ID

18314

Descrição

Exploratory Study of IMATINIB High Dose in Intermediate Risk Chronic Myeloid Leukemia in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT00510926

Link

https://clinicaltrials.gov/show/NCT00510926

Palavras-chave

Versões (1)
  1. 30/10/2016 30/10/2016 -
Transferido a

30 de outubro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00510926

Inglês

Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00510926

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >/=18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
first chronic phase, less than 6 months of duration
Descrição

Leukemia, Myeloid, Chronic-Phase First Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0449238
intermediate sokal's risk
Descrição

Chronic Myeloid Leukemia Intermediate Risk | Chronic Myeloid Leukemia Risk Score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C3640764
UMLS CUI [2,1]
C0023474
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0449820
ph positive
Descrição

Philadelphia Chromosome Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031526
UMLS CUI [1,2]
C1514241
no previous treatment or hydroxiurea only.
Descrição

Prior Therapy | hydroxyurea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0020402
performance status (ecog/who) < or = 2
Descrição

performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518965
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
low or high sokal risk score.
Descrição

Chronic Myeloid Leukemia Low Risk | Chronic Myeloid Leukemia High Risk | Chronic Myeloid Leukemia Risk Score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C3538919
UMLS CUI [2,1]
C0023474
UMLS CUI [2,2]
C0332167
UMLS CUI [3,1]
C0023474
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0449820
more than 6 months from diagnosis.
Descrição

Diagnosis Period Since

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1948053
UMLS CUI [1,3]
C1711239
second chronic, accelerated or blastic phase
Descrição

Leukemia, Myeloid, Chronic-Phase second | Leukemia, Myeloid, Accelerated Phase second | Blast Phase second

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0205436
UMLS CUI [2,1]
C0023472
UMLS CUI [2,2]
C0205436
UMLS CUI [3,1]
C0005699
UMLS CUI [3,2]
C0205436
scheduled allogeneic stem cell transplantation within 1 year from diagnosis.
Descrição

Allogeneic Stem Cell Transplantation Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2242529
UMLS CUI [1,2]
C1301732
performance status (ecog/who) > 2 (see appendix 2)
Descrição

performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518965
inability to provide written informed consent
Descrição

Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
pregnancy
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
formal refusal of any recommendation of a safe contraception
Descrição

Contraceptive methods Refused

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1705116
alcohol or drug addiction
Descrição

Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
altered hepatic or renal function as defined by ast/alt or bilirubine > 3 times upper normal limits (unl) and by creatinine ³ 20mg/l any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
Descrição

Liver function altered | Renal function altered | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum | Condition Resulting in Risk patient safety | Condition Resulting in Study Subject Participation Status Inappropriate | Physical health problems | Psychiatric problem | Social Problems | Abnormal behavior

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0392747
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0392747
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201976
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C0332294
UMLS CUI [7,3]
C0035647
UMLS CUI [7,4]
C1113679
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0332294
UMLS CUI [8,3]
C2348568
UMLS CUI [8,4]
C1548788
UMLS CUI [9]
C1446390
UMLS CUI [10]
C1306597
UMLS CUI [11]
C0037431
UMLS CUI [12]
C0233514
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Similar models

Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00510926

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >/=18 years
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myeloid, Chronic-Phase First Duration
Item
first chronic phase, less than 6 months of duration
boolean
C0023474 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Chronic Myeloid Leukemia Intermediate Risk | Chronic Myeloid Leukemia Risk Score
Item
intermediate sokal's risk
boolean
C0023474 (UMLS CUI [1,1])
C3640764 (UMLS CUI [1,2])
C0023474 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Philadelphia Chromosome Positive
Item
ph positive
boolean
C0031526 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Prior Therapy | hydroxyurea
Item
no previous treatment or hydroxiurea only.
boolean
C1514463 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
performance status
Item
performance status (ecog/who) < or = 2
boolean
C1518965 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <18
boolean
C0001779 (UMLS CUI [1])
Chronic Myeloid Leukemia Low Risk | Chronic Myeloid Leukemia High Risk | Chronic Myeloid Leukemia Risk Score
Item
low or high sokal risk score.
boolean
C0023474 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
C0023474 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0023474 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0449820 (UMLS CUI [3,3])
Diagnosis Period Since
Item
more than 6 months from diagnosis.
boolean
C0011900 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
Leukemia, Myeloid, Chronic-Phase second | Leukemia, Myeloid, Accelerated Phase second | Blast Phase second
Item
second chronic, accelerated or blastic phase
boolean
C0023474 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0023472 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0005699 (UMLS CUI [3,1])
C0205436 (UMLS CUI [3,2])
Allogeneic Stem Cell Transplantation Planned
Item
scheduled allogeneic stem cell transplantation within 1 year from diagnosis.
boolean
C2242529 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
performance status
Item
performance status (ecog/who) > 2 (see appendix 2)
boolean
C1518965 (UMLS CUI [1])
Informed Consent Unable
Item
inability to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Contraceptive methods Refused
Item
formal refusal of any recommendation of a safe contraception
boolean
C0700589 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Substance Dependence
Item
alcohol or drug addiction
boolean
C0038580 (UMLS CUI [1])
Liver function altered | Renal function altered | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum | Condition Resulting in Risk patient safety | Condition Resulting in Study Subject Participation Status Inappropriate | Physical health problems | Psychiatric problem | Social Problems | Abnormal behavior
Item
altered hepatic or renal function as defined by ast/alt or bilirubine > 3 times upper normal limits (unl) and by creatinine ³ 20mg/l any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
boolean
C0232741 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0348080 (UMLS CUI [7,1])
C0332294 (UMLS CUI [7,2])
C0035647 (UMLS CUI [7,3])
C1113679 (UMLS CUI [7,4])
C0348080 (UMLS CUI [8,1])
C0332294 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C1548788 (UMLS CUI [8,4])
C1446390 (UMLS CUI [9])
C1306597 (UMLS CUI [10])
C0037431 (UMLS CUI [11])
C0233514 (UMLS CUI [12])
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