ID

15177

Description

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

Mots-clés

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  1. 21/05/2016 21/05/2016 -
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21 mai 2016

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Licence

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

Anglais

Protocol IB AIEOP-BFM ALL 2009 NCT01117441

1 Formulaires  
Patient Information
Description

Patient Information

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

Patient ID

Type de données

text

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

Patient birthday

Type de données

date

Alias
UMLS CUI [1]
C0421451
Body weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body height
Description

Height

Type de données

float

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body surface
Description

Body surface

Type de données

float

Unités de mesure
  • mˆ2
Alias
UMLS CUI [1]
C0005902
mˆ2
Chemotherapy Regimen
Description

Chemotherapy Regimen

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

CPM: administration form

Type de données

boolean

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

CPM: dosage

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C0178602
mg
Cyclophosphamide Date of administration
Description

CPM: date of administration

Type de données

date

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

ARA-C: administration form

Type de données

boolean

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

ARA-C: dosage

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0178602
mg
ARA-C Date of administration
Description

ARA-C: date of administration

Type de données

date

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

6-MP: administration form

Type de données

boolean

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

6-MP: dosage

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1,1]
C0000618
UMLS CUI [1,2]
C0178602
mg
6-MP Start date of therapy
Description

6-MP: start date

Type de données

date

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

6-MP: end date

Type de données

date

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

MTX: administration form

Type de données

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
Description

MTX: dosage

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
mg
MTX Date of administration (while MTX infusion)
Description

MTX: date of administration

Type de données

date

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

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)
Description

Hospital nights

Type de données

float

Unités de mesure
  • nights
Alias
UMLS CUI [1]
C0420496
nights
Identification and Signature
Description

Identification and Signature

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

Chemotherapy creator: signature

Type de données

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
Description

Chemotherapy administration: signature

Type de données

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1533734
UMLS CUI [2]
C1519316
Retour au début de la page

Similar models

Protocol IB AIEOP-BFM ALL 2009 NCT01117441

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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