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. For optimal accuracy use black ink

1 forms

StudyEvent: CALGB: 90401 TREATMENT 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. For optimal accuracy use black ink

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Unnamed1

Item Group

Unnamed1

CALGBFormIdentifierNumber

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No.

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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB 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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

TreatmentCourseBeginDate

Item

Cycle start date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)

TreatmentCourseEndDate

Item

Cycle end date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

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

Are data amended

CL Item

Yes (Yes)

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

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)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (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)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

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)

Unnamed3

Item Group

Unnamed3

TreatmentCurrentCourseNumber

Item

Currrent cycle number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)

PatientHeightMeasurement

Item

Height

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

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)

PatientBodySurfaceAreaMeasurement

Item

BSA

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

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)

AgentAdministeredDayDuration

Item

No. of days administered

double

C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)

AgentPlaceboAdministeredInd-2

Item

Administered?

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C753 (NCI Thesaurus Property)
C0032042 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.2

Code List

Administered?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DoseModificationStatus

Item

Dose modification (^1)

text

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

CL.3

Code List

Dose modification (^1)

CL Item

No Dose Modification (No dose modification)

CL Item

Dose Held (Dose held)

CL Item

Dose Delayed (Dose delayed)

CL Item

Dose Reduced (Dose reduced)

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

CL Item

Dose Delayed And Reduced (Dose delayed and reduced)

CL Item

Drug Discontinued (Drug discontinued)

DoseModificationReason

Item

Dose modification reason (^2)

text

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

CL.4

Code List

Dose modification reason (^2)

CL Item

Hypersensitivity (Hypersensitivity)

C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)

CL Item

Patient Refusal/noncompliance (Patient refusal/noncompliance)

CL Item

Scheduling (Scheduling)

CL Item

Dosing Error (Dosing error)

CL Item

Change In Bsa (Change in BSA)

CL Item

Hematologic Toxicity (Hematologic toxicity)

CL Item

Hepatic Dysfunction (Hepatic dysfunction)

CL Item

Pns Toxicity (PNS toxicity)

CL Item

Cns Toxicity (CNS toxicity)

CL Item

Gi Toxicity (GI toxicity)

CL Item

Cardiotoxicity (Cardiotoxicity)

C27994 (NCI Thesaurus)
C0876994 (UMLS 2011AA)

CL Item

Pulmonary Toxicity (Pulmonary toxicity)

CL Item

Renal Toxicity (Renal toxicity)

CL Item

Infection/fever (Infection/fever)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

DoseModificationReasonSpecify

Item

If dose modification = 99, specify

text

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

ConcomitantMedicationReceivedType

Item

Concomitant medications received this cycle (Mark all that apply with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)

CL.5

Code List

Concomitant medications received this cycle (Mark all that apply with an X.)

CL Item

Growth Factor (Growth factor)

C20424 (NCI Thesaurus)
C0018284 (UMLS 2011AA)

CL Item

Anti-platelet Agents (Anti-platelet agents)

CL Item

Aspirin (Aspirin)

CL Item

Anti-coagulant Agents (Anti-coagulant agents)

CL Item

Lipid-lowering Drugs (Lipid-lowering drugs)

GrowthFactorAgentCurrentReportPeriodAdministeredType

Item

Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)

text

C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.6

Code List

Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)

CL Item

Epoetin Alfa (Epoetin)

C2695 (NCI Thesaurus)
C0357126 (UMLS 2011AA)

CL Item

Granulocyte-macrophage Colony-stimulating Factor (G-CSF)

CL Item

Oprelvekin (Neumega)

C1303 (NCI Thesaurus)
C0537668 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

GrowthFactorAgentCurrentReportPeriodAdministeredSpecify

Item

Other, specify

text

C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

AcetylsalicylicAcidAdministeredDailyAmount

Item

Aspirin (Mark one with an X.)

text

C25473 (NCI Thesaurus ValueDomain)
C0332173 (UMLS 2011AA ValueDomain)
C287 (NCI Thesaurus ObjectClass)
C0004057 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)

CL.7

Code List

Aspirin (Mark one with an X.)

CL Item

81 Mg/daily (81 mg/daily)

CL Item

325 Mg/daily (325 mg/daily)

ReducedPlateletAgentAdministeredCode

Item

Agent code (*)

text

C25640 (NCI Thesaurus ObjectClass)
C0392756 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C12520 (NCI Thesaurus ObjectClass)
C0005821 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

CL.8

Code List

Agent code (*)

CL Item

Clopidogrel (clopidogrel)

CL Item

Ticlopidine (ticlopidine)

CL Item

Dipyridamole (dipyridamole)

C445 (NCI Thesaurus)
C0012582 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ReducedPlateletAgentSpecify

Item

Other, specify generic name

text

C25640 (NCI Thesaurus ObjectClass)
C0392756 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C12520 (NCI Thesaurus ObjectClass)
C0005821 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

AgentAdministeredDose

Item

Dose

double

C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

AgentAdministeredDose

Item

Dose

double

AgentAdministeredDose

Item

Dose

double

AgentAdministeredDose

Item

Dose

double

DailyDoseAdministeredCount

Item

Frequency (no. of daily doses)

double

C25473 (NCI Thesaurus ObjectClass)
C0332173 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

DailyDoseAdministeredCount

Item

Frequency (no. of daily doses)

double

DailyDoseAdministeredCount

Item

Frequency (no. of daily doses)

double

AgentBeginDate

Item

Agent start date

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)

AgentBeginDate

Item

Agent start date

date

AnticoagulantAgentAdministeredName

Item

Agent code (**)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.9

Code List

Agent code (**)

CL Item

Low Molecular Weight Heparin (Low molecular weight heparin)

CL Item

Warfarin (Warfarin)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

AnticoagulantAgentAdministeredSpecify

Item

Other, specify generic name

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

AgentEndDate

Item

Agent end date

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)

AgentEndDate

Item

Agent end date

date

ReducedLipidAgentAdministeredCode

Item

Agent code (***)

text

C25640 (NCI Thesaurus ObjectClass)
C0392756 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C616 (NCI Thesaurus ObjectClass)
C0023779 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C0027365 (NCI Metathesaurus ValueDomain)

CL.10

Code List

Agent code (***)

CL Item

Atorvastatin (atorvastatin)

C28837 (NCI Thesaurus)
C0082029 (UMLS 2011AA)

CL Item

Fluvastatin (fluvastatin)

CL Item

Lovastatin (lovastatin)

C620 (NCI Thesaurus)
C0024027 (UMLS 2011AA)

CL Item

Pravastatin (pravastatin)

CL Item

Rosuvastatin (rosuvastatin)

CL Item

Simvastatin (simvastatin)

CL Item

Fenofibrate (fenofibrate)

C29047 (NCI Thesaurus)
C0033228 (UMLS 2011AA)

CL Item

Gemfibrozil (gemfibrozil)

C29071 (NCI Thesaurus)
C0017245 (UMLS 2011AA)

CL Item

Cholestyramine (cholestyramine)

C28929 (NCI Thesaurus)
C0008402 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ReducedLipidAgentSpecify

Item

Other, specify generic name

text

Off-TreatmentOtherReasonSpecify

Item

If Other reason, specify:

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

Off-TreatmentOtherReasonSpecify

Item

If Other reason, specify:

text

ChemotherapyTotalCycleCompleteCount

Item

Total number of cycles completed (bevacizumab/placebo)

double

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

ChemotherapyTotalCycleCompleteCount

Item

Total number of cycles completed (bevacizumab/placebo)

double

LastDoseDate

Item

last dose date (bevacizumab/placebo)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

LastDoseDate

Item

last dose date (bevacizumab/placebo)

date

TreatmentCurrentCycleDiscontinuedInd-2

Item

Was treatment permanently discontinued during this cycle (bevacizumab/placebo)

text

C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.13

Code List

Was treatment permanently discontinued during this cycle (bevacizumab/placebo)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TreatmentCurrentCycleDiscontinuedInd-2

Item

Was treatment permanently discontinued during this cycle (bevacizumab/placebo)

text

CL.13

Code List

Was treatment permanently discontinued during this cycle (bevacizumab/placebo)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

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.14

Code List

Reason treatment ended (*)

CL Item

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

CL Item

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

CL Item

Adverse Event/side Effects/complications (Adverse event/side effects/complications)

CL Item

Death On Study (Death on study)

CL Item

Patient Withdrawal Or Refusal (Patient withdrawal or refusal prior to beginning protocol therapy)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

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

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Off-treatmentReason

Item

Reason treatment ended (*)

text

CL.14

Code List

Reason treatment ended (*)

CL Item

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

CL Item

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

CL Item

Adverse Event/side Effects/complications (Adverse event/side effects/complications)

CL Item

Death On Study (Death on study)

CL Item

Patient Withdrawal Or Refusal (Patient withdrawal or refusal prior to beginning protocol therapy)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

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

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PatientWithdrawnConsentClinicalInd-2

Item

Patient has withdrawn consent for clinical follow-up.

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25398 (NCI Thesaurus ValueDomain)
C0205210 (UMLS 2011AA ValueDomain)

CL.15

Code List

Patient has withdrawn consent for clinical follow-up.

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientWithdrawnConsentSurvivalInd-2

Item

Patient has withdrawn consent for survival follow-up.

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17177 (NCI Thesaurus ValueDomain)
C0038952 (UMLS 2011AA ValueDomain)

CL.16

Code List

Patient has withdrawn consent for survival follow-up.

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientWithdrawConsentDate

Item

Withdrawn consent date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)

ResponsiblePersonName

Item

Completed by

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompleteDate

Item

Date form completed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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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. For optimal accuracy use black ink

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