ID
44775
Description
Study documentation part: On- 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
Versions (3)
- 8/2/15 8/2/15 -
- 8/6/15 8/6/15 -
- 11/18/21 11/18/21 -
Copyright Holder
Bristol-Myers Squibb
Uploaded on
November 18, 2021
DOI
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License
Creative Commons BY-NC 4.0
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment
On-Treatment 8
Description
PHYSICAL MEASUREMENTS (END OF MONTH 24)
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Description
Were any physical measurements taken?
Data type
boolean
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Description
Date of measurement
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Weight
Data type
float
Measurement units
- Kg
Alias
- UMLS CUI [1]
- C0005910
Description
Performance status (ECOG)
Data type
text
Alias
- UMLS CUI-1
- C1520224
Description
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 24)
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C1314939
Description
Date of assessment
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Is extramedullary disease present?
Data type
boolean
Alias
- UMLS CUI-1
- C1515974
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C1314939
- UMLS CUI-4
- C1517060
Description
If 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
Description
TRANSFUSIONS
Alias
- UMLS CUI-1
- C1879316
Description
Did the subject recieve any transfusion(s) since the last data collection?
Data type
boolean
Alias
- UMLS CUI-1
- C1879316
Description
Date of transfusion
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
Data type
text
Alias
- UMLS CUI-1
- C1879316
- UMLS CUI-2
- C0332307
Description
EXTERNAL DATA TRACKING
Alias
- UMLS CUI-1
- C1516800
Description
BONE MARROW BIOPSY/ ASPIRATE
Alias
- UMLS CUI-1
- C0005954
Description
Was a bone marrow procedure performed?
Data type
boolean
Alias
- UMLS CUI-1
- C0005954
Description
Date of procedure:
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Indicate procedure
Data type
text
Alias
- UMLS CUI-1
- C0184661
Description
Was cytogenetic analysis performed?
Data type
boolean
Alias
- UMLS CUI-1
- C0752095
- UMLS CUI-2
- C0162789
- UMLS CUI-3
- C0022526
- UMLS CUI-4
- C0884358
- UMLS CUI-5
- C0011008
Description
Number of metaphases examined:
Data type
integer
Alias
- UMLS CUI-1
- C1512699
- UMLS CUI-2
- C0936012
- UMLS CUI-3
- C0025564
Description
Number of metaphases positive for philadelphia chromosome:
Data type
integer
Alias
- UMLS CUI-1
- C0031526
Description
Was the specimen adequate for light microscopic analysis?
Data type
boolean
Description
Number of blasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C1982687
Description
Number of promyelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455279
Description
Number of basophils:
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200641
Description
Cellularity form
Data type
text
Description
Cellularity results
Data type
text
Description
If "Not done", please specify:
Data type
text
Alias
- UMLS CUI-1
- C2348235
Description
DRUG DISPENSATION
Description
BMS-354825 DOSING
Alias
- UMLS CUI-1
- C1455147
- UMLS CUI-2
- C0178602
Description
Start date
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Stop date
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Actual dose taken per day (in mg)
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0205344
- UMLS CUI [1,3]
- C0439423
- UMLS CUI [1,4]
- C1533734
- UMLS CUI [1,5]
- C0205435
Description
Reason for dose modification
Data type
text
Alias
- UMLS CUI-1
- C1707811
Description
For the reasons asking for specification, please explain the cause
Data type
text
Alias
- UMLS CUI-1
- C2348235
Description
CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Description
Were any additions or changes made to concomitant medications since the last data collection?
Data type
boolean
Alias
- UMLS CUI-1
- C2347852
Description
Medication name
Data type
text
Alias
- UMLS CUI-1
- C2360065
Description
Date started
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Date stopped
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Reason
Data type
text
Alias
- UMLS CUI-1
- C0392360
Description
NON-SERIOUS ADVERSE EVENTS
Description
Did the subject experience any new or changed non- serious adverse events since the last collection?
Data type
boolean
Description
CTC code
Data type
text
Alias
- UMLS CUI-1
- C0805701
- UMLS CUI-2
- C1516728
- UMLS CUI-3
- C1705313
Description
CTC grade
Data type
text
Alias
- UMLS CUI-1
- C2985911
Description
Onset date
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Resolution date
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Relationship to study drug
Data type
text
Alias
- UMLS CUI-1
- C0013227
Description
Action taken regarding study drug
Data type
text
Alias
- UMLS CUI-1
- C0013227
Description
Treatment required?
Data type
boolean
Alias
- UMLS CUI-1
- C0332307
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0087111
- UMLS CUI-4
- C1521801
Description
PREGNANCY TEST (END OF MONTH 20)
Alias
- UMLS CUI-1
- C0032976
Description
Was a pregnancy test performed?
Data type
boolean
Alias
- UMLS CUI-1
- C0032976
Description
Date of test
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
If no test was performed, specify reason
Data type
text
Alias
- UMLS CUI-1
- C0392360
Description
If a test was performed, please specify result
Data type
text
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0884358
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C0332281
- UMLS CUI-5
- C0449438
Description
Specify test
Data type
text
Alias
- UMLS CUI-1
- C0032976
Description
PREGNANCY TEST (END OF MONTH 22
Alias
- UMLS CUI-1
- C0032976
Description
Was a pregnancy test performed?
Data type
boolean
Alias
- UMLS CUI-1
- C0032976
Description
Date of test
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
If no test was performed, specify reason
Data type
text
Alias
- UMLS CUI-1
- C0392360
Description
If a test was performed, please specify result
Data type
text
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0884358
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C0332281
- UMLS CUI-5
- C0449438
Description
Specify test
Data type
text
Alias
- UMLS CUI-1
- C0032976
Description
PREGNANCY TEST (END OF MONTH 24)
Alias
- UMLS CUI-1
- C0032976
Description
Was a pregnancy test performed?
Data type
boolean
Alias
- UMLS CUI-1
- C0032976
Description
Date of test
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
If no test was performed, specify reason
Data type
text
Alias
- UMLS CUI-1
- C0392360
Description
If a test was performed, please specify result
Data type
text
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0884358
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C0332281
- UMLS CUI-5
- C0449438
Description
Specify test
Data type
text
Alias
- UMLS CUI-1
- C0032976
Similar models
On-Treatment 8
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
C1314939 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
C1314939 (UMLS CUI-3)
C1517060 (UMLS CUI-4)
C0332307 (UMLS CUI-2)
C0162789 (UMLS CUI-2)
C0022526 (UMLS CUI-3)
C0884358 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0936012 (UMLS CUI-2)
C0025564 (UMLS CUI-3)
C0205344 (UMLS CUI [1,2])
C0439423 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
C0884358 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C0449438 (UMLS CUI-5)
C0884358 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C0449438 (UMLS CUI-5)
C0884358 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C0449438 (UMLS CUI-5)