ID

11667

Description

Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide (VOD-DF) ODM derived from http://clinicaltrials.gov/show/NCT00272948

Link

http://clinicaltrials.gov/show/NCT00272948

Keywords

  1. 2/24/12 2/24/12 -
  2. 7/25/15 7/25/15 - Martin Dugas
Uploaded on

July 25, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Veno-Occlusive Disease Prophylactic Use of Defibrotide NCT00272948

Eligibility Veno-Occlusive Disease Prophylactic Use of Defibrotide NCT00272948

Inclusion Criteria
Description

Inclusion Criteria

Age below 18 years
Description

Age below 18 years

Data type

boolean

Alias
UMLS CUI-1
C0001779
myeloablative conditioning and autologous or allogeneic stem cell transplantation with at least one of the following risk factors for VOD: Pre-existing liver disease, Second myeloablative HSCT, History of treatment with gemtuzumab ozogamicin (MYLOTARGO, GO, CMA-676, Wyeth), Allogeneic HSCT for leukemia beyond the second relapse, Osteopetrosis (OP), Conditioning with busulfan and melphalan, Macrophage activating syndromes (MAS, like hemophagocytic lymphohistiocytosis, Griscelli, Chediak-Higashi), Adrenoleukodystrophy (ALD)
Description

myeloablative conditioning and autologous or allogeneic stem cell transplantation with at least one risk factor for VOD

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Pregnant patients
Description

Pregnant patients

Data type

boolean

Patients who are transplanted but do not fulfill any of the above mentioned criteria
Description

Patients who are transplanted but do not fulfill any of the above mentioned criteria

Data type

boolean

Medical Concepts
Description

Medical Concepts

Stem cell transplantation
Description

Stem cell transplant

Data type

string

Alias
UMLS CUI
C1504389
MedDRA 13.1
10063581
Autologous Hematopoietic Stem Cell Transplantation
Description

Autologous Stem Cell Transplantation

Data type

string

Alias
UMLS CUI
C1831743
Allogeneic Hematopoietic Stem Cell Transplantation, HSCT
Description

Allogeneic Stem Cell Transplantation

Data type

string

Alias
UMLS CUI
C2242529
MedDRA 13.1
10067862
Venoocclusive disease
Description

VOD

Data type

string

Alias
UMLS CUI
C0948441
MedDRA 13.1
10062173
Liver diseases
Description

Liver disorder

Data type

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
235856003
MedDRA 13.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Gemtuzumab ozogamicin, CMA-676
Description

Gemtuzumab ozogamicin

Data type

string

Alias
UMLS CUI
C1533699
SNOMED CT 2010_0731
127964000
leukemia
Description

leukemia

Data type

string

Alias
UMLS CUI
C0023418
SNOMED CT 2010_0731
93143009
MedDRA 13.1
10024288
ICD-10-CM Version 2010
C95.90
ICD-9-CM Version 2011
208
Recurrent Disease
Description

Relapse

Data type

string

Alias
UMLS CUI
C0277556
SNOMED CT 2010_0731
58184002
Albers-Schonberg disease
Description

Osteopetrosis

Data type

string

Alias
UMLS CUI
C0029454
SNOMED CT 2010_0731
1926006
MedDRA 13.1
10031280
ICD-10-CM Version 2010
Q78.2
ICD-9-CM Version 2011
756.52
Myleran
Description

Busulfan

Data type

string

Alias
UMLS CUI
C0700015
SNOMED CT 2010_0731
387138002
LOINC Version 232
MTHU004760
Melphalan
Description

Melphalan

Data type

string

Alias
UMLS CUI
C0025241
SNOMED CT 2010_0731
387297002
Macrophage-Activating Factors
Description

Macrophage-Activating Factors

Data type

string

Alias
UMLS CUI
C0079786
SNOMED CT 2010_0731
6532006
Hemophagocytic Lymphohistiocytosis
Description

Hemophagocytic Lymphohistiocytosis

Data type

string

Alias
UMLS CUI
C0024291
SNOMED CT 2010_0731
234437005
MedDRA 13.1
10071580
ICD-10-CM Version 2010
D76.1
Chediak-Higashi Syndrome
Description

Chediak-Higashi Syndrome

Data type

string

Alias
UMLS CUI
C0007965
SNOMED CT 2010_0731
111396008
MedDRA 13.1
10008415
ICD-10-CM Version 2010
E70.330
Adrenoleukodystrophy
Description

ALD

Data type

string

Alias
UMLS CUI
C0162309
SNOMED CT 2010_0731
65389002
MedDRA 13.1
10051260
ICD-10-CM Version 2010
E71.529
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Transplant procedure
Description

Transplantation

Data type

string

Alias
UMLS CUI
C0040732
SNOMED CT 2010_0731
77465005
MedDRA 13.1
10057677

Similar models

Eligibility Veno-Occlusive Disease Prophylactic Use of Defibrotide NCT00272948

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age below 18 years
boolean
C0001779 (UMLS CUI-1)
myeloablative conditioning and autologous or allogeneic stem cell transplantation with at least one risk factor for VOD
Item
myeloablative conditioning and autologous or allogeneic stem cell transplantation with at least one of the following risk factors for VOD: Pre-existing liver disease, Second myeloablative HSCT, History of treatment with gemtuzumab ozogamicin (MYLOTARGO, GO, CMA-676, Wyeth), Allogeneic HSCT for leukemia beyond the second relapse, Osteopetrosis (OP), Conditioning with busulfan and melphalan, Macrophage activating syndromes (MAS, like hemophagocytic lymphohistiocytosis, Griscelli, Chediak-Higashi), Adrenoleukodystrophy (ALD)
boolean
Item Group
Exclusion Criteria
Pregnant patients
Item
Pregnant patients
boolean
Patients who are transplanted but do not fulfill any of the above mentioned criteria
Item
Patients who are transplanted but do not fulfill any of the above mentioned criteria
boolean
Item Group
Medical Concepts
Stem cell transplant
Item
Stem cell transplantation
string
C1504389 (UMLS CUI)
10063581 (MedDRA 13.1)
Autologous Stem Cell Transplantation
Item
Autologous Hematopoietic Stem Cell Transplantation
string
C1831743 (UMLS CUI)
Allogeneic Stem Cell Transplantation
Item
Allogeneic Hematopoietic Stem Cell Transplantation, HSCT
string
C2242529 (UMLS CUI)
10067862 (MedDRA 13.1)
VOD
Item
Venoocclusive disease
string
C0948441 (UMLS CUI)
10062173 (MedDRA 13.1)
Liver disorder
Item
Liver diseases
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Gemtuzumab ozogamicin
Item
Gemtuzumab ozogamicin, CMA-676
string
C1533699 (UMLS CUI)
127964000 (SNOMED CT 2010_0731)
leukemia
Item
leukemia
string
C0023418 (UMLS CUI)
93143009 (SNOMED CT 2010_0731)
10024288 (MedDRA 13.1)
C95.90 (ICD-10-CM Version 2010)
208 (ICD-9-CM Version 2011)
Relapse
Item
Recurrent Disease
string
C0277556 (UMLS CUI)
58184002 (SNOMED CT 2010_0731)
Osteopetrosis
Item
Albers-Schonberg disease
string
C0029454 (UMLS CUI)
1926006 (SNOMED CT 2010_0731)
10031280 (MedDRA 13.1)
Q78.2 (ICD-10-CM Version 2010)
756.52 (ICD-9-CM Version 2011)
Busulfan
Item
Myleran
string
C0700015 (UMLS CUI)
387138002 (SNOMED CT 2010_0731)
MTHU004760 (LOINC Version 232)
Melphalan
Item
Melphalan
string
C0025241 (UMLS CUI)
387297002 (SNOMED CT 2010_0731)
Macrophage-Activating Factors
Item
Macrophage-Activating Factors
string
C0079786 (UMLS CUI)
6532006 (SNOMED CT 2010_0731)
Hemophagocytic Lymphohistiocytosis
Item
Hemophagocytic Lymphohistiocytosis
string
C0024291 (UMLS CUI)
234437005 (SNOMED CT 2010_0731)
10071580 (MedDRA 13.1)
D76.1 (ICD-10-CM Version 2010)
Chediak-Higashi Syndrome
Item
Chediak-Higashi Syndrome
string
C0007965 (UMLS CUI)
111396008 (SNOMED CT 2010_0731)
10008415 (MedDRA 13.1)
E70.330 (ICD-10-CM Version 2010)
ALD
Item
Adrenoleukodystrophy
string
C0162309 (UMLS CUI)
65389002 (SNOMED CT 2010_0731)
10051260 (MedDRA 13.1)
E71.529 (ICD-10-CM Version 2010)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Transplantation
Item
Transplant procedure
string
C0040732 (UMLS CUI)
77465005 (SNOMED CT 2010_0731)
10057677 (MedDRA 13.1)

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