ID

18307

Beschrijving

Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00114764

Link

https://clinicaltrials.gov/show/NCT00114764

Trefwoorden

  1. 29-10-16 29-10-16 -
Geüploaded op

29 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Myeloid Leukemia NCT00114764

Eligibility Myeloid Leukemia NCT00114764

Criteria
Beschrijving

Criteria

histologically confirmed de novo aml as evidenced by absence of an antecedent hematologic disease of > 1 months duration, prior chemotherapy, prior radiation therapy or myelodysplastic cytogenetics (as per exclusion criteria)
Beschrijving

Acute Myelocytic Leukemia de novo | Hematological Disease antecedent Absent | Prior Chemotherapy | prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0018939
UMLS CUI [2,2]
C0683336
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C1514457
UMLS CUI [4]
C0279134
life expectancy, with treatment, > 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
age > 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0, 1 or 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function to receive protocol specified chemotherapy
Beschrijving

organ function | Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0392920
exclusion
Beschrijving

Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
subjects in blast transformation of chronic myeloid leukaemia (cml)
Beschrijving

Leukemia, Myeloid, Chronic-Phase | Lymphocyte Activation

Datatype

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2]
C0024262
patients with secondary aml (received previous chemotherapy or radiotherapy)
Beschrijving

secondary acute myeloid leukemia | Prior Chemotherapy | prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0280449
UMLS CUI [2]
C1514457
UMLS CUI [3]
C0279134
previous treatment for aml
Beschrijving

Prior Therapy Acute Myelocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023467
patients with aml fab type m3 (acute promyelocytic leukemia, apl) or m7
Beschrijving

Acute Promyelocytic Leukemia | Acute Megakaryocytic Leukemias

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
UMLS CUI [2]
C0023462
high risk (unfavourable) cytogenetics [(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(>3 abnormalities)]
Beschrijving

Cytogenetic Analysis High risk | Loss of Chromosome 5q | Loss of Chromosome 7q | t(8;21) | Loss of Chromosome 9q | Complex Karyotype | t(9;22) | Chromosome Aberrations Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0752095
UMLS CUI [1,2]
C0332167
UMLS CUI [2]
C1521461
UMLS CUI [3]
C1517990
UMLS CUI [4]
C3897139
UMLS CUI [5]
C1517995
UMLS CUI [6]
C3273253
UMLS CUI [7]
C3897138
UMLS CUI [8,1]
C0008625
UMLS CUI [8,2]
C1265611

Similar models

Eligibility Myeloid Leukemia NCT00114764

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Acute Myelocytic Leukemia de novo | Hematological Disease antecedent Absent | Prior Chemotherapy | prior radiation therapy
Item
histologically confirmed de novo aml as evidenced by absence of an antecedent hematologic disease of > 1 months duration, prior chemotherapy, prior radiation therapy or myelodysplastic cytogenetics (as per exclusion criteria)
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0018939 (UMLS CUI [2,1])
C0683336 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
Life Expectancy
Item
life expectancy, with treatment, > 3 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
organ function | Chemotherapy
Item
adequate organ function to receive protocol specified chemotherapy
boolean
C0678852 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
Leukemia, Myeloid, Chronic-Phase | Lymphocyte Activation
Item
subjects in blast transformation of chronic myeloid leukaemia (cml)
boolean
C0023474 (UMLS CUI [1])
C0024262 (UMLS CUI [2])
secondary acute myeloid leukemia | Prior Chemotherapy | prior radiation therapy
Item
patients with secondary aml (received previous chemotherapy or radiotherapy)
boolean
C0280449 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
C0279134 (UMLS CUI [3])
Prior Therapy Acute Myelocytic Leukemia
Item
previous treatment for aml
boolean
C1514463 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Acute Promyelocytic Leukemia | Acute Megakaryocytic Leukemias
Item
patients with aml fab type m3 (acute promyelocytic leukemia, apl) or m7
boolean
C0023487 (UMLS CUI [1])
C0023462 (UMLS CUI [2])
Cytogenetic Analysis High risk | Loss of Chromosome 5q | Loss of Chromosome 7q | t(8;21) | Loss of Chromosome 9q | Complex Karyotype | t(9;22) | Chromosome Aberrations Quantity
Item
high risk (unfavourable) cytogenetics [(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(>3 abnormalities)]
boolean
C0752095 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1521461 (UMLS CUI [2])
C1517990 (UMLS CUI [3])
C3897139 (UMLS CUI [4])
C1517995 (UMLS CUI [5])
C3273253 (UMLS CUI [6])
C3897138 (UMLS CUI [7])
C0008625 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])

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