INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
TreatmentFirstDoseBeginDate
Item
Date of First dose for this reporting period
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
Chemotherapy Cycle End Date
Item
Cycle end date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
FormOriginalCompleteDate
Item
Date Form Originally Completed
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property-2)
C0205313 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Treatment Data
Cycle Number
Item
Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Body Surface Area
Item
BSA
float
C25190 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1)
Doxorubicin dose received this cycle
Item
Total doxorubicin dose received this cycle (mg)
float
C456 (NCI Thesaurus ObjectClass)
C0013089 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0178602 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
Item
Dose level received on reporting period start date
text
C1708 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C1521801 (UMLS CUI-2)
C25375 (NCI Thesaurus Property-2)
C25431 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
CL.5
Code List
Dose level received on reporting period start date
CL Item
400 Mg Every 12 Hrs (400 mg every 12 hrs)
CL Item
400 Mg Every Day (400 mg every day)
CL Item
400 Mg Every Other Day (400 mg every other day)
CL Item
Not Received (Not received)
Item
Method of administration
text
C25284 (NCI Thesaurus ValueDomain)
C0449311 (UMLS CUI-1)
CL111054 (NCI Metathesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
CL.3
Code List
Method of administration
CL Item
Bolus Injection (Bolus injection)
CL Item
Infusion (Infusion)
C15388 (NCI Thesaurus)
C0574032 (UMLS 2011AA)
Item
Was the doxorubicin dose reduced this cycle
text
C456 (NCI Thesaurus ObjectClass)
C0013089 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C1707814 (UMLS CUI-2)
C25640 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C25256 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
CL.4
Code List
Was the doxorubicin dose reduced this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
Sorafenib dose received this cycle
Item
Total sorafenib dose received this cycle
float
C25304 (NCI Thesaurus ValueDomain)
C1516119 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C0178602 (UMLS CUI-2)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C61948 (NCI Thesaurus ObjectClass-2)
Item
Was the sorafenib dose reduced during this cycle
text
C1708 (NCI Thesaurus ObjectClass)
C1516119 (UMLS CUI-1)
C61948 (NCI Thesaurus ObjectClass-2)
C1707814 (UMLS CUI-2)
C25640 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C25256 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
CL.6
Code List
Was the sorafenib dose reduced during this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
Item
Were any doses of sorafenib missed this cycle
text
C1708 (NCI Thesaurus ObjectClass)
C61948 (NCI Thesaurus ObjectClass-2)
C54031 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C25256 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C1516119 (UMLS CUI-1)
C1709043 (UMLS CUI-2)
CL.7
Code List
Were any doses of sorafenib missed this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
Number of missed doses Sorafenib
Item
Number of missed Sorafenib doses
integer
C1708 (NCI Thesaurus ObjectClass)
C61948 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C1516119 (UMLS CUI-1)
C0750480 (UMLS CUI-2)
C1709043 (UMLS CUI-3)
G-CSF or GM-CSF
Item
Did patient receive G-CSF or GM-CSF per protocol
boolean
C38148 (NCI Thesaurus ValueDomain)
C0796404 (UMLS CUI-1)
C20586 (NCI Thesaurus ObjectClass)
C25340 (NCI Thesaurus Property)
G-CSF or GM-CSF start date
Item
Date of first dose of G-CSF/GM-CSF during this reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C0796404 (UMLS CUI-1)
C20586 (NCI Thesaurus ObjectClass)
C0808070 (UMLS CUI-2)
C25340 (NCI Thesaurus Property)
Protocol Deviation Description
Item
Specify deviation (If no,)
text
C25704 (NCI Thesaurus ValueDomain)
C1705236 (UMLS CUI-1)
C50996 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
Item
Did the patient receive any additional supportive care during this reporting period
text
C38148 (NCI Thesaurus ValueDomain)
C0344211 (UMLS CUI-1)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
CL.9
Code List
Did the patient receive any additional supportive care during this reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Supportive Care non-Protocol, specify
Item
Yes specify
text
C25704 (NCI Thesaurus ValueDomain)
C0344211 (UMLS CUI-1)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
C1521902 (UMLS CUI-3)
Item
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
CL.10
Code List
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Alternative therapy, specify
Item
Alternative therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0949216 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
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