ID

15174

Beschreibung

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Study Protocol IA (Study Protocol IA: 4 doses of Daunorubicin, Study Protocol IA': 2 doses of Daunorubicin). Clinical Trial Number: NCT01117441.

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  1. 21.05.16 21.05.16 -
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21. Mai 2016

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Protocol IA AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

Englisch

Protocol IA AIEOP-BFM ALL 2009 NCT01117441

1 Formulare  
Patient Information
Beschreibung

Patient Information

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

Patient ID

Datentyp

text

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

Patient birthday

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Body weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body height
Beschreibung

Height

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body surface
Beschreibung

Body surface

Datentyp

float

Maßeinheiten
  • mˆ2
Alias
UMLS CUI [1]
C0005902
mˆ2
Chemotherapy Regimen
Beschreibung

Chemotherapy Regimen

Alias
UMLS CUI-1
C0392920
Prednisone administration form
Beschreibung

Prednisone: administration form

Datentyp

text

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0013153
Prednisone dosage 60 mg/mˆ2/d
Beschreibung

Prednisone: dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0178602
mg
Prednisone Date of administration
Beschreibung

Prednisone: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C2584899
VCR administration form i.v.
Beschreibung

VCR: administration form

Datentyp

boolean

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

VCR: dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0042679
UMLS CUI [1,2]
C0178602
mg
VCR Date of administration
Beschreibung

VCR: date of administration

Datentyp

date

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

DNR: administration form

Datentyp

boolean

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

DNR: dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0011015
UMLS CUI [1,2]
C0178602
mg
DNR Date of administration (If Randomisation in Group R1: reduced arm, no 3rd or 4th dose of DNR = Prot.IA')
Beschreibung

DNR: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0011015
UMLS CUI [1,2]
C2584899
MTX administration form i.th
Beschreibung

MTX: administration form

Datentyp

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
Beschreibung

MTX: dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
mg
MTX Date of administration (while MTX infusion)
Beschreibung

MTX: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C2584899
If CNS status CNS2 or CNS3, extra MTX dose (i.th., on day 19 and 26): Date of administration
Beschreibung

MTX and CNS status: date of administration

Datentyp

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)
Beschreibung

PEG-L-ASP: administration form

Datentyp

boolean

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

PEG-L-ASP: dosage

Datentyp

float

Maßeinheiten
  • E
Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C0178602
E
PEG-L-ASP (If Randomisation in Group HR-ASP+, continue PEG-L-ASP therapy 14 days after dose on day 26) Date of administration
Beschreibung

PEG-L-ASP: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C2584899
PEG-L-ASP/ Erwinase
Beschreibung

PEG-L-ASP/ Erwinase

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

Change from PEG-L-ASP to Erwinase

Datentyp

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
Beschreibung

Erwinase: date of first administration

Datentyp

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
Beschreibung

Erwinase: date of last administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C2584899
UMLS CUI [1,3]
C1517741
If "yes", specify: Numbers of Erwinase doses
Beschreibung

Numbers of Erwinase doses

Datentyp

float

Alias
UMLS CUI [1,1]
C0591457
UMLS CUI [1,2]
C0237753
If "yes", specify: Reason for change to erwinase: Hypersensitivity
Beschreibung

Reason for drug change: Hypersensitivity

Datentyp

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
Beschreibung

Reason for drug change: date of hypersensitivity

Datentyp

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
Beschreibung

Reason for drug change: Other reason

Datentyp

text

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

Hospitalization

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

Hospital nights

Datentyp

float

Maßeinheiten
  • nights
Alias
UMLS CUI [1]
C0420496
nights
Identification and Signature
Beschreibung

Identification and Signature

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

Chemotherapy creator: signature

Datentyp

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
Beschreibung

Chemotherapy administration: signature

Datentyp

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1533734
UMLS CUI [2]
C1519316
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Ähnliche Modelle

Protocol IA AIEOP-BFM ALL 2009 NCT01117441

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Prednisone administration form
text
C0032952 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Dexamethasone: administration form
Code List
Prednisone administration form
CL Item
p.o (p.o)
CL Item
i.v. (i.v.)
Prednisone: dosage
Item
Prednisone dosage 60 mg/mˆ2/d
float
C0032952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prednisone: date of administration
Item
Prednisone Date of administration
date
C0032952 (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])
DNR: administration form
Item
DNR administration form p.i. (1h)
boolean
C0011015 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
DNR: dosage
Item
DNR dosage 30 mg/mˆ2/d
float
C0011015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
DNR: date of administration
Item
DNR Date of administration (If Randomisation in Group R1: reduced arm, no 3rd or 4th dose of DNR = Prot.IA')
date
C0011015 (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 CNS status CNS2 or CNS3, extra MTX dose (i.th., on day 19 and 26): 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 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 (If Randomisation in Group HR-ASP+, continue PEG-L-ASP therapy 14 days after dose on day 26) Date of administration
date
C0071568 (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
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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