ID
44775
Beschrijving
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
Trefwoorden
Versies (3)
- 02-08-15 02-08-15 -
- 06-08-15 06-08-15 -
- 18-11-21 18-11-21 -
Houder van rechten
Bristol-Myers Squibb
Geüploaded op
18 november 2021
DOI
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Licentie
Creative Commons BY-NC 4.0
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment
On-Treatment 2
Beschrijving
PHYSICAL MEASUREMENTS (END OF MONTH 2)
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beschrijving
Were any physical measurements taken?
Datatype
boolean
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beschrijving
Date of measurement
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Weight
Datatype
float
Maateenheden
- Kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Performance status (ECOG)
Datatype
text
Alias
- UMLS CUI-1
- C1520224
Beschrijving
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 2)
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C1314939
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Is extramedullary disease present?
Datatype
boolean
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C0012634
Beschrijving
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
Datatype
text
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C0012634
Beschrijving
CHEST X-RAY
Alias
- UMLS CUI-1
- C0039985
Beschrijving
Was a chest X-ray performed?
Datatype
boolean
Alias
- UMLS CUI-1
- C0039985
Beschrijving
Date of chest X-ray:
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Interpretation of X-ray report:
Datatype
text
Alias
- UMLS CUI-1
- C0459471
Beschrijving
If Abnormal, please specify clinically relevant abnormalities:
Datatype
text
Beschrijving
TRANSFUSIONS
Alias
- UMLS CUI-1
- C1879316
Beschrijving
Did the subject recieve any transfusion(s) since the last data collection?
Datatype
boolean
Alias
- UMLS CUI-1
- C1879316
Beschrijving
Date of transfusion
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
Datatype
text
Alias
- UMLS CUI-1
- C1879316
- UMLS CUI-2
- C0332307
Beschrijving
EXTERNAL DATA TRACKING
Alias
- UMLS CUI-1
- C1516800
Beschrijving
Were any of the following protocol specified activities performed?
Datatype
boolean
Alias
- UMLS CUI-1
- C1516800
Beschrijving
If yes, provide date and time
Datatype
datetime
Alias
- UMLS CUI-1
- C0011008
Beschrijving
BONE MARROW BIOPSY/ ASPIRATE
Alias
- UMLS CUI-1
- C0005954
Beschrijving
Was a bone marrow procedure performed?
Datatype
boolean
Alias
- UMLS CUI-1
- C0005954
Beschrijving
Date of procedure:
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Indicate procedure
Datatype
text
Alias
- UMLS CUI-1
- C0184661
Beschrijving
Was cytogenetic analysis performed?
Datatype
boolean
Alias
- UMLS CUI-1
- C0752095
- UMLS CUI-2
- C0162789
- UMLS CUI-3
- C0022526
- UMLS CUI-4
- C0884358
- UMLS CUI-5
- C0011008
Beschrijving
Number of metaphases examined
Datatype
integer
Alias
- UMLS CUI-1
- C1512699
- UMLS CUI-2
- C0936012
- UMLS CUI-3
- C0025564
Beschrijving
Number of metaphases positive for philadelphia chromosome
Datatype
integer
Alias
- UMLS CUI-1
- C0031526
Beschrijving
Was the specimen adequate for light microscopic analysis?
Datatype
boolean
Beschrijving
Number of blasts
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C1982687
Beschrijving
Number of promyelocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0455279
Beschrijving
Number of basophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Cellularity form
Datatype
text
Beschrijving
Cellularity results
Datatype
text
Beschrijving
If "Not done", please specify
Datatype
text
Alias
- UMLS CUI-1
- C2348235
Beschrijving
DRUG DISPENSATION
Beschrijving
BMS-354825 DOSING
Alias
- UMLS CUI [1,1]
- C1455147
- UMLS CUI [1,2]
- C0178602
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Stop date
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Actual dose taken per day (in mg)
Datatype
float
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C0205344
- UMLS CUI-3
- C0439423
- UMLS CUI-4
- C1533734
- UMLS CUI-5
- C0205438
Beschrijving
Reason for dose modification
Datatype
text
Alias
- UMLS CUI-1
- C1707811
Beschrijving
For the reasons asking for specification, please explain the cause
Datatype
text
Alias
- UMLS CUI-1
- C2348235
Beschrijving
CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Were any additions or changes made to concomitant medications since the last data collection?
Datatype
boolean
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Medication name
Datatype
text
Alias
- UMLS CUI-1
- C2360065
Beschrijving
Date started
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Date stopped
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Reason
Datatype
text
Alias
- UMLS CUI-1
- C0392360
Beschrijving
NON-SERIOUS ADVERSE EVENTS
Beschrijving
Did the subject experience any new or changed non- serious adverse events since the last collection?
Datatype
boolean
Beschrijving
CTC code
Datatype
text
Alias
- UMLS CUI-1
- C0805701
- UMLS CUI-2
- C1516728
- UMLS CUI-3
- C1705313
Beschrijving
CTC grade
Datatype
integer
Alias
- UMLS CUI-1
- C2985911
Beschrijving
Onset date
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Resolution date
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Relationship to study drug
Datatype
text
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Action taken regarding study drug
Datatype
text
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Treatment required?
Datatype
boolean
Alias
- UMLS CUI-1
- C0332307
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0087111
- UMLS CUI-4
- C1521801
Beschrijving
PREGNANCY TEST (END OF MONTH 2)
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Was a pregnancy test performed?
Datatype
boolean
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Date of test
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
If no test was performed, specify reason
Datatype
text
Alias
- UMLS CUI-1
- C0392360
Beschrijving
If a test was performed, please specify result
Datatype
text
Alias
- UMLS CUI-1
- C0392360
Beschrijving
Specify test
Datatype
text
Alias
- UMLS CUI-1
- C0032976
Beschrijving
EQ-5D
Alias
- UMLS CUI-1
- C2733251
Similar models
On-Treatment 2
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
C1314939 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
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-2)
C0439423 (UMLS CUI-3)
C1533734 (UMLS CUI-4)
C0205438 (UMLS CUI-5)
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)