PHYSICAL MEASUREMENTS (DAY 1)
Were any physical measurements taken?
boolean
Date of measurement
date
Weight
float
Performance status (ECOG)
integer
EXTRAMEDULLARY INVOLVEMENT (DAY 1)
Date of assessment
date
Is extramedullary disease presen?
boolean
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
VITAL SIGNS (END OF MONTH 1)
Were vital signs taken?
boolean
Date
date
Position
text
Blood pressure systolic
float
Blood pressure diastolic
float
Heart rate
integer
PHYSICAL MEASUREMENTS (END OF MONTH 1)
Were any physical measurements taken?
boolean
Date of measurement
date
Weight
float
Performance status (ECOG)
integer
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 1)
Date of assessment
date
Is extramedullary disease present?
boolean
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
CHEST X-RAY
Was a chest X-ray performed?
boolean
Date of chest X-ray:
date
Interpretation of X-ray report:
text
If Abnormal, please specify clinically relevant abnormalities:
text
TRANSFUSION
Did the subject recieve any transfusion(s) since the last data collection?
boolean
Date of transfusion
date
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
text
EXTERNAL DATA TRACKING
Were any of the following protocol specified activities performed?
boolean
If yes, provide date and time
datetime
ELECTROCARDIOGRAM
Was an Electrocardiogram done?
boolean
Date and time:
datetime
Heart rate
integer
PR Interval
float
QRS Width
float
QT Interval
float
Bazett's QTc (in msec):
float
Fridericia's QTc
float
Electrocardiogram interpretation
text
If abnormal, ECG corresponds to Hypertrophy?
text
If abnormal, ECG corresponds to infarction? Select from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction
text
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
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
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
Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)
text
BONE MARROW BIOPSY/ ASPIRATE
Was a bone marrow procedure performed?
boolean
Date of procedure:
date
Indicate procedure
text
Was cytogenetic analysis performed?
boolean
Number of metaphases examined
integer
Number of metaphases positive for philadelphia chromosome
integer
Was the specimen adequate for light microscopic analysis?
boolean
Number of blasts
float
Number of promyelocytes
float
Number of basophils
float
Cellularity form
text
Cellularity results
text
If "Not done", please specify:
text
DRUG DISPENSATION
BMS-354825 DOSING
Start date
date
Stop date
date
Actual dose taken per day (in mg)
float
Reason for dose modification
text
For the reasons asking for specification, please explain the cause
text
CONCOMITANT MEDICATIONS
Were any additions or changes made to concomitant medications since the last data collection?
boolean
Medication name
text
Date started:
date
Date stopped
date
Reason
text
NON-SERIOUS ADVERSE EVENTS
Did the subject experience any new or changed non- serious adverse events since the last collection?
boolean
CTC code
text
CTC grade
integer
Onset date
date
Resolution date
date
Relationship to study drug:
text
Action taken regarding study drug
text
Treatment required
boolean