ID

14932

Beschreibung

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

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  1. 09.05.16 09.05.16 -
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9. Mai 2016

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HR-3 therapy documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

Englisch

HR-3 therapy documentation 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
Dexamethasone administration form
Beschreibung

Dexamethasone: administration form

Datentyp

text

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0013153
Dexamethasone dosage 20 mg/mˆ2/d
Beschreibung

Dexamethasone: dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0178602
mg
Dexamethasone Date of administration
Beschreibung

Dexamethasone: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C2584899
ARA-C administration form p.i. (3h)
Beschreibung

ARA-C: administration form

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C1827465
ARA-C dosage 2000 mg/mˆ2/ED
Beschreibung

ARA-C: dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0178602
mg
ARA-C Date of administration
Beschreibung

ARA-C: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C2584899
VP-16 administration form p.i. (1h) (with MESNA: 70 mg/ˆ2 at hour 0, 4 and 8 of CPM-infusion regimen)
Beschreibung

VP-16: administration form

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0733688
UMLS CUI [1,2]
C1827465
VP-16 dosage 200 mg/mˆ2/ED
Beschreibung

VP-16: dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0733688
UMLS CUI [1,2]
C0178602
mg
VP-16 Date of administration
Beschreibung

VP-16: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0733688
UMLS CUI [1,2]
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 Date of administration
Beschreibung

PEG-L-ASP: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0071568
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
Beschreibung

MTX: date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0025677
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
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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

HR-3 therapy documentation 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
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])
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])
VP-16: administration form
Item
VP-16 administration form p.i. (1h) (with MESNA: 70 mg/ˆ2 at hour 0, 4 and 8 of CPM-infusion regimen)
boolean
C0733688 (UMLS CUI [1,1])
C1827465 (UMLS CUI [1,2])
VP-16: dosage
Item
VP-16 dosage 200 mg/mˆ2/ED
float
C0733688 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
VP-16: date of administration
Item
VP-16 Date of administration
date
C0733688 (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
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])
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