ID

15179

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

Versions (1)
  1. 5/21/16 5/21/16 -
Uploaded on

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
Dexamethasone administration form
Description

Dexamethasone: administration form

Data type

text

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0013153
Dexamethasone dosage 10 mg/mˆ2/d
Description

Dexamethasone: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0178602
mg
Dexamethasone Date of administration
Description

Dexamethasone: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C2584899
VCR administration form i.v.
Description

VCR: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0042679
UMLS CUI [1,2]
C1522726
VCR dosage 1,5 mg/mˆ2/ED (max. 2 mg/ED)
Description

VCR: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0042679
UMLS CUI [1,2]
C0178602
mg
VCR Date of administration
Description

VCR: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0042679
UMLS CUI [1,2]
C2584899
Doxorubicin administration form p.i. (1h)
Description

DOX: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C1827465
Doxorubicin dosage 30 mg/mˆ2/ED
Description

DOX: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C0178602
mg
Doxorubicin Date of administration
Description

DOX: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2584899
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
If initial CNS status CNS3, MTX dose (i.th., on day 1 and 18): Date of administration
Description

MTX and CNS status: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0449389
UMLS CUI [1,3]
C2584899
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 E/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 (Next PEG-L-ASP dose: 14 days after dose of day 22)) Date of administration
Description

PEG-L-ASP: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0071568
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 Protocol IIA-ASP+?
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: 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
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

text

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C2584899
UMLS CUI [1,3]
C1517741
Change to Erwinase?
Description

Change to Erwinase

Data type

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0591457
If change to Erwinase, specify: Erwinase: date of first administration
Description

Erwinase: date of first administration

Data type

date

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C2584899
UMLS CUI [1,3]
C0205435
If change to Erwinase, specify: Erwinase: date of last administration
Description

Erwinase: date of last administration

Data type

date

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C2584899
UMLS CUI [1,3]
C1517741
If change to Erwinase, specify: Numbers of Erwinase doses
Description

Numbers of Erwinase doses

Data type

float

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C0237753
If change to Erwinase, specify: Erwinase dose
Description

Erwinase dose

Data type

float

Measurement units
  • E
Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C3174092
E
Hospitalization
Description

Hospitalization

Alias
UMLS CUI-1
C0019993
Number of Nights in Hospital (Day 1 until start of Protocol IIB-ASP+)
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)
Dexamethasone: administration form
Item
Dexamethasone administration form
text
C0011777 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Dexamethasone: dosage
Item
Dexamethasone dosage 10 mg/mˆ2/d
float
C0011777 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dexamethasone: date of administration
Item
Dexamethasone Date of administration
date
C0011777 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
VCR: administration form
Item
VCR administration form i.v.
boolean
C0042679 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
VCR: dosage
Item
VCR dosage 1,5 mg/mˆ2/ED (max. 2 mg/ED)
float
C0042679 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
VCR: date of administration
Item
VCR Date of administration
date
C0042679 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
DOX: administration form
Item
Doxorubicin administration form p.i. (1h)
boolean
C0013089 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
DOX: dosage
Item
Doxorubicin dosage 30 mg/mˆ2/ED
float
C0013089 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
DOX: date of administration
Item
Doxorubicin Date of administration
date
C0013089 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
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])
MTX and CNS status: date of administration
Item
If initial CNS status CNS3, MTX dose (i.th., on day 1 and 18): Date of administration
date
C0025677 (UMLS CUI [1,1])
C0449389 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,3])
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 E/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 (Next PEG-L-ASP dose: 14 days after dose of day 22)) Date of administration
date
C0071568 (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 Protocol IIA-ASP+?
boolean
C0071568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
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
If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
text
C0071568 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
PEG-L-ASP: date of last administration
Code List
If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
CL Item
Protocol Day 8 (Protocol Day 8)
CL Item
Protocol Day 22 (Protocol Day 22)
Change to Erwinase
Item
Change to Erwinase?
boolean
C0580105 (UMLS CUI [1,1])
C0591457 (UMLS CUI [1,2])
Erwinase: date of first administration
Item
If change to Erwinase, specify: Erwinase: date of first administration
date
C0591457 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Erwinase: date of last administration
Item
If change to Erwinase, specify: Erwinase: date of last administration
date
C0591457 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Numbers of Erwinase doses
Item
If change to Erwinase, specify: Numbers of Erwinase doses
float
C0591457 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Erwinase dose
Item
If change to Erwinase, specify: Erwinase dose
float
C0591457 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item Group
Hospitalization
C0019993 (UMLS CUI-1)
Hospital nights
Item
Number of Nights in Hospital (Day 1 until start of Protocol IIB-ASP+)
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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