ID

14930

Description

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

Keywords

  1. 5/9/16 5/9/16 -
Uploaded on

May 9, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC-ND 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

HR-1 therapy documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

HR-1 therapy documentation AIEOP-BFM ALL 2009 NCT01117441

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
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 (max. 2 mg) 1,5 mg/mˆ2/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
ARA-C administration form p.i. (3h)
Description

ARA-C: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C1827465
ARA-C dosage 2000 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
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) (with MESNA: 70 mg/ˆ2 at hour 0, 4 and 8 of CPM-infusion regimen)
Description

CPM: administration form

Data type

boolean

Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C1827465
CPM dosage 200 mg/mˆ2/ED
Description

CPM: dosage

Data type

float

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

CPM: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0010583
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
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

Similar models

HR-1 therapy documentation AIEOP-BFM ALL 2009 NCT01117441

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])
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])
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 (max. 2 mg) 1,5 mg/mˆ2/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])
ARA-C: administration form
Item
ARA-C administration form p.i. (3h)
boolean
C0010711 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
ARA-C: dosage
Item
ARA-C dosage 2000 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])
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])
CPM: administration form
Item
CPM administration form p.i. (1h) (with MESNA: 70 mg/ˆ2 at hour 0, 4 and 8 of CPM-infusion regimen)
boolean
C0010583 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
CPM: dosage
Item
CPM dosage 200 mg/mˆ2/ED
float
C0010583 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
CPM: date of administration
Item
CPM Date of administration
date
C0010583 (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])
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial