ID

6666

Descripción

Tamoxifen/Exemestane Form (Form 24-TE) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B70B84C2-ED22-2268-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B70B84C2-ED22-2268-E034-0003BA12F5E7

Palabras clave

Klinische Studie [Dokumenttyp]

Treatment Form

C50.9

26/8/12 26/8/12 -
8/1/15 8/1/15 - Martin Dugas

Subido en

8 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00659373 Treatment - Tamoxifen/Exemestane Form (Form 24-TE) - 2080772v3.0

model
Detalles

TAMOXIFEN/EXEMESTANE FORM (Form 24-TE) Instructions: This form is to be completed and submitted for all patients at each follow-up period (every 3 months in Year 1, and every 6 months in Years 2-6) until the completion of Tamoxifen/Exemestane. Report Tamoxifen/Exemestane given as treatment for recurrence/second primary on the Follow-Up Form (24-E). If patient is receiving another aromatase inhibitor,report on the Concomitant Medications Form (24-CCM). Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable, or not done.

1 formularios

StudyEvent: Tamoxifen/Exemestane Form (Form 24-TE)
1. TAMOXIFEN/EXEMESTANE FORM (Form 24-TE) Instructions: This form is to be completed and submitted for all patients at each follow-up period (every 3 months in Year 1, and every 6 months in Years 2-6) until the completion of Tamoxifen/Exemestane. Report Tamoxifen/Exemestane given as treatment for recurrence/second primary on the Follow-Up Form (24-E). If patient is receiving another aromatase inhibitor,report on the Concomitant Medications Form (24-CCM). Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable, or not done.

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

CCRR MODULE

Item Group

Ccrr Module For Tamoxifen/exemestane Form - Revised (form 24-te)

PatientStudyID,CoordinatingGroup

Item

Patient ID No.

text

Patient Initials

Item

Patient Initials (f m fl sl)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Patient Birth Date

Item

Patient's Date of Birth (day)

date

C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)

ParticipatingCenter/Affiliate

Item

Participating Center/Affiliate

text

ParticipatingGroupCode

Item

Center Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)

Reporting Period Start Date

Item

Reporting Period Start Date (if this is the first follow-up period, enter date started)

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 (day month year)

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

PatientTamoxifenExemestaneTherapyInd-2

Item

Is this the first follow-up period during which the patient has taken Tamoxifen or Exemestane

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C855 (NCI Thesaurus Property)
C0039286 (UMLS 2011AA Property)
C1097 (NCI Thesaurus Property-2)
C0060116 (UMLS 2011AA Property-2)
C15368 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientTamoxifenExemestaneTherapyDate

Item

Date started

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C855 (NCI Thesaurus Property)
C0039286 (UMLS 2011AA Property)
C1097 (NCI Thesaurus Property-2)
C0060116 (UMLS 2011AA Property-2)
C15368 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

TAMOXIFEN

Item Group

Tamoxifen

DidpatientreceiveTamoxifenduringthisfollow-upperiod?

Item

Did patient receive Tamoxifen during this follow-up period (select all that apply)

text

CL.2

Code List

Did patient receive Tamoxifen during this follow-up period (select all that apply)

CL Item

No, Not Randomized To Tamoxifen (No, not randomized to Tamoxifen)

CL Item

No, Will Never Start (No, will never start)

CL Item

No, Will Start Later, Submit Another Form 24-te With Next 24-e Follow-up Form (No, will start later, submit another Form 24-TE with next 24-E Follow-Up Form)

CL Item

Yes, Continuing As Per Protocol (Yes, continuing as per protocol)

CL Item

Yes, But At Non-protocol Dose Or Interrupted For At Least One Month (Yes, but at non-protocol dose or interrupted for at least one month)

CL Item

Yes, But Stopped Early (Yes, but stopped early)

CL Item

Yes, Completed 5 Years After Randomization (Yes, completed 5 years after randomization)

CL Item

Yes, Took Tamoxifen But Randomized To Exemestane, Check Reason (Yes, took Tamoxifen but randomized to Exemestane, check reason)

Yes,tookTamoxifenbutrandomizedtoExemestane,checkreason(selectone)

Item

Yes, took Tamoxifen but randomized to Exemestane, check reason (select one) (select one)

text

CL.3

Code List

Yes, took Tamoxifen but randomized to Exemestane, check reason (select one) (select one)

CL Item

Adverse Event(s) Report On Form 24-ae (Adverse Event(s) Report on Form 24-AE)

CL Item

Patient Refusal (Patient refusal)

CL Item

Medical Decision (Medical decision)

CL Item

Other, Specify (Other, specify)

Other,specify(tookTamoxifenbutrandomizedtoExemestane)

Item

Other, specify (took Tamoxifen but randomized to Exemestane)

text

ComplianceCode

Item

Compliance Code

text

CL.12

Code List

Compliance Code

CL Item

Interrupted For At Least One Month (Interrupted for at least one month)

CL Item

Not Taken At All (Not taken at all)

CL Item

Other, Specify (Other, specify)

CL Item

Taken As Per Protocol (Taken as per protocol)

Other,specify(compliancecode)

Item

Other, specify (compliance code)

text

Reasonnottakencode

Item

Reason not taken code

text

CL.13

Code List

Reason not taken code

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Other, Specify (Other, specify)

CL Item

Patient Refusal (Patient refusal)

CL Item

Recurrence/relapse (Recurrence/relapse)

Adverseevent,specify

Item

Adverse event, specify

text

Adverseevent,specify

Item

Adverse event, specify

text

Adverseevent,specify

Item

Adverse event, specify

text

Other,specify(reasonnottaken)

Item

Other, specify (reason not taken)

text

Ifnon-protocoldosewasusedduringthisfollow-upperiod,whatdosagewasgiven?

Item

If non-protocol dose was used during this follow-up period, what dosage was given

text

TreatmentFirstDoseBeginDate

Item

Date of first dose for this reporting period

date

Enddateofnon-protocoldose

Item

End date of non-protocol dose

text

Reasonnon-protocoldoseused

Item

Reason non-protocol dose used

text

CL.14

Code List

Reason non-protocol dose used

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Medical Decision (Medical decision)

CL Item

Other, Specify (Other, specify)

CL Item

Patient Refusal (Patient refusal)

Adverseevent,specify(reasonnon-protocoldoseused)

Item

Adverse event, specify (reason non-protocol dose used)

text

Medicaldecision,specify(reasonnon-protocoldoseused)

Item

Medical decision, specify (reason non-protocol dose used)

text

Other,specify(reasonnon-protocoldoseused)

Item

Other, specify (reason non-protocol dose used)

text

DateInterruptionStarted

Item

Drug Stop Date

text

DateDrugResumed

Item

Drug Resume Date

text

ReasonforInterruptionCode

Item

Reason for Interruption Code

text

CL.15

Code List

Reason for Interruption Code

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Other, Specify (Other, specify)

CL Item

Patient Refusal (Patient refusal)

CL Item

Recurrence/relapse (Recurrence/relapse)

Other,specify(reasonforinterruption)

Item

Other, specify (reason for interruption)

text

IfpatientpermanentlydiscontinuedTamoxifenduringthisfollow-upperiodgivedateoflastdose.

Item

If patient permanently discontinued Tamoxifen during this follow-up period give date of last dose (or prior follow-up period if not previously reported,)

text

IfTamoxifenstoppedearlyorneverstarted,reason

Item

If Tamoxifen stopped early or never started, reason (select one)

text

CL.8

Code List

If Tamoxifen stopped early or never started, reason (select one)

CL Item

Patient Refusal (Patient refusal)

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Medical Decision, Specify (Medical decision, specify)

CL Item

Recurrence (Recurrence)

C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)

CL Item

Death On Study (Death on study)

CL Item

Error (Error)

C0743559 (NCI Metathesaurus)

CL Item

Other, Specify (Other, specify)

Medicaldecision,specify

Item

Medical decision, specify

text

Other,specify

Item

Other, specify

text

IfTamoxifenwillstartlater,reason

Item

If Tamoxifen will start later, reason

text

CL.9

Code List

If Tamoxifen will start later, reason

CL Item

Patient Refusal (Patient refusal)

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Medical Decision, Specify (Medical decision, specify)

CL Item

Error (Error)

C0743559 (NCI Metathesaurus)

CL Item

Other, Specify (Other, specify)

Adverseevent,specify(ifTamoxifenwillstartlater,reason)

Item

Adverse event, specify (if Tamoxifen will start later, reason)

text

Medicaldecision,specify(ifTamoxifenwillstartlater,reason)

Item

Medical decision, specify (if Tamoxifen will start later, reason)

text

Other,specify(ifTamoxifenwillstartlater,reason)

Item

Other, specify (if Tamoxifen will start later, reason)

text

EXEMESTANE

Item Group

Exemestane

DidpatientreceiveExemestaneduringthisfollow-upperiod?

Item

Did patient receive Exemestane during this follow-up period (select all that apply)

text

CL.10

Code List

Did patient receive Exemestane during this follow-up period (select all that apply)

CL Item

No, Not Randomized To Exemestane (No, not randomized to Exemestane)

CL Item

No, Will Never Start (No, will never start)

CL Item

No, Will Start Later, Submit Another Form 24-te With Next 24-e Follow-up Form (No, will start later, submit another Form 24-TE with next 24-E Follow-Up Form)

CL Item

Yes, Continuing As Per Protocol (Yes, continuing as per protocol)

CL Item

Yes, But Interrupted For At Least One Month (Yes, but interrupted for at least one month)

CL Item

Yes, But Stopped Early (Yes, but stopped early)

CL Item

Yes, Completed 5 Years After Randomization (Yes, completed 5 years after randomization)

CL Item

Yes, Took Exemestane But Randomized To Tamoxifen, Check Reason (select One) (Yes, took Exemestane but randomized to Tamoxifen, check reason (select one))

Yes,tookExemestanebutrandomizedtoTamoxifen,checkreason

Item

Yes, took Exemestane but randomized to Tamoxifen, check reason (select one)

text

CL.11

Code List

Yes, took Exemestane but randomized to Tamoxifen, check reason (select one)

CL Item

Adverse Event(s) Report On Form 24-ae (Adverse Event(s) Report on Form 24-AE)

CL Item

Patient Refusal (Patient refusal)

CL Item

Medical Decision (Medical decision)

CL Item

Other, Specify (Other, specify)

Other,sourceofsurvivalinformation

Item

Other, specify (specify)

text

Dose

Item

Dose

float

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

ComplianceCode

Item

Compliance Code

text

CL.12

Code List

Compliance Code

CL Item

Interrupted For At Least One Month (Interrupted for at least one month)

CL Item

Not Taken At All (Not taken at all)

CL Item

Other, Specify (Other, specify)

CL Item

Taken As Per Protocol (Taken as per protocol)

Numberoftabletsdispensed

Item

Number of tablets dispensed

text

Other,specify(compliancecode)

Item

Other, specify (compliance code)

text

BatchNumber

Item

Batch Number

text

Reasonnottakencode

Item

Reason not taken code

text

CL.13

Code List

Reason not taken code

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Other, Specify (Other, specify)

CL Item

Patient Refusal (Patient refusal)

CL Item

Recurrence/relapse (Recurrence/relapse)

PillsReceivedDate

Item

Date tablets dispensed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)

Adverseevent,specify

Item

Adverse event, specify

text

Adverseevent,specify

Item

Adverse event, specify

text

Adverseevent,specify

Item

Adverse event, specify

text

Tabletsdispensedby(initials)

Item

Tablets dispensed by (initials)

text

Other,specify(reasonnottaken)

Item

Other, specify (reason not taken)

text

Numberoftabletsreturned

Item

Number of tablets returned

text

Ifnon-protocoldosewasusedduringthisfollow-upperiod,whatdosagewasgiven?

Item

If non-protocol dose was used during this follow-up period, what dosage was given

text

PillsRemainingDate

Item

Date tablets returned

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)

Enddateofnon-protocoldose

Item

End date of non-protocol dose

text

Reasonnon-protocoldoseused

Item

Reason non-protocol dose used

text

CL.14

Code List

Reason non-protocol dose used

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Medical Decision (Medical decision)

CL Item

Other, Specify (Other, specify)

CL Item

Patient Refusal (Patient refusal)

Adverseevent,specify(reasonnon-protocoldoseused)

Item

Adverse event, specify (reason non-protocol dose used)

text

Medicaldecision,specify(reasonnon-protocoldoseused)

Item

Medical decision, specify (reason non-protocol dose used)

text

Other,specify(reasonnon-protocoldoseused)

Item

Other, specify (reason non-protocol dose used)

text

DateInterruptionStarted

Item

Drug Stop Date

text

Treatment Start Date

Item

Date of First dose for this reporting period

date

C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25256 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

DateDrugResumed

Item

Drug Resume Date

text

ReasonforInterruptionCode

Item

Reason for Interruption Code

text

CL.15

Code List

Reason for Interruption Code

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Other, Specify (Other, specify)

CL Item

Patient Refusal (Patient refusal)

CL Item

Recurrence/relapse (Recurrence/relapse)

Other,specify(reasonforinterruption)

Item

Other, specify (reason for interruption)

text

Medicaldecision,specify

Item

Medical decision, specify

text

Other,specify

Item

Other, specify

text

IfpatientpermanentlydiscontinuedExemestaneduringthisfollow-upperiodgivedateoflastdose.

Item

If patient permanently discontinued Exemestane during this follow-up period give date of last dose (or prior follow-up period if not previously reported,)

text

IfExemestanestoppedearlyorneverstarted,reason

Item

If Exemestane stopped early or never started, reason (select one)

text

CL.16

Code List

If Exemestane stopped early or never started, reason (select one)

CL Item

Patient Refusal (Patient refusal)

CL Item

Gnrh Stopped Early And Patient Remained Premenopausal (GnRH stopped early and patient remained premenopausal)

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Medical Decision, Specify (Medical decision, specify)

CL Item

Recurrence (Recurrence)

C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)

CL Item

Death On Study (Death on study)

CL Item

Error (Error)

C0743559 (NCI Metathesaurus)

CL Item

Other, Specify (Other, specify)

IfExemestanewillstartlater,reason

Item

If Exemestane will start later, reason

text

CL.17

Code List

If Exemestane will start later, reason

CL Item

Patient Refusal (Patient refusal)

CL Item

Adverse Event, Specify (Adverse event, specify)

CL Item

Medical Decision, Specify (Medical decision, specify)

CL Item

Error (Error)

C0743559 (NCI Metathesaurus)

CL Item

Other, Specify (Other, specify)

Adverseevent,specify(ifExemestanewillstartlater,reason)

Item

Adverse event, specify (if Exemestane will start later, reason)

text

Medicaldecision,specify(ifExemestanewillstartlater,reason)

Item

Medical decision, specify (if Exemestane will start later, reason)

text

Other,specify(ifExemestanewillstartlater,reason)

Item

Other, specify (if Exemestane will start later, reason)

text

Investigator Signature

Item

Investigator Signature (Designee)

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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Subido en

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Breast Cancer NCT00659373 Treatment - Tamoxifen/Exemestane Form (Form 24-TE) - 2080772v3.0

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