ID

15176

Description

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Study Protocol IB (Study Protocol IB with PEG-L-ASP). Clinical Trial Number: NCT01117441.

Keywords

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  1. 5/21/16 5/21/16 -
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May 21, 2016

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

English

Protocol IB-ASP+ AIEOP-BFM ALL 2009 NCT01117441

1 forms  
Patient Information
Description

Patient Information

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

Patient ID

Data type

text

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

Patient birthday

Data type

date

Alias
UMLS CUI [1]
C0421451
Body weight
Description

Weight

Data type

float

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

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body surface
Description

Body surface

Data type

float

Measurement units
  • mˆ2
Alias
UMLS CUI [1]
C0005902
mˆ2
Chemotherapy Regimen
Description

Chemotherapy Regimen

Alias
UMLS CUI-1
C0392920
PEG-L-ASP administration form p.i. (2h)
Description

PEG-L-ASP: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C1827465
PEG-L-ASP dosage 2500 mg/mˆ2/ED (ONCASPAR: 3750 E/ED)
Description

PEG-L-ASP: dosage

Data type

float

Measurement units
  • E
Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C0178602
E
PEG-L-ASP (First dose of PEG-L-ASP in Phase IB: 14 days after last dose in Phase IA. No delay because of uncomplicated myelosupression or coagulopathy) Date of administration
Description

PEG-L-ASP: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C2584899
Cyclophosphamide administration form p.i. (1h) (+ MESNA)
Description

CPM: administration form

Data type

boolean

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

CPM: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C0178602
mg
Cyclophosphamide Date of administration
Description

CPM: date of administration

Data type

date

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

ARA-C: administration form

Data type

boolean

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

ARA-C: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0178602
mg
ARA-C Date of administration
Description

ARA-C: date of administration

Data type

date

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

6-MP: administration form

Data type

boolean

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

6-MP: dosage

Data type

float

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

6-MP: start date

Data type

date

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

6-MP: end date

Data type

date

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

MTX: administration form

Data type

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

Data type

float

Measurement units
  • 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

Data type

date

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C2584899
PEG-L-ASP discontinuation
Description

PEG-L-ASP discontinuation

Alias
UMLS CUI-1
C0071568
UMLS CUI-2
C0457454
Discontinuation of PEG-L-ASP therapy in this element?
Description

PEG-L-ASP discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C0457454
If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
Description

PEG-L-ASP: date of last administration

Data type

date

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C2584899
UMLS CUI [1,3]
C1517741
If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation:
Description

Reason for discontinuation of PEG-L-ASP therapy

Data type

text

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0392360
If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation: If other medical or non-medical reason, specify:
Description

Reason for discontinuation of PEG-L-ASP therapy: specification

Data type

text

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C2348235
Hospitalization
Description

Hospitalization

Alias
UMLS CUI-1
C0019993
Number of Nights in Hospital (Day 1 until start of Protocol IB)
Description

Hospital nights

Data type

float

Measurement units
  • 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

Data type

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

Data type

text

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

Protocol IB-ASP+ AIEOP-BFM ALL 2009 NCT01117441

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
PEG-L-ASP: administration form
Item
PEG-L-ASP administration form p.i. (2h)
boolean
C0071568 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
PEG-L-ASP: dosage
Item
PEG-L-ASP dosage 2500 mg/mˆ2/ED (ONCASPAR: 3750 E/ED)
float
C0071568 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
PEG-L-ASP: date of administration
Item
PEG-L-ASP (First dose of PEG-L-ASP in Phase IB: 14 days after last dose in Phase IA. No delay because of uncomplicated myelosupression or coagulopathy) Date of administration
date
C0071568 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
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
PEG-L-ASP discontinuation
C0071568 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
PEG-L-ASP discontinuation
Item
Discontinuation of PEG-L-ASP therapy in this element?
boolean
C0071568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
PEG-L-ASP: date of last administration
Item
If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
date
C0071568 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Item
If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation:
text
C0071568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for discontinuation of PEG-L-ASP therapy
Code List
If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation:
CL Item
allergic reaction to PEG-L-ASP (allergic reaction to PEG-L-ASP)
CL Item
DVT or SVT (DVT or SVT)
CL Item
Pancreatitis (Pancreatitis)
CL Item
Insulin-dependent hyperglycaemia (Insulin-dependent hyperglycaemia)
CL Item
other medical reason (other medical reason)
CL Item
other non-medical reason (other non-medical reason)
Reason for discontinuation of PEG-L-ASP therapy: specification
Item
If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation: If other medical or non-medical reason, specify:
text
C0071568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Hospitalization
C0019993 (UMLS CUI-1)
Hospital nights
Item
Number of Nights in Hospital (Day 1 until start of Protocol IB)
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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