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ID
11830
Beschrijving
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
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Versies (1)
- 06-08-15 06-08-15 -
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6 augustus 2015
DOI
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Licentie
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
Similar models
Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
C0205145 (UMLS CUI-2)
C1709628 (UMLS CUI-3)
C0600091 (UMLS CUI-4)
C0237753 (UMLS CUI-5)
Vital signs
Item
Were vital signs taken?
boolean
C0518766 (UMLS CUI-1)
DATE
Item
Date:
date
C0011008 (UMLS CUI-1)
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])
Physical measurements
Item
Were any physical measurements taken?
boolean
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
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)
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)
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)
C0221198 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1513040 (UMLS CUI-4)
Progression
Item
Did the subject progress?
boolean
C0242656 (UMLS CUI-1)
DATE
Item
Date of progression:
date
C0011008 (UMLS CUI-1)
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)
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)
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)
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)
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)
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)
C0871261 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332307 (UMLS CUI-4)
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)
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)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
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)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
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)
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)
DATE
Item
Date of subject off treatment:
date
C0011008 (UMLS CUI-1)
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)
SUBJECT STATUS
Item
Will the subject continue to be followed?
boolean
C2348568 (UMLS CUI-1)
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)