ID

1040

Beschreibung

E1105 Treatment Form First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17256C2D-9F93-4AD8-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17256C2D-9F93-4AD8-E044-0003BA3F9857

Stichworte

Mammatumoren, Mensch

Hochgeladen am

26. August 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00520975 Treatment - E1105 Treatment Form - 2491666v1.0

Modell
Details

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

1 Formulare

StudyEvent: E1105 Treatment Form
1. INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Unnamed1

Item Group

Unnamed1

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

CollectedDataFormName

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

ON TREATMENT

Item Group

On Treatment

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (since start of treatment)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)

CL.2

Code List

On Treatment Report Period (since start of treatment)

CL Item

Cycle 1 (Cycle 1)

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)

CL Item

Cycle 10 (Cycle 10)

CL Item

Cycle 11 (Cycle 11)

CL Item

> Cycle 11 (> Cycle 11)

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (since start of treatment)

text

CL.2

Code List

On Treatment Report Period (since start of treatment)

CL Item

Cycle 1 (Cycle 1)

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)

CL Item

Cycle 10 (Cycle 10)

CL Item

Cycle 11 (Cycle 11)

CL Item

> Cycle 11 (> Cycle 11)

TreatmentEvaluationPeriodCycleSpecify

Item

Specify Cycle (specify)

text

C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)

Unnamed2

Item Group

Unnamed2

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)

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

ProtocolParticipatingIdentifierNumber

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

Unnamed3

Item Group

Unnamed3

DataAmendedText

Item

Please mark an 'X' if data have been amended. (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

DataAmendedDate

Item

Date data amended (s)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

Vital Status

Item Group

Section I - Vital Status

PatientVitalStatus

Item

Vital Status

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25717 (NCI Thesaurus Property)
C1148433 (UMLS 2011AA Property)

CL.3

Code List

Vital Status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

PatientLastContactDate

Item

Date of Last Contact or Death

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

PatientDeathPrimaryReason

Item

Primary Cause of Death (if applicable)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ValueDomain)
C0205225 (UMLS 2011AA ValueDomain)

CL.4

Code List

Primary Cause of Death (if applicable)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

CL Item

Due To Other Cause (Due to other cause)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientDeathSpecify

Item

Describe cause of death (other)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)

Patient Charastics

Item Group

Patient Charastics

PatientWeightMeasurement

Item

Weight (Day 1 of this report period)

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)

Therapy Administered

Item Group

Unnamed4

TreatmentReportingPeriodBeginDate

Item

Reporting Period Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

TreatmentReportingPeriodEndDate

Item

Reporting Period End Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)

AgentName

Item

Agent Name (Sunitinib/Placebo)

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)

CumulativeAgentTotalDose

Item

Agent Total Cumulative Dose (mg)

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)

DoseModificationStatus

Item

Dose modification

text

C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25572 (NCI Thesaurus Property)

CL.5

Code List

Dose modification

CL Item

Dose Held (Dose held)

CL Item

Dose Reduced (Dose reduced)

C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)

CL Item

Dose Delayed (Dose delayed)

CL Item

Dose Delayed And Reduced (Dose delayed and reduced)

CL Item

Drug Discontinued (Drug discontinued)

CL Item

No Dose Modification (No dose modification)

DoseModificationReason

Item

Dose Modification Reason

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

CL.6

Code List

Dose Modification Reason

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Alternative Therapy For Other Reason (Alternative therapy for other reason)

CL Item

Dosing Error (Dosing error)

CL Item

Patient Refusal/noncompliance (Patient refusal/noncompliance)

CL Item

Scheduling (Scheduling)

CL Item

Second Primary Cancer (Second primary)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

DoseModificationReasonSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

LaboratoryProcedureCreatinineResultSpecifiedValue

Item

Serum creatinine (Value used to calculate Creatinine Clearance)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

HematologySpecimenCollectedDate

Item

Date Hematology (Blood) Sample Obtained

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)

LaboratoryProcedureCreatinineClearanceOutcomeValue

Item

Creatinine Clearance (Calculated - Record value used to determine Carboplatin dose)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

DoseChemotherapyAdverseEventModificationType

Item

Adverse Event (If chemotherapy was modified for adverse event, mark all that apply)

text

C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.7

Code List

Adverse Event (If chemotherapy was modified for adverse event, mark all that apply)

CL Item

Cardiac Toxicity (Cardiac Toxicity)

CL Item

Gi Toxicity (GI Toxicity)

CL Item

Hematologic Toxicity (Hematologic Toxicity)

CL Item

Hepatic Toxicity (Hepatic Toxicity)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Thrombosis (Thrombosis/Embolism)

C26891 (NCI Thesaurus)
C0040053 (UMLS 2011AA)

DoseAdverseEventModificationReason

Item

Adverse Event (If trastuzumab was modified for adverse event, mark all that apply)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

CL.8

Code List

Adverse Event (If trastuzumab was modified for adverse event, mark all that apply)

CL Item

Allergic Reaction/hypersensitivity (Allergic reaction/hypersensitivity)

CL Item

Gi Toxicity (GI toxicity)

CL Item

Cardiac Toxicity (Cardiac Toxicity)

CL Item

Hematologic Toxicity (Hematologic toxicity)

CL Item

Hepatic Toxicity (Hepatic Toxicity)

CL Item

Neurotoxicity (Neurotoxicity)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Thrombosis/embolism (Thrombosis/Embolism)

DoseBevacizumabAdverseEventModificationType

Item

Adverse Event (If bevacizumab/placebo was modified for adverse event, mark all that apply)

text

C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.9

Code List

Adverse Event (If bevacizumab/placebo was modified for adverse event, mark all that apply)

CL Item

Cardiac Toxicity (Cardiac Toxicity)

CL Item

Gi Toxicity (GI Toxicity)

CL Item

Hepatic Toxicity (Hepatic Toxicity)

CL Item

Neurotoxicity (Neurotoxicity)

CL Item

Arterial Thrombotic Event (Arterial Thrombotic Event)

CL Item

Wound Dehiscence (Wound Dehiscence)

C50863 (NCI Thesaurus)
C0259768 (UMLS 2011AA)

CL Item

Venous Thrombosis/embolism (Venous Thrombosis/Embolism)

CL Item

Hemorrhage (Hemorrhage)

C26791 (NCI Thesaurus)
C0019080 (UMLS 2011AA)

CL Item

Proteinuria (Proteinuria)

C38012 (NCI Thesaurus)
C0033687 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

DoseAdverseEventModificationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

DoseAdverseEventModificationSpecify

Item

Other, specify

text

DoseAdverseEventModificationSpecify

Item

Other, specify

text

Non-Protocol Therapy

Item Group

Section Vi - Non-protocol Therapy

Non-protocolCancerTreatmentConcurrentClinicalTrialProtocolTherapeuticProcedureAdministeredInd-3

Item

Was any non-protocol therapy given during protocol treatment (not previously reported)

text

C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C16212 (NCI Thesaurus ObjectClass)
C0920425 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.10

Code List

Was any non-protocol therapy given during protocol treatment (not previously reported)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

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

Investigator Signature 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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Lizenz

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Breast Cancer NCT00520975 Treatment - E1105 Treatment Form - 2491666v1.0

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

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