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
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)
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
float
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
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
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
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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