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 1
Description
PHYSICAL MEASUREMENTS (DAY 1)
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
integer
Alias
- UMLS CUI-1
- C1520224
Description
EXTRAMEDULLARY INVOLVEMENT (DAY 1)
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 presen?
Data type
boolean
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C0012634
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
Alias
- UMLS CUI-1
- C0805701
- UMLS CUI-2
- C1517060
- UMLS CUI-3
- C0012634
Description
VITAL SIGNS (END OF MONTH 1)
Alias
- UMLS CUI-1
- C0518766
Description
Were vital signs taken?
Data type
boolean
Alias
- UMLS CUI-1
- C0518766
Description
Date
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Position
Data type
text
Alias
- UMLS CUI-1
- C0733755
Description
Blood pressure systolic
Data type
float
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure diastolic
Data type
float
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PHYSICAL MEASUREMENTS (END OF MONTH 1)
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
integer
Alias
- UMLS CUI-1
- C1520224
Description
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 1)
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
- C1517060
- UMLS CUI-2
- C0012634
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
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1517060
- UMLS CUI [1,3]
- C0012634
Description
CHEST X-RAY
Alias
- UMLS CUI-1
- C0039985
Description
Was a chest X-ray performed?
Data type
boolean
Alias
- UMLS CUI-1
- C0039985
Description
Date of chest X-ray:
Data type
date
Alias
- UMLS CUI-1
- C0011008
Description
Interpretation of X-ray report:
Data type
text
Alias
- UMLS CUI-1
- C0043299
- UMLS CUI-2
- C0684224
Description
If Abnormal, please specify clinically relevant abnormalities:
Data type
text
Alias
- UMLS CUI-1
- C0436503
Description
TRANSFUSION
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
- C0011008
- UMLS CUI-2
- C0332307
Description
EXTERNAL DATA TRACKING
Alias
- UMLS CUI-1
- C1516800
Description
Were any of the following protocol specified activities performed?
Data type
boolean
Alias
- UMLS CUI-1
- C1516800
Description
If yes, provide date and time
Data type
datetime
Alias
- UMLS CUI-1
- C0011008
Description
ELECTROCARDIOGRAM
Alias
- UMLS CUI-1
- C1623258
Description
Was an Electrocardiogram done?
Data type
boolean
Alias
- UMLS CUI-1
- C1623258
Description
Date and time:
Data type
datetime
Alias
- UMLS CUI-1
- C0011008
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Data type
float
Measurement units
- sec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Width
Data type
float
Measurement units
- sec
Alias
- UMLS CUI [1]
- C0520880
Description
QT Interval
Data type
float
Alias
- UMLS CUI-1
- C0429028
Description
Bazett's QTc (in msec):
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
Fridericia's QTc
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
Electrocardiogram interpretation
Data type
text
Alias
- UMLS CUI-1
- C2826714
Description
If abnormal, ECG corresponds to Hypertrophy?
Data type
text
Alias
- UMLS CUI-1
- C1383860
Description
If abnormal, ECG corresponds to infarction? Select from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction
Data type
text
Alias
- UMLS CUI-1
- C0027051
Description
If abnormal, ECG corresponds to ST/T Morphology? Provide from the following: 8= Myocardial ischemia, 9= Digitalis effect, 10= Symmetrical T- Wave inversions, 12= Other non-specific ST/T
Data type
text
Alias
- UMLS CUI [1,1]
- C0489650
- UMLS CUI [1,2]
- C1623258
- UMLS CUI [1,3]
- C0332437
Description
If abnormal, ECG corresponds to disorders of Rhythm? Provide from the following: 13= Sinus tachycardia, 14= Sinus bradycardia, 15= Supraventricular premature beat, 17= Supraventricular tachycardia, 19= Atrial fibrillation, 20= Atrial flutter, 16= Ventricular premature beat, 18= Ventricular tachycardia, 73= Ventricular fibrillation, 55=Torsade de pointes, 21= Other rhythm abnormalities, 22= Pacemaker rhythm
Data type
text
Alias
- UMLS CUI-1
- C0199571
Description
If abnormal, ECG corresponds to disorders of conduction? Provide from the following: 23= 1° A-V Block, 24= 2° A-V Block, 25= 3° A-V Block, 26= LBB Block, 27= RBB Block, 29= Other intraventricular conduction defect, 28= Pre-excitation syndrom
Data type
text
Alias
- UMLS CUI-1
- C0264886
Description
Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)
Data type
text
Alias
- UMLS CUI-1
- C0522055
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
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C0205410
- UMLS CUI [1,3]
- C0430389
Description
Number of blasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0368761
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
Alias
- UMLS CUI [1,1]
- C1561532
- UMLS CUI [1,2]
- C0449438
Description
Cellularity results
Data type
text
Alias
- UMLS CUI [1]
- C1561532
Description
If "Not done", please specify:
Data type
text
Alias
- UMLS CUI [1,1]
- C0005954
- UMLS CUI [1,2]
- C1272696
Description
DRUG DISPENSATION
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1880359
Description
Was drug dispensed?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1880359
Description
Date of dispensation
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1880359
Description
Container number
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
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
Alias
- UMLS CUI-1
- C0450442
- UMLS CUI-2
- C0677800
- UMLS CUI-3
- C1521941
- UMLS CUI-4
- C1521801
- UMLS CUI-5
- C0178602
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
Alias
- UMLS CUI [1]
- C1518404
Description
Did the subject experience any new or changed non- serious adverse events since the last collection?
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
CTC code
Data type
text
Alias
- UMLS CUI-1
- C0805701
- UMLS CUI-2
- C1516728
- UMLS CUI-3
- C1705313
Description
CTC grade
Data type
integer
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
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On-Treatment 1
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