ID

42033

Descripción

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

Palabras clave

Versiones (2)
  1. 31/5/16 31/5/16 -
  2. 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Subido en

15 de marzo de 2021

DOI

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Licencia

Creative Commons BY-NC-ND 3.0
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SAE documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

Inglés

SAE documentation AIEOP-BFM ALL 2009 NCT01117441

1 formularios  
Patient Information
Descripción

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Study ID
Descripción

Patient Study ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Patient Date of Birth
Descripción

Patient Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Therapy
Descripción

Therapy

Alias
UMLS CUI-1
C0039798
Specify Protocol I:
Descripción

Protocol I

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0205435
Specify Methotrexate protocol:
Descripción

Methotrexate protocol

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0025677
Specify Protocol II:
Descripción

Protocol II

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0205436
Specify high risk block:
Descripción

High risk block

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0684030
UMLS CUI [1,2]
C0039798
Specify interval therapy:
Descripción

Interval therapy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0039798
Specify maintenance therapy:
Descripción

Maintenance therapy

Tipo de datos

text

Alias
UMLS CUI [1]
C0677908
Specify other therapeutic aspects:
Descripción

Other therapeutic aspects

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0039798
UMLS CUI [1,2]
C2348235
Therapy start date
Descripción

Therapy start date

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Severe adverse event: reported SAE must meet criteria 1) at least one of the following (a) death of patient, b) life-threatening, c) not planned hospitalization or necessary prelongiation of stay, d) conditions which may lead to disability, e) congenital anomaly or malformations in descendants) 2. other for study relevant toxicities
Descripción

Severe adverse event: reported SAE must meet criteria 1) at least one of the following (a) death of patient, b) life-threatening, c) not planned hospitalization or necessary prelongiation of stay, d) conditions which may lead to disability, e) congenital anomaly or malformations in descendants) 2. other for study relevant toxicities

Alias
UMLS CUI-1
C1519275
Severe adverse event: Infection
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
Severe adverse event: Infection: If "Yes", has it been reported?
Descripción

Infection: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0700287
Severe adverse event: Pancreas
Descripción

Pancreas

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030274
Severe adverse event: Pancreas: If "Yes", has it been reported?
Descripción

Pancreas: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030274
UMLS CUI [1,2]
C0700287
Severe adverse event: Thrombosis
Descripción

Thrombosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040053
Severe adverse event: Thrombosis: If "Yes", has it been reported?
Descripción

Thrombosis: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C0700287
Severe adverse event: Liver
Descripción

Liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023884
Severe adverse event: Liver: If "Yes", has it been reported?
Descripción

Liver: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0700287
Severe adverse event: Neurologic/ Psychologic aspects
Descripción

Neurologic/ Psychologic aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027763
UMLS CUI [2]
C0205486
Severe adverse event: Neurologic/ Psychologic aspects: If "Yes", has it been reported?
Descripción

Neurologic/ Psychologic aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027763
UMLS CUI [1,2]
C0700287
UMLS CUI [2,1]
C0205486
UMLS CUI [2,2]
C0700287
Severe adverse event: Gastrointestinal aspects
Descripción

Gastrointestinal aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012240
Severe adverse event: Gastrointestinal aspects: If "Yes", has it been reported?
Descripción

Gastrointestinal aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012240
UMLS CUI [1,2]
C0700287
Severe adverse event: Dermatologic aspects
Descripción

Dermatologic aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037274
Severe adverse event: Dermatologic aspects: If "Yes", has it been reported?
Descripción

Dermatologic aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0700287
Severe adverse event: Cardiac aspects
Descripción

Cardiac aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522601
Severe adverse event: Cardiac aspects: If "Yes", has it been reported?
Descripción

Cardiac aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522601
UMLS CUI [1,2]
C0700287
Severe adverse event: Renal aspects
Descripción

Renal aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022646
Severe adverse event: Renal aspects: If "Yes", has it been reported?
Descripción

Renal aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0700287
Severe adverse event: Metabolic/ endocrinologic aspects
Descripción

Metabolic/ endocrinologic aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0694557
Severe adverse event: Metabolic/ endocrinologic aspects: If "Yes", has it been reported?
Descripción

Metabolic/ endocrinologic aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0700287
UMLS CUI [2,1]
C0694557
UMLS CUI [2,2]
C0700287
Severe adverse event: Drug intolerance
Descripción

Drug intolerance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277585
Severe adverse event: Drug intolerance: If "Yes", has it been reported?
Descripción

Drug intolerance: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0277585
UMLS CUI [1,2]
C0700287
Severe adverse event: Skeleton aspects
Descripción

Skeleton aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0816871
Severe adverse event: Skeleton aspects: If "Yes", has it been reported?
Descripción

Skeleton aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0816871
UMLS CUI [1,2]
C0700287
Severe adverse event: Not classified aspects
Descripción

Not classified aspects

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205426
Severe adverse event: Not classified aspects: If "Yes", has it been reported?
Descripción

Not classified aspects: reporting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205426
UMLS CUI [1,2]
C0700287
Identification and Signature
Descripción

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-2
C1519316
Date of report
Descripción

Date of report

Tipo de datos

date

Alias
UMLS CUI [1]
C1302584
Docotor's name
Descripción

Doctor's name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0031831
Doctor's signature
Descripción

Doctor's signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
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Similar models

SAE documentation AIEOP-BFM ALL 2009 NCT01117441

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
text
C2348585 (UMLS CUI [1])
Patient Date of Birth
Item
Patient Date of Birth
date
C0421451 (UMLS CUI [1])
Item Group
Therapy
C0039798 (UMLS CUI-1)
Item
Specify Protocol I:
text
C2348563 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
Protocol I
Code List
Specify Protocol I:
CL Item
Prot. IA (Prot. IA)
CL Item
Prot. IAD (Prot. IAD)
CL Item
Prot. IA' (Prot. IA')
CL Item
Prot. IA-CPM (Prot. IA-CPM)
CL Item
Prot. IB (Prot. IB)
CL Item
Prot. IB-ASP+ (Prot. IB-ASP+)
Item
Specify Methotrexate protocol:
text
C2348563 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
Methotrexate protocol
Code List
Specify Methotrexate protocol:
CL Item
1st HD-MTX (1st HD-MTX)
CL Item
2nd HD-MTX (2nd HD-MTX)
CL Item
3rd HD-MTX (3rd HD-MTX)
CL Item
4th HD-MTX (4th HD-MTX)
Item
Specify Protocol II:
text
C2348563 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
Protocol II
Code List
Specify Protocol II:
CL Item
Prot. IIA (Prot. IIA)
CL Item
Prot. IIA-ASP+ (Prot. IIA-ASP+)
CL Item
Prot. IIB (Prot. IIB)
CL Item
Prot. IIB-ASP+ (Prot. IIB-ASP+)
Item
Specify high risk block:
text
C0684030 (UMLS CUI [1,1])
C0039798 (UMLS CUI [1,2])
High risk block
Code List
Specify high risk block:
CL Item
HR-1' (HR-1')
CL Item
HR-2' (HR-2')
CL Item
HR-3' (HR-3')
CL Item
DNX-FLA (DNX-FLA)
Item
Specify interval therapy:
text
C1272706 (UMLS CUI [1,1])
C0039798 (UMLS CUI [1,2])
Interval therapy
Code List
Specify interval therapy:
CL Item
1st interval therapy (1st interval therapy)
CL Item
2nd interval therapy (2nd interval therapy)
Item
Specify maintenance therapy:
text
C0677908 (UMLS CUI [1])
Maintenance therapy
Code List
Specify maintenance therapy:
CL Item
Maintenance therapy (Maintenance therapy)
Other therapeutic aspects
Item
Specify other therapeutic aspects:
text
C0039798 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Therapy start date
Item
Therapy start date
date
C3173309 (UMLS CUI [1])
Item Group
Severe adverse event: reported SAE must meet criteria 1) at least one of the following (a) death of patient, b) life-threatening, c) not planned hospitalization or necessary prelongiation of stay, d) conditions which may lead to disability, e) congenital anomaly or malformations in descendants) 2. other for study relevant toxicities
C1519275 (UMLS CUI-1)
Infection
Item
Severe adverse event: Infection
boolean
C0009450 (UMLS CUI [1])
Infection: reporting
Item
Severe adverse event: Infection: If "Yes", has it been reported?
boolean
C0009450 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Pancreas
Item
Severe adverse event: Pancreas
boolean
C0030274 (UMLS CUI [1])
Pancreas: reporting
Item
Severe adverse event: Pancreas: If "Yes", has it been reported?
boolean
C0030274 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Thrombosis
Item
Severe adverse event: Thrombosis
boolean
C0040053 (UMLS CUI [1])
Thrombosis: reporting
Item
Severe adverse event: Thrombosis: If "Yes", has it been reported?
boolean
C0040053 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Liver
Item
Severe adverse event: Liver
boolean
C0023884 (UMLS CUI [1])
Liver: reporting
Item
Severe adverse event: Liver: If "Yes", has it been reported?
boolean
C0023884 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Neurologic/ Psychologic aspects
Item
Severe adverse event: Neurologic/ Psychologic aspects
boolean
C0027763 (UMLS CUI [1])
C0205486 (UMLS CUI [2])
Neurologic/ Psychologic aspects: reporting
Item
Severe adverse event: Neurologic/ Psychologic aspects: If "Yes", has it been reported?
boolean
C0027763 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
C0205486 (UMLS CUI [2,1])
C0700287 (UMLS CUI [2,2])
Gastrointestinal aspects
Item
Severe adverse event: Gastrointestinal aspects
boolean
C0012240 (UMLS CUI [1])
Gastrointestinal aspects: reporting
Item
Severe adverse event: Gastrointestinal aspects: If "Yes", has it been reported?
boolean
C0012240 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Dermatologic aspects
Item
Severe adverse event: Dermatologic aspects
boolean
C0037274 (UMLS CUI [1])
Dermatologic aspects: reporting
Item
Severe adverse event: Dermatologic aspects: If "Yes", has it been reported?
boolean
C0037274 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Cardiac aspects
Item
Severe adverse event: Cardiac aspects
boolean
C1522601 (UMLS CUI [1])
Cardiac aspects: reporting
Item
Severe adverse event: Cardiac aspects: If "Yes", has it been reported?
boolean
C1522601 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Renal aspects
Item
Severe adverse event: Renal aspects
boolean
C0022646 (UMLS CUI [1])
Renal aspects: reporting
Item
Severe adverse event: Renal aspects: If "Yes", has it been reported?
boolean
C0022646 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Metabolic/ endocrinologic aspects
Item
Severe adverse event: Metabolic/ endocrinologic aspects
boolean
C0025517 (UMLS CUI [1])
C0694557 (UMLS CUI [2])
Metabolic/ endocrinologic aspects: reporting
Item
Severe adverse event: Metabolic/ endocrinologic aspects: If "Yes", has it been reported?
boolean
C0025517 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
C0694557 (UMLS CUI [2,1])
C0700287 (UMLS CUI [2,2])
Drug intolerance
Item
Severe adverse event: Drug intolerance
boolean
C0277585 (UMLS CUI [1])
Drug intolerance: reporting
Item
Severe adverse event: Drug intolerance: If "Yes", has it been reported?
boolean
C0277585 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Skeleton aspects
Item
Severe adverse event: Skeleton aspects
boolean
C0816871 (UMLS CUI [1])
Skeleton aspects: reporting
Item
Severe adverse event: Skeleton aspects: If "Yes", has it been reported?
boolean
C0816871 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Not classified aspects
Item
Severe adverse event: Not classified aspects
boolean
C0205426 (UMLS CUI [1])
Not classified aspects: reporting
Item
Severe adverse event: Not classified aspects: If "Yes", has it been reported?
boolean
C0205426 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Doctor's name
Item
Docotor's name
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Doctor's signature
Item
Doctor's signature
text
C1519316 (UMLS CUI [1])
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