The CML Study Performa
Was the informed consent signed by patient:
Yes
No
Attach Scanned Form:
Date of Singnature:
Name
Hospital Record ID(File No.):
Date of Birth:
Gender:
Male
Female
Address
Hospital Name:
Phone No:
Phone No. 2:
Date Of Diagnosis:
CNIC
Height (cm)
Weight(kg)
ECOG/WHO Score:
0-Symptomatic
1-Symptomatic but completely ambulatory
2-Symptomatic, less then 50%in bed during the day
3-Symptomatic greater then50% in bed but not bedbound
4-Bedbound
5-Dead
N/A
Comorbidities:
Yes
No
if yes please specify:
Neurological disorder
Cardiovascular disorder
Hypertension
Diabetes
Chronic liver disease
Chronic renal disease
Behavior disorder
Other:
Smoking status:
Non Smoker
Current Smoker
Former Smoker
Unknown
Clincal data before Treatment
Spleen Size (cm below the costal margin):
Disease Related Symptoms:
Yes
No
N/A
if yes please specify:
Weight loss
Fever
Bone pain
Abdominal Pain
Hemorrhagic Syndrome
Fatigue
Infection
Other:
Extramedullary Involvement (with exception of liver and spleen):
Yes
No
Unknown
if yes please specify:
Skin
Lymphnodes
Bone
CNS
Other:
Phase of the Disease at Diagnosis:
Chronic Phase
Accelerated Phase
Blast Phase
Part C : Hematological Data
Date Of laboratory analysis:
Hemoglobin (g/dl)
Hemoglobin (%)
WBC (x 109/L)
Platelets(x109/L)
Blasts in Peripheral blood (%)
Basophils (%)
Eosinophils (%)
Was the above analysis carried out before any treatment?:
Yes
No
Risk Score: The risk will be calculated automatically if the above data refer to diagnosis prior to any treatment.
SoKal Score
EUTOS Score
Cytogenetics | Chromosome Banding analysis :
Yes
No
Unknown
Chromosome Banding Date:
If yes please specify
Ph+t(9;22) (q34;q11)
Yes
No
Unknown
Variant Translocations
Yes
No
Unknown
Number of evaluated metaphases
Yes
No
Unknown
Number of ph metaphases
Yes
No
Unknown
% of Ph+ metaphases
Clonal Chromosome abnormalities in Ph+ cells
Yes
No
Unknown
Interphase FISH Analysis
Yes
No
Unknown
Interphase FISH Analysis Date:
If Yes Plz specify:
Number of scored nuclei:
Unknown
Number of positive nuclei:
Unknown
% of positive nuclei:
Unknown
Part D: Molecular Biology
BCR-ABL Transcript type:
Type of Transcript :
b2a2
b3a2
Others (if any):
BCR-ABL Transcript level:
Control gene:
ABL
GUS
B2M
BCR
Others if any:
BCR-ABL/ control gene % on international scale?:
Part 2: Tratment
Start date of first TKI treatment:
Imatigliv 100mg:
Initial daily dose
Maximum Daily Dose
Other concomitant drugs:
Monthly Response Assessment
Month 1:
CBC
Creatinine
Urine Analysis
Month 3:
CBC
Creatinine
Urine Analysis
Month 6:
CBC
Creatinine
Urine Analysis
Month 9:
CBC
Creatinine
Urine Analysis
Month 12:
CBC
Creatinine
Urine Analysis
Molecular Assessments (at month 3, 6 and 12 of treatment)
3 Months
BCR-ABL
Detected
Not Detected
Response Rate
Early Molecular response(EMR)
Major Molecular response(MMR)
Deep Molecular response(DMR)
None
6 Months
BCR-ABL
Detected
Not Detected
Response Rate
Early Molecular response(EMR)
Major Molecular response(MMR)
Deep Molecular response(DMR)
None
12 Months
BCR-ABL
Detected
Not Detected
Response Rate
Early Molecular response(EMR)
Major Molecular response(MMR)
Deep Molecular response(DMR)
None
Side effect Profile :
Month 1 :
Non- Hematological :
Oedema
Grade (I-IV):
Management:
Nausea & Vomiting
Grade (I-IV):
Management:
Muscle cramps
Grade (I-IV):
Management:
Diarrhea
Grade (I-IV):
Management:
Rash
Grade (I-IV):
Management:
Hepatic toxicity
Grade (I-IV):
Management:
Hypophosphatemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Hematological Toxicity :
Neutropenia
Grade (I-IV):
Management:
Thrombocytopenia
Grade (I-IV):
Management:
Anemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Month 3 :
Non- Hematological :
Oedema
Grade (I-IV):
Management:
Nausea & Vomiting
Grade (I-IV):
Management:
Muscle cramps
Grade (I-IV):
Management:
Diarrhea
Grade (I-IV):
Management:
Rash
Grade (I-IV):
Management:
Hepatic toxicity
Grade (I-IV):
Management:
Hypophosphatemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Hematological Toxicity :
Neutropenia
Grade (I-IV):
Management:
Thrombocytopenia
Grade (I-IV):
Management:
Anemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Month 6 :
Non- Hematological :
Oedema
Grade (I-IV):
Management:
Nausea & Vomiting
Grade (I-IV):
Management:
Muscle cramps
Grade (I-IV):
Management:
Diarrhea
Grade (I-IV):
Management:
Rash
Grade (I-IV):
Management:
Hepatic toxicity
Grade (I-IV):
Management:
Hypophosphatemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Hematological Toxicity :
Neutropenia
Grade (I-IV):
Management:
Thrombocytopenia
Grade (I-IV):
Management:
Anemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Month 9 :
Non- Hematological :
Oedema
Grade (I-IV):
Management:
Nausea & Vomiting
Grade (I-IV):
Management:
Muscle cramps
Grade (I-IV):
Management:
Diarrhea
Grade (I-IV):
Management:
Rash
Grade (I-IV):
Management:
Hepatic toxicity
Grade (I-IV):
Management:
Hypophosphatemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Hematological Toxicity :
Neutropenia
Grade (I-IV):
Management:
Thrombocytopenia
Grade (I-IV):
Management:
Anemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Month 12 :
Non- Hematological :
Oedema
Grade (I-IV):
Management:
Nausea & Vomiting
Grade (I-IV):
Management:
Muscle cramps
Grade (I-IV):
Management:
Diarrhea
Grade (I-IV):
Management:
Rash
Grade (I-IV):
Management:
Hepatic toxicity
Grade (I-IV):
Management:
Hypophosphatemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Hematological Toxicity :
Neutropenia
Grade (I-IV):
Management:
Thrombocytopenia
Grade (I-IV):
Management:
Anemia
Grade (I-IV):
Management:
Any Others:
Grade (I-IV):
Management:
Patient off Protocol
Intolerance
Progressive Disease
Death due to other causes
Submitted by:
Name:
Email:
Phone No:
Institute/Organization:
Supervised by:
Supervisor's Name:
Supervisor's Email:
Supervisor's Phone No:
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