Vital signs
Item
Were vital signs taken?
boolean
C0518766 (UMLS CUI-1)
Date
Item
Date:
date
C0011008 (UMLS CUI-1)
Item
Position:
text
C0733755 (UMLS CUI-1)
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)
Physical measurements
Item
Were any physical measurements taken?
boolean
C0205485 (UMLS CUI-1)
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)
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)
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)
Vital signs
Item
Were vital signs taken?
boolean
C0518766 (UMLS CUI-1)
DATE
Item
Date:
date
C0011008 (UMLS CUI-1)
Item
Position:
text
C0733755 (UMLS CUI-1)
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)
Physical measurements
Item
Were any physical measurements taken?
boolean
C0205485 (UMLS CUI-1)
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)
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)
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 C1517060 C0012634 (UMLS CUI-1)
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)
Item
Interpretation of X-ray report:
text
C0043299 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Code List
Interpretation of X-ray report:
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)
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)
Item
Electrocardiogram interpretation:
text
C2826714 (UMLS CUI-1)
Code List
Electrocardiogram interpretation:
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
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)
Item
Indicate procedure:
text
C0184661 (UMLS CUI-1)
Code List
Indicate procedure:
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)
Metaphase
Item
Number of metaphases examined:
integer
C1512699 (UMLS CUI-1)
C0936012 (UMLS CUI-2)
C0025564 (UMLS CUI-3)
Philadelphia chromosome
Item
Number of metaphases positive for philadelphia chromosome:
integer
C0031526 (UMLS CUI-1)
LIGHT MICROSCOPIC ANALYSIS
Item
Was the specimen adequate for light microscopic analysis?
boolean
BLASTS
Item
Number of blasts:
integer
C1982687 (UMLS CUI-1)
PROMYELOCYTES
Item
Number of promyelocytes:
integer
C0455279 (UMLS CUI-1)
BASOPHILS
Item
Number of basophils:
integer
C0200641 (UMLS CUI-1)
Item
Cellularity form:
text
Code List
Cellularity form:
Item
Cellularity results:
text
Code List
Cellularity results:
CL Item
2 Hypocellular (less than 20%) (2)
CL Item
3 Normal (20-40%) (3)
CL Item
4 Hypercellular (41-100%) (4)
CELLULARITY RESULTS
Item
If "Not done", please specify:
text
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)
Item
Reason for dose modification:
text
C1707811 (UMLS CUI-1)
Code List
Reason for dose modification:
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)
Item
Reason:
text
C0392360 (UMLS CUI-1)
CL Item
3 Adverse event (1)
NON-SERIOUS ADVERSE EVENTS
Item
Did the subject experience any new or changed non- serious adverse events since the last collection?
boolean
CTC CODE
Item
CTC code:
text
C0805701 (UMLS CUI-1)
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)
Item
Relationship to study drug:
text
C0013227 (UMLS CUI-1)
Code List
Relationship to study drug:
Item
Action taken regarding study drug:
text
C0013227 (UMLS CUI-1)
Code List
Action taken regarding study drug:
Treatment required
Item
Treatment required?
boolean
C0332307 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)