ID

11320

Beskrivning

Study documentation part: Screening 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.

Nyckelord

Versioner (1)
  1. 30/06/15 30/06/15 -
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30 giugno 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Screening

Engelsk

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Screening

1 Formulär  
Subject details
Beskrivning

Subject details

Subject number:
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI-1
C1709561
Subject initial:
Beskrivning

Subject initial

Datatyp

text

Alias
UMLS CUI-1
C2986440
Visit date:
Beskrivning

Visit date

Datatyp

date

Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C0545082
Demographics
Beskrivning

Demographics

Alias
UMLS CUI-1
C1704791
Date of birth:
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI-1
C0421451
Gender at birth:
Beskrivning

Gender at birth

Datatyp

text

Alias
UMLS CUI-1
C0079399
Race:
Beskrivning

Race

Datatyp

text

Alias
UMLS CUI-1
C0034510
If you chose the option "Other race" above, please specify:
Beskrivning

Other race

Datatyp

text

Alias
UMLS CUI-1
C0034510
Ethnicity (For United states only):
Beskrivning

Ethnicity (For United states only)

Datatyp

text

Informed consent
Beskrivning

Informed consent

Alias
UMLS CUI-1
C0514044
UMLS CUI-2
C0805443
Was informed consent obtained prior to any study related procedures?
Beskrivning

Was informed consent obtained prior to any study related procedures?

Datatyp

boolean

Alias
UMLS CUI-1
C0021430
If you chose "Yes" above, please enter the date subject or legally authorized representative signed informed consent.
Beskrivning

If you chose above the option "Yes", please enter the date subject or legally authorized representative signed informed consent.

Datatyp

date

Alias
UMLS CUI-1
C0011008
Eligibility criteria
Beskrivning

Eligibility criteria

Alias
UMLS CUI-1
C0332307
UMLS CUI-2
C0030705
UMLS CUI-3
C1513905
UMLS CUI-4
C1516637
Did the subject fail any eligibility criteria?
Beskrivning

Did the subject fail any eligibility criteria?

Datatyp

boolean

Alias
UMLS CUI-1
C0332307
UMLS CUI-2
C0030705
UMLS CUI-3
C1513905
UMLS CUI-4
C1516637
If you chose "Yes" above, record the failed criteria number(s) as specified in the protocol or on the Eligibility criteria worksheet as follow: Inclusion Number(s), Exclusion Number(s).
Beskrivning

If you chose "Yes" above, record the failed criteria number(s) as specified in the protocol or on the Eligibility criteria worksheet as follow: Inclusion Number(s), Exclusion Number(s)

Datatyp

text

Alias
UMLS CUI-1
C0231175
UMLS CUI-2
C1516637
UMLS CUI-3
C1512693
UMLS CUI-4
C0680251
Pre-randomization status
Beskrivning

Pre-randomization status

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0449438
Will the subject be randomized?
Beskrivning

Will the subject be randomized?

Datatyp

boolean

Alias
UMLS CUI-1
C0034656
If you chose "No" above, please indicate primary reason for not being randomized?
Beskrivning

If you chose "No" above, please indicate primary reason for not being randomized?

Datatyp

text

Alias
UMLS CUI-1
C0034656
Please specify if you chose "Subject withdrew consent" , "Poor/ Non-Compliance" , "Subject no longer meets study criteria" or "Other":
Beskrivning

Please specify if you chose "Subject withdrew consent", "Poor/ Non-Compliance", "Subject no longer meets study criteria" or "Other"

Datatyp

text

Alias
UMLS CUI-1
C0392360
Please specify the date of last contact, if you chose "Lost to follow-up":
Beskrivning

Please specify the date of last contact, if you chose "Lost to follow-up".

Datatyp

date

Alias
UMLS CUI-1
C0011008
Treatment assignment
Beskrivning

Treatment assignment

Alias
UMLS CUI-1
C1522541
Please choose the treatment group the subject is assigned:
Beskrivning

Please choose the treatment group the subject is assigned.

Datatyp

text

Alias
UMLS CUI-1
C1522541
Name of the investigator:
Beskrivning

Investigator's name

Datatyp

text

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0027365
Tillbaka till toppen

Similar models

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Screening

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Subject details
Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI-1)
Subject initial
Item
Subject initial:
text
C2986440 (UMLS CUI-1)
Visit date
Item
Visit date:
date
C0011008 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item Group
Demographics
C1704791 (UMLS CUI-1)
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI-1)
Item
Gender at birth:
text
C0079399 (UMLS CUI-1)
Gender
Code List
Gender at birth:
CL Item
Male (1)
CL Item
Female (2)
Item
Race:
text
C0034510 (UMLS CUI-1)
Race
Code List
Race:
CL Item
White (1)
CL Item
Black or African American (2)
CL Item
Asian (3)
CL Item
American Indian or Alaska Native (4)
CL Item
Native Hawaiian or Other Pacific Islander (5)
CL Item
Other Race (6)
Race
Item
If you chose the option "Other race" above, please specify:
text
C0034510 (UMLS CUI-1)
Item
Ethnicity (For United states only):
text
Ethnicity
Code List
Ethnicity (For United states only):
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Informed consent
C0514044 (UMLS CUI-1)
C0805443 (UMLS CUI-2)
Informed consent
Item
Was informed consent obtained prior to any study related procedures?
boolean
C0021430 (UMLS CUI-1)
Date
Item
If you chose "Yes" above, please enter the date subject or legally authorized representative signed informed consent.
date
C0011008 (UMLS CUI-1)
Item Group
Eligibility criteria
C0332307 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C1513905 (UMLS CUI-3)
C1516637 (UMLS CUI-4)
Eligibility criteria
Item
Did the subject fail any eligibility criteria?
boolean
C0332307 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C1513905 (UMLS CUI-3)
C1516637 (UMLS CUI-4)
Failed criteria
Item
If you chose "Yes" above, record the failed criteria number(s) as specified in the protocol or on the Eligibility criteria worksheet as follow: Inclusion Number(s), Exclusion Number(s).
text
C0231175 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0680251 (UMLS CUI-4)
Item Group
Pre-randomization status
C0034656 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Randomization
Item
Will the subject be randomized?
boolean
C0034656 (UMLS CUI-1)
Item
If you chose "No" above, please indicate primary reason for not being randomized?
text
C0034656 (UMLS CUI-1)
Randomization
Code List
If you chose "No" above, please indicate primary reason for not being randomized?
CL Item
Adverse event (1)
CL Item
Subject withdrew consent (2)
CL Item
Death (3)
CL Item
Lost to follow-up (4)
CL Item
Poor/ Non-compliance (5)
CL Item
Pregnancy (6)
CL Item
Subject no longer meets study criteria (7)
CL Item
Administrative reason by sponsor (8)
CL Item
Other (9)
Reason
Item
Please specify if you chose "Subject withdrew consent" , "Poor/ Non-Compliance" , "Subject no longer meets study criteria" or "Other":
text
C0392360 (UMLS CUI-1)
Date
Item
Please specify the date of last contact, if you chose "Lost to follow-up":
date
C0011008 (UMLS CUI-1)
Item Group
Treatment assignment
C1522541 (UMLS CUI-1)
Item
Please choose the treatment group the subject is assigned:
text
C1522541 (UMLS CUI-1)
Treatment group
Code List
Please choose the treatment group the subject is assigned:
CL Item
70 mg twice daily (1)
CL Item
140 mg once daily (2)
Investigator's name
Item
Name of the investigator:
text
C2346576 (UMLS CUI-1)
C0027365 (UMLS CUI-2)
Tillbaka till toppen 

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