INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
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)
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)
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Pre-registration Hematology/chemistry
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
C25213 (NCI Thesaurus-3)
C1442488 (UMLS 2011AA-4)
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 11 (Cycle 11)
CL Item
Cycle 12 (Cycle 12)
CL Item
Cycle 13 (Cycle 13)
CL Item
Cycle 14 (Cycle 14)
CL Item
Cycle 15 (Cycle 15)
CL Item
Cycle 16 (Cycle 16)
CL Item
Cycle 17 (Cycle 17)
CL Item
Cycle 18 (Cycle 18)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 9 (Cycle 9)
HematologyLabCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ValueDomain-2)
C1317250 (UMLS CUI-1)
Hematology lab
Item
Were hematology/chemistry results obtained this report period (cycle)?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25217 (NCI Thesaurus Property)
C16673 (NCI Thesaurus ObjectClass)
C0474523 (UMLS CUI-1)
Granulocyte count
Item
Peripheral Granulocytes Count (AGC/ANC/mm^3 - Do not report % granulocytes: report absolute count without decimal.)
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
Platelets
Item
Peripheral Platelet Count (/mm^3x1000)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, Serum
Item
Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Creatinine, serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Sodium
Item
Sodium
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C830 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0337443 (UMLS CUI-1)
Laboratory Procedure Not Performed
Item
Test not done (Please mark "X" in Box only if test not done)
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS CUI-1)
CL.4
Code List
Units
CL Item
Grams Per Deciliter (g/dL)
C0439267 (UMLS CUI-1)
CL Item
Grams Per Liter (g/L)
C0439294 (UMLS CUI-1)
CL Item
Milligrams Per Deciliter (mg/dL)
C0439269 (UMLS CUI-1)
CL Item
Milligrams Per Liter (mg/L)
C0439268 (UMLS CUI-1)
CL Item
Millimole Per Liter (mmol/L)
C1532563 (UMLS CUI-1)
CL Item
Milliequivalent Per Liter (mEq/L)
C0439375 (UMLS CUI-1)
Item
CTC AE Attribution Code (Leave attribution box blank if no adverse event.)
text
C25664 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
C1706735 (UMLS CUI-1)
CL.5
Code List
CTC AE Attribution Code (Leave attribution box blank if no adverse event.)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
C1704787 (UMLS CUI-1)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
C0332149 (UMLS CUI-1)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
C1709683 (UMLS CUI-1)
CL Item
Unlikely (Unlikely)
C0750558 (UMLS CUI-1)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS CUI-1)
Item
Action taken for this AE for Chemotherapy
text
C25488 (NCI Thesaurus ObjectClass)
C15632 (NCI Thesaurus Property)
C41331 (NCI Thesaurus Property-2)
C25572 (NCI Thesaurus Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0178602 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0449438 (UMLS CUI-4)
CL.6
Code List
Action taken for this AE for Chemotherapy
CL Item
Dose Held (Dose held)
C0178602 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
CL Item
Dose Delayed (Dose delayed)
C0178602 (UMLS CUI-1)
C0205421 (UMLS CUI-2)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS CUI-1)
CL Item
Dose Held and Reduced (Dose held and reduced)
C49505 (NCI Thesaurus)
C49505 (NCI Thesaurus-3)
C1553387 (UMLS CUI-1)
C1707814 (UMLS CUI-2)
CL Item
Drug Discontinued (Drug discontinued)
C0558681 (UMLS CUI-1)
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