCT01117441

1 Formulieren  
Patient Information
Beschrijving

Patient Information

Alias
UMLS CUI-1
C1955348
Stud.-Nr. (Pat.-ID)
Beschrijving

Patient ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Patient date of birth
Beschrijving

Patient birthday

Datatype

date

Alias
UMLS CUI [1]
C0421451
Body weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body height
Beschrijving

Height

Datatype

float

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body surface
Beschrijving

Body surface

Datatype

float

Maateenheden
  • mˆ2
Alias
UMLS CUI [1]
C0005902
mˆ2
Chemotherapy Regimen
Beschrijving

Chemotherapy Regimen

Alias
UMLS CUI-1
C0392920
Cyclophosphamide administration form p.i. (1h) (+ MESNA)
Beschrijving

CPM: administration form

Datatype

boolean

Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C1827465
Cyclophosphamide 1000 mg/mˆ2/ED
Beschrijving

CPM: dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C0178602
mg
Cyclophosphamide Date of administration
Beschrijving

CPM: date of administration

Datatype

date

Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C2584899
ARA-C administration form i.v.
Beschrijving

ARA-C: administration form

Datatype

boolean

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0013153
ARA-C dosage 75 mg/mˆ2/ED
Beschrijving

ARA-C: dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0178602
mg
ARA-C Date of administration
Beschrijving

ARA-C: date of administration

Datatype

date

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C2584899
6-MP administration form p.o. (28d)
Beschrijving

6-MP: administration form

Datatype

boolean

Alias
UMLS CUI [1,1]
C0000618
UMLS CUI [1,2]
C0013153
6-MP dosage 60 mg/mˆ2/d
Beschrijving

6-MP: dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0000618
UMLS CUI [1,2]
C0178602
mg
6-MP Start date of therapy
Beschrijving

6-MP: start date

Datatype

date

Alias
UMLS CUI [1,1]
C0000618
UMLS CUI [1,2]
C0808070
6-MP End date of therapy
Beschrijving

6-MP: end date

Datatype

date

Alias
UMLS CUI [1]
C0806020
MTX administration form i.th
Beschrijving

MTX: administration form

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0677897
MTX dosage (Age-dependent: 1 - < 2 y/o: 8 mg 2 - < 3y/o: 10 mg >= 3 y/o: 12 mg
Beschrijving

MTX: dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
mg
MTX Date of administration (while MTX infusion)
Beschrijving

MTX: date of administration

Datatype

date

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C2584899
Hospitalization
Beschrijving

Hospitalization

Alias
UMLS CUI-1
C0019993
If member of randomization group R-HR, specify: Number of Nights in Hospital (Day 36 until start of HR-Block)
Beschrijving

Hospital nights

Datatype

float

Maateenheden
  • nights
Alias
UMLS CUI [1]
C0420496
nights
Identification and Signature
Beschrijving

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-3
C1519316
Date and signature of the doctor who calculated and created chemotherapy regimen
Beschrijving

Chemotherapy creator: signature

Datatype

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1707531
UMLS CUI [2]
C1519316
Date and signature of the person who administered chemotherapy
Beschrijving

Chemotherapy administration: signature

Datatype

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1533734
UMLS CUI [2]
C1519316
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Similar models

Protocol IB AIEOP-BFM ALL 2009 NCT01117441

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient ID
Item
Stud.-Nr. (Pat.-ID)
text
C2348585 (UMLS CUI [1])
Patient birthday
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Height
Item
Body height
float
C0005890 (UMLS CUI [1])
Body surface
Item
Body surface
float
C0005902 (UMLS CUI [1])
Item Group
Chemotherapy Regimen
C0392920 (UMLS CUI-1)
CPM: administration form
Item
Cyclophosphamide administration form p.i. (1h) (+ MESNA)
boolean
C0010583 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
CPM: dosage
Item
Cyclophosphamide 1000 mg/mˆ2/ED
float
C0010583 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
CPM: date of administration
Item
Cyclophosphamide Date of administration
date
C0010583 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
ARA-C: administration form
Item
ARA-C administration form i.v.
boolean
C0010711 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
ARA-C: dosage
Item
ARA-C dosage 75 mg/mˆ2/ED
float
C0010711 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
ARA-C: date of administration
Item
ARA-C Date of administration
date
C0010711 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
6-MP: administration form
Item
6-MP administration form p.o. (28d)
boolean
C0000618 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
6-MP: dosage
Item
6-MP dosage 60 mg/mˆ2/d
float
C0000618 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
6-MP: start date
Item
6-MP Start date of therapy
date
C0000618 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
6-MP: end date
Item
6-MP End date of therapy
date
C0806020 (UMLS CUI [1])
MTX: administration form
Item
MTX administration form i.th
boolean
C0025677 (UMLS CUI [1,1])
C0677897 (UMLS CUI [1,2])
MTX: dosage
Item
MTX dosage (Age-dependent: 1 - < 2 y/o: 8 mg 2 - < 3y/o: 10 mg >= 3 y/o: 12 mg
float
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
MTX: date of administration
Item
MTX Date of administration (while MTX infusion)
date
C0025677 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
Item Group
Hospitalization
C0019993 (UMLS CUI-1)
Hospital nights
Item
If member of randomization group R-HR, specify: Number of Nights in Hospital (Day 36 until start of HR-Block)
float
C0420496 (UMLS CUI [1])
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-3)
Chemotherapy creator: signature
Item
Date and signature of the doctor who calculated and created chemotherapy regimen
text
C0392920 (UMLS CUI [1,1])
C1707531 (UMLS CUI [1,2])
C1519316 (UMLS CUI [2])
Chemotherapy administration: signature
Item
Date and signature of the person who administered chemotherapy
text
C0392920 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C1519316 (UMLS CUI [2])
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