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ID

11830

Description

Study documentation part: End of 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. 8/6/15 8/6/15 -
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August 6, 2015

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Creative Commons BY-NC 3.0 Legacy

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    Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

    Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

    SUBJECT DETAILS
    Description

    SUBJECT DETAILS

    Subject number :
    Description

    Subject number

    Data type

    integer

    Subject initial:
    Description

    Subject initial

    Data type

    text

    Alias
    UMLS CUI-1
    C2986440
    Visit date:
    Description

    Visit date

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Site number:
    Description

    Site number:

    Data type

    integer

    Alias
    UMLS CUI-1
    C0008972
    UMLS CUI-2
    C0205145
    UMLS CUI-3
    C1709628
    UMLS CUI-4
    C0600091
    UMLS CUI-5
    C0237753
    VITAL SIGNS
    Description

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Were vital signs taken?
    Description

    Were vital signs taken?

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0518766
    Date:
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Position:
    Description

    Position

    Data type

    text

    Alias
    UMLS CUI-1
    C0733755
    Blood pressure systolic (in mm Hg):
    Description

    Blood pressure systolic

    Data type

    float

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure diastolic (in mm Hg):
    Description

    Blood pressure diastolic

    Data type

    float

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate (in bpm):
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    PHYSICAL MEASUREMENTS
    Description

    PHYSICAL MEASUREMENTS

    Alias
    UMLS CUI-1
    C0205485
    UMLS CUI-2
    C0242485
    Were any physical measurements taken?
    Description

    Were any physical measurements taken?

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0205485
    UMLS CUI-2
    C0242485
    Date of measurement:
    Description

    Date of measurement

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Weight (in Kg):
    Description

    Weight

    Data type

    float

    Measurement units
    • Kg
    Alias
    UMLS CUI [1]
    C0005910
    Kg
    Performance status (ECOG):
    Description

    Performance status (ECOG)

    Data type

    text

    Alias
    UMLS CUI-1
    C1520224
    EXTRAMEDULLARY INVOLVEMENT
    Description

    EXTRAMEDULLARY INVOLVEMENT

    Alias
    UMLS CUI-1
    C1517060
    UMLS CUI-2
    C1314939
    Date of assessment:
    Description

    Date of assessment

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Is extramedullary disease present?
    Description

    Is extramedullary disease present?

    Data type

    boolean

    Alias
    UMLS CUI-1
    C1517060
    UMLS CUI-2
    C0012634
    f yes, please provide the side code(s) from below: 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other
    Description

    f yes, please provide the side code(s) from below: 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other

    Data type

    text

    Alias
    UMLS CUI-1
    C1515974
    UMLS CUI-2
    C0221198
    UMLS CUI-3
    C0220825
    UMLS CUI-4
    C1513040
    PROGRESSION
    Description

    PROGRESSION

    Alias
    UMLS CUI-1
    C0242656
    Did the subject progress?
    Description

    Did the subject progress?

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0242656
    Date of progression:
    Description

    Date of progression

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Reason for progression:
    Description

    Reason for progression

    Data type

    text

    Alias
    UMLS CUI-1
    C0392360
    BEST OVERALL HEMATOLOGIC RESPONSE
    Description

    BEST OVERALL HEMATOLOGIC RESPONSE

    Alias
    UMLS CUI-1
    C0205488
    UMLS CUI-2
    C0871261
    UMLS CUI-3
    C0939537
    Was the hematologic response confirmed?
    Description

    Was the hematologic response confirmed?

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0026764
    UMLS CUI-2
    C0871261
    UMLS CUI-3
    C0332152
    UMLS CUI-4
    C0332307
    Complete hematologic response (CHR):
    Description

    Complete hematologic response

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0205488
    UMLS CUI-2
    C0871261
    UMLS CUI-3
    C0939537
    If yes, date of CHR:
    Description

    If yes, date of CHR

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    No evidence of leukemia (NEL):
    Description

    No evidence of leukemia (NEL)

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0023418
    If yes, date of NEL:
    Description

    If yes, date of NEL

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Return to chronic phase (RTC):
    Description

    Return to chronic phase (RTC)

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0457343
    UMLS CUI-2
    C1516669
    If yes, date of RTC:
    Description

    If yes, date of RTC

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Minor hematologic response (MiHR):
    Description

    Minor hematologic response

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0026764
    UMLS CUI-2
    C0871261
    UMLS CUI-3
    C0332152
    UMLS CUI-4
    C0332307
    No hematologic response:
    Description

    No hematologic response

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0026764
    UMLS CUI-2
    C0871261
    UMLS CUI-3
    C0332152
    UMLS CUI-4
    C0332307
    Unable to determine:
    Description

    Unable to determine

    Data type

    text

    Alias
    UMLS CUI-1
    C1148554
    Please specify "The reason other than toxicity or progression":
    Description

    Please specify "The reason other than toxicity or progression":

    Data type

    text

    Alias
    UMLS CUI-1
    C2348235
    BEST OVERALL CYTOGENETIC RESPONSE
    Description

    BEST OVERALL CYTOGENETIC RESPONSE

    Alias
    UMLS CUI-1
    C0332307
    UMLS CUI-2
    C1704632
    UMLS CUI-3
    C0314603
    Date of best cytogenetic response:
    Description

    Date of best cytogenetic response

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Best cytogenetic response:
    Description

    Best cytogenetic response

    Data type

    text

    Alias
    UMLS CUI-1
    C0332307
    UMLS CUI-2
    C1704632
    UMLS CUI-3
    C0314603
    No cytogenetic response:
    Description

    No cytogenetic response

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0332307
    UMLS CUI-2
    C1704632
    UMLS CUI-3
    C0314603
    Unable to determine:
    Description

    Unable to determine

    Data type

    text

    Alias
    UMLS CUI-1
    C1148554
    Please specify "The reason other than toxicity or progression":
    Description

    Please specify "The reason other than toxicity or progression"

    Data type

    text

    Alias
    UMLS CUI-1
    C2348235
    EXTERNAL DATA TRACKING
    Description

    EXTERNAL DATA TRACKING

    Alias
    UMLS CUI-1
    C1516800
    Were any of the following protocol specified activities performed?
    Description

    Were any of the following protocol specified activities performed?

    Data type

    boolean

    Alias
    UMLS CUI-1
    C1516800
    If yes, provide date and time:
    Description

    If yes, provide date and time

    Data type

    datetime

    Alias
    UMLS CUI-1
    C0011008
    Mutation analysis:
    Description

    Mutation analysis

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0796357
    END OF TREATMENT STATUS
    Description

    END OF TREATMENT STATUS

    Alias
    UMLS CUI-1
    C0749659
    Date of subject off treatment:
    Description

    Date of subject off treatment

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Reason for discontinuing:
    Description

    Reason for discontinuing

    Data type

    text

    Alias
    UMLS CUI-1
    C0392360
    For the reasons with "Specify", please mention the details:
    Description

    For the reasons with "Specify", please mention the details:

    Data type

    text

    Alias
    UMLS CUI-1
    C2348235
    SUBJECT STATUS
    Description

    SUBJECT STATUS

    Alias
    UMLS CUI-1
    C2348568
    Will the subject continue to be followed?
    Description

    Will the subject continue to be followed?

    Data type

    boolean

    Alias
    UMLS CUI-1
    C2348568
    If no, please indicate the primary reason:
    Description

    If no, please indicate the primary reason

    Data type

    text

    Alias
    UMLS CUI-1
    C0392360
    In case of "Lost to follow-up", please mention the date of last contact:
    Description

    In case of "Lost to follow-up", please mention the date of last contact

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    For the reasons with "Specify", please mention the details:
    Description

    For the reasons with "Specify", please mention the details

    Data type

    text

    Alias
    UMLS CUI-1
    C2348235

    Similar models

    Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    SUBJECT DETAILS
    Subject number
    Item
    Subject number :
    integer
    Subject initial
    Item
    Subject initial:
    text
    C2986440 (UMLS CUI-1)
    DATE
    Item
    Visit date:
    date
    C0011008 (UMLS CUI-1)
    Site number
    Item
    Site number:
    integer
    C0008972 (UMLS CUI-1)
    C0205145 (UMLS CUI-2)
    C1709628 (UMLS CUI-3)
    C0600091 (UMLS CUI-4)
    C0237753 (UMLS CUI-5)
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    Vital signs
    Item
    Were vital signs taken?
    boolean
    C0518766 (UMLS CUI-1)
    DATE
    Item
    Date:
    date
    C0011008 (UMLS CUI-1)
    Item
    Position:
    text
    C0733755 (UMLS CUI-1)
    Code List
    Position:
    CL Item
    Sitting (1)
    CL Item
    Standing (2)
    CL Item
    Supine (3)
    BLOOD PRESSURE SYSTOLIC
    Item
    Blood pressure systolic (in mm Hg):
    float
    C0871470 (UMLS CUI [1])
    BLOOD PRESSURE DIASTOLIC
    Item
    Blood pressure diastolic (in mm Hg):
    float
    C0428883 (UMLS CUI [1])
    HEART RATE
    Item
    Heart rate (in bpm):
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    PHYSICAL MEASUREMENTS
    C0205485 (UMLS CUI-1)
    C0242485 (UMLS CUI-2)
    Physical measurements
    Item
    Were any physical measurements taken?
    boolean
    C0205485 (UMLS CUI-1)
    C0242485 (UMLS CUI-2)
    DATE
    Item
    Date of measurement:
    date
    C0011008 (UMLS CUI-1)
    Weight
    Item
    Weight (in Kg):
    float
    C0005910 (UMLS CUI [1])
    ECOG
    Item
    Performance status (ECOG):
    text
    C1520224 (UMLS CUI-1)
    Item Group
    EXTRAMEDULLARY INVOLVEMENT
    C1517060 (UMLS CUI-1)
    C1314939 (UMLS CUI-2)
    DATE
    Item
    Date of assessment:
    date
    C0011008 (UMLS CUI-1)
    Extramedullary disease
    Item
    Is extramedullary disease present?
    boolean
    C1517060 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    SITE CODE
    Item
    f yes, please provide the side code(s) from below: 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other
    text
    C1515974 (UMLS CUI-1)
    C0221198 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    C1513040 (UMLS CUI-4)
    Item Group
    PROGRESSION
    C0242656 (UMLS CUI-1)
    Progression
    Item
    Did the subject progress?
    boolean
    C0242656 (UMLS CUI-1)
    DATE
    Item
    Date of progression:
    date
    C0011008 (UMLS CUI-1)
    Item
    Reason for progression:
    text
    C0392360 (UMLS CUI-1)
    Code List
    Reason for progression:
    CL Item
    10 Loss of hematologic response (CHR, NEL or RTC) (1)
    CL Item
    12 Development of blast phase CML (2)
    CL Item
    9 No decrease from baseline percent blasts despite maximum dose (3)
    CL Item
    18 Development of new extra- medullary sites (other than liver or spleen) (4)
    Item Group
    BEST OVERALL HEMATOLOGIC RESPONSE
    C0205488 (UMLS CUI-1)
    C0871261 (UMLS CUI-2)
    C0939537 (UMLS CUI-3)
    HEMATOLOGIC RESPONSE
    Item
    Was the hematologic response confirmed?
    boolean
    C0026764 (UMLS CUI-1)
    C0871261 (UMLS CUI-2)
    C0332152 (UMLS CUI-3)
    C0332307 (UMLS CUI-4)
    HEMATOLOGIC RESPONSE
    Item
    Complete hematologic response (CHR):
    boolean
    C0205488 (UMLS CUI-1)
    C0871261 (UMLS CUI-2)
    C0939537 (UMLS CUI-3)
    DATE
    Item
    If yes, date of CHR:
    date
    C0011008 (UMLS CUI-1)
    leukemia
    Item
    No evidence of leukemia (NEL):
    boolean
    C0023418 (UMLS CUI-1)
    DATE
    Item
    If yes, date of NEL:
    date
    C0011008 (UMLS CUI-1)
    Chronic phase
    Item
    Return to chronic phase (RTC):
    boolean
    C0457343 (UMLS CUI-1)
    C1516669 (UMLS CUI-2)
    DATE
    Item
    If yes, date of RTC:
    date
    C0011008 (UMLS CUI-1)
    HEMATOLOGIC RESPONSE
    Item
    Minor hematologic response (MiHR):
    boolean
    C0026764 (UMLS CUI-1)
    C0871261 (UMLS CUI-2)
    C0332152 (UMLS CUI-3)
    C0332307 (UMLS CUI-4)
    HEMATOLOGIC RESPONSE
    Item
    No hematologic response:
    boolean
    C0026764 (UMLS CUI-1)
    C0871261 (UMLS CUI-2)
    C0332152 (UMLS CUI-3)
    C0332307 (UMLS CUI-4)
    Item
    Unable to determine:
    text
    C1148554 (UMLS CUI-1)
    Code List
    Unable to determine:
    CL Item
    Early death attributed to toxicity. (1)
    CL Item
    Early discontinuation attributed to toxicity. (2)
    CL Item
    No assessment due to reason other than toxicity or progression (Specify) (3)
    Specification
    Item
    Please specify "The reason other than toxicity or progression":
    text
    C2348235 (UMLS CUI-1)
    Item Group
    BEST OVERALL CYTOGENETIC RESPONSE
    C0332307 (UMLS CUI-1)
    C1704632 (UMLS CUI-2)
    C0314603 (UMLS CUI-3)
    DATE
    Item
    Date of best cytogenetic response:
    date
    C0011008 (UMLS CUI-1)
    Item
    Best cytogenetic response:
    text
    C0332307 (UMLS CUI-1)
    C1704632 (UMLS CUI-2)
    C0314603 (UMLS CUI-3)
    Code List
    Best cytogenetic response:
    CL Item
    Complete cytogenetic response (CCyR) (1)
    CL Item
    Partial cytogenetic response (PCyR) (2)
    CL Item
    Minor cytogenetic response (3)
    CL Item
    Minimal cytogenetic response (4)
    CYTOGENETIC RESPONSE
    Item
    No cytogenetic response:
    boolean
    C0332307 (UMLS CUI-1)
    C1704632 (UMLS CUI-2)
    C0314603 (UMLS CUI-3)
    Item
    Unable to determine:
    text
    C1148554 (UMLS CUI-1)
    Code List
    Unable to determine:
    CL Item
    Early death attributed to toxicity. (1)
    CL Item
    Early discontinuation attributed to toxicity. (2)
    CL Item
    No assessment due to reason other than toxicity or progression (Specify) (3)
    Specification
    Item
    Please specify "The reason other than toxicity or progression":
    text
    C2348235 (UMLS CUI-1)
    Item Group
    EXTERNAL DATA TRACKING
    C1516800 (UMLS CUI-1)
    EXTERNAL DATA TRACKING
    Item
    Were any of the following protocol specified activities performed?
    boolean
    C1516800 (UMLS CUI-1)
    DATE AND TIME
    Item
    If yes, provide date and time:
    datetime
    C0011008 (UMLS CUI-1)
    MUTATION ANALYSIS
    Item
    Mutation analysis:
    boolean
    C0796357 (UMLS CUI-1)
    Item Group
    END OF TREATMENT STATUS
    C0749659 (UMLS CUI-1)
    DATE
    Item
    Date of subject off treatment:
    date
    C0011008 (UMLS CUI-1)
    Item
    Reason for discontinuing:
    text
    C0392360 (UMLS CUI-1)
    Code List
    Reason for discontinuing:
    CL Item
    Disease progression (1)
    CL Item
    Study drug toxicity (Specify) (2)
    CL Item
    Adverse event unrelated to study drug (Specify) (3)
    CL Item
    Subject request (4)
    CL Item
    Investigator request (5)
    CL Item
    Other (Specify) (6)
    Specification
    Item
    For the reasons with "Specify", please mention the details:
    text
    C2348235 (UMLS CUI-1)
    Item Group
    SUBJECT STATUS
    C2348568 (UMLS CUI-1)
    SUBJECT STATUS
    Item
    Will the subject continue to be followed?
    boolean
    C2348568 (UMLS CUI-1)
    Item
    If no, please indicate the primary reason:
    text
    C0392360 (UMLS CUI-1)
    Code List
    If no, please indicate the primary reason:
    CL Item
    Subject withdrew consent (Specify) (1)
    CL Item
    Death (2)
    CL Item
    Lost to follow-up (3)
    CL Item
    Other (Specify) (4)
    DATE
    Item
    In case of "Lost to follow-up", please mention the date of last contact:
    date
    C0011008 (UMLS CUI-1)
    Specification
    Item
    For the reasons with "Specify", please mention the details:
    text
    C2348235 (UMLS CUI-1)

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