Please see https://medical-data-models.org/forms/11515 (Previous and current medications)
Please see https://medical-data-models.org/forms/11515 (Pre- treatment events)
Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
Please see https://medical-data-models.org/forms/11515 (Medical tests and examinations)
Please see https://medical-data-models.org/forms/11515 (General Medical History)
Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
FLUORESCENT IN SITU HYBRIDIZATION (FISH)
Was a FISH analysis performed?
boolean
Date
date
Sample type
text
For extramedullary site, please mention the site from the followings, 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
Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)
LABORATORY TEST RESULTS
Were laboratory tests performed?
boolean
Name of laboratory
text
Date of hematology specimen collection
date
Differential
text
Hemoglobin
float
Hematocrit
float
Red blood cells
float
White blood cells
float
Platelet count
float
Neutrophils
float
Bands
float
Lymphocytes
float
Monocytes
float
Eosinophils
float
Basophils
float
Blasts
float
Promyelocytes
float
Myelocytes
float
Metamyelocytes
float
Other, please specify
text
Date of coagulation specimen collection
date
International normalized ratio
float
Other, please specify
text
Was the subject fasting?
text
Date of chemistry specimen collection
date
AST (SGOT)
integer
ALT (SGPT)
integer
Total bilirubin
float
Alkaline phosphatase
integer
Lactate dehydrogenase (LDH)
integer
Creatinine
integer
Blood urea nitrogen (BUN)
float
Urea
float
Potassium
float
Uric acid
float
Ionized calcium
float
Calcium
float
Phosphorus
float
Magnesium
float
Sodium
float
Please see https://medical-data-models.org/forms/11783 (On- Treatment 8)
Please see https://medical-data-models.org/forms/11783 (On- Treatment 1)
Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)
Please see https://medical-data-models.org/forms/11783 (On- Treatment 6)
DEATH DATA
Did the subject die?
boolean
Date of death
date
Cause of death
text
For the causes asking for specification, please mention details
text
ENROLLMENT IN PREVIOUS BMS CA180 PROTOCOL
Previous protocol number
text
Previous site number
integer
Previous subject number
integer
Date subject or legally authorized representative signed informed consent for previous protocol?
date
DOSE ADMINISTRATION FOR UNSCHEDULED CSF
Date and time of dose administration
datetime
Last dose received (in mg)
float
Date and time of dose administration (Day of CSF)
datetime
Morning dose received (in mg)
float
CSF PHARMACOKINETICS
Were any samples collected?
boolean
Actual date and time (3- 4 hours post dose)
datetime
Pharmacokinetic sample label
text
Comments
text
BLOOD PHARMACOKINETICS
Were any samples collected?
boolean
Pharmacokinetic sample label
text
Actual date and time (3-4 hr post dose)
datetime
Comments
text
DOSE ADMINISTRATION
PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS
Were any samples collected?
boolean
Actual date and time of sample collection
datetime
Pharmacokinetic sample label
text
Comments
text
DIAGNOSTIC PROCEDURES
Did the subject have any non protocol specified diagnostic procedures performed?
boolean
Procedure
text
Date of procedure
date
Reason
text
Findings
text