ID
11830
Beskrivning
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
Nyckelord
Versioner (1)
- 2015-08-06 2015-08-06 -
Uppladdad den
6 augusti 2015
DOI
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Licens
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
Beskrivning
VITAL SIGNS
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Were vital signs taken?
Datatyp
boolean
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Position
Datatyp
text
Alias
- UMLS CUI-1
- C0733755
Beskrivning
Blood pressure systolic
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure diastolic
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PHYSICAL MEASUREMENTS
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beskrivning
Were any physical measurements taken?
Datatyp
boolean
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beskrivning
Date of measurement
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Weight
Datatyp
float
Måttenheter
- Kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Performance status (ECOG)
Datatyp
text
Alias
- UMLS CUI-1
- C1520224
Beskrivning
EXTRAMEDULLARY INVOLVEMENT
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C1314939
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Is extramedullary disease present?
Datatyp
boolean
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C0012634
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI-1
- C1515974
- UMLS CUI-2
- C0221198
- UMLS CUI-3
- C0220825
- UMLS CUI-4
- C1513040
Beskrivning
PROGRESSION
Alias
- UMLS CUI-1
- C0242656
Beskrivning
BEST OVERALL HEMATOLOGIC RESPONSE
Alias
- UMLS CUI-1
- C0205488
- UMLS CUI-2
- C0871261
- UMLS CUI-3
- C0939537
Beskrivning
Was the hematologic response confirmed?
Datatyp
boolean
Alias
- UMLS CUI-1
- C0026764
- UMLS CUI-2
- C0871261
- UMLS CUI-3
- C0332152
- UMLS CUI-4
- C0332307
Beskrivning
Complete hematologic response
Datatyp
boolean
Alias
- UMLS CUI-1
- C0205488
- UMLS CUI-2
- C0871261
- UMLS CUI-3
- C0939537
Beskrivning
If yes, date of CHR
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
No evidence of leukemia (NEL)
Datatyp
boolean
Alias
- UMLS CUI-1
- C0023418
Beskrivning
If yes, date of NEL
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Return to chronic phase (RTC)
Datatyp
boolean
Alias
- UMLS CUI-1
- C0457343
- UMLS CUI-2
- C1516669
Beskrivning
If yes, date of RTC
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Minor hematologic response
Datatyp
boolean
Alias
- UMLS CUI-1
- C0026764
- UMLS CUI-2
- C0871261
- UMLS CUI-3
- C0332152
- UMLS CUI-4
- C0332307
Beskrivning
No hematologic response
Datatyp
boolean
Alias
- UMLS CUI-1
- C0026764
- UMLS CUI-2
- C0871261
- UMLS CUI-3
- C0332152
- UMLS CUI-4
- C0332307
Beskrivning
Unable to determine
Datatyp
text
Alias
- UMLS CUI-1
- C1148554
Beskrivning
Please specify "The reason other than toxicity or progression":
Datatyp
text
Alias
- UMLS CUI-1
- C2348235
Beskrivning
BEST OVERALL CYTOGENETIC RESPONSE
Alias
- UMLS CUI-1
- C0332307
- UMLS CUI-2
- C1704632
- UMLS CUI-3
- C0314603
Beskrivning
Date of best cytogenetic response
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Best cytogenetic response
Datatyp
text
Alias
- UMLS CUI-1
- C0332307
- UMLS CUI-2
- C1704632
- UMLS CUI-3
- C0314603
Beskrivning
No cytogenetic response
Datatyp
boolean
Alias
- UMLS CUI-1
- C0332307
- UMLS CUI-2
- C1704632
- UMLS CUI-3
- C0314603
Beskrivning
Unable to determine
Datatyp
text
Alias
- UMLS CUI-1
- C1148554
Beskrivning
Please specify "The reason other than toxicity or progression"
Datatyp
text
Alias
- UMLS CUI-1
- C2348235
Beskrivning
EXTERNAL DATA TRACKING
Alias
- UMLS CUI-1
- C1516800
Beskrivning
Were any of the following protocol specified activities performed?
Datatyp
boolean
Alias
- UMLS CUI-1
- C1516800
Beskrivning
If yes, provide date and time
Datatyp
datetime
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Mutation analysis
Datatyp
boolean
Alias
- UMLS CUI-1
- C0796357
Beskrivning
END OF TREATMENT STATUS
Alias
- UMLS CUI-1
- C0749659
Beskrivning
Date of subject off treatment
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
Reason for discontinuing
Datatyp
text
Alias
- UMLS CUI-1
- C0392360
Beskrivning
For the reasons with "Specify", please mention the details:
Datatyp
text
Alias
- UMLS CUI-1
- C2348235
Beskrivning
SUBJECT STATUS
Alias
- UMLS CUI-1
- C2348568
Beskrivning
Will the subject continue to be followed?
Datatyp
boolean
Alias
- UMLS CUI-1
- C2348568
Beskrivning
If no, please indicate the primary reason
Datatyp
text
Alias
- UMLS CUI-1
- C0392360
Beskrivning
In case of "Lost to follow-up", please mention the date of last contact
Datatyp
date
Alias
- UMLS CUI-1
- C0011008
Beskrivning
For the reasons with "Specify", please mention the details
Datatyp
text
Alias
- UMLS CUI-1
- C2348235
Similar models
Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment
C0205145 (UMLS CUI-2)
C1709628 (UMLS CUI-3)
C0600091 (UMLS CUI-4)
C0237753 (UMLS CUI-5)
C0242485 (UMLS CUI-2)
C1314939 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
C0221198 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1513040 (UMLS CUI-4)
C0871261 (UMLS CUI-2)
C0939537 (UMLS CUI-3)
C0871261 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332307 (UMLS CUI-4)
C0871261 (UMLS CUI-2)
C0939537 (UMLS CUI-3)
C1516669 (UMLS CUI-2)
C0871261 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332307 (UMLS CUI-4)
C0871261 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332307 (UMLS CUI-4)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)