ID

16694

Description

Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00101647

Link

https://clinicaltrials.gov/show/NCT00101647

Keywords

Versions (1)
  1. 8/1/16 8/1/16 -
Uploaded on

August 1, 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.

Back to model comments
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 Chronic Myelogenous Leukemia NCT00101647

English

Eligibility Chronic Myelogenous Leukemia NCT00101647

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with philadelphia chromosome positive (ph+) or the fused gene bcr/abl positive (bcr/abl+) accelerated phase chronic myeloid leukemia (cml) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Description

Philadelphia chromosome positive chronic myelogenous leukemia | Chronic myeloid leukemia, BCR/ABL-positive | Leukemia, Myeloid, Accelerated Phase | Resistance Hematologic Primary Imatinib mesylate | Resistance Hematologic Acquired Imatinib mesylate | intolerance to Imatinib mesylate

Data type

boolean

Alias
UMLS CUI [1]
C0279543
UMLS CUI [2]
C2861580
UMLS CUI [3]
C0023472
UMLS CUI [4,1]
C1514892
UMLS CUI [4,2]
C0205488
UMLS CUI [4,3]
C0205225
UMLS CUI [4,4]
C0939537
UMLS CUI [5,1]
C1514892
UMLS CUI [5,2]
C0205488
UMLS CUI [5,3]
C0439661
UMLS CUI [5,4]
C0939537
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0939537
subjects must have had prior exposure to imatinib. however, imatinib mesylate does not need to be their most recent cml treatment prior to coming on this study.
Description

imatinib; Exposure to | Imatinib mesylate | Therapeutic procedure Chronic Myeloid Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C0939537
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0023473
men and women, 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate hepatic function.
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
adequate renal function.
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
Description

Childbearing Potential Contraceptive methods | Low risk pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0404841
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who are eligible and willing to undergo transplantation during the screening period.
Description

Transplantation Suitable Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0600109
a serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
Description

Disease Uncontrolled Serious Impairing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0221099
UMLS CUI [1,5]
C0525058
uncontrolled or significant cardiovascular disease.
Description

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
medications that increase bleeding risk.
Description

Pharmaceutical Preparations Bleeding Risk Increase

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3251812
UMLS CUI [1,3]
C0442805
medications that change heart rhythms.
Description

Pharmaceutical Preparations Changing Cardiac rhythms

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0232187
dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
Description

Dementia Preventing Informed Consent | Abnormal mental state Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0278061
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
history of significant bleeding disorder unrelated to cml.
Description

Blood Coagulation Disorders Significant Independent of Chronic Myeloid Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332291
UMLS CUI [1,4]
C0023473
concurrent incurable malignancy other than cml.
Description

Malignant Neoplasm incurable | Myeloid Leukemia, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0175969
UMLS CUI [2]
C0023473
evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
Description

organ dysfunction Evidence Preventing Protocol Compliance | Digestive organ Dysfunction Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0227435
UMLS CUI [2,2]
C3887504
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
prior therapy with dasatinib (bms-354825).
Description

dasatinib | BMS 354825

Data type

boolean

Alias
UMLS CUI [1]
C1455147
UMLS CUI [2]
C1328005
prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Description

Prisoners | In prison Involuntary Therapeutic procedure Mental disorders | In prison Involuntary Therapeutic procedure physical illness | In prison Involuntary Therapeutic procedure Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2,1]
C0392751
UMLS CUI [2,2]
C2986385
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0004936
UMLS CUI [3,1]
C0392751
UMLS CUI [3,2]
C2986385
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0683323
UMLS CUI [4,1]
C0392751
UMLS CUI [4,2]
C2986385
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0009450
Back to the top of the page

Similar models

Eligibility Chronic Myelogenous Leukemia NCT00101647

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia | Chronic myeloid leukemia, BCR/ABL-positive | Leukemia, Myeloid, Accelerated Phase | Resistance Hematologic Primary Imatinib mesylate | Resistance Hematologic Acquired Imatinib mesylate | intolerance to Imatinib mesylate
Item
subjects with philadelphia chromosome positive (ph+) or the fused gene bcr/abl positive (bcr/abl+) accelerated phase chronic myeloid leukemia (cml) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
boolean
C0279543 (UMLS CUI [1])
C2861580 (UMLS CUI [2])
C0023472 (UMLS CUI [3])
C1514892 (UMLS CUI [4,1])
C0205488 (UMLS CUI [4,2])
C0205225 (UMLS CUI [4,3])
C0939537 (UMLS CUI [4,4])
C1514892 (UMLS CUI [5,1])
C0205488 (UMLS CUI [5,2])
C0439661 (UMLS CUI [5,3])
C0939537 (UMLS CUI [5,4])
C1744706 (UMLS CUI [6,1])
C0939537 (UMLS CUI [6,2])
imatinib; Exposure to | Imatinib mesylate | Therapeutic procedure Chronic Myeloid Leukemia
Item
subjects must have had prior exposure to imatinib. however, imatinib mesylate does not need to be their most recent cml treatment prior to coming on this study.
boolean
C0935989 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0939537 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0023473 (UMLS CUI [3,2])
Age
Item
men and women, 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Liver function
Item
adequate hepatic function.
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
adequate renal function.
boolean
C0232804 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Low risk pregnancy
Item
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0404841 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Transplantation Suitable Willing
Item
subjects who are eligible and willing to undergo transplantation during the screening period.
boolean
C0040732 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Disease Uncontrolled Serious Impairing Protocol Compliance
Item
a serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
C0525058 (UMLS CUI [1,5])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant
Item
uncontrolled or significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Pharmaceutical Preparations Bleeding Risk Increase
Item
medications that increase bleeding risk.
boolean
C0013227 (UMLS CUI [1,1])
C3251812 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
Pharmaceutical Preparations Changing Cardiac rhythms
Item
medications that change heart rhythms.
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0232187 (UMLS CUI [1,3])
Dementia Preventing Informed Consent | Abnormal mental state Preventing Informed Consent
Item
dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0278061 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Blood Coagulation Disorders Significant Independent of Chronic Myeloid Leukemia
Item
history of significant bleeding disorder unrelated to cml.
boolean
C0005779 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332291 (UMLS CUI [1,3])
C0023473 (UMLS CUI [1,4])
Malignant Neoplasm incurable | Myeloid Leukemia, Chronic
Item
concurrent incurable malignancy other than cml.
boolean
C0006826 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0023473 (UMLS CUI [2])
organ dysfunction Evidence Preventing Protocol Compliance | Digestive organ Dysfunction Preventing Protocol Compliance
Item
evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
boolean
C0349410 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0227435 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
dasatinib | BMS 354825
Item
prior therapy with dasatinib (bms-354825).
boolean
C1455147 (UMLS CUI [1])
C1328005 (UMLS CUI [2])
Prisoners | In prison Involuntary Therapeutic procedure Mental disorders | In prison Involuntary Therapeutic procedure physical illness | In prison Involuntary Therapeutic procedure Communicable Diseases
Item
prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
boolean
C0033167 (UMLS CUI [1])
C0392751 (UMLS CUI [2,1])
C2986385 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0004936 (UMLS CUI [2,4])
C0392751 (UMLS CUI [3,1])
C2986385 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0683323 (UMLS CUI [3,4])
C0392751 (UMLS CUI [4,1])
C2986385 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0009450 (UMLS CUI [4,4])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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