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.

1 formularios

StudyEvent: CALGB: 30610 Treatment and Response Form
1. 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.

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Header

Item Group

Ccrr Module For Calgb 90202: Skeletal Survey Form

Form ID CALGB

Item

CALGB Form (C-1244)

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)

Reporting Period Start Date

Item

Reporting Period Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Reporting Period End Date

Item

Reporting Period End Date

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-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)

Survival Date

Item Group

Survival Date

Patient Status

Item

Vital Status (Mark one with an X.)

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)

CL.2

Code List

Vital Status (Mark one with an X.)

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Date last contact

Item

Date of Last Contact or Death

date

C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Treatment Data

Item Group

Treatment Data

Clinical Trial Period

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.3

Code List

Reporting Period

CL Item

Cycles 1 & 2 (Cycles 1 & 2)

CL Item

Cycles 3 & 4 (Cycles 3 & 4)

Body Surface Area

Item

BSA

float

C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)

TherapyCourseAdministeredCount

Item

Number of cycles given (this reporting period)

float

C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)

CisplatinAgentDuringReportingPeriodAdministeredDose

Item

Total dose of cisplatin administered this reporting period (mg)

float

C376 (NCI Thesaurus ObjectClass)
C0008838 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25490 (NCI Thesaurus Property-4)
C0347984 (UMLS 2011AA Property-4)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

EtoposideAgentDuringReportingPeriodAdministeredDose

Item

Total dose of etoposide administered this reporting period (mg)

float

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C491 (NCI Thesaurus ObjectClass-2)
C0015133 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25490 (NCI Thesaurus Property-4)
C0347984 (UMLS 2011AA Property-4)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

RadiationTherapyReportPeriodAdministeredDose

Item

Total dose of radiation therapy administered during this reporting period

float

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

Dose Modification

Item

Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)

text

C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)

CL.5

Code List

Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)

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)

Dose Modification

Item

Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)

text

C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)

CL.5

Code List

Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)

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 Treatment Reason

Item

Reason Treatment Ended

text

C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)

CL.6

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

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)

Off-treatmentAlternativeReasonSpecify

Item

Alternative Therapy

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)

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)

Response Data

Item Group

Response Data

Follow-Up Date

Item

Date of Last Clinical Assessment

date

C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Best Overall Response

Item

Best Overall Response to date

text

C3262 (NCI Thesaurus ObjectClass)
C2986560 (UMLS CUI-1)
C25605 (NCI Thesaurus ObjectClass-2)
C25432 (NCI Thesaurus ObjectClass-3)
C25755 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)

CL.7

Code List

Best Overall Response to date

CL Item

Complete Response (CR)

CL Item

Partial Response (PR)

C18212 (NCI Thesaurus)

CL Item

Stable Disease (SD)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Progressive Disease (PD)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Insufficient Evaluation (Insufficient evaluation to determine response status)

Complete Response First Observed Date

Item

Complete Response (CR) First Observed Date

date

C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Partial Response First Observed Date

Item

Partial Response (PR) First Observed Date

date

C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Progressive Disease Observed Date

Item

Progressive Disease (PD) Observed Date

date

C25164 (NCI Thesaurus ValueDomain)
C1335499 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)

Progression Site

Item

Sites of Progression

text

C13717 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)

CL.8

Code List

Sites of Progression

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Brain (Brain)

C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)

CL Item

Hilar Lymph Node (Hilar lymph nodes)

C1305372 (NCI Metathesaurus)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung, Nos (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Mediastinal Lymph Node (Mediastinal lymph nodes)

C33073 (NCI Thesaurus)
C0588055 (UMLS 2011AA)

CL Item

Contralateral Lung (Opposite lung)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

Progression Site, specify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)

RadiationFieldCancerProgressionAnatomicSite

Item

Site of progression with regard to RT fields

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C54648 (NCI Thesaurus ObjectClass)
C1882536 (UMLS 2011AA ObjectClass)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)

CL.9

Code List

Site of progression with regard to RT fields

CL Item

Outside The Rt Field And Outside The Initial (pre-chemotherapy) Tumor Volume (Outside the RT field and outside the initial (pre-chemotherapy) tumor volume)

CL Item

Outside The Rt Field And Within The Initial (pre-chemotherapy) Tumor Volume (Outside the RT field and within the initial (pre-chemotherapy) tumor volume)

CL Item

Within Delivered/intended Low Dose Volume (Within delivered/intended low dose volume)

CL Item

Within The Delivered/intended High Dose Volume (Within the delivered/intended high dose volume)

Footer

Item Group

Footer

Person Completing Form

Item

Completed by (Last name, First name)

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Form Completion Date

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Volver a la parte superior de la página

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.

Descripción

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Unidades de medida

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias

Descripción

Tipo de datos

Alias