ID

42024

Description

Study documentation part: Pre-Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3.

Keywords

  1. 7/6/15 7/6/15 -
  2. 8/6/15 8/6/15 -
  3. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

March 15, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Pre-Treatment

Imatinib Mesylate

PRIOR IMATINIB MESYLATE HISTORY
Description

PRIOR IMATINIB MESYLATE HISTORY

Alias
UMLS CUI-2
C0939537
Date of first dose of imatinib mesylate received:
Description

DATE OF FIRST DOSE OF IM A TINIB MESYLATE RECEIVED

Data type

date

Alias
UMLS CUI-1
C3173309
Date of last dose of imatinib mesylate received:
Description

DATE OF LAST DOSE OF IM A TINIB MESYLATE RECEIVED

Data type

date

Alias
UMLS CUI-1
C1762893
Highest dose of imatinib mesylate received (in mg):
Description

HIGHEST DOSE OF IM A TINIB MESYLATE RECEIVED

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0178602
mg
Subject is eligible due to:
Description

SUBJECT IS ELIGIBLE DUE TO

Data type

text

Alias
UMLS CUI-1
C1548635
Has the subject ever tolerated a dose of imatinib mesylate greater than or equal to 600mg?
Description

HAS THE SUBJECT EVER TOLERATED A DOSE OF IMATINIB MESYLATE GREATER THAN OR EQUAL TO 600 mg?

Data type

boolean

Alias
UMLS CUI-1
C3658296
UMLS CUI-2
C0178602
Reasons for intolerance:
Description

REASONS FOR INTOLERANCE

Data type

text

Alias
UMLS CUI-1
C1744706
If other, please specify:
Description

If other, please specify:

Data type

text

Alias
UMLS CUI-1
C2348235
BEST HEMATOLOGIC RESPONSE TO IMATINIB MESYLATE
Description

BEST HEMATOLOGIC RESPONSE TO IMATINIB MESYLATE

Alias
UMLS CUI-1
C0205488
UMLS CUI-2
C0871261
UMLS CUI-3
C0939537
Best hematologic response to imatinib mesylate:
Description

BEST HEMATOLOGIC RESPONSE TO IMATINIB MESYL A TE

Data type

text

Alias
UMLS CUI-1
C0205488
UMLS CUI-2
C0871261
UMLS CUI-3
C0939537
Date of most recent hematologic progression while on imatinib mesylate:
Description

DATE OF MOST RECENT HEMATOLOGIC PROGRESSION WHILE ON IMATINIB MESYLATE

Data type

date

Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C0449258
UMLS CUI-3
C0205488
Imatinib mesylate dose at time of most recent hematologic progression (in mg):
Description

IMATINIB MESYLATE DOSE AT TIME OF MOST RECENT HEMATOLOGIC PROGRESSION

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0450442
UMLS CUI [1,2]
C0677800
UMLS CUI [1,3]
C1521941
UMLS CUI [1,4]
C1521801
UMLS CUI [1,5]
C0178602
mg
BEST CYTOGENETIC RESPONSE TO IMATINIB MESYLATE
Description

BEST CYTOGENETIC RESPONSE TO IMATINIB MESYLATE

Best cytogenetic response to imatinib mesylate:
Description

BEST CYTOGENETIC RESPONSE TO IMATINIB MESYLATE

Data type

text

Date of most recent cytogenetic progression while on imatinib mesylate:
Description

DATE OF MOST RECENT CYTOGENETIC PROGRESSION WHILE ON IMATINIB MESYLATE

Data type

date

Alias
UMLS CUI-1
C0011008
Imatinib mesylate dose at time of most recent cytogenetic progression (in mg):
Description

IMATINIB MESYLATE DOSE AT TIME OF MOST RECENT CYTOGENETIC PROGRESSION

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0450442
UMLS CUI [1,2]
C0677800
UMLS CUI [1,3]
C1521941
UMLS CUI [1,4]
C1521801
UMLS CUI [1,5]
C0178602
mg

Similar models

Imatinib Mesylate

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PRIOR IMATINIB MESYLATE HISTORY
C0939537 (UMLS CUI-2)
Date of first dose
Item
Date of first dose of imatinib mesylate received:
date
C3173309 (UMLS CUI-1)
Date of last dose
Item
Date of last dose of imatinib mesylate received:
date
C1762893 (UMLS CUI-1)
HIGHEST DOSE
Item
Highest dose of imatinib mesylate received (in mg):
float
C1522410 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
Subject is eligible due to:
text
C1548635 (UMLS CUI-1)
Code List
Subject is eligible due to:
CL Item
Primary resistance (1)
CL Item
Acquired resistance (2)
CL Item
Intolerance (3)
TOLERABLE DOSE
Item
Has the subject ever tolerated a dose of imatinib mesylate greater than or equal to 600mg?
boolean
C3658296 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item
Reasons for intolerance:
text
C1744706 (UMLS CUI-1)
Code List
Reasons for intolerance:
CL Item
Fluid retention (1)
CL Item
Gastrointestinal symptoms (2)
CL Item
Arthralgia/ Myalgia (3)
CL Item
Rash (4)
CL Item
Other (5)
Specification
Item
If other, please specify:
text
C2348235 (UMLS CUI-1)
Item Group
BEST HEMATOLOGIC RESPONSE TO IMATINIB MESYLATE
C0205488 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0939537 (UMLS CUI-3)
Item
Best hematologic response to imatinib mesylate:
text
C0205488 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0939537 (UMLS CUI-3)
Code List
Best hematologic response to imatinib mesylate:
CL Item
Complete hematologic response (CHR) (1)
CL Item
Return to chronic phase (RTC) (2)
CL Item
No evidence of Leukemia (NEL) (3)
CL Item
No response to imatinib mesylate (4)
HEMATOLOGIC PROGRESSION DATE
Item
Date of most recent hematologic progression while on imatinib mesylate:
date
C0011008 (UMLS CUI-1)
C0449258 (UMLS CUI-2)
C0205488 (UMLS CUI-3)
DOSE
Item
Imatinib mesylate dose at time of most recent hematologic progression (in mg):
float
C0450442 (UMLS CUI [1,1])
C0677800 (UMLS CUI [1,2])
C1521941 (UMLS CUI [1,3])
C1521801 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,5])
Item Group
BEST CYTOGENETIC RESPONSE TO IMATINIB MESYLATE
Item
Best cytogenetic response to imatinib mesylate:
text
Code List
Best cytogenetic response to imatinib mesylate:
CL Item
Complete cytogenetic response (CCyR) (1)
CL Item
Partial cytogenetic response (PCyR) (2)
CL Item
Minor cytogenetic response (3)
CL Item
Minimal cytogenetic respose (4)
CL Item
No response to Imatinib mesylate (5)
DATE
Item
Date of most recent cytogenetic progression while on imatinib mesylate:
date
C0011008 (UMLS CUI-1)
DOSE
Item
Imatinib mesylate dose at time of most recent cytogenetic progression (in mg):
float
C0450442 (UMLS CUI [1,1])
C0677800 (UMLS CUI [1,2])
C1521941 (UMLS CUI [1,3])
C1521801 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,5])

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