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 1
Beschrijving
PHYSICAL MEASUREMENTS (DAY 1)
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
integer
Alias
- UMLS CUI-1
- C1520224
Beschrijving
EXTRAMEDULLARY INVOLVEMENT (DAY 1)
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C1314939
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Is extramedullary disease presen?
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
- C0805701
- UMLS CUI-2
- C1517060
- UMLS CUI-3
- C0012634
Beschrijving
VITAL SIGNS (END OF MONTH 1)
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Were vital signs taken?
Datatype
boolean
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Position
Datatype
text
Alias
- UMLS CUI-1
- C0733755
Beschrijving
Blood pressure systolic
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure diastolic
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PHYSICAL MEASUREMENTS (END OF MONTH 1)
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
integer
Alias
- UMLS CUI-1
- C1520224
Beschrijving
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 1)
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 [1,1]
- C0805701
- UMLS CUI [1,2]
- C1517060
- UMLS CUI [1,3]
- 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
- C0043299
- UMLS CUI-2
- C0684224
Beschrijving
If Abnormal, please specify clinically relevant abnormalities:
Datatype
text
Alias
- UMLS CUI-1
- C0436503
Beschrijving
TRANSFUSION
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
- C0011008
- 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
ELECTROCARDIOGRAM
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Was an Electrocardiogram done?
Datatype
boolean
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Date and time:
Datatype
datetime
Alias
- UMLS CUI-1
- C0011008
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Width
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0520880
Beschrijving
QT Interval
Datatype
float
Alias
- UMLS CUI-1
- C0429028
Beschrijving
Bazett's QTc (in msec):
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Fridericia's QTc
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Electrocardiogram interpretation
Datatype
text
Alias
- UMLS CUI-1
- C2826714
Beschrijving
If abnormal, ECG corresponds to Hypertrophy?
Datatype
text
Alias
- UMLS CUI-1
- C1383860
Beschrijving
If abnormal, ECG corresponds to infarction? Select from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction
Datatype
text
Alias
- UMLS CUI-1
- C0027051
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0489650
- UMLS CUI [1,2]
- C1623258
- UMLS CUI [1,3]
- C0332437
Beschrijving
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
Datatype
text
Alias
- UMLS CUI-1
- C0199571
Beschrijving
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
Datatype
text
Alias
- UMLS CUI-1
- C0264886
Beschrijving
Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)
Datatype
text
Alias
- UMLS CUI-1
- C0522055
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
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C0205410
- UMLS CUI [1,3]
- C0430389
Beschrijving
Number of blasts
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0368761
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
Alias
- UMLS CUI [1,1]
- C1561532
- UMLS CUI [1,2]
- C0449438
Beschrijving
Cellularity results
Datatype
text
Alias
- UMLS CUI [1]
- C1561532
Beschrijving
If "Not done", please specify:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005954
- UMLS CUI [1,2]
- C1272696
Beschrijving
DRUG DISPENSATION
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1880359
Beschrijving
Was drug dispensed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1880359
Beschrijving
Date of dispensation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1880359
Beschrijving
Container number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beschrijving
BMS-354825 DOSING
Alias
- UMLS CUI-1
- C1455147
- UMLS CUI-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
- C0450442
- UMLS CUI-2
- C0677800
- UMLS CUI-3
- C1521941
- UMLS CUI-4
- C1521801
- UMLS CUI-5
- C0178602
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
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Did the subject experience any new or changed non- serious adverse events since the last collection?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
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
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