ID

22895

Beschrijving

Treatment Protocol for Relapsed Acute Promyelocytic Leukemia (APL) With Arsenic; ODM derived from: https://clinicaltrials.gov/show/NCT00196768

Link

https://clinicaltrials.gov/show/NCT00196768

Trefwoorden

  1. 14-06-17 14-06-17 -
Geüploaded op

14 juni 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Relapsed Acute Promyelocytic Leukemia NCT00196768

Eligibility Relapsed Acute Promyelocytic Leukemia NCT00196768

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients in first or subsequent hematological or molecular relapse of apl
Beschrijving

Acute promyelocytic leukemia in relapse | First Relapse Hematologic | First Relapse Molecular | Subsequent Relapse Hematologic | Subsequent Relapse Molecular

Datatype

boolean

Alias
UMLS CUI [1]
C2861595
UMLS CUI [2,1]
C4054953
UMLS CUI [2,2]
C0205488
UMLS CUI [3,1]
C4054953
UMLS CUI [3,2]
C1521991
UMLS CUI [4,1]
C4053982
UMLS CUI [4,2]
C0205488
UMLS CUI [5,1]
C4053982
UMLS CUI [5,2]
C1521991
persistence of a positive pcr or no hematological complete remission (cr) after first line therapy
Beschrijving

Polymerase chain reaction positive Persistence | First line treatment | Complete remission Hematologic Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3888499
UMLS CUI [1,2]
C0546816
UMLS CUI [2]
C1708063
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C0205488
UMLS CUI [3,3]
C0332197
no complete hematological remission after first line therapy
Beschrijving

First line treatment | Complete remission Hematologic Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0205488
UMLS CUI [2,3]
C0332197
age over 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
no upper age limit
Beschrijving

Age Upper limit numbers Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0439085
UMLS CUI [1,3]
C0332197
informed consent of the patient
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
absolute qtc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the qt-interval)
Beschrijving

Prolonged QTc interval Absolute | Electrolytes normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1560305
UMLS CUI [1,2]
C0205344
UMLS CUI [2]
C0438240
heart failure new york health association grade iii and iv
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
renal or hepatic failure world health organization grade >= iii
Beschrijving

Kidney Failure WHO performance status scale | Liver Failure WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1298650
UMLS CUI [2,1]
C0085605
UMLS CUI [2,2]
C1298650
pneumonia with hypoxemia
Beschrijving

Pneumonia | Hypoxemia

Datatype

boolean

Alias
UMLS CUI [1]
C0032285
UMLS CUI [2]
C0700292
uncontrolled sepsis
Beschrijving

Sepsis Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
pregnancy and lactation period
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
secondary malignancy, which will have major influence on the prognosis
Beschrijving

Secondary Malignant Neoplasm Affecting Prognosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C3266877
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0033325
expected noncompliance
Beschrijving

Non-compliance Expected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C1517001
no informed consent of the patient.
Beschrijving

Informed Consent Missing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492

Similar models

Eligibility Relapsed Acute Promyelocytic Leukemia NCT00196768

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Acute promyelocytic leukemia in relapse | First Relapse Hematologic | First Relapse Molecular | Subsequent Relapse Hematologic | Subsequent Relapse Molecular
Item
patients in first or subsequent hematological or molecular relapse of apl
boolean
C2861595 (UMLS CUI [1])
C4054953 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C4054953 (UMLS CUI [3,1])
C1521991 (UMLS CUI [3,2])
C4053982 (UMLS CUI [4,1])
C0205488 (UMLS CUI [4,2])
C4053982 (UMLS CUI [5,1])
C1521991 (UMLS CUI [5,2])
Polymerase chain reaction positive Persistence | First line treatment | Complete remission Hematologic Absent
Item
persistence of a positive pcr or no hematological complete remission (cr) after first line therapy
boolean
C3888499 (UMLS CUI [1,1])
C0546816 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2])
C0677874 (UMLS CUI [3,1])
C0205488 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
First line treatment | Complete remission Hematologic Absent
Item
no complete hematological remission after first line therapy
boolean
C1708063 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Age
Item
age over 18 years
boolean
C0001779 (UMLS CUI [1])
Age Upper limit numbers Absent
Item
no upper age limit
boolean
C0001779 (UMLS CUI [1,1])
C0439085 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Informed Consent
Item
informed consent of the patient
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prolonged QTc interval Absolute | Electrolytes normal
Item
absolute qtc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the qt-interval)
boolean
C1560305 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
C0438240 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
heart failure new york health association grade iii and iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Kidney Failure WHO performance status scale | Liver Failure WHO performance status scale
Item
renal or hepatic failure world health organization grade >= iii
boolean
C0035078 (UMLS CUI [1,1])
C1298650 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2,1])
C1298650 (UMLS CUI [2,2])
Pneumonia | Hypoxemia
Item
pneumonia with hypoxemia
boolean
C0032285 (UMLS CUI [1])
C0700292 (UMLS CUI [2])
Sepsis Uncontrolled
Item
uncontrolled sepsis
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy and lactation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Secondary Malignant Neoplasm Affecting Prognosis
Item
secondary malignancy, which will have major influence on the prognosis
boolean
C3266877 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0033325 (UMLS CUI [1,3])
Non-compliance Expected
Item
expected noncompliance
boolean
C0457432 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Informed Consent Missing
Item
no informed consent of the patient.
boolean
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])

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