ID

18314

Beschreibung

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

Stichworte

Versionen (1)
  1. 30.10.16 30.10.16 -
Hochgeladen am

30. Oktober 2016

DOI

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Lizenz

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

Englisch

Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00510926

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >/=18 years
Beschreibung

Age

Datentyp

boolean

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

Leukemia, Myeloid, Chronic-Phase First Duration

Datentyp

boolean

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

Chronic Myeloid Leukemia Intermediate Risk | Chronic Myeloid Leukemia Risk Score

Datentyp

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
Beschreibung

Philadelphia Chromosome Positive

Datentyp

boolean

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

Prior Therapy | hydroxyurea

Datentyp

boolean

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

performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18
Beschreibung

Age

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Diagnosis Period Since

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Allogeneic Stem Cell Transplantation Planned

Datentyp

boolean

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

performance status

Datentyp

boolean

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

Informed Consent Unable

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Contraceptive methods Refused

Datentyp

boolean

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

Substance Dependence

Datentyp

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.
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Myeloid Leukemia, Chronic, Chronic-Phase NCT00510926

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

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