Terminology P38 Oncology

Oncology Package 38 Terminology
For CDISC Oncology Controlled Terminology Package 38 review, there are additions to 3 existing
codelists: 1 new term for TUIDRS; 4 new terms for TUTEST-CD; and 8 new terms for ONCRSR. Prop
changes to the RS_ONC_Codetable_Mapping and RS_RANO_Codetable_Mapping files are propose
the subsequent tabs. Proposed definition changes and/or additions of synonyms and/or removals f
existing term are included in the last tab.
For the TEST-CD and codelist-specific tabs, Column D contains the TESTCD, PARMCD or Submissi
Value, Column E the TEST or PARM, Column F the Synonym, and Column G the CDISC definition. F
additional information about Test Short Name and Test Name see SDTMIG v 3.2.
Codelist Name: Tumor or Lesion Identification Test Results
Codelist Description: Terminology relevant to tumor and lesion identification test results.
Codelist Extensible: Yes
Addition(s) to an existing codelist
NCI/EVS
Therapeutic Codelist TESTCD, PARMCD or
Request TEST or PARM
Area Request Short Name Submission Value
Number
Pending TUIDRS LOCATION OF INTEREST

on test results.
Synonym(s) CDISC Definition
The identification of an anatomical location that may contain a tumor, lesion or

site of disease, and is part of the assessment of the response to the therapeutic
intervention.
Codelist Name: Tumor Identification Test Code/Test Name
Codelist Description: Terminology relevant to the test codes/names that describe tumor assessmen
identification purposes.
NCI/EVS
Number
TUTEST;
Pending MEASIND Measurable Tumor Indicator
TUTESTCD
TUTEST;
Pending NTIND Non-Target Indicator
TUTESTCD
TUTEST;
Pending FIBLIND Fibrotic Lesion Indicator
TUTESTCD
TUTEST; Cardiovascular Lesion

Pending CVLIND
TUTESTCD Indicator
scribe tumor assessments for
Measurable Tumor Indicator An indication as to whether a measurable tumor is present.
An indication as to whether a non-target tumor, lesion, or site of disease is

Non-Target Indicator
present.
Fibrotic Lesion Indicator An indication as to whether a fibrotic lesion is present.
Cardiovascular Lesion
An indication as to whether a cardiovascular lesion is present.
Indicator
Codelist Name: Oncology Response Assessment Result
Codelist Description: Terminology for oncology studies relevant to the result of response to treatm
classification domain.
NCI/EVS
Number
Pending ONCRSR IMPROVED
Pending ONCRSR WORSENED
Pending ONCRSR STABLE
NONE BEYOND
Pending ONCRSR PHYSIOLOGIC
REPLACEMENT DOSE
Pending ONCRSR DECREASED
Pending ONCRSR INCREASED
Pending ONCRSR PSEUDOPROGRESSION
Pending ONCRSR PSEUDORESPONSE

ult of response to treatment or therapy assessment within the disease response and clinical
Better A subjective response indicating that something has improved or gotten better.
In a declining condition or state.
Subject to little fluctuation; showing little if any change.
An indication that the subject's steroid dose is the same as their physiologic
replacement dose.
Reduced Made less in size, amount, degree, or extent.
A process of becoming larger, more numerous, more important, or more likely.
Apparent increase in tumor burden, not proven to be disease progression.
Apparent decrease in tumor burden, not proven to be favorable treatment

response.
Tumor or Lesion Tumor or Lesion Identification Test
C-code
Identification Test Code Name
(Concept
(TUTESTCD) (TUTEST)
Code)
(codelist code = C96784) (codelist code = C96783)
CNEW CVLIND Cardiovascular Lesion Indicator
C123633 DRCRLTLC Disease Recurrence Relative Location
CNEW FIBLIND Fibrotic Lesion Indicator
C119567 GRLIDENT Graft Lesion Identification
C119567 GRLIDENT Graft Lesion Identification
C94189 LESIDENT Lesion Identification
C94189 LESIDENT Lesion Identification
C119568 LMLIDENT Limb Lesion Identification
C119568 LMLIDENT Limb Lesion Identification
CNEW MEASIND Measurable Tumor Indicator
C154853 METIND Metastatic Tumor Site Indicator
CNEW NTIND Non-Target Indicator
C94525 TUMERGE Tumor Merged
C94523 TUMIDENT Tumor Identification
C96642 TUSPLIT Tumor Split
C119569 VSLIDENT Vessel Lesion Identification
C119569 VSLIDENT Vessel Lesion Identification
Tumor or Lesion Identification Test
C-code C-code
Results
(Concept (Concept
(TUIDRS)
Code) Code)
(codelist code = C123650)
C49487
C17998
C49488
C25321 DISTANT
C67263 LOCAL
C25388 LOCOREGIONAL
C25643 REGIONAL
C49487
C17998
C49488
C94521 NON-TARGET
C94520 TARGET
C94521 NON-TARGET
C94520 TARGET
C94521 NON-TARGET
C94520 TARGET
C49487
C17998
C49488
C49487
C17998
C49488
C49487
C17998
C49488
C94520 TARGET
C14172 BENIGN
C132466 BONE LESION
C103416 MEASURED
C94522 NEW
C132467 NEW BONE LESION
C103423 NON-MEASURABLE
C94521 NON-TARGET
C132468 NON-TARGET ENHANCING
C132469 NON-TARGET EXTRA NODAL
C132470 NON-TARGET NODAL
C132471 NON-TARGET NON-ENHANCING
C103425 NOT MEASURED
C94520 TARGET
C103442 TARGET EXTRA NODAL
C103443 TARGET NODAL
C103444 TARGET NODULE
CNEW LOCATION OF INTEREST
C139126 NEW NON-TARGET
C139127 NEW TARGET
C94520 TARGET
C94521 NON-TARGET
C94520 TARGET
No Yes Response
(NY)
N
U
Y
N
U
Y
N
U
Y
N
U
Y
N
U
Y
Oncology Response Oncology Response Assessment Test
C-code
Assessment Test Code Name
(Concept
(ONCRTSCD) (ONCRTS)
Code)
C94536 BESTRESP Best Overall Response

C135477 BMIVLIND Bone Marrow Involvement Indicator
C132455 BONERESP Bone Response
C123619 CLINRESP Clinical Response
C123619 CLINRESP Clinical Response
C135478 CPRFSTAT Clinical Performance Status
C123620 CYTORESP Cytogenetic Response
C123621 DRCRIND Disease Recurrence Indicator
C123622 HEMARESP Hematologic Response
C135479 LIVRRESP Liver Response
C123623 METBRESP Metabolic Response
C132456 METSIND Metastatic Indicator
C123624 MOLRESP Molecular Response
C123624 MOLRESP Molecular Response
C124433 MRDRESP Minimal Residual Disease Response
C123625 MRPHRESP Morphologic Response
C142362 NEWLIND New Lesion Indicator
C103420 NEWLPROG New Lesion Progression
C103420 NEWLPROG New Lesion Progression
C142363 NEWLWIND New Lesion Worsening Indicator
C135480 NTERESP Non-Target Enhancing Response
C142364 NTLWIND Non-Target Lesion Worsening Indicator
C135481 NTNERESP Non-Target Non-Enhancing Response
C135481 NTNERESP Non-Target Non-Enhancing Response
C94535 NTRGRESP Non-target Response
C96613 OVRLRESP Overall Response
C123626 PATHRESP Pathologic Response
C123627 RDIORESP Radiologic Response
C132457 SFTSRESP Soft Tissue Response
C135482 SPLNRESP Spleen Response
C135483 STRUSTAT Steroid Use Status

C124434 SYMPTDTR Symptomatic Deterioration

C132458 TMRESP Tumor Marker Response
C94534 TRGRESP Target Response
C-code Oncology Response Assessment Result C-code
(Concept (ONCRSR) (Concept
Code) (codelist code = C96785) Code)
C4870 CR
C103385 CRi
C123578 CYTOGENETIC CR
C123583 DISEASE TRANSFORMATION
C62222 NE
C96700 NON-CR/NON-PD
C123599 NON-PD
C103422 nPR
C35571 PD
C18058 PR
C123614 sCR
C18213 SD
C123618 VGPR
C49487
C17998
C49488
C62222 NE
C40413 NED
C123599 NON-PD
C35571 PD
C123607 PDu
C123574 cCR
C123576 cPR
C125459 IMPROVED
C30103 STABLE
C71686 WORSENED
C62222 NE
C123579 CYTOGENETIC MINIMAL RESPONSE
C123580 CYTOGENETIC MINOR RESPONSE
C123581 CYTOGENETIC NO RESPONSE
C123582 CYTOGENETIC PR
C49487
C17998
C49488
C123575 CHR
C123585 HI-E
C123586 HI-N
C123587 HI-P
C4870 CR
C18213 SD
C35571 PD
C62222 NE
C123407 CMR
C123608 PMD
C123609 PMR
C123616 SMD
C49487
C17998
C49488
C123593 MOLECULAR CR
C123594 MOLECULAR MAJOR RESPONSE
C124427 COMPLETE MRD RESPONSE
C124428 MRD NEGATIVITY
C124429 MRD PERSISTENCE
C124430 MRD RELAPSE
C124431 NON-QUANTIFIABLE MRD POSITIVITY
C124432 QUANTIFIABLE MRD POSITIVITY
C123571 ABSENT MORPHOLOGIC RESPONSE
C123595 MORPHOLOGIC CR
C123596 MORPHOLOGIC CRi
C123597 MORPHOLOGIC LEUKEMIA-FREE STATE
C123601 OPTIMAL MORPHOLOGIC RESPONSE
C123602 PARTIAL MORPHOLOGIC RESPONSE
C49487
C17998
C49488
C86071 EQUIVOCAL
C123645 UNEQUIVOCAL
C49487
C17998
C49488
C4870 CR
C18213 SD
C35571 PD
C62222 NE
C49487
C17998
C49488
C25533 INCREASED
C25640 DECREASED
C4870 CR
C62222 NE
C103424 NOT ALL EVALUATED
C35571 PD
C123607 PDu
C18213 SD
C4870 CR
C103385 CRi
C123579 CYTOGENETIC MINIMAL RESPONSE
C123580 CYTOGENETIC MINOR RESPONSE
C123581 CYTOGENETIC NO RESPONSE
C123582 CYTOGENETIC PR
C123583 DISEASE TRANSFORMATION
C123584 FAVORABLE RESPONSE
C123588 IMMUNOPHENOTYPIC CR
C123589 INDETERMINATE RESPONSE
C123591 mCR
C158264 MINIMAL RESPONSE
C123593 MOLECULAR CR
C123598 MR
C62222 NE
C40413 NED
C123599 NON-PD
C103422 nPR
C123600 NR
C35571 PD
C123604 PD FROM PR
C123605 PD/RELAPSE AFTER HI
C123607 PDu
C18058 PR
C128998 PR WITH LYMPHOCYTOSIS
C38155 RELAPSED DISEASE
C123612 RELAPSED DISEASE FROM CR
C123613 RELAPSED DISEASE FROM CR OR PR
C123614 sCR
C18213 SD
C48226 TREATMENT FAILURE
C123617 UNFAVORABLE RESPONSE
C123618 VGPR
CNEW PSEUDOPROGRESSION
CNEW PSEUDORESPONSE
C123590 MAJOR PATHOLOGIC RESPONSE
C123592 MINOR PATHOLOGIC RESPONSE
C123603 pCR
C123577 CR-CT
C123606 PD-CT
C123610 PR-CT
C123615 SD-CT
CNEW PSEUDOPROGRESSION
CNEW PSEUDORESPONSE
C4870 CR
C62222 NE
C40413 NED
C35571 PD
C18058 PR
C18213 SD
C4870 CR
C18058 PR
C18213 SD
C35571 PD
CNEW NONE BEYOND PHYSIOLOGIC
REPLACEMENT DOSE
C25640 DECREASED
C30103 STABLE
C25533 INCREASED
CNEW NONE BEYOND PHYSIOLOGIC
REPLACEMENT DOSE
C35571 PD
C123572 CA125 50% RESPONSE
C123573 CA125 75% RESPONSE
C4870 CR
C62222 NE
C35571 PD
C18058 PR
C123611 PSA PROGRESSION
C18213 SD
C4870 CR
C62222 NE
C103424 NOT ALL EVALUATED
C35571 PD
C18058 PR
C18213 SD
No Yes Response
(NY)
N
U
Y
N
U
Y
N
U
Y
N
U
Y
N
U
Y
N
U
Y
Category of Oncology Oncology Response
C-code Response Assessment C-code Assessment Test Code
(Concept (ONCRSCAT) (Concept (ONCRTSCD)
Code) (codelist code = Code) (codelist code =
C124298) C96782)
C114879 RANO C135483 CPRFSTAT

C114879 RANO C142362 NEWLIND
C114879 RANO C142362 NEWLIND
C114879 RANO C135480 NTERESP
C114879 RANO C135481 NTNERESP
C114879 RANO C96613 OVRLRESP
C114879 RANO C135483 STRUSTAT

C114879 RANO C94534 TRGRESP
C114879 RANO C123627 RDIORESP
Oncology Response Assessment Oncology Response
C-code C-code
Test Name Assessment Result
(Concept (Concept
(ONCRTS) (ONCRSR)
Code) Code)
Clinical Performance Status C125459 IMPROVED

Clinical Performance Status C30103 STABLE
Clinical Performance Status C71686 WORSENED
Clinical Performance Status C62222 NE
New Lesion Indicator C49487
New Lesion Indicator C49488
Non-target Enhancing Response C4870 CR
Non-target Enhancing Response C18213 SD
Non-target Enhancing Response C35571 PD
Non-target Enhancing Response C62222 NE
Non-target Non-enhancing Response C25533 INCREASED
Non-target Non-enhancing Response C25640 DECREASED
Non-target Non-enhancing Response C18213 SD
Non-target Non-enhancing Response C62222 NE
Overall Response C4870 CR
Overall Response C18058 PR
Overall Response C18213 SD
Overall Response C35571 PD
Overall Response C62222 NE
Overall Response CNEW PSEUDOPROGRESSION
Overall Response CNEW PSEUDORESPONSE
NONE BEYOND
Steroid Use Status CNEW PHYSIOLOGIC
REPLACEMENT DOSE
Steroid Use Status C25640 DECREASED
Steroid Use Status C30103 STABLE
Steroid Use Status C25533 INCREASED
Target Response C4870 CR
Target Response C18058 PR
Target Response C18213 SD
Target Response C35571 PD
Target Response C62222 NE
Radiologic Response C4870 CR
Radiologic Response C18058 PR
Radiologic Response C18213 SD
Radiologic Response C35571 PD
Radiologic Response C62222 NE
Radiologic Response CNEW PSEUDOPROGRESSION
Radiologic Response CNEW PSEUDORESPONSE
No Yes
Response
(NY)
(codelist
code =
C66742)
N
Y
NCI/EVS Codelist
Therapeutic Codelist
Request Code Extensible Codelist Name
Area Request Code
Number (Yes/No)
Tumor or Lesion
Pending C25640 C124309
Properties Test Result
Tumor or Lesion
Pending C150897 C123650 Identification Test
Results
Tumor or Lesion
Pending C48190 C123650 Identification Test
Results
CDISC Submission
CDISC Synonym(s) CDISC Definition
Value
DECREASED Reduced Made less in size, amount, degree, or extent.
The identification of an organ that may contain a

tumor, lesion or site of disease, and is part of the
ORGAN OF INTEREST
assessment of the response to the therapeutic
intervention.
Not existing in a specified place at a specified

ABSENT
time. (NCI)
NCI Preferred Term Changes
Reduced Update synonym
Retire from codelist.

Please use new term
'LOCATION OF
INTEREST' (new with
Organ of Interest
P38) as it is broader and
can encompass
anatomical locations
beyond organs.
Retire from codelist. This

was added as a
response value for a
TUTEST (Targeted
Examination) that was
ultimately determined
not to be appropriate to
add. This response does
Absent not currently fit as a
response for any
published TUTEST so
we will remove it from
the codelist. It could be
added in future if a
TUTEST is published
that has this as a
response.

Terminology P38 Oncology

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Terminology P38 Oncology

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Oncology Package 38 Terminology

Addition(s) to an existing codelist

Pending TUIDRS LOCATION OF INTEREST

Synonym(s) CDISC Definition

The identification of an anatomical location that may contain a tumor, lesion or

Addition(s) to an existing codelist

TUTEST; Cardiovascular Lesion

Synonym(s) CDISC Definition

Measurable Tumor Indicator An indication as to whether a measurable tumor is present.

An indication as to whether a non-target tumor, lesion, or site of disease is

Fibrotic Lesion Indicator An indication as to whether a fibrotic lesion is present.

Addition(s) to an existing codelist

Pending ONCRSR IMPROVED

Pending ONCRSR WORSENED

Pending ONCRSR STABLE

Pending ONCRSR DECREASED

Pending ONCRSR INCREASED

Pending ONCRSR PSEUDOPROGRESSION

Pending ONCRSR PSEUDORESPONSE

Synonym(s) CDISC Definition

In a declining condition or state.

Subject to little fluctuation; showing little if any change.

Reduced Made less in size, amount, degree, or extent.

A process of becoming larger, more numerous, more important, or more likely.

Apparent increase in tumor burden, not proven to be disease progression.

Apparent decrease in tumor burden, not proven to be favorable treatment

C94536 BESTRESP Best Overall Response

C135483 STRUSTAT Steroid Use Status

C124434 SYMPTDTR Symptomatic Deterioration

C114879 RANO C135483 CPRFSTAT

C114879 RANO C135483 STRUSTAT

C114879 RANO C135483 STRUSTAT

Clinical Performance Status C125459 IMPROVED

DECREASED Reduced Made less in size, amount, degree, or extent.

The identification of an organ that may contain a

Not existing in a specified place at a specified

Reduced Update synonym

Retire from codelist.

Retire from codelist. This

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