ID

1065

Description

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

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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

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.

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

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

Patient ID No.
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (f m fl sl)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient's Date of Birth (day)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Participating Center/Affiliate
Description

ParticipatingCenter/Affiliate

Data type

text

Center Code
Description

ParticipatingGroupCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Reporting Period Start Date (if this is the first follow-up period, enter date started)
Description

TreatmentReportingPeriodBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Reporting Period End Date (day month year)
Description

TreatmentReportingPeriodEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Is this the first follow-up period during which the patient has taken Tamoxifen or Exemestane
Description

PatientTamoxifenExemestaneTherapyInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C855
UMLS 2011AA Property
C0039286
NCI Thesaurus Property
C1097
UMLS 2011AA Property
C0060116
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date started
Description

PatientTamoxifenExemestaneTherapyDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C855
UMLS 2011AA Property
C0039286
NCI Thesaurus Property
C1097
UMLS 2011AA Property
C0060116
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Tamoxifen
Description

Tamoxifen

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

DidpatientreceiveTamoxifenduringthisfollow-upperiod?

Data type

text

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

Yes,tookTamoxifenbutrandomizedtoExemestane,checkreason(selectone)

Data type

text

Other, specify (took Tamoxifen but randomized to Exemestane)
Description

Other,specify(tookTamoxifenbutrandomizedtoExemestane)

Data type

text

Compliance Code
Description

ComplianceCode

Data type

text

Other, specify (compliance code)
Description

Other,specify(compliancecode)

Data type

text

Reason not taken code
Description

Reasonnottakencode

Data type

text

Adverse event, specify
Description

Adverseevent,specify

Data type

text

Adverse event, specify
Description

Adverseevent,specify

Data type

text

Adverse event, specify
Description

Adverseevent,specify

Data type

text

Other, specify (reason not taken)
Description

Other,specify(reasonnottaken)

Data type

text

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

Ifnon-protocoldosewasusedduringthisfollow-upperiod,whatdosagewasgiven?

Data type

text

Date of first dose for this reporting period
Description

TreatmentFirstDoseBeginDate

Data type

date

End date of non-protocol dose
Description

Enddateofnon-protocoldose

Data type

text

Reason non-protocol dose used
Description

Reasonnon-protocoldoseused

Data type

text

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

Adverseevent,specify(reasonnon-protocoldoseused)

Data type

text

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

Medicaldecision,specify(reasonnon-protocoldoseused)

Data type

text

Other, specify (reason non-protocol dose used)
Description

Other,specify(reasonnon-protocoldoseused)

Data type

text

Drug Stop Date
Description

DateInterruptionStarted

Data type

text

Drug Resume Date
Description

DateDrugResumed

Data type

text

Reason for Interruption Code
Description

ReasonforInterruptionCode

Data type

text

Other, specify (reason for interruption)
Description

Other,specify(reasonforinterruption)

Data type

text

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

IfpatientpermanentlydiscontinuedTamoxifenduringthisfollow-upperiodgivedateoflastdose.

Data type

text

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

IfTamoxifenstoppedearlyorneverstarted,reason

Data type

text

Medical decision, specify
Description

Medicaldecision,specify

Data type

text

Other, specify
Description

Other,specify

Data type

text

If Tamoxifen will start later, reason
Description

IfTamoxifenwillstartlater,reason

Data type

text

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

Adverseevent,specify(ifTamoxifenwillstartlater,reason)

Data type

text

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

Medicaldecision,specify(ifTamoxifenwillstartlater,reason)

Data type

text

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

Other,specify(ifTamoxifenwillstartlater,reason)

Data type

text

Exemestane
Description

Exemestane

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

DidpatientreceiveExemestaneduringthisfollow-upperiod?

Data type

text

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

Yes,tookExemestanebutrandomizedtoTamoxifen,checkreason

Data type

text

Other, specify (specify)
Description

Other,sourceofsurvivalinformation

Data type

text

Dose
Description

Dose

Data type

double

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
Compliance Code
Description

ComplianceCode

Data type

text

Number of tablets dispensed
Description

Numberoftabletsdispensed

Data type

text

Other, specify (compliance code)
Description

Other,specify(compliancecode)

Data type

text

Batch Number
Description

BatchNumber

Data type

text

Reason not taken code
Description

Reasonnottakencode

Data type

text

Date tablets dispensed
Description

PillsReceivedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
Adverse event, specify
Description

Adverseevent,specify

Data type

text

Adverse event, specify
Description

Adverseevent,specify

Data type

text

Adverse event, specify
Description

Adverseevent,specify

Data type

text

Tablets dispensed by (initials)
Description

Tabletsdispensedby(initials)

Data type

text

Other, specify (reason not taken)
Description

Other,specify(reasonnottaken)

Data type

text

Number of tablets returned
Description

Numberoftabletsreturned

Data type

text

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

Ifnon-protocoldosewasusedduringthisfollow-upperiod,whatdosagewasgiven?

Data type

text

Date tablets returned
Description

PillsRemainingDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25649
UMLS 2011AA Property
C1527428
End date of non-protocol dose
Description

Enddateofnon-protocoldose

Data type

text

Reason non-protocol dose used
Description

Reasonnon-protocoldoseused

Data type

text

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

Adverseevent,specify(reasonnon-protocoldoseused)

Data type

text

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

Medicaldecision,specify(reasonnon-protocoldoseused)

Data type

text

Other, specify (reason non-protocol dose used)
Description

Other,specify(reasonnon-protocoldoseused)

Data type

text

Drug Stop Date
Description

DateInterruptionStarted

Data type

text

Date of First dose for this reporting period
Description

TreatmentFirstDoseBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Drug Resume Date
Description

DateDrugResumed

Data type

text

Reason for Interruption Code
Description

ReasonforInterruptionCode

Data type

text

Other, specify (reason for interruption)
Description

Other,specify(reasonforinterruption)

Data type

text

Medical decision, specify
Description

Medicaldecision,specify

Data type

text

Other, specify
Description

Other,specify

Data type

text

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

IfpatientpermanentlydiscontinuedExemestaneduringthisfollow-upperiodgivedateoflastdose.

Data type

text

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

IfExemestanestoppedearlyorneverstarted,reason

Data type

text

If Exemestane will start later, reason
Description

IfExemestanewillstartlater,reason

Data type

text

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

Adverseevent,specify(ifExemestanewillstartlater,reason)

Data type

text

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

Medicaldecision,specify(ifExemestanewillstartlater,reason)

Data type

text

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

Other,specify(ifExemestanewillstartlater,reason)

Data type

text

Investigator Signature (Designee)
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Description

InvestigatorSignatureDate

Data type

date

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

Similar models

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
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Tamoxifen/exemestane Form - Revised (form 24-te)
PatientStudyID,CoordinatingGroup
Item
Patient ID No.
text
PatientInitialsName
Item
Patient Initials (f m fl sl)
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)
PatientBirthDate
Item
Patient's Date of Birth (day)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
ParticipatingCenter/Affiliate
Item
Participating Center/Affiliate
text
ParticipatingGroupCode
Item
Center Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
TreatmentReportingPeriodBeginDate
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)
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 (day month year)
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)
Item
Is this the first follow-up period during which the patient has taken Tamoxifen or Exemestane
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C855 (NCI Thesaurus Property)
C0039286 (UMLS 2011AA Property)
C1097 (NCI Thesaurus Property)
C0060116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Is this the first follow-up period during which the patient has taken Tamoxifen or Exemestane
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
C0060116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Tamoxifen
Item
Did patient receive Tamoxifen during this follow-up period (select all that apply)
text
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)
Item
Yes, took Tamoxifen but randomized to Exemestane, check reason (select one) (select one)
text
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
Item
Compliance Code
text
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
Item
Reason not taken code
text
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
Item
Reason non-protocol dose used
text
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
Item
Reason for Interruption Code
text
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
Item
If Tamoxifen stopped early or never started, reason (select one)
text
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
Item
If Tamoxifen will start later, reason
text
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
Item Group
Exemestane
Item
Did patient receive Exemestane during this follow-up period (select all that apply)
text
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))
Item
Yes, took Exemestane but randomized to Tamoxifen, check reason (select one)
text
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
double
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
Item
Compliance Code
text
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
Item
Reason not taken code
text
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
Item
Reason non-protocol dose used
text
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
TreatmentFirstDoseBeginDate
Item
Date of First dose for this reporting period
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
DateDrugResumed
Item
Drug Resume Date
text
Item
Reason for Interruption Code
text
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
Item
If Exemestane stopped early or never started, reason (select one)
text
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)
Item
If Exemestane will start later, reason
text
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
InvestigatorSignatureText
Item
Investigator Signature (Designee)
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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