ID
44775
Beschreibung
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
Stichworte
Versionen (3)
- 02.08.15 02.08.15 -
- 06.08.15 06.08.15 -
- 18.11.21 18.11.21 -
Rechteinhaber
Bristol-Myers Squibb
Hochgeladen am
18. November 2021
DOI
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Creative Commons BY-NC 4.0
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment
On-Treatment 1
Beschreibung
PHYSICAL MEASUREMENTS (DAY 1)
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beschreibung
Were any physical measurements taken?
Datentyp
boolean
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beschreibung
Date of measurement
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- Kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Performance status (ECOG)
Datentyp
integer
Alias
- UMLS CUI-1
- C1520224
Beschreibung
EXTRAMEDULLARY INVOLVEMENT (DAY 1)
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C1314939
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Is extramedullary disease presen?
Datentyp
boolean
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C0012634
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI-1
- C0805701
- UMLS CUI-2
- C1517060
- UMLS CUI-3
- C0012634
Beschreibung
VITAL SIGNS (END OF MONTH 1)
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Were vital signs taken?
Datentyp
boolean
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Position
Datentyp
text
Alias
- UMLS CUI-1
- C0733755
Beschreibung
Blood pressure systolic
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Blood pressure diastolic
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
PHYSICAL MEASUREMENTS (END OF MONTH 1)
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beschreibung
Were any physical measurements taken?
Datentyp
boolean
Alias
- UMLS CUI-1
- C0205485
- UMLS CUI-2
- C0242485
Beschreibung
Date of measurement
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- Kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Performance status (ECOG)
Datentyp
integer
Alias
- UMLS CUI-1
- C1520224
Beschreibung
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 1)
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C1314939
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Is extramedullary disease present?
Datentyp
boolean
Alias
- UMLS CUI-1
- C1517060
- UMLS CUI-2
- C0012634
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1517060
- UMLS CUI [1,3]
- C0012634
Beschreibung
CHEST X-RAY
Alias
- UMLS CUI-1
- C0039985
Beschreibung
Was a chest X-ray performed?
Datentyp
boolean
Alias
- UMLS CUI-1
- C0039985
Beschreibung
Date of chest X-ray:
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Interpretation of X-ray report:
Datentyp
text
Alias
- UMLS CUI-1
- C0043299
- UMLS CUI-2
- C0684224
Beschreibung
If Abnormal, please specify clinically relevant abnormalities:
Datentyp
text
Alias
- UMLS CUI-1
- C0436503
Beschreibung
TRANSFUSION
Alias
- UMLS CUI-1
- C1879316
Beschreibung
Did the subject recieve any transfusion(s) since the last data collection?
Datentyp
boolean
Alias
- UMLS CUI-1
- C1879316
Beschreibung
Date of transfusion
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
Datentyp
text
Alias
- UMLS CUI-1
- C0011008
- UMLS CUI-2
- C0332307
Beschreibung
EXTERNAL DATA TRACKING
Alias
- UMLS CUI-1
- C1516800
Beschreibung
Were any of the following protocol specified activities performed?
Datentyp
boolean
Alias
- UMLS CUI-1
- C1516800
Beschreibung
If yes, provide date and time
Datentyp
datetime
Alias
- UMLS CUI-1
- C0011008
Beschreibung
ELECTROCARDIOGRAM
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Was an Electrocardiogram done?
Datentyp
boolean
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Date and time:
Datentyp
datetime
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
PR Interval
Datentyp
float
Maßeinheiten
- sec
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Width
Datentyp
float
Maßeinheiten
- sec
Alias
- UMLS CUI [1]
- C0520880
Beschreibung
QT Interval
Datentyp
float
Alias
- UMLS CUI-1
- C0429028
Beschreibung
Bazett's QTc (in msec):
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Fridericia's QTc
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Electrocardiogram interpretation
Datentyp
text
Alias
- UMLS CUI-1
- C2826714
Beschreibung
If abnormal, ECG corresponds to Hypertrophy?
Datentyp
text
Alias
- UMLS CUI-1
- C1383860
Beschreibung
If abnormal, ECG corresponds to infarction? Select from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction
Datentyp
text
Alias
- UMLS CUI-1
- C0027051
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0489650
- UMLS CUI [1,2]
- C1623258
- UMLS CUI [1,3]
- C0332437
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI-1
- C0199571
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI-1
- C0264886
Beschreibung
Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)
Datentyp
text
Alias
- UMLS CUI-1
- C0522055
Beschreibung
BONE MARROW BIOPSY/ ASPIRATE
Alias
- UMLS CUI-1
- C0005954
Beschreibung
Was a bone marrow procedure performed?
Datentyp
boolean
Alias
- UMLS CUI-1
- C0005954
Beschreibung
Date of procedure:
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Indicate procedure
Datentyp
text
Alias
- UMLS CUI-1
- C0184661
Beschreibung
Was cytogenetic analysis performed?
Datentyp
boolean
Alias
- UMLS CUI-1
- C0752095
- UMLS CUI-2
- C0162789
- UMLS CUI-3
- C0022526
- UMLS CUI-4
- C0884358
- UMLS CUI-5
- C0011008
Beschreibung
Number of metaphases examined
Datentyp
integer
Alias
- UMLS CUI-1
- C1512699
- UMLS CUI-2
- C0936012
- UMLS CUI-3
- C0025564
Beschreibung
Number of metaphases positive for philadelphia chromosome
Datentyp
integer
Alias
- UMLS CUI-1
- C0031526
Beschreibung
Was the specimen adequate for light microscopic analysis?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C0205410
- UMLS CUI [1,3]
- C0430389
Beschreibung
Number of blasts
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0368761
Beschreibung
Number of promyelocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0455279
Beschreibung
Number of basophils
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0200641
Beschreibung
Cellularity form
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1561532
- UMLS CUI [1,2]
- C0449438
Beschreibung
Cellularity results
Datentyp
text
Alias
- UMLS CUI [1]
- C1561532
Beschreibung
If "Not done", please specify:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005954
- UMLS CUI [1,2]
- C1272696
Beschreibung
DRUG DISPENSATION
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1880359
Beschreibung
Was drug dispensed?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1880359
Beschreibung
Date of dispensation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1880359
Beschreibung
Container number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beschreibung
BMS-354825 DOSING
Alias
- UMLS CUI-1
- C1455147
- UMLS CUI-2
- C0178602
Beschreibung
Start date
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Stop date
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Actual dose taken per day (in mg)
Datentyp
float
Alias
- UMLS CUI-1
- C0450442
- UMLS CUI-2
- C0677800
- UMLS CUI-3
- C1521941
- UMLS CUI-4
- C1521801
- UMLS CUI-5
- C0178602
Beschreibung
Reason for dose modification
Datentyp
text
Alias
- UMLS CUI-1
- C1707811
Beschreibung
For the reasons asking for specification, please explain the cause
Datentyp
text
Alias
- UMLS CUI-1
- C2348235
Beschreibung
CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Were any additions or changes made to concomitant medications since the last data collection?
Datentyp
boolean
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Medication name
Datentyp
text
Alias
- UMLS CUI-1
- C2360065
Beschreibung
Date started:
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Date stopped
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Reason
Datentyp
text
Alias
- UMLS CUI-1
- C0392360
Beschreibung
NON-SERIOUS ADVERSE EVENTS
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Did the subject experience any new or changed non- serious adverse events since the last collection?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
CTC code
Datentyp
text
Alias
- UMLS CUI-1
- C0805701
- UMLS CUI-2
- C1516728
- UMLS CUI-3
- C1705313
Beschreibung
CTC grade
Datentyp
integer
Alias
- UMLS CUI-1
- C2985911
Beschreibung
Onset date
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Resolution date
Datentyp
date
Alias
- UMLS CUI-1
- C0011008
Beschreibung
Relationship to study drug:
Datentyp
text
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Action taken regarding study drug
Datentyp
text
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Treatment required
Datentyp
boolean
Alias
- UMLS CUI-1
- C0332307
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0087111
- UMLS CUI-4
- C1521801
Ähnliche Modelle
On-Treatment 1
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
C1314939 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
C1517060 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
C1314939 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
C1517060 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0332307 (UMLS CUI-2)
C1623258 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
C0162789 (UMLS CUI-2)
C0022526 (UMLS CUI-3)
C0884358 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0936012 (UMLS CUI-2)
C0025564 (UMLS CUI-3)
C0205410 (UMLS CUI [1,2])
C0430389 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,3])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0677800 (UMLS CUI-2)
C1521941 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
C0178602 (UMLS CUI-5)
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)