Information:
Fel:
ID
44775
Beskrivning
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
Nyckelord
Versioner (3)
- 2015-08-02 2015-08-02 -
- 2015-08-06 2015-08-06 -
- 2021-11-18 2021-11-18 -
Rättsinnehavare
Bristol-Myers Squibb
Uppladdad den
18 november 2021
DOI
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Licens
Creative Commons BY-NC 4.0
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment
On-Treatment 1
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Vital signs
Item
Were vital signs taken?
boolean
C0518766 (UMLS CUI-1)
Date
Item
Date:
date
C0011008 (UMLS CUI-1)
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
BLOOD PRESSURE SYSTOLIC
Item
Blood pressure systolic (in mm Hg):
float
C0871470 (UMLS CUI [1])
BLOOD PRESSURE DIASTOLIC
Item
Blood pressure diastolic (in mm Hg):
float
C0428883 (UMLS CUI [1])
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
Item Group
PHYSICAL MEASUREMENTS (DAY 1)
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
Physical measurements
Item
Were any physical measurements taken?
boolean
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
DATE
Item
Date of measurement:
date
C0011008 (UMLS CUI-1)
Weight
Item
Weight (in Kg):
float
C0005910 (UMLS CUI [1])
ECOG
Item
Performance status (ECOG):
integer
C1520224 (UMLS CUI-1)
Item Group
EXTRAMEDULLARY INVOLVEMENT (DAY 1)
C1517060 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
C1314939 (UMLS CUI-2)
DATE
Item
Date of assessment:
date
C0011008 (UMLS CUI-1)
Extramedullary disease
Item
Is extramedullary disease presen?
boolean
C1517060 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
Extramedullary disease code
Item
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
text
C0805701 (UMLS CUI-1)
C1517060 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C1517060 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Vital signs
Item
Were vital signs taken?
boolean
C0518766 (UMLS CUI-1)
DATE
Item
Date:
date
C0011008 (UMLS CUI-1)
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
BLOOD PRESSURE SYSTOLIC
Item
Blood pressure systolic (in mm Hg):
float
C0871470 (UMLS CUI [1])
BLOOD PRESSURE DIASTOLIC
Item
Blood pressure diastolic (in mm Hg):
float
C0428883 (UMLS CUI [1])
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
Item Group
PHYSICAL MEASUREMENTS (END OF MONTH 1)
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
Physical measurements
Item
Were any physical measurements taken?
boolean
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0242485 (UMLS CUI-2)
Date
Item
Date of measurement:
date
C0011008 (UMLS CUI-1)
Weight
Item
Weight (in Kg):
float
C0005910 (UMLS CUI [1])
ECOG
Item
Performance status (ECOG):
integer
C1520224 (UMLS CUI-1)
Item Group
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 1)
C1517060 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
C1314939 (UMLS CUI-2)
Date
Item
Date of assessment:
date
C0011008 (UMLS CUI-1)
Extramedullary disease
Item
Is extramedullary disease present?
boolean
C1517060 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
Extramedullary disease code
Item
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
text
C0805701 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
CHEST X-RAY
Item
Was a chest X-ray performed?
boolean
C0039985 (UMLS CUI-1)
Date
Item
Date of chest X-ray:
date
C0011008 (UMLS CUI-1)
CL Item
Normal (1)
CL Item
Abnormal (2)
X-ray report interpretation
Item
If Abnormal, please specify clinically relevant abnormalities:
text
C0436503 (UMLS CUI-1)
Transfusion
Item
Did the subject recieve any transfusion(s) since the last data collection?
boolean
C1879316 (UMLS CUI-1)
Date
Item
Date of transfusion:
date
C0011008 (UMLS CUI-1)
transfusion type
Item
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
text
C0011008 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
C0332307 (UMLS CUI-2)
EXTERNAL DATA TRACKING
Item
Were any of the following protocol specified activities performed?
boolean
C1516800 (UMLS CUI-1)
DATE AND TIME
Item
If yes, provide date and time:
datetime
C0011008 (UMLS CUI-1)
Electrocardiogram
Item
Was an Electrocardiogram done?
boolean
C1623258 (UMLS CUI-1)
DATE AND TIME
Item
Date and time:
datetime
C0011008 (UMLS CUI-1)
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
PR INTERVAL
Item
PR Interval (in sec):
float
C0429087 (UMLS CUI [1])
QRS WIDTH
Item
QRS Width (in sec):
float
C0520880 (UMLS CUI [1])
QT INTERVAL
Item
QT Interval (in sec):
float
C0429028 (UMLS CUI-1)
Bazett's QTc
Item
Bazett's QTc (in msec):
float
C0489625 (UMLS CUI [1])
QTc
Item
Fridericia's QTc (in msec):
float
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Cardiac hypertrophy
Item
If abnormal, ECG corresponds to Hypertrophy? Provide from the following: 1= Left atrial hypertrophy, 2= Right atrial hypertrophy, 3= Left ventricular hypertrophy, 4= Right ventricular hypertrophy
text
C1383860 (UMLS CUI-1)
Cardiac infarction
Item
If abnormal, ECG corresponds to infarction? Provide from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction
text
C0027051 (UMLS CUI-1)
ST/T MORPHOLOGY
Item
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
text
C0489650 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
C1623258 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
RHYTHM
Item
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
text
C0199571 (UMLS CUI-1)
CONDUCTION
Item
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
text
C0264886 (UMLS CUI-1)
Electrocardiogram abnormalities
Item
Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)
text
C0522055 (UMLS CUI-1)
Bone marrow biopsy
Item
Was a bone marrow procedure performed?
boolean
C0005954 (UMLS CUI-1)
DATE
Item
Date of procedure:
date
C0011008 (UMLS CUI-1)
CL Item
31 Aspirate (1)
CL Item
16 Biopsy (2)
CL Item
89 Both (Aspirate and Biopsy) (3)
CYTOGENETIC ANALYSIS
Item
Was cytogenetic analysis performed?
boolean
C0752095 (UMLS CUI-1)
C0162789 (UMLS CUI-2)
C0022526 (UMLS CUI-3)
C0884358 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0162789 (UMLS CUI-2)
C0022526 (UMLS CUI-3)
C0884358 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
Metaphase
Item
Number of metaphases examined:
integer
C1512699 (UMLS CUI-1)
C0936012 (UMLS CUI-2)
C0025564 (UMLS CUI-3)
C0936012 (UMLS CUI-2)
C0025564 (UMLS CUI-3)
Philadelphia chromosome
Item
Number of metaphases positive for philadelphia chromosome:
integer
C0031526 (UMLS CUI-1)
specimen adequate for light microscopic analysis
Item
Was the specimen adequate for light microscopic analysis?
boolean
C0370003 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0430389 (UMLS CUI [1,3])
C0205410 (UMLS CUI [1,2])
C0430389 (UMLS CUI [1,3])
BLASTS
Item
Number of blasts:
float
C0368761 (UMLS CUI [1])
PROMYELOCYTES
Item
Number of promyelocytes:
float
C0455279 (UMLS CUI [1])
BASOPHILS
Item
Number of basophils:
float
C0200641 (UMLS CUI [1])
CL Item
Clot (1)
CL Item
Biopsy (2)
CL Item
1 Absent (1)
CL Item
2 Hypocellular (less than 20%) (2)
CL Item
3 Normal (20-40%) (3)
CL Item
4 Hypercellular (41-100%) (4)
CL Item
95 Not done (5)
Bone marrow biopsy not done
Item
If "Not done", please specify:
text
C0005954 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
drug dispensation
Item
Was drug dispensed?
boolean
C0013227 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,2])
DATE of dispensation
Item
Date of dispensation:
date
C0011008 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,3])
Container number
Item
Container number:
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
DATE
Item
Start date:
date
C0011008 (UMLS CUI-1)
DATE
Item
Stop date:
date
C0011008 (UMLS CUI-1)
DOSE
Item
Actual dose taken per day (in mg):
float
C0450442 (UMLS CUI-1)
C0677800 (UMLS CUI-2)
C1521941 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
C0178602 (UMLS CUI-5)
C0677800 (UMLS CUI-2)
C1521941 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
C0178602 (UMLS CUI-5)
CL Item
3 Hematologic toxicity (specify) (1)
CL Item
4 Non hematologic toxicity (specify) (2)
CL Item
56 Dosing error (3)
CL Item
57 Raising % blasts (4)
CL Item
59 Loss of response (5)
CL Item
66 No CHR, NEL or RTC within 6 weeks (6)
CL Item
67 NoCCyR after 6 months (7)
CL Item
68 No MCyR after 3 months (8)
CL Item
98 Other (specify) (9)
Specification
Item
For the reasons asking for specification, please explain the cause:
text
C2348235 (UMLS CUI-1)
CONCOMITANT MEDICATIONS
Item
Were any additions or changes made to concomitant medications since the last data collection?
boolean
C2347852 (UMLS CUI-1)
Medication name
Item
Medication name:
text
C2360065 (UMLS CUI-1)
DATE
Item
Date started:
date
C0011008 (UMLS CUI-1)
DATE
Item
Date stopped:
date
C0011008 (UMLS CUI-1)
CL Item
3 Adverse event (1)
CL Item
98 Other (2)
NON-SERIOUS ADVERSE EVENTS
Item
Did the subject experience any new or changed non- serious adverse events since the last collection?
boolean
C1518404 (UMLS CUI [1])
CTC CODE
Item
CTC code:
text
C0805701 (UMLS CUI-1)
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
CTC grade
Item
CTC grade:
integer
C2985911 (UMLS CUI-1)
DATE
Item
Onset date:
date
C0011008 (UMLS CUI-1)
DATE
Item
Resolution date:
date
C0011008 (UMLS CUI-1)
CL Item
Certain (1)
CL Item
Probable (2)
CL Item
Possible (3)
CL Item
Not likely (4)
CL Item
Not related (5)
CL Item
None (1)
CL Item
Reduced (2)
CL Item
Increased (3)
CL Item
Interrupted (4)
CL Item
Discontinued (5)
Treatment required
Item
Treatment required?
boolean
C0332307 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)