ID

14002

Beschrijving

GRASPA Treatment for Patients With Acute Myeloblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01810705

Link

https://clinicaltrials.gov/show/NCT01810705

Trefwoorden

  1. 21-03-16 21-03-16 -
Geüploaded op

21 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT01810705

Eligibility Acute Myeloid Leukemia NCT01810705

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient over 65 years old and less than 85 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Newly diagnosed acute myeloid leukemia or post myelodysplastic syndrome diagnosed in the 6 months prior study enrollment
Beschrijving

AML or myelodysplastic syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) or patient unwilling to receive intensive chemotherapy
Beschrijving

Unfit for intensive chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3665472
who performance status ≤2 and estimated life expectancy ≥ 3 months
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
eligible to receive low-dose cytarabine treatment
Beschrijving

Cytarabine treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0010711
Evidence of post-menopausal status for female (absence of menstruation for 12 months)
Beschrijving

Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patients with m3 aml of french american british classification ( acute promyelocytic leukemia)
Beschrijving

Acute Promyelocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
Patients with aml involving chromosome 16 abnormalities or translocation (8:21)
Beschrijving

Aml involving chromosome 16

Datatype

boolean

Alias
UMLS CUI [1]
C3688691
history of grade 3-4 pancreatitis or grade 3-4 thromboembolic event
Beschrijving

Pancreatitis or thromboembolic event

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0040038
presenting with a general or visceral contraindication (uncontrolled or severe cardiovascular disease ; plasma creatinine concentration 2 times greater than the upper limit of laboratory ranges ; aspartate aminotransferase (ast) or alanine aminotransferase (alt) levels, 3.5 times greater than the upper limit of laboratory ranges ; patient presenting evolutive cancer other than aml, except in situ basal-cell carcinoma or in situ cervix cancer ; severe evolutive infection, or, hiv seropositive or, active hepatitis related to b or c viral infection)
Beschrijving

Medical contraindication

Datatype

boolean

Alias
UMLS CUI [1]
C1301624
History of grade 3 transfusional incident
Beschrijving

Transfusion Reaction

Datatype

boolean

Alias
UMLS CUI [1]
C0274435
Has known or suspected hypersensitivity or intolerance to mannitol
Beschrijving

Hypersensitivity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0024730
Patient presenting contraindication to cytarabine treatment
Beschrijving

Contraindication to cytarabine

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0010711
Participation in an investigational drug study within the 30 days prior to entry
Beschrijving

Participation in other study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Acute Myeloid Leukemia NCT01810705

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Patient over 65 years old and less than 85 years old
boolean
C0001779 (UMLS CUI [1])
AML or myelodysplastic syndrome
Item
Newly diagnosed acute myeloid leukemia or post myelodysplastic syndrome diagnosed in the 6 months prior study enrollment
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
Unfit for intensive chemotherapy
Item
unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) or patient unwilling to receive intensive chemotherapy
boolean
C3665472 (UMLS CUI [1])
WHO performance status scale
Item
who performance status ≤2 and estimated life expectancy ≥ 3 months
boolean
C1298650 (UMLS CUI [1])
Cytarabine treatment
Item
eligible to receive low-dose cytarabine treatment
boolean
C0010711 (UMLS CUI [1])
Postmenopausal state
Item
Evidence of post-menopausal status for female (absence of menstruation for 12 months)
boolean
C0232970 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
Patients with m3 aml of french american british classification ( acute promyelocytic leukemia)
boolean
C0023487 (UMLS CUI [1])
Aml involving chromosome 16
Item
Patients with aml involving chromosome 16 abnormalities or translocation (8:21)
boolean
C3688691 (UMLS CUI [1])
Pancreatitis or thromboembolic event
Item
history of grade 3-4 pancreatitis or grade 3-4 thromboembolic event
boolean
C0030305 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
Medical contraindication
Item
presenting with a general or visceral contraindication (uncontrolled or severe cardiovascular disease ; plasma creatinine concentration 2 times greater than the upper limit of laboratory ranges ; aspartate aminotransferase (ast) or alanine aminotransferase (alt) levels, 3.5 times greater than the upper limit of laboratory ranges ; patient presenting evolutive cancer other than aml, except in situ basal-cell carcinoma or in situ cervix cancer ; severe evolutive infection, or, hiv seropositive or, active hepatitis related to b or c viral infection)
boolean
C1301624 (UMLS CUI [1])
Transfusion Reaction
Item
History of grade 3 transfusional incident
boolean
C0274435 (UMLS CUI [1])
Hypersensitivity
Item
Has known or suspected hypersensitivity or intolerance to mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0024730 (UMLS CUI [1,2])
Contraindication to cytarabine
Item
Patient presenting contraindication to cytarabine treatment
boolean
C1301624 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
Participation in other study
Item
Participation in an investigational drug study within the 30 days prior to entry
boolean
C2348568 (UMLS CUI [1])

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