PHYSICAL MEASUREMENTS (END OF MONTH 24)
Were any physical measurements taken?
boolean
Date of measurement
date
Weight
float
Performance status (ECOG)
text
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 24)
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
TRANSFUSIONS
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
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
text
Onset date
date
Resolution date
date
Relationship to study drug
text
Action taken regarding study drug
text
Treatment required?
boolean
PREGNANCY TEST (END OF MONTH 20)
Was a pregnancy test performed?
boolean
Date of test
date
If no test was performed, specify reason
text
If a test was performed, please specify result
text
Specify test
text
PREGNANCY TEST (END OF MONTH 22
Was a pregnancy test performed?
boolean
Date of test
date
If no test was performed, specify reason
text
If a test was performed, please specify result
text
Specify test
text
PREGNANCY TEST (END OF MONTH 24)
Was a pregnancy test performed?
boolean
Date of test
date
If no test was performed, specify reason
text
If a test was performed, please specify result
text
Specify test
text