INSTRUCTIONS: Form is submitted 1 week after completion or termination of adjuvant systemic treatment. All 4 pages of the form must be submitted. Dates are mm-dd-yyyy unless otherwise specified.

1 forms

StudyEvent: RTOG 0848: Phase III Pancreas-Resected + Adjuvant Treatment Systemic Treatment Summary Form (SF)
1. INSTRUCTIONS: Form is submitted 1 week after completion or termination of adjuvant systemic treatment. All 4 pages of the form must be submitted. Dates are mm-dd-yyyy unless otherwise specified.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header Module

Item Group

Module 1

ProtocolRTOGIdentifierNumber

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property)
C1706256 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

InstitutionName

Item

Institution Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

InstitutionIdentifierNumber

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientInitialsName

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

PatientRadiationTherapyOncologyGroupIdentifierNumber

Item

RTOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Unnamed1

Item Group

Unnamed1

ProtocolTreatmentArmFirstRandomizationAssignmentType

Item

Assigned Treatment Arm First Randomization

text

C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.2

Code List

Assigned Treatment Arm First Randomization

CL Item

Arm 1 (Arm 1)

CL Item

Arm 2 (Arm 2)

Summary of Systemic Treatment

Item Group

Assessment

PatientHeightMeasurement

Item

Height (CM)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Weight (CM)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PersonBodySurfaceAreaValue

Item

BSA

double

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

AgentAdministeredType

Item

Which drug will be administered

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.3

Code List

Which drug will be administered

CL Item

Not Applicable, No Drug Administered (Not applicable, no drug administered)

CL Item

Fluorouracil (5-FU)

C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)
C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)

CL Item

Capecitabine (Capecitabine)

C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)

Treatment Summary

Item Group

Unnamed 3

AgentName

Item

Agent Name

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

AgentBeginDate

Item

Date Agent Started (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

AgentEndDate

Item

Date Agent Ended (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

AgentTotalDoseCount

Item

Total number of doses

double

C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

CumulativeAgentTotalDose

Item

Total Dose

double

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25470 (NCI Thesaurus ObjectClass)
C1511559 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

DoseModificationInd

Item

Dose Modification (Change)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)

CL.4

Code List

Dose Modification (Change)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)

CL Item

Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)

Off-treatmentReason

Item

Reason Treatment Ended

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.5

Code List

Reason Treatment Ended

CL Item

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Death On Study (Death on study)

CL Item

Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

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

Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)

AlternativeTherapyAdministeredSpecify

Item

Alternative therapy, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass)
C1523987 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Off-treatmentComplicatingReasonSpecify

Item

Other Complicating Disease specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)

Off-treatmentReasonSpecify

Item

Other specify

text

TherapyModificationText

Item

Details of any treatment modification

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

Adverse Events

Item Group

Protocol Specific Adverse Event Evaluation

TreatmentRelatedAdverseEventReportInd-3

Item

Any adverse events

text

C25648 (NCI Thesaurus ObjectClass)
C0439849 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.6

Code List

Any adverse events

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)

MedDRACode

Item

MedDRA disease code

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

CommonToxicityCriteriaAdverseEventTermType

Item

CTC AE Term

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC AE Grade

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.7

Code List

CTC AE Grade

CL Item

No Adverse Event Or Within Normal Limits (0)

CL Item

Mild Adverse Event (1)

C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CTCAdverseEventReportBeginDate

Item

CTCAE Begin Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Code

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.8

Code List

CTC Adverse Event Attribution Code

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Unlikely (Unlikely)

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

SeriousAdverseEventReportInd-3

Item

SAE report submitted

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass)
C0205404 (UMLS 2011AA ObjectClass)

CL.9

Code List

SAE report submitted

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)

Footer Module

Item Group

Unnamed Module 4

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

InvestigatorSignatureText

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorSignatureDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

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INSTRUCTIONS: Form is submitted 1 week after completion or termination of adjuvant systemic treatment. All 4 pages of the form must be submitted. Dates are mm-dd-yyyy unless otherwise specified.

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