Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
1- CR=Complete Response
Item
1- CR=Complete Response
boolean
C0521982 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
If Yes to Complete Response
text
C0521982 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Code List
If Yes to Complete Response
CL Item
Hematologic Response (8)
CL Item
Cytogenic Response (9)
CL Item
Hematologic and Cytogenic Response (10)
2- PR=Partial Response
Item
2- PR=Partial Response
boolean
C1521726 (UMLS CUI [1])
15- HI=Hematologic Improvement
Item
15- HI=Hematologic Improvement
boolean
C0012634 (UMLS CUI [1,1])
C0018943 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C2986411 (UMLS CUI [1,4])
3- SD=Stable Disease
Item
3- SD=Stable Disease
boolean
C0677946 (UMLS CUI [1])
4- PD=Progressive Disease
Item
4- PD=Progressive Disease
boolean
C1335499 (UMLS CUI [1])
Item
If Yes to Progressive Disease
text
C1335499 (UMLS CUI [1])
Code List
If Yes to Progressive Disease
CL Item
By Bone Marrow Evaluation and Peripheral Blood Counts (5)
CL Item
By Bone Marrow Evaluation Only (6)
CL Item
By Peripheral Blood Counts Only (7)
8- ND= Complete Evaluation Not Done
Item
8- ND= Complete Evaluation Not Done (Bone marrow evaluation and peripheral blood counts were not done) -> Complete the Study Conclusion section
boolean
C0220825 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Response Assessment performed by
Item
Response Assessment performed by
text
C0220825 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Item
Is the patient continuing in the study?
text
C2348568 (UMLS CUI [1])
Code List
Is the patient continuing in the study?
CL Item
If 'No' Complete Best Overall Response Assessment, Study Conclusion and Investigator's Signature on the following page (No)
CL Item
If 'Yes' do NOT complete Best Overall Response Assessment or Study Conclusion on the following page. Only complete Investigator's Signature (Yes)
Not Required
Item
Not Required
boolean
C1514873 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
Item
Best Overall Response Assessment
text
C2986560 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Code List
Best Overall Response Assessment
CL Item
CR, Complete Response (1)
CL Item
PR, Partial Response (2)
CL Item
HI, Hematologic Improvement (15)
CL Item
SD, Stable Disease (3)
CL Item
PD, Progressive Disease (4)
CL Item
NE, Non-evaluable for Response (8)
Date for blood counts return to normal or have stabilized
Item
Date for blood counts return to normal or have stabilized
date
C0011008 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,3])
C0079107 (UMLS CUI [1,4])
C0005771 (UMLS CUI [1,5])
Complete the study
Item
Did the patient complete the study as planned
boolean
C2348577 (UMLS CUI [1])
Item
If 'No', mark the Primary cause of withdrawal
text
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Code List
If 'No', mark the Primary cause of withdrawal
CL Item
Adverse experience (Complete AE From) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol Deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify:.............................. (7)
Date of Final Study Evaluation
Item
Date of Final Study Evaluation
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator`s Signature
Item
Investigator`s Signature
text
C2346576 (UMLS CUI [1])
Date of Investigator`s Signature
Item
Date of Investigator`s Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])