ID

18307

Description

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

Keywords

  1. 10/29/16 10/29/16 -
Uploaded on

October 29, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Myeloid Leukemia NCT00114764

Eligibility Myeloid Leukemia NCT00114764

Criteria
Description

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)
Description

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

Data type

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
Description

Life Expectancy

Data type

boolean

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

Age

Data type

boolean

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

ECOG performance status

Data type

boolean

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

organ function | Chemotherapy

Data type

boolean

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

Exclusion Criteria

Data type

boolean

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

Leukemia, Myeloid, Chronic-Phase | Lymphocyte Activation

Data type

boolean

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

secondary acute myeloid leukemia | Prior Chemotherapy | prior radiation therapy

Data type

boolean

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

Prior Therapy Acute Myelocytic Leukemia

Data type

boolean

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

Acute Promyelocytic Leukemia | Acute Megakaryocytic Leukemias

Data type

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)]
Description

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

Data type

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)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial