ID

14931

Description

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

Keywords

Versions (1)
  1. 5/9/16 5/9/16 -
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May 9, 2016

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Creative Commons BY-NC-ND 3.0
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HR-2 therapy documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

English

HR-2 therapy documentation 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 20 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
VDS administration form i.v.
Description

VDS: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0042682
UMLS CUI [1,2]
C1522726
VDS dosage (max. 5 mg) 3 mg/mˆ2/ED
Description

VDS: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0042682
UMLS CUI [1,2]
C0178602
mg
VDS Date of administration
Description

VDS: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0042682
UMLS CUI [1,2]
C2584899
DNR administration form p.i. (24h)
Description

DNR: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0011015
UMLS CUI [1,2]
C1827465
DNR dosage 30 mg/mˆ2/ED
Description

DNR: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0011015
UMLS CUI [1,2]
C0178602
mg
DNR Date of administration
Description

DNR: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0011015
UMLS CUI [1,2]
C2584899
HD-MTX administration form p.i. (24h) (10% in 0,5 h, 90% in 23,5h)
Description

HD-MTX: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0149710
UMLS CUI [1,3]
C1827465
HD-MTX dosage 5000 mg/ˆ2
Description

HD-MTX: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0149710
UMLS CUI [1,3]
C0178602
mg
HD-MTX Date of administration
Description

HD-MTX: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0149710
UMLS CUI [1,3]
C2584899
LCV-Rescue administration form i.v.
Description

LCV-Rescue: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0023413
UMLS CUI [1,2]
C1522726
LCV-rescue dosage 15 mg/ˆ2
Description

LCV-rescue: dosage

Data type

float

Measurement units
  • mg/ED
Alias
UMLS CUI [1,1]
C0023413
UMLS CUI [1,2]
C0178602
mg/ED
LCV-rescue Date of administration (at hour 42, 48, 54)
Description

LCV-rescue: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0023413
UMLS CUI [1,2]
C2584899
CPM administration form p.i. (1h)
Description

IFO: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0020823
UMLS CUI [1,2]
C1827465
IFO dosage 800 mg/mˆ2/ED (with MESNA: 300 mg/mˆ2 at hour 0, 4 and 8 of IFO infusion)
Description

IFO: dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0020823
UMLS CUI [1,2]
C0178602
mg
IFO Date of administration
Description

IFO: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0020823
UMLS CUI [1,2]
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 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 Date of administration
Description

PEG-L-ASP: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0071568
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 CNS leukemia, extra MTX dose (while MTX infusion): Date of administration
Description

MTX and CNS leukemia: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1332884
UMLS CUI [1,3]
C2584899
PEG-L-ASP/ Erwinase
Description

PEG-L-ASP/ Erwinase

Alias
UMLS CUI-1
C0071568
UMLS CUI-3
C0591457
Change from PEG-L-ASP to Erwinase in this element
Description

Change from PEG-L-ASP to Erwinase

Data type

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0071568
UMLS CUI [1,3]
C0591457
If "yes", 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 "yes", 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 "yes", 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 "yes", specify: Reason for change to erwinase: Hypersensitivity
Description

Reason for drug change: Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C0392747
UMLS CUI [2]
C0020517
If "yes", specify: Reason for change to erwinase: Date of allergic reaction
Description

Reason for drug change: date of hypersensitivity

Data type

date

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C0392747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0011008
If "yes", specify: Reason for change to erwinase: Other reason
Description

Reason for drug change: Other reason

Data type

text

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C0392747
UMLS CUI [2]
C3840932
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

HR-2 therapy documentation 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)
Item
Dexamethasone administration form
text
C0011777 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Dexamethasone: administration form
Code List
Dexamethasone administration form
CL Item
p.o (p.o)
CL Item
i.v. (i.v.)
Dexamethasone: dosage
Item
Dexamethasone dosage 20 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])
VDS: administration form
Item
VDS administration form i.v.
boolean
C0042682 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
VDS: dosage
Item
VDS dosage (max. 5 mg) 3 mg/mˆ2/ED
float
C0042682 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
VDS: date of administration
Item
VDS Date of administration
date
C0042682 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
DNR: administration form
Item
DNR administration form p.i. (24h)
boolean
C0011015 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
DNR: dosage
Item
DNR dosage 30 mg/mˆ2/ED
float
C0011015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
DNR: date of administration
Item
DNR Date of administration
date
C0011015 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
HD-MTX: administration form
Item
HD-MTX administration form p.i. (24h) (10% in 0,5 h, 90% in 23,5h)
boolean
C0025677 (UMLS CUI [1,1])
C0149710 (UMLS CUI [1,2])
C1827465 (UMLS CUI [1,3])
HD-MTX: dosage
Item
HD-MTX dosage 5000 mg/ˆ2
float
C0025677 (UMLS CUI [1,1])
C0149710 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
HD-MTX: date of administration
Item
HD-MTX Date of administration
date
C0025677 (UMLS CUI [1,1])
C0149710 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,3])
LCV-Rescue: administration form
Item
LCV-Rescue administration form i.v.
boolean
C0023413 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
LCV-rescue: dosage
Item
LCV-rescue dosage 15 mg/ˆ2
float
C0023413 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
LCV-rescue: date of administration
Item
LCV-rescue Date of administration (at hour 42, 48, 54)
date
C0023413 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
IFO: administration form
Item
CPM administration form p.i. (1h)
boolean
C0020823 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
IFO: dosage
Item
IFO dosage 800 mg/mˆ2/ED (with MESNA: 300 mg/mˆ2 at hour 0, 4 and 8 of IFO infusion)
float
C0020823 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
IFO: date of administration
Item
IFO Date of administration
date
C0020823 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
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 Date of administration
date
C0071568 (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 leukemia: date of administration
Item
If CNS leukemia, extra MTX dose (while MTX infusion): Date of administration
date
C0025677 (UMLS CUI [1,1])
C1332884 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,3])
Item Group
PEG-L-ASP/ Erwinase
C0071568 (UMLS CUI-1)
C0591457 (UMLS CUI-3)
Change from PEG-L-ASP to Erwinase
Item
Change from PEG-L-ASP to Erwinase in this element
boolean
C0580105 (UMLS CUI [1,1])
C0071568 (UMLS CUI [1,2])
C0591457 (UMLS CUI [1,3])
Erwinase: date of first administration
Item
If "yes", 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 "yes", 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 "yes", specify: Numbers of Erwinase doses
float
C0591457 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Reason for drug change: Hypersensitivity
Item
If "yes", specify: Reason for change to erwinase: Hypersensitivity
boolean
C0591457 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2])
Reason for drug change: date of hypersensitivity
Item
If "yes", specify: Reason for change to erwinase: Date of allergic reaction
date
C0591457 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Reason for drug change: Other reason
Item
If "yes", specify: Reason for change to erwinase: Other reason
text
C0591457 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C3840932 (UMLS CUI [2])
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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